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510(k) Data Aggregation
(256 days)
The SD Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. The multi-unit abutments are designed for use in multi-unit restorations. They should be used in cases where multiple implants are placed to support a prosthetic dental restoration not suitable for single-unit restorations. All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
SD Implant System consist of below:
Fixture
- SD Bone Level Fixture
Abutment - Cover Screw
- Healing Abutment
- Scan Healing Abutment
- Scan Healing Abutment Screw
- Cemented Abutment
- Angled Abutment
- Master Fix
- Master Fix Screw
- Digital Abutment
- Temporary Abutment
- Multi Abutment
- Multi Angled Abutment
- Abutment Screw
- Multi Scan Healing Cap
- Multi Scan Healing Cap Screw
- Multi Master Fix
- Multi Master Fix Screw
- Multi Ti Cylinder
- Multi Digital Cylinder
- Multi Temporary Cylinder
SD Implant System is consisted with Fixtures (SD Bone Level Fixture) and Abutments (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment, Master Fix, Digital Abutment, Temporary Abutment, Multi Abutment, Multi Angled Abutment, Multi Scan Healing Cap, Multi Master Fix, Multi Ti Cylinder, Multi Digital Cylinder, Multi Temporary Cylinder)
This product is a dental implant which is placed into alveolar bone to replace the function of missing teeth. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA (Sandblasted with Large-grit and Acid-etching). As a dental implant which is placed into alveolar bone to support dental prostheses such as artificial teeth used to rehabilitate a patient's masticatory function.
An endosseous dental implant is a device made of a material Pure titanium (Conforming to ASTM F67) which will be placed in the alveclar bone to replace the function of missing tooth. The SD Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.
The subject device abutments are not compatible with 3.8mm diameter implant bodies cleared in K213506 and K230725, nor with 3.2mm diameter implant bodies cleared in K240091.
SD Implant System Abutment is compatible with the SD Implant Fixture and Some of the SD Implant System connections are compatible with NB 1 Compatible with SA Implant System, NB Implant System and NB Mini Implant System. (Cleared K213506, K230725, K240091)
SD Implant System Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures, Separate sets of abutments are presented for compatibility with each Fixture. Dental Abutments are similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
The Multi Abutments and Multi Angled Abutments intended to be placed onto osseointegrated dental implants to provide support for prosthetic superstructures at the gingival level. Multi Abutments are available as straight abutments, which have an integrated thread and can be placed directly onto the implant. Multi Angled Abutments are angled abutments, which can be attached to the implant with the corresponding abutment screw. The multi-unit abutments are intended for multi-unit restoration only.
The Cover Screw, Healing Abutment, Scan Healing Abutment, Scan Healing Abutment Screw, Multi Scan Healing Cap and Multi Scan Healing Cap Screw are provided sterile by the manufacturer. All other abutments are provided non-sterile and should be sterilized by the end user before use. The multi-unit abutments included in this system are specifically intended to be used solely for multiunit restorations. The SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are composed of two-piece abutment that is a titanium base at the bottom and zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction. All digitally designed custom abutments for use with SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinderare intended for single-unit or multi-unit restorations.
For the Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder the design parameters for the CAD/CAM zirconia superstructure are:
Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations (length above the abutment collar / gingival height) – 4.5 mm; Maximum gingival height - 5.0 mm; Minimum gingival height - 1.5 mm; Angulation - 0° and All zirconia superstructures are for straight abutments only.
The Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder are used as part of a twopiece abutment, where the base is premanufactured from titanium alloy (Ti-6AI-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
The SD Implant System is intended for single use only. The Abutments are made of Ti-6AI-4V Eli (Conforming to ASTM F136) The SD Implant System connections compatible with NB 1 SA Implant System, NB Implant System and NB Mini Implant System
The provided text is a 510(k) summary for a dental implant system (SD Implant System) and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data in the format typically used for performance studies of AI/ML-enabled devices.
Therefore, I cannot extract the acceptance criteria and study details as requested for an AI/ML device.
The document details the device's components, materials, dimensions, indications for use, and a comparison to predicate devices, along with non-clinical performance data like biocompatibility, sterilization validation, shelf-life, and mechanical testing (ISO 14801). It does not contain information about:
- Acceptance Criteria for AI/ML performance: The document is for a physical dental implant system, not a software/AI device.
- Reported device performance for AI/ML: There's no AI component described.
- Sample size for test set and data provenance: Not applicable to this type of device submission.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for ground truth: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (pathology, outcomes data, etc.): Not applicable in the context of AI. Ground truth here refers to engineering specifications met by physical testing.
- Sample size for training set/How ground truth for training set was established: Not applicable, as there's no AI/ML training involved for a physical implant.
The document primarily focuses on demonstrating that the physical dental implant system meets established performance standards and is comparable to previously cleared devices through non-clinical testing.
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(175 days)
Ti Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
All digitally designed abutments for use with Ti Link Abutment are intended to be manufactured at a Izenimplant validated milling center.
The Ti Link Abutment is a two-piece abutment intended to provide support for restorations such as crowns and bridges. The two pieces which compose the final abutment consist of the pre-manufactured titanium base component composed of titanium alloy conforming to ASTM F136, and the CAD/CAM patient matched mesostructure composed of zirconia (K091096). The diameters of the premanufactured titanium base component are 4.0/4.5mm. The final two-piece abutment is fixed to the implant with an abutment screw composed of titanium alloy conforming to ASTM F136. Ti Link Abutment is provided non-sterile, therefore must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component.
The abutments are compatible with the implants cleared under K211090.
The CAD/CAM patient matched mesostructure that is added to the pre-manufactured titanium base component to create the final abutment design should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the Ti Link Abutment. The coping would be manufactured by Izenimplant only with design input using CAD/CAM Software from and by Izenimplant milling center.
CAD/CAM patient matched mesostructure is made from NaturaZ (K091096) and is cemented to the pre-manufactured titanium base component using RelyX cement (K110508) to complete the final finished abutment.
This document, a 510(k) Premarket Notification from the FDA, concerns the "Ti Link Abutment" device, an endosseous dental implant abutment. It aims to demonstrate the device's substantial equivalence to previously cleared predicate devices.
Crucially, this document does NOT describe the acceptance criteria and study proving a device meets those criteria for software or AI-based medical devices. This is a hardware dental implant abutment, and the "testing" performed is for mechanical and biocompatibility properties, not algorithmic performance.
Therefore, many of the requested points related to AI/software study design (sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific FDA submission document.
However, I can extract and present the information that is relevant to the document regarding the device's acceptance criteria and the studies performed:
Acceptance Criteria and Study for Ti Link Abutment (Hardware Device)
Since this is a hardware device (dental implant abutment) and not an AI/software device, the concept of "acceptance criteria" and "performance" is based on mechanical, material, and biocompatibility standards rather than algorithmic metrics like accuracy, sensitivity, or specificity.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion / Test Type | Description / Standard | Acceptance Criteria | Reported Device Performance / Outcome |
|---|---|---|---|
| Fatigue Test | According to ISO 14801:2016 under worst-case scenario (two occurrences) | Meets requirements of ISO 14801:2016 | "The results of the above tests have met the criteria of the standard" |
| End User Steam Sterilization | According to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010 | Meets requirements of ISO 17665 and ANSI/AAMI ST79 | "The results of the above tests have met the criteria of the standard" |
| Cytotoxicity Testing | According to ISO 10993-5:2009 | Meets requirements of ISO 10993-5:2009 | "The results of the above tests have met the criteria of the standard" |
| Biocompatibility Tests | According to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 (leveraged from predicate K211090) | Meets requirements of ISO 10993 series | "Biocompatibility test data was used to evaluate the proposed device's substantial equivalence... The results... have met the criteria of the standard" |
| Material Composition | Ti-6Al-4V ELI (ASTM F136) for titanium base, Zirconia Oxide for mesostructure | Conforms to specified ASTM and Zirconia standards | Stated as conforming to ASTM F136 (Ti-6Al-4V ELI) and using Zirconia (K091096). |
| Design Parameters | Angulation, cuff height, thickness, abutment post length | Within specified design limits (e.g., 0-15° angulation) | Explicitly stated design limits. Implicitly met. |
| Magnetic Resonance (MR) Safety | Evaluation performed based on scientific rationale and published literature | Compatible with MR environment | "Non-clinical worst-case MRI review was performed... rationale addressed parameters per the FDA guidance." (Implies deemed safe) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of number of manufactured units tested for the fatigue, sterilization, and cytotoxicity tests. These types of tests typically follow specific ISO/ASTM standards that dictate sample sizes based on statistical methods or industry practice, but the exact numbers are not detailed in this summary.
