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510(k) Data Aggregation
(302 days)
CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
The CeraRoot TL Implant System is the two-piece tissue level variant of the original ceramic dental implant one-piece CeraRoot Implant System (K093595) available since 2011 in the USA and 2006 in Europe. CeraRoot® dental implants are made of Y-TZP zirconium dioxide ceramics in accordance with ISO 13356. CeraRoot® dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The outer surface is acid etched for good osseointegration. The new TL (two-piece) variants are available in different lengths (8,10, 12 and 14mm) and only for the models CeraRoot 34TL (⌀ 5mm), CeraRoot 21TL (⌀ 5.6mm) and CeraRoot 16TL (⌀ 7mm).
The implants are provided sterile in sterile packaging and are intended for single use. CeraRoot implants must not be re-sterilized or disinfected either.
The CeraRoot TL abutments are made of the same Y-TZP ceramic material as the implants, and are attached to the CeraRoot TL implants by cementation. After the cementation of the abutments into the implant then the restorative prosthesis can be custom-made, produced and cemented on top to finish the treatment.
The CeraRoot TL abutments are available with the lengths 4.3 and 5.8 mm.
The CeraRoot TL abutments are provided non-sterile. They are intended for single use and must not be reused. Before use they must be cleaned, disinfected and sterilized according to the instructions given in the "instructions for use of CeraRoot TL abutments" document.
The provided document is an FDA 510(k) clearance letter for the CeraRoot TL Implant System. This type of document is generally a summary for a medical device, specifically a dental implant, and not an AI/ML-enabled device used for diagnostic or screening purposes that would involve image analysis or similar data interpretation.
Therefore, the typical acceptance criteria and study designs described in your request (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, type of ground truth, adjudication methods) are not applicable to this specific device. These criteria are usually for devices that perform a measurement, classification, or diagnostic function, often involving AI/ML.
The "study that proves the device meets the acceptance criteria" in the context of this dental implant is primarily the non-clinical testing (bench testing) and biocompatibility evaluations to demonstrate that the device is substantially equivalent to existing, legally marketed predicate devices.
Here's how to interpret the provided information in the context of the CeraRoot TL Implant System:
1. Table of acceptance criteria and reported device performance:
The acceptance criteria for a dental implant focus on its physical properties, biocompatibility, and mechanical performance rather than diagnostic accuracy.
| Acceptance Criteria Category | Specific Criteria (from standards/demonstrated equivalence) | Reported Device Performance (as demonstrated by testing and equivalence) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, -5, -7 (cytotoxicity, sterilization residuals), -12. No additional risks identified compared to predicate due to identical materials and processes. | Demonstrated by testing results from accredited laboratories for cytotoxicity, bioburden, and endotoxins. Biocompatibility for ethylