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510(k) Data Aggregation
(205 days)
which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980
which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980
The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.
Sterilization parameters:
Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.
Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.
The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface.
Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).
The provided text describes the acceptance criteria and the results of the study conducted to demonstrate the safety and effectiveness of the Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Type of Testing | Test Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Manual Cleaning Validation (ANSI/AAMI ST98:2022) | Evaluate and validate the manual cleaning of the subject device | Visual Inspection: No visible soil | |
| Hemoglobin Test: 70%, which is considered non-cytotoxic. | Pass | ||
| Packaging Validation (ASTM D4169-23e1) | Packaging performance testing | Packaging must withstand the distribution environment | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of number of individual units tested for each non-clinical test. However, it indicates:
- Worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio, and worst-case instruments to be contained.
- Data Provenance: The study is reported as non-clinical testing conducted by the manufacturer, Prismatik Dentalcraft, Inc. The document doesn't specify the country of origin of the data, but it refers to international standards (e.g., ANSI/AAMI, ISO, ASTM). The nature of these tests suggests they are prospective in that they are performed specifically to validate the device's performance against predefined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The tests performed are non-clinical, objective evaluations against established scientific and engineering standards (e.g., visual inspection for soil, chemical tests for residue, biological indicators for sterility, mechanical testing for durability). They do not involve human interpretation of medical images or expert consensus to establish a "ground truth" in the way a diagnostic AI device would.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document for the reasons stated above. Adjudication typically applies to studies where human interpretation or consensus is required to determine a reference standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided in the document. The device in question is an "Autoclavable Cassette" (sterilization wrap accessory), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document. The device is a physical medical device (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on objective, measurable standards and criteria established by recognized regulatory and industry standards (e.g., SAL ≤10^-6 for sterility, specific chemical residue limits for cleaning, visual inspection for damage, cellular vitality percentages for biocompatibility). These are not based on expert consensus, pathology, or outcomes data in the usual sense of diagnostic or therapeutic devices.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. The device is a physical product and does not involve AI/machine learning, thus there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided in the document, as there is no training set for this type of device.
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(84 days)
all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980
all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980
The Anthogyr Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.
The cycle of sterilization, for Anthogyr INTEGRAL Guided Surgery Cassettes, uses pre-vacuum steam: 132 °C (270° F) during 4 minutes with 30 minutes drying time.
Anthogyr INTEGRAL Guided Surgery Cassettes have been validated for a maximum load of with the associated instrument. The worst-case recommended load is: 886 g.
The device dimension of Anthogyr INTEGRAL Guided Surgery Cassettes is 290x176x62 mm.
The cassettes are not intended to be stacked during sterilization process.
Anthoqyr cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.
The provided text is a 510(k) Summary for the Anthogyr INTEGRAL Guided Surgery Cassettes. It does not describe a study involving an AI/software device that requires establishing ground truth by experts or evaluating human reader performance. Instead, it focuses on demonstrating substantial equivalence of a medical device (sterilization cassettes) to a predicate device through non-clinical performance testing.
Therefore, many of the requested criteria, such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "standalone (i.e. algorithm only) performance" are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance for the non-clinical tests mentioned.
Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" (N/A) for criteria that do not fit the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Custom | • Test Soil: Blood Soil (BLSO) | ||
| • Cleaning Method: Manual | |||
| • Residuals Tested: Hemoglobin and Protein | Visual Inspection: No Visible Soil | ||
| Hemoglobin Test: |
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(120 days)
}------------------------------------------------
Anthogyr Surgical Cassettes
510(k) Summary
872.3980
all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980
The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.
The cycle of sterilization is:
INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V,
INMODIGMV: Pre-vacuum steam: 132 ℃ (270°F) during 4 minutes with 20 minutes drying time
The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g.
The device dimensions are listed below for Anthogyr Surgical Cassettes:
-
INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3V: 130x155x47 mm
-
INMODIGM, INMODIGMV: 76x155x47 mm
The cassettes are not intended to be stacked during sterilization process.
Anthogyr Surgical Cassettes are reusable rigid containers, comprising a case bottom (base), one or more removable inner tray base (tray) and a tray lid (lid). The trays are composed of brackets made of medical grade silicone, namely brackets used to maintain the Anthogyr dental instruments in place during the surgical or prosthetic procedure and during sterilization. The base and trays have markings and/or colors code to indicate either the surgical workflow, or the position of the instruments in the kit. The lid holds all the instruments securely in place during treatment.
To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Anthogyr Dental Implant System intended to be placed in the Anthogyr Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Anthogyr Dental Implant System. These devices are all Class I exempt or already have class II pre-market notification clearance as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.
The Anthogyr Surgical Cassettes are designed to organize, steam sterilize, and protect dental surgical instruments. They are intended for healthcare providers and must be enclosed in an FDA-cleared steam sterilizable pouch.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual Inspection (after cleaning): No Visible Soil | Passed |
| Hemoglobin Test (after cleaning): |
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(60 days)
------------|--------|
| Zygoma Handle | 37786 | Class I | 872.3980
-------------|--------|
| Brånemark System Zygoma Round Bur | DIA 578-0 | Class I | 872.3980
NDP | Exempt |
| NobelZygoma 0° Twist Drill 2.9mm | 377661 | Class I | 872.3980
NDP | Exempt |
| Bmk Syst Zygoma Twist Drill 2.9mm | 326281 | Class I | 872.3980
NDP | Exempt |
| NobelZygoma 0° Twist Drill 2.9mm Short | 377672 | Class I | 872.3980
The Nobel Biocare PureSet™ Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic instruments and components during cleaning/sterilization and during implant/prosthetic treatment.