- Data Provenance: The tests were conducted for the subject device. Biocompatibility test data was "leveraged" from a predicate device (K211090), which is owned by the applicant. This implies in-house or contracted lab testing for the subject device-specific tests, and prior testing data for the predicate. No information about country of origin for the data is provided, but it's likely originating from the manufacturer's region (Republic of Korea, as per submitter address) or contract laboratories they engaged.
- Retrospective/Prospective: The testing described (Fatigue, Sterilization, Cytotoxicity, Biocompatibility) are prospective tests specifically conducted to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This document pertains to the physical and material properties of a dental device, not an AI or software device requiring human expert annotation for ground truth. Ground truth for these tests is established by objective measurements against engineering standards (e.g., force applied, temperature, cell viability, chemical composition).
4. Adjudication Method for the Test Set:
- Not Applicable. As there are no human expert reviewers establishing observational data, there is no need for an adjudication method. Test results are typically objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is relevant to AI/software performance with human users. It is not applicable to a hardware dental abutment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device; there is no standalone algorithm to evaluate.
7. The Type of Ground Truth Used:
- For mechanical, sterilization, and cytotoxicity tests: The ground truth is defined by the acceptance criteria of the relevant ISO, ASTM, and ANSI/AAMI standards. For example, the fatigue test ground truth is whether the device withstands a specified number of cycles at a specific load without failure, as per ISO 14801. Cytotoxicity is measured against living cell responses.
- For material composition: Ground truth is established by material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI).
- For biocompatibility: Ground truth is established by the safety profiles defined in the ISO 10993 series for medical device biological evaluation.
8. The Sample Size for the Training Set:
- Not Applicable. This is a hardware device; there is no AI/ML model with a "training set." The CAD/CAM design process does not involve machine learning in this context; it refers to computer-aided design and manufacturing.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. No training set exists for this hardware device.
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(83 days)
The ZENEX Implant System_Short is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ZENEX Implant System Short are intended to be used in the molar region.
ZENEX Implant System_Short is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost. The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). The entire length of 6.25mm of implant bodies are implanted into the bone to connect prosthetic devices of a dental implant set with the human body (mandibular or maxillary bone).
This is a premarket notification (510(k)) for the ZENEX Implant System Short, a dental implant device. The provided text describes the device, its intended use, and comparative information against predicate devices to demonstrate substantial equivalence. However, it does not contain acceptance criteria for device performance nor a study that directly proves it meets those criteria in the way you've outlined for an AI/software device.
Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (TS Implant System, K121585) and leveraging testing from a reference predicate (Zenex Implant System, K211090) through a series of non-clinical bench tests and analyses. These tests are designed to show that the new device is as safe and effective as the predicate, not to report on clinical performance or AI algorithm metrics.
Therefore, many of the requested points in your template are not applicable or cannot be extracted from this document, as it's not a study evaluating an AI algorithm's performance against specific acceptance criteria with ground truth.
Here's an attempt to answer your questions based on the provided text, while also noting what information is not present given the nature of this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria for clinical performance metrics (like sensitivity, specificity, or F1 score) that would be relevant for an AI device, nor does it report device performance in that manner. Instead, the "performance" discussed relates to meeting engineering and biocompatibility standards to demonstrate substantial equivalence to a predicate device.
The "acceptance criteria" are implicitly meeting the standards of the referenced ISO and ASTM guidelines for non-clinical testing. The "reported device performance" is that the device met these standards and demonstrated substantial equivalence.
| Acceptance Criteria (Implicit from referenced standards) | Reported Device Performance |
|---|---|
| Fatigue Testing (ISO 14801:2016) | Results showed that subject devices are substantially equivalent under worst-case scenario. |
| Biocompatibility (ISO 10993-1:2009) | Subject device is biocompatible and substantially equivalent with the predicate. |
| Sterilization (ISO 11137-1, 11137-2, 11137-3) | Sterility Assurance Level (SAL) of 10-6 validated. |
| Shelf Life (ASTM F1980) | Results demonstrated equivalence to the predicate devices. Shelf life: 5 years. |
| Bacterial Endotoxin (ANSI/AAMI ST72:2011, USP , ) | (Not explicitly stated "met," but implied by leveraging predicate data for equivalence.) |
| Surface Area Analysis (Comparative) | Results showed that subject devices are substantially equivalent. |
| MR Environment Condition (Scientific rationale & literature review) | Rationale addressed parameters; implied safety in MR environment. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an AI study. The "test set" here refers to the physical samples of the device used in bench testing. The specific number of physical implants or components tested for each non-clinical test (e.g., fatigue, shelf-life) is not detailed, beyond stating "worst-case scenario" constructs were tested.
- Data Provenance: Not applicable for an AI study. The testing is non-clinical/bench testing performed on physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical dental implant, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical dental implant, not an AI algorithm study requiring adjudication of expert opinions.
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 a physical dental implant, not an AI algorithm. The text mentions "MR Environment Condition" but this refers to Magnetic Resonance (MR) safety, not Multi-Reader Multi-Case (MRMC) studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this device, "ground truth" would be established by physical measurements, material properties, and biological responses according to established standards (e.g., ISO, ASTM, biocompatibility guidelines), rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set
Not applicable. This is a physical dental implant, not an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
Not applicable. This is a physical dental implant, not an AI algorithm.
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(86 days)
The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
ZENEX FreeMilling & CCM Cast Abutment consists of FreeMilling Abutment and CCM Cast Abutment.
ZENEX FreeMilling & CCM Cast Abutment is compatible with the fixtures below:
K number: K211090
Device Name: ZENEX Implant System (ZENEX MULTI&PLUS Fixture)
Dimension Ranges: Diameter 3.75 x 8.5, 10, 11.5, 13, 15; Diameter 4.25 x 7, 8.5, 10, 11.5, 13, 15; Diameter 4.6 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.05 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.4 x 7, 8.5, 10, 11.5, 13; Diameter 5.9 x 7, 8.5, 10, 11.5, 13; Diameter 6.75 x 7, 8.5, 10, 11.5, 13
Tolerance of dimension shall be within ± 1% range.
The dimensions of abutments are as following:
Device Name: FreeMilling Abutment
Dimension Ranges: Diameter 4.0/4.5/5.0/5.2/5.7/6.0/6.5/7.0
Gingival Heights (mm): 1.3/1.8/2.8/3.8
Minimum Post height (mm): 4
Angulation: 0°
Device Name: CCM Cast Abutment
Dimension Ranges: Diameter 4.0 / 4.5
Gingival Heights (mm): 0.8 / 2.8
Minimum Post height (mm): 4
Angulation: 0°
The Abutments have below featured:
Name: FreeMilling Abutment
Uses: The Abutment is connected with fixture, and it supports prosthesis which restores tooth function.
Surface: Partial TiN coated in upper
Connection: Screw retained
Name: CCM Cast Abutment
Uses: It is an abutment that is used when making a retained / customized prosthesis.
Surface: NA
Connection: Screw retained
Tolerance of dimensions for Abutments shall be within ± 1% range.
ZENEX FreeMilling & CCM Cast Abutment is provided non-sterile.