Nobel Biocare PureSet™ Trays are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization container, sterilization pouch or sterilization wrap.
Sterilization validations for the worst-case PureSet™ Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screwdrivers, and irrigation needles.
The PureSet™ Trays were validated for a maximum load of 1635 grams (Trefoil™ PureSet™ Tray), 1122 grams (NobelActive® / NobelParallel™ CC PureSet™ Tray), 1063 grams (NobelReplace® CC PureSet™ Tray), 454 grams (Nobel Biocare N1™ PureSet™ Tray), 486 grams (Prosthetic PureSet™ Tray), 1143 grams (NobelActive® Guided PureSet™ Tray), 1146 grams (NobelParallel™ CC Guided PureSet™ Tray), 1176 grams (NobelReplace® CC Guided PureSet™ Tray), and 1035 grams (NobelSpeedy® Groovy® / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray) and 1202 grams (NobelZygoma PureSet™ Tray).
Method: Steam Sterilization (Moist Heat Sterilization) for Wrapped Instruments
Cycle: Dynamic-Air-Removal (fractionated vacuum), Gravity-Displacement
Temperature: 132°C (270°F), 132°C (270°F)
Exposure time for a single-use pouched device: 4 minutes (full-cycle), 15 minutes (full-cycle)
Minimum drying times: 20 minutes, 30 minutes
PureSet Trays are reusable surgical trays to be used in combination with Nobel Biocare surgical instruments and components. PureSet Trays are used to organize and store the instruments and components during both surgical and reprocessing procedures.
PureSet Trays are not intended to maintain sterility on their own; they are intended to be used in conjunction with an FDA cleared sterilization wrap, pouch, or container.
All components of the PureSet Tray are perforated with an evenly-distributed hole pattern and are designed to be used for sterilization via steam sterilization. Because the PureSet Trays are perforated, an FDA-cleared sterilization wrap, pouch, or container must be used during sterilization and storage to maintain the sterility of the contents.
PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.
This is a 510(k) Pre-Market Notification for a medical device called the "NobelZygoma PureSet™ Tray," a type of sterilization wrap. The document is primarily concerned with demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a groundbreaking study with novel acceptance criteria and deep dives into AI performance statistics.
However, I can extract the relevant information regarding acceptance criteria and the types of studies performed, as described in the provided text, recognizing that these are not clinical studies in the typical sense for AI devices.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like the NobelZygoma PureSet™ Tray (a sterilization tray), acceptance criteria are typically related to its functionality in terms of cleaning, sterilization, biocompatibility, and durability, ensuring it performs as intended and is safe for patient contact.
| Acceptance Criteria Category | Specific Criteria/Standard (as implied or stated) | Reported Device Performance |
|---|---|---|
| Cleaning & Sterilization | Validation according to AAMI TIR12, AAMI TIR 30, ISO 15883-1, ISO 15883-5, ISO 10993-5, AAMI ST79, AAMI ST77, ISO 17665-1, ISO14161, ISO14937, AAMI ST8, ISO 11737-2, AAMI TIR17, and FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. | |
| (Ensuring effective removal of contaminants and sterilization of instruments within the tray, including worst-case scenarios). | Cleaning and sterilization validation testing on representative worst-case devices was performed according to the listed standards. | |
| Result: PASS | ||
| Biocompatibility | Evaluation and testing in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-12. | Biocompatibility testing on representative worst-case devices demonstrated that the Subject device is biocompatible. |
| Result: PASS | ||
| Repeated Reprocessing | Withstand repeated reprocessing cycles as described in ANSI/AAMI ST77 and ISO 17664. | Testing on representative worst-case devices demonstrated that the Subject device can withstand repeated reprocessing cycles. |
| Result: PASS | ||
| Instrument Retention | Retention ability of instrument features during reprocessing; no dislodgment of instruments; no protrusion of sharp edges/components from the tray after reprocessing. | The retention ability of the instrument retention features in the Subject NobelZygoma PureSet™ Tray during reprocessing was assessed. Testing demonstrated that instruments are not dislodged after reprocessing. There was no sign of protrusion of sharp edges or components from the tray. |
| Result: PASS | ||
| Durability (Handle & Closing Mechanism) | Withstand at least 4 times the maximum weight of a full loaded tray. (Acceptance criteria fulfilling ANSI/AAMI ST77 requirements). | Testing on representative worst-case device demonstrated that the tray handle and the closing mechanism can withstand at least 4 times the maximum weight of a full loaded tray. |
| Result: PASS | ||
| Maximum Load Support | Specific maximum load capacities were validated for various PureSet™ Trays (e.g., 1202 grams for NobelZygoma PureSet™ Tray). | The PureSet™ Trays were validated for a maximum load of 1202 grams (NobelZygoma PureSet™ Tray). This specific value is presented as a validated performance characteristic rather than a distinct "test result" in the summary table, but it's an inherent part of the device's acceptable performance. |
| Result: Met (implied) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes validations for a physical medical device, not an AI/ML model for diagnostic or prognostic purposes involving patient data. Therefore, the concept of a "test set" and "data provenance" in the context of country of origin or retrospective/prospective data as it applies to software or AI is not directly applicable here.
- Sample Size for Testing: The document refers to "representative worst-case devices" for all non-clinical tests. It doesn't specify a numerical sample size (e.g., N=3, N=50) for these physical device tests. The selection of "worst-case" implies that a specific configuration or condition that would pose the greatest challenge to cleaning, sterilization, or durability was chosen for testing.
- Data Provenance: Not applicable in the context of clinical/patient data for AI. The tests are laboratory-based, non-clinical evaluations of the device itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not explicitly provided in the document. For physical device validations like these, "ground truth" is established through adherence to recognized international and national consensus standards (e.g., ISO, AAMI) and testing protocols, rather than expert consensus on diagnostic images or pathology. The testing laboratories performing these validations would employ qualified personnel, but their specific roles or number are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective, laboratory-based validations against predefined physical/mechanical and microbiological criteria defined by recognized standards. There isn't a need for expert adjudication in the way it's used for interpreting ambiguous clinical data or establishing ground truth for AI model outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance for diagnostic tasks, usually involving medical images or clinical data. The NobelZygoma PureSet™ Tray is a physical sterilization tray, not an AI/ML diagnostic or therapeutic device.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study in the context of an "algorithm only" or AI performance was not done. This device is not an algorithm. The non-clinical tests described were "standalone" in the sense that they evaluated the device's intrinsic characteristics (cleaning, sterilization, durability) without human intervention in the performance of the device itself, but not in the AI-specific meaning.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by adherence to and successful completion of recognized international and national consensus standards for sterilization, cleaning, biocompatibility, and durability. These standards incorporate scientific principles and validated methodologies to empirically determine if a device meets safety and effectiveness requirements.
- Examples of such standards cited: AAMI TIR12, AAMI TIR 30, ISO 15883-1, ISO 15883-5, ISO 10993-1, ISO 10993-5, ISO 10993-12, AAMI ST79, AAMI ST77, ISO 17665-1, ISO14161, ISO14937, AAMI ST8, ISO 11737-2, AAMI TIR17, FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, ISO 17664-1, ANSI/AAMI ST77.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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(209 days)
| K192458 |
| Scan Adapter | NDP | 872.3980
| EXEMPT |
| Castable Coping | NDP | 872.3980
| EXEMPT |
| Implant Analog | NDP | 872.3980
| EXEMPT |
| Off-axis Tools | NDP | 872.3980
The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations.
The SMARTbase Abutment System integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment.
- SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors.
- SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandbular and maxillary central and lateral incisors.
- SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.
The SMARTbase Abutment System is a two-piece engaging and non-engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). There are three device lines offered in the SMARTbase Abutment System: Legacy™ SMARTbase Abutment, InterActive™ SMARTbase Abutment, and SMARTbase Cylinder.
The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm for Legacy™ and 3.0mm, 3.4mm for InterActive™, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The SMARTbase Cylinder is a two-piece non-engaging dental implant and multi-unit abutment cylinder comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The SMARTbase Cylinder is offered in two heights 9.0mm (that can be shortened to 4.0mm) and 4.0mm and in one width, platform diameters and collar (titanium base) height in order to accommodate different patient anatomies.
The subject device is supplied with fixation screws that function as an extension of the implant or multi-unit abutment to which the SMARTbase Abutment or SMARTbase Cylinder is secured and is used with several accessories in digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.
The available design options for the zirconia top components to be provided either as a superstructure (to then receive a separate crown or bridge) or hybrid abutment-crown. There are three workflow options for fabricating the zirconia top component which fits the titanium abutment base:
(1) end user creation of a press-ceramic material by conventional wax-up technique,
(2) Implant Direct design and milling of zirconia in stock sizes using ceramic material of ZirCAD Prime (K142233) and provision of same to the end user, and
(3) digital workflow using 3Shape or Exocad software where CAD design and milling of the superstructure or hybrid crown component is done at the end user's dental laboratory/office; the CAD design requires loading of Implant Direct's abutment design library to the 3Shape or Exocad software to design the superstructure or hybrid crown component within the established design limitations and specifications. The digital workflow includes use of the following products (not subject devices of this submission):
- Ceramic material: ZirCAD Prime (K142233) .
- . Cement: Maxcem Elite Self-Etch/Self-Adhesive Resin Cement (K060469)
- . Composite: Kerr Harmonized (K151332)
- Intra oral scanners: Medit Scanner, ITero Scanner Trios Scanner, CareStream . Scanner
- Abutment design software: 3Shape Abutment Designer™ Software (K151455) and • Exocad AbutmentCAD Software (K193352)
- . Milling machine: Wieland-Zenotec Select, Zenotec CAM, iCAM V5, and imes icore
This document describes a premarket notification for the "SMARTbase Abutment System," a dental implant abutment. The document focuses on demonstrating that the new device is substantially equivalent to existing predicate devices through various performance tests.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, clear format for each test. Instead, it states that "The test results support that the Subject Device met the performance specifications as intended." and "The difference does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent."