Materials:
- FreeMilling Abutment is fabricated of Ti-6Al-4V ELI according to ASTM F136-13
- CCM Cast Abutment is fabricated of Co-Cr-Mo according to ASTM F1537-11
I'm sorry, but your prompt asks for details about acceptance criteria and a study proving device performance, including a table of acceptance criteria and reported device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC study information, standalone performance, and training set details.
However, the provided text is a 510(k) summary for a dental abutment, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a primary clinical or non-clinical performance study. It mentions non-clinical test data for biocompatibility and sterilization, but it doesn't present performance metrics against specific acceptance criteria in the format you've requested for a device that relies on a performance study to prove its criteria.
The 510(k) summary establishes equivalence based on:
- Indications for Use: Same as predicate.
- Technological Characteristics: Similar design, dimensions (with minor, deemed non-critical differences), materials, and sterilization methods.
- Non-Clinical Test Data: Biocompatibility and sterilization (often leveraged from predicate devices or performed according to recognized standards).
Therefore, I cannot extract the specific information you've requested about acceptance criteria and a study proving those criteria from the given text. The document's purpose is to argue substantial equivalence, not to present a standalone performance study with detailed acceptance criteria and results.
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(221 days)
The LW Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.
The LW Implant System consists of a fixture, cover screw, healing abutments, and abutment screw. The Fixture is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: internal hex connection, submerged type, tapered body, sided cutting edge. The Cover Screw and Healing Abutment are made of CP Ti Grade 4(ASTM F67) without any surface treatment. The Abutments consist of the LW Solid, LW Angled, LW Vis and LW Temporary Abutment, and LW Abutment Screw. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136).
The provided text is a 510(k) Summary for the LW Implant System. It outlines substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data for this device. Therefore, a table of acceptance criteria and direct device performance is not explicitly available in the provided text in the way one would typically find for a new, de novo device or a clinical study.
The document focuses on demonstrating that the LW Implant System is "substantially equivalent" to already legally marketed predicate devices. This means that the device meets the same safety and effectiveness standards, often by showing it performs as well as, or better than, a known predicate device.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't present specific acceptance criteria and performance data in a dedicated table for the LW Implant System, as it's a 510(k) submission focused on substantial equivalence. Instead, it describes various non-clinical tests performed to demonstrate that the device meets established standards and performs comparably to predicate devices. The "acceptance criteria" are implied by adherence to relevant ISO and ASTM standards and FDA guidance documents, and the "reported device performance" is essentially that the device "met the acceptance criteria" or "demonstrated substantial equivalence."
Here's an interpretation of the implied acceptance criteria and the summary of reported performance:
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Gamma Sterilization Validation | Compliance with ISO 11137-1, -2, -3 to achieve a Sterility Assurance Level (SAL) of 10-6. | Validated to achieve SAL of 10-6. Results prove equivalence to predicate device. |
| End-User Sterilization Validation | Compliance with ISO 17665-1, -2 and FDA guidance "Reprocessing Medical Devices in Health Care Settings". | Validated. Results showed equivalence to predicate device. |
| Shelf-life Test | Compliance with ASTM F1980; no degradation of device functionality over specified shelf-life. | Devices function adequately for 5 years without degradation. Demonstrated equivalence to predicate devices. |
| Biocompatibility Tests (Cytotoxicity) | Compliance with ISO 10993-1, -5 and FDA Guidance. | Demonstrated biocompatibility of the material used. |
| Fatigue Test (Dynamic Fatigue & Static Compression) | Compliance with ISO 14801:2016 and FDA guidance "Class II Special Controls Guidance Document". | Expected to function properly for intended use. |
| Bacterial Endotoxin Testing (LAL) | Compliance with USP , USP , and FDA guidance for pyrogen limit specifications. | Met acceptance criteria. Demonstrated substantial equivalence with the predicate device. |
| Surface Treatment Evaluation (SLA) | Compliance with 'Section 11 of Class II Special Controls Guidance Document'; comparable surface roughness, composition, and SEM imaging to predicate. | Demonstrated substantial equivalence through surface roughness, composition analysis, SEM imaging, and ICP analysis. |
| MRI Safety Review | Compliance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" for magnetically induced displacement force and torque. | Performed using scientific rationale and published literature; rationale addressed parameters. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test performed (e.g., how many devices were subjected to fatigue testing, or how many samples for biocompatibility). It references standards like ISO and ASTM, which inherently define sample size requirements, but the exact numbers are not reported in this summary.