However, we can infer the types of performance tests and the general acceptance (i.e., compliance) from the "x. Performance Testing Data" section.
| Acceptance Criteria (Inferred Standard Compliance) | Reported Device Performance (Implied) |
|---|---|
| Fatigue Resistance (according to ISO 14801 and FDA Guidance Document: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments") | The device met performance specifications as intended, demonstrating substantial equivalence. |
| Magnetic Resonance Compatibility (according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182) | The device met performance specifications as intended, demonstrating substantial equivalence. |
| Biocompatibility (according to ISO 10993-1) | The device is biocompatible as per the standard. |
| Steam Sterilization Validation (according to ISO 17665-1) | Sterilization process was validated. |
| Shipping Validation (according to ASTM D4169) | Shipping validation was performed. |
| Software Verification & Validation (Abutment Design Library) (demonstrating use with 3Shape Abutment Designer Software and Exocad AbutmentCAD software) | Demonstrated that design restrictions prevent creation of components outside allowable limitations; established design limitations are locked and unmodifiable. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the performance tests (e.g., number of abutments subjected to fatigue testing).
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that this is a premarket notification for regulatory clearance, the testing would generally be conducted by the manufacturer or a contract research organization on manufactured devices, following established protocols. It is non-clinical testing, meaning it's not performed on patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable as the document describes non-clinical performance testing for a medical device (dental abutment), not studies involving expert evaluation of diagnostic outputs or ground truth for AI algorithms. The "ground truth" here is defined by engineering standards (e.g., ISO, ASTM).
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as #3. Adjudication methods (like 2+1) are typically used for establishing ground truth in clinical or diagnostic studies involving human interpretation or pathology.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This question is not applicable. The document describes non-clinical performance testing of a physical dental abutment and associated design software. It does not involve human readers, cases, or AI assistance in a diagnostic context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
For the software component:
- Standalone Performance: Yes, standalone software verification and validation testing was performed for the abutment design library. This testing demonstrated that the software's inherent design restrictions and specifications for creating the top half of the two-piece abutment prevent designs outside allowable limitations and that the design limitations are locked and cannot be modified. This is essentially an "algorithm only" test to ensure the software functions as designed within its specified parameters.
7. The Type of Ground Truth Used
- For Physical Device Performance (Fatigue, MR Compatibility, Biocompatibility, Sterilization, Shipping): The ground truth is based on established international and national standards (e.g., ISO 14801, ISO 10993-1, ISO 17665-1, ASTM F2052, ASTM D4169). Compliance with these standards serves as the "ground truth" for acceptable mechanical, safety, and operational performance.
- For Software Verification & Validation: The ground truth is the defined design limitations and specifications established by the manufacturer for the abutment components. The software's ability to enforce these limitations (preventing designs outside them and locking specifications) constitutes meeting this "ground truth."
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical dental abutment and associated design software. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data to make predictions or classifications. The "training" for the software is its programmed adherence to design rules and specifications.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8. There is no training set mentioned for an AI/ML model. The software's functional parameters are established through engineering design and specifications.
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(221 days)
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| 300852 | Screwdriver Machine Omnigrip Mini 20mm | NDP | 872.3980
|
| 300853 | Screwdriver Machine Omnigrip Mini 28mm | NDP | 872.3980
|
| 300854 | Screwdriver Machine Omnigrip Mini 36mm | NDP | 872.3980
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| 300969 | Clinical Screw Nobel Biocare N1™ TCC RP | NHA | 872.3980
Clearance |
| 300852 | Screwdriver Machine Omnigrip Mini 20mm | NDP | 872.3980
Esthetic Abutment Nobel Biocare N1™ TCC: The Esthetic Abutment Nobel Biocare N1™ TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation. Esthetic Abutment Nobel Biocare N1TM Base: The Esthetic Abutment Nobel Biocare N1™ Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.
Esthetic Abutments Nobel Biocare N1™ are pre-manufactured dental implant abutments, intended for use as an aid in prosthetic rehabilitation. Esthetic Abutments Nobel Biocare N1™ are intended for use in the upper and/or lower jaw in combination with Nobel Biocare's Nobel Biocare N1™ implant system in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The abutments are made from titanium vanadium allov. Esthetic Abutments Nobel Biocare N1 ™ is composed of two device lines: Esthetic Abutment Nobel Biocare N1™ TCC and Esthetic Abutment Nobel Biocare N1™ Base.
The acceptance criteria and device performance for the Nobel Biocare N1™ Esthetic Abutments are described based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Standard / Guidance) | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Fatigue) | ISO 14801 and FDA Guidance Document: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) | The tests demonstrated the Subject Devices are substantially equivalent to the Primary Predicate Device and Reference Device #1 (for TCC abutments) and to Predicate Device #2 and Reference Device #1 (for Base abutments). The Subject Device met the performance specifications. |
| Magnetic Resonance (MR) Compatibility | ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182 | MR Conditional |
| Biocompatibility | ISO 10993-1:2018 Biological Evaluation of Medical Devices | Biocompatible |
| Cleaning and Sterilization | ISO 17665-1 and AAMI TIR12 | Validation performed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test. However, it mentions that dynamic loading (fatigue) testing was conducted in saline at 37 °C. The data provenance is from non-clinical testing, therefore not involving human subjects or data from a specific country of origin in the context of clinical studies. The testing was performed in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The reported performance data for this device (dental abutments) is based on non-clinical, laboratory-based testing (mechanical, MRI compatibility, biocompatibility, cleaning/sterilization), rather than expert assessment of clinical data or images to establish a "ground truth."
4. Adjudication Method for the Test Set
Not applicable. As the testing mentioned is non-clinical and laboratory-based, an adjudication method in the context of human assessment is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical dental abutment, not a diagnostic or AI-assisted interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical dental abutment, not an algorithm or software. The performance evaluations are of the physical product's characteristics.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria is established by adherence to recognized international and FDA standards for medical device testing. For example:
- Mechanical strength: Conformance to force/stress limits defined by ISO 14801.
- MRI compatibility: Conformance to safety and performance specifications outlined in ASTM F2052, F2213, F2119, F2182.
- Biocompatibility: Conformance to safety requirements defined by ISO 10993-1.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
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(204 days)
Regulation
Number | 872.3630 | 872.3980
| 872.3980
| 872.3630 | 872.3980
| 872.3980 | 872.3980
· NobelProcera® Zirconia Abutment/Implant Crown N1™ Base:
The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.
· Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:
The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.
NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines:
- NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and -
- -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following:
a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration
b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design
The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing.
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3.
The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).
The provided document is a 510(k) premarket notification for a dental device, specifically the NobelProcera® Zirconia N1™ Base and its associated Prosthetic Screw. The notification aims to demonstrate substantial equivalence to previously marketed predicate devices, rather than establishing de novo acceptance criteria or proving performance against novel criteria through clinical studies. Therefore, much of the requested information regarding a device meeting specific acceptance criteria and the nature of the study that proves it, as it would apply to a new classification or a device with new indications requiring extensive clinical validation, is not directly available or applicable in the provided context of a 510(k) submission for substantial equivalence.
However, I can extract information related to the performance data used to support substantial equivalence, which serves a similar purpose to demonstrating acceptance criteria in this regulatory pathway. The acceptance criteria here are implicitly alignment with the performance of the predicate and reference devices.
Here's a summary based on the provided text, addressing what can be inferred or directly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in a quantitative table format that a device must meet to be considered "safe and effective." Instead, it focuses on demonstrating substantial equivalence by comparing its characteristics and performance to legally marketed predicate and reference devices. The "reported device performance" is primarily comparative in nature.
Implicit Acceptance Criteria (Demonstrated Equivalence) & Reported Performance:
| Category | Implicit Acceptance Criteria (Comparative) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Indications for Use | Same as predicate/reference devices. | NobelProcera® Zirconia Abutment / Implant Crown N1™ Base: Same as Primary Predicate (On1 Concept - K161655), expressed through similar wording. |
| Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: Same as Reference Device No. 1 (Prosthetic Screw Nobel Biocare N1™ Base), expressed through similar wording. | ||
| Technological Characteristics | Similar to predicate/reference devices, with any differences not raising new concerns. | NobelProcera® Zirconia Abutment / Implant Crown N1™ Base: Device design, compatible Implant/Base platforms (NP/RP), device connection/connector, materials of the connector, screw access, and device attachment method are identical or similar to the Primary Predicate. Ceramic material is Y-TZP, similar to predicate, and specifically "Nacera Pearl" (K143071), which is also used in Reference Device No. 1. Design methods, ASC angulation (0°-25°), and dimensions are similar to Reference Device No. 2. Maximum device body angulation limits are similar to Reference Device No.1, with differences substantiated by fatigue testing. |
Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: Principle of operation, compatible Implant/Base platforms (NP/RP), device material (Ti6Al4V ELI), thread design, and screw interfaces (Omnigrip Mini) are the same as Reference Device No. 1. DLC coating applied to screw body, similar to Reference Device No. 1. Differences in screw body dimensions, anodization (subject device is not anodized), and packaging do not raise new concerns. |
| Performance (Non-clinical) | Performance as good as predicate/reference devices for intended use, as demonstrated by recognized standards (e.g., ISO 14801, ISO 10993-1, ASTM). | Fatigue Performance: Dynamic loading testing performed according to ISO 14801. Testing found acceptable, including evaluation of removal torque and no screw-loosening for run-out samples.
Biocompatibility: Demonstrated according to ISO 10993-1.
Wear Assessment: Light optical and SEM imaging following ISO 14801 fatigue loading showed similar wear patterns to reference device systems (NobelProcera® Zirconia Implant Bridge (K202452) and NobelProcera® ASC Abutment CC (K132746)).
Packaging System Performance: Tested per ASTM D4169.
Magnetic Resonance Compatibility: Tested according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182.