Data Provenance: The tests are non-clinical (laboratory-based) and were conducted to support the safety and performance of the device against established standards and predicate device comparisons. The "country of origin of the data" is not explicitly stated for each test, but the applicant, Ossvis Co., Ltd., is based in the Republic of Korea. The data is retrospective in the sense that the tests were completed before this submission.
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 the provided document. The "ground truth" in this context is established through adherence to recognized international standards (ISO, ASTM) and national regulations (FDA guidance documents). These standards typically involve scientific and engineering principles, and the "experts" are the scientific and engineering professionals who developed these standards and those who conducted the tests in accordance with them. There is no mention of a ground truth established by a panel of clinical experts for a test set in a diagnostic or clinical performance study for this device.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results by multiple readers (e.g., radiologists, pathologists) to establish a consensus ground truth. Since the reported studies are non-clinical performance and safety tests, a human adjudication method is not used. The "adjudication" is essentially the determination of whether the device passed the specified test according to the defined acceptance criteria in the relevant standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance and safety to demonstrate substantial equivalence, not on the comparative effectiveness of human readers with or without AI assistance. This device is a physical dental implant system, not an AI/software as a medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, this is not applicable. This device is a physical medical device (dental implant system), not an algorithm or software. The concept of "standalone performance" without human-in-the-loop is relevant to AI/software applications, not to this type of medical device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and regulatory guidance limits. For example:
- Sterility: Defined by ISO 11137 with an SAL of 10-6.
- Biocompatibility: Defined by ISO 10993 standards.
- Fatigue: Defined by ISO 14801.
- Bacterial Endotoxin: Defined by USP and .
- Surface Characteristics: Defined by FDA special controls guidance for dental implants.
The comparison is also made against the performance and characteristics of legally marketed predicate devices, implying that their established safety and effectiveness serve as a practical "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The LW Implant System is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms where data is used to train a model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this physical medical device.
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(146 days)
The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately
- with a temporary prosthesis that is not in functional occlusion,
- when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
- for denture stabilization using multiple implants in the anterior mandible and maxilla.
The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.
The provided text is a 510(k) summary for the ZENEX Implant System Narrow, a dental implant device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document.
The document details:
- Device Description: Components (fixtures, abutments), materials (Ti-6Al-4V ELI, Co-Cr-Mo Alloy), and surface treatments (SLA, TiN coated).
- Indications for Use: Single tooth replacement, multiple tooth replacement, denture stabilization.
- Predicate Devices: A list of previously cleared dental implants and accessories used for comparison.
- Substantial Equivalence Discussion: A comparative table outlining various characteristics of the subject device against its primary predicate and reference devices, focusing on design, connection, material, surface, sterilization, shelf life, and indications for use.
- Non-Clinical Data: Lists mechanical and material tests conducted (Bacterial Endotoxin, Fatigue Testing on fixture) and leveraged from predicate devices (Sterilization Validation, Shelf-Life, End User Sterilization Validation, Biocompatibility). It also mentions an MR environment review.
There is no information in this document about:
- Acceptance criteria for an AI/ML device.
- Reported device performance metrics (e.g., sensitivity, specificity, accuracy) of an AI/ML device.
- Sample sizes for test sets in an AI/ML study.
- Data provenance for an AI/ML study.
- Number or qualifications of experts for AI/ML ground truth.
- Adjudication methods for AI/ML ground truth.
- MRMC comparative effectiveness study results for AI/ML.
- Standalone performance of an AI/ML algorithm.
- Type of ground truth used for an AI/ML study.
- Sample size for the training set of an AI/ML model.
- How ground truth for the training set was established for an AI/ML model.
This 510(k) summary is for a physical dental implant system, not a software or AI/ML-driven device.
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