Cleaning and Sterilization Validation: End user cleaning and sterilization validation in accordance with ISO 17665-1 and AAMI TIR12. |
| Performance (Clinical/Real-World Evidence) | No evidence of new safety/effectiveness concerns with differences in materials or design. | Post-Market Surveillance (PMS) Data:
- NPr ASC Ab Zirconia CC (K132746): 8.1 years in patient, low complaint rates, no concerns regarding dissimilar materials (DLC-coated screw with Zirconia abutment).
- NobelProcera® Zr Implant Bridge (K202452): 1.7 years in patient, low complaint rates, no concerns regarding dissimilar materials.
Clinical Data: Five clinical studies on NPr ASC Ab Zirconia CC (K132746) with mean follow-ups of 0.6-3.6 years, reporting on 277 devices. No reports of wear debris from Zirconia/DLC-coated screw contact or other adverse events raising concerns about dissimilar materials. A gap analysis was provided to support the relevance and reliability of this real-world evidence. |
2. Sample Size for the Test Set and Data Provenance
The document does not define a single "test set" in the context of a clinical trial for direct performance measurement. Instead, it refers to various non-clinical tests and real-world evidence.
- Non-clinical testing (Fatigue, Wear, MRI Compatibility, Packaging): The sample sizes for these specific tests are not provided in the summary. For example, ISO 14801 fatigue testing typically involves a certain number of samples (e.g., n=10-12 per group) but this detail is omitted.
- Real-World Evidence (PMS Data):
- NPr ASC Ab Zirconia CC (K132746): Data collected from December 2013 up to January 2022. The longest time in a patient was approx. 8.1 years.
- NobelProcera® Zr Implant Bridge (K202452): Data collected from May 2020 up to January 2022. The longest time in a patient was approx. 1.7 years.
- Data Provenance: This is post-market surveillance data, likely originating from clinical use of the cleared predicate/reference devices, implicitly from various countries where Nobel Biocare products are marketed. It is retrospective in nature.
- Clinical Data (NPr ASC Ab Zirconia CC):
- Sample Size: 277 NPr ASC Ab Zirconia CC (K132746) devices were reported across 5 clinical studies.
- Data Provenance: The document states the studies were "included consecutively with no selection regarding study inclusion made besides the inclusion criterion that the NPr ASC Ab Zirconia CC had to be used in the study." The studies were published in international journals, suggesting prospective clinical studies from potentially diverse geographical origins, but specific countries are not mentioned (e.g., "[1] Greer, A.C., et al., Int J Prosthodont, 2017"). These are considered Real World Evidence in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This specific information is not provided in the document. For 510(k) submissions focusing on substantial equivalence, the "ground truth" for the test set is usually the performance of the predicate device as established by its clearance and recognized standards, rather than a new expert consensus process for the subject device. The clinical studies mentioned were about observing device performance in patients, not establishing a new ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for interpreting subjective endpoints in clinical trials or for establishing ground truth from multiple expert readings (e.g., in AI/imaging studies). The provided clinical evidence references published studies with their own methodologies, which are not detailed here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The studies cited are focused on the clinical performance and safety of existing devices (predicates/references) and a "gap analysis" for using that as real-world evidence for the subject device, or non-clinical engineering tests. There is no mention of comparing human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical dental abutment and prosthetic screw, not an AI algorithm or software. Therefore, there is no "standalone" performance in the context of an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence is primarily:
- Engineering Standards: Compliance with ISO 14801, ISO 10993-1, ASTM F2052, F2213, F2119, F2182, ISO 17665-1, AAMI TIR12.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate and reference devices (On1 Concept K161655, N1™ TiUltra™ TCC Implant system K211109, NobelProcera Angulated Screw Channel Abutment Conical Connection K132746, Nacera Pearl K143071).
- Outcomes Data/Real-World Evidence: Post-market surveillance data and clinical study outcomes for the predicate/reference devices, showing low complaint rates, good tissue health, and no unexpected adverse events related to material interactions. These outcomes serve as a proxy for acceptable performance.
8. The Sample Size for the Training Set
This concept is not applicable as the device is a physical dental component and not an AI/machine learning model that undergoes a "training" phase with a dataset.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
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(95 days)
endosseous dental implant accessories considered Class I 510(k)-exempt devices as defined in 21 CFR 872.3980
endosseous dental implant accessories considered Class I 510(k)-exempt devices as defined in 21 CFR 872.3980
The PrimeLOC Attachment System is designed to facilitate patient removal of a dental prosthesis for use with full arch overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The PrimeLOC Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) to serve in a similar function to LOCATOR® abutments for resilient attachment of prostheses to endosseous dental implants. All PrimeLOC abutments are made of titanium alloy and have the same coronal ridge retention design that attaches to the overdenture component by an interference (snap) fit. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. The PrimeLOC Attachment System is designed to accommodate a path of insertion divergence of up to 20° per implant and no more than 40° of divergence between implants. PrimeLOC abutments are provided with a titanium nitride (TiN) coating and are available in cuff heights up to 6 mm, with an implant interface diameter of 3.5 mm. Retention inserts are fixed within a metal denture housing which is embedded in an overdenture prosthesis. The retention inserts allow for varying levels of retention. This connection allows the denture to be retained on the abutments while the majority of loading is supported by the contact of the denture with the gingival tissue surrounding the mandibular and maxillary ridges. The PrimeLOC Attachment System are compatible with OEM implants, specifically Tapered Screw-Vent 3.5 mm platform dental implants manufactured by Zimmer Dental, Inc. Compatibility is based on agreements with the OEM to ensure that the abutments are designed to fit the corresponding implants. All interfaces of the subject device have been designed and verified by the OEM implant manufacturer. This ensures that the interface of the subject device with the identified compatible implants is appropriate. A thin titanium nitride coating is applied to the PrimeLOC abutments in the area that contacts gingival tissue and in the area that contacts the retention inserts. The denture attachment housing, which sits within the denture, may be colored through a titanium anodization process. This system includes instruments used for seating and removing abutments and retention inserts, and processing inserts, impression copings, and laboratory components used to facilitate the fixation of the retention insert and denture housing in the appropriate position within the denture. These components are endosseous dental implant accessories considered Class I 510(k)-exempt devices as defined in 21 CFR 872.3980.
The provided text describes the 510(k) summary for the PrimeLOC Attachment System, a dental device. It outlines the device's administrative information, classification, predicate devices, indications for use, description, and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, the provided text does not contain information about "acceptance criteria" and how the device's performance measured against those criteria in a structured, quantitative table, as would be typical for an AI/ML medical device submission. The performance data section describes non-clinical testing for areas like sterilization, biocompatibility, mechanical testing (dynamic loading, removal force), and MRI compatibility. It does not mention any clinical study involving a test dataset, ground truth established by experts, or metrics like accuracy, sensitivity, or specificity that would be relevant for an AI/ML device in the context of an "acceptance criteria" table.
Therefore, I cannot fulfill parts 1-9 of your request as the information is not present in the provided document. The document describes a traditional medical device (dental attachment system) clearance, not an AI/ML device that would typically involve the type of study design and data points you're asking about.
To answer your request based on the provided document, the following points are addressable:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The document describes non-clinical performance characteristics (sterilization, biocompatibility, mechanical properties) and demonstrates substantial equivalence to a predicate device. It does not present quantitative acceptance criteria for clinical performance in the manner of an AI/ML device (e.g., accuracy, sensitivity, specificity) against a test set. The "Performance Data" section discusses:
- Sterilization validation (ISO 17665-1, ISO 17665-2)
- Biocompatibility testing (ISO 10993-5, ISO 10993-12)
- Mechanical testing (ISO 14801 for dynamic loading; testing removal force of retention insert)
- Non-clinical worst-case MRI review (using scientific rationale and published literature)
Regarding the study that proves the device meets "acceptance criteria" (interpreting "acceptance criteria" in the context of this traditional device as demonstrating substantial equivalence through non-clinical testing):
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable/Not Provided. The performance data mentioned are non-clinical tests (e.g., sterilization, biocompatibility, mechanical testing). These are laboratory/benchtop tests, not a clinical "test set" in the context of patient data for an AI/ML algorithm. The document does not specify typical sample sizes for these tests (e.g., how many abutments were tested for removal force), nor data provenance (as it's not patient-derived data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. This is not an AI/ML device where expert radiologists or similar professionals would establish ground truth for a test set. The "ground truth" for the non-clinical tests would be the established standards for sterilization, biocompatibility, and mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Not a clinical study requiring adjudication of expert readings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable / Pre-defined standards. For the non-clinical tests:
- Sterilization: Ground truth is defined by the requirements of ISO 17665-1 and 17665-2.
- Biocompatibility: Ground truth is defined by the requirements of ISO 10993-5 and 10993-12.
- Mechanical Testing: Ground truth is defined by the requirements of ISO 14801 for dynamic loading, and internal company specifications for retention force (compared to the predicate).
- MRI Review: Ground truth is based on scientific rationale and published literature for material properties in an MR environment.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set."
In summary, the provided FDA 510(k) clearance letter and summary are for a traditional Class II dental device (an attachment system for dental implants), not an AI/ML medical device. Therefore, the questions related to AI/ML specific study design elements (test sets, ground truth by experts, MRMC studies, training sets) are not applicable to the content of this document.
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(251 days)
|
| Regulatory Number/
Device Classification
Name | 21 CFR§872.3980
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.
The provided text describes the regulatory clearance of a dental implant system (N1™ TiUltra™ TCC Implant system) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving the device meets those criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, indications for use, and comprehensive non-clinical and clinical testing. The concept of "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate, rather than meeting specific performance metrics for a diagnostic task.
Therefore, I will interpret "acceptance criteria" as the criteria for establishing substantial equivalence and "reported device performance" as the outcomes of the non-clinical and clinical studies conducted to support that equivalence.
Here's a breakdown of the information based on the provided text, addressing your specific questions, with explanations for what is not present:
1. Table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence, the "acceptance criteria" are demonstrating similarity to predicate devices and acceptable performance in various non-clinical and clinical tests.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (N1™ TiUltra™ TCC Implant system) |
|---|---|
| Substantial Equivalence in Intended Use and Indications for Use. | N1™ TiUltra™ TCC Implant system shares the same or similar intended use and indications for use as predicate devices, with differences adequately addressed. |
| Sterilization Validation (SAL 10⁻⁶) | Successfully demonstrated sterility assurance level of 10⁻⁶ via gamma sterilization, confirming safety for use. |
| Endotoxin Levels (meeting USP , , ANSI/AAMI ST72) | Testing confirmed endotoxin levels are within acceptable limits, demonstrating pyrogen-free status. |
| End-User Cleaning & Sterilization Validation (for reusable components) | Validation performed per ISO 17665-1, AAMI TIR12, AAMI/ANSI ST79, ANSI/AAMI ST77, ISO 17664, ensuring safe reprocessing for reusable components. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Packaging Performance (maintaining sterility and device integrity) | Met standards (ISO 11607-1, ASTM D4169, D4332, F1886/F1886M, F2096, F1980), demonstrating packaging efficacy in maintaining sterility and integrity. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Biocompatibility (ISO 10993-1, -5, -12, -18) | All materials passed biocompatibility tests (cytotoxicity, chemical characterization), confirming safety for patient contact. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mechanical Resistance (ISO 14801, FDA Guidance) | Demonstrated sufficient fatigue resistance and mechanical stability in dynamic loading tests, comparable to predicate devices. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Insertion Parameters (Heat Generation, Torque) | Comparative testing demonstrated equivalence in heat generation and insertion torque to the Primary Predicate, indicating similar surgical experience and bone response. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Osseointegration (Animal Study) | Animal study showed representative osseointegration behavior comparable to the predicate (TiUltra Implants and Xeal Abutments) at 13 ± 2 weeks, supporting the new drilling technique. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mesostructure Design & Manufacturing (Software & E2E Validation) | Software verification for abutment design library ensured adherence to design limitations; validation confirmed locked specifications, and end-to-end (E2E) validation demonstrated proper manufacturing workflow. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| MR Conditional Labeling (Referencing K212125) | Met acceptable outcomes in MR conditional testing for safe use in specific MR environments, leveraging prior clearance. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Long-term Clinical Performance (MBLC, Survival, Safety, Tissue Health) | Primary Endpoint (MBLC): Non-inferiority to historical data for the predicate device (NobelActive implant system) was met with statistical significance (p |
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(218 days)
These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories
These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories
The Straumann Cassettes are used to organize, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals.
The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time.
The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments.
Straumann® Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, sterilize and protect the instruments that are sterilized by the healthcare provider. The subject devices consist of reusable rigid containers, comprising of a case bottom (base), a removable inner tray base (tray), and tray lid (lid). The case base, tray base, and tray lid are designed to be integrated into a single unit which contains and protects the interior components during sterilization and subsequent storage. The tray lid latches to the case bottom is designed to secure the kit into a single unit. The kits are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap to maintain sterility. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays and modules have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Straumann® Dental Implant System intended to be placed in the Straumann® Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Straumann® Dental Implant System. These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.
In addition, the Straumann Screw Container is included in this submission. The Straumann Screw Container is used for storing and sterilizing closure screws and healing caps. All the closure screws and healing caps that may be contained in the Screw Container are cleared Class II devices according to 21 CFR 872.3630 (Endosseous dental implant abutment) and are not subject devices of this submission.
The provided document describes the acceptance criteria and the performance testing for the Straumann® Surgical Cassettes, which are used to organize, sterilize, and transport surgical instruments.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Type of Testing | Purpose (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Manual Cleaning Validation (AAMI TIR 30:2011) | Evaluate and validate the manual cleaning of the subject devices: | |
| • No visible soil | ||
| • Amount of protein per sample 70% | Pass |
2. Sample size used for the test set and the data provenance:
- The document states: "The worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio and worst-case instruments to be contained."
- It also mentions "Test samples must withstand 100 cycles of use". This indicates that at least one "worst-case" sample was subjected to repeated testing for the life cycle validation.
- Specific numerical sample sizes for each test (e.g., number of cassettes for cleaning validation, or number of sterilization runs) are not provided in the excerpt.
- Data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device and study. The "ground truth" for these performance tests is based on established scientific and regulatory standards (e.g., ISO, AAMI standards) and objective measurements of sterilization, cleaning efficacy, and material biocompatibility, rather than expert consensus on interpretive tasks.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the evaluation of device performance in these tests is based on objective measurements against defined criteria, not on subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable. The device is not an AI-powered diagnostic or assistive tool for human readers. It is a physical medical device (sterilization cassette).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing is based on objective measurements against established scientific and regulatory standards. For example:
- Cleaning efficacy: Measured levels of protein and hemoglobin, and visual inspection for soil, compared against quantitative thresholds.
- Sterilization: Sterility Assurance Level (SAL) of ≤10⁻⁶ using biological indicators, which is a quantitative measure of microbial inactivation.
- Biocompatibility: Cell viability percentage (>70%) compared against a quantitative threshold in cytotoxicity testing.
- Life cycle: Functional integrity after a specified number of cycles, assessed objectively.
8. The sample size for the training set:
- This information is not applicable as the device is not an AI algorithm that requires a training set. The performance testing validates the physical characteristics and reprocessing effectiveness of the cassettes.
9. How the ground truth for the training set was established:
- This information is not applicable as the device is not an AI algorithm.
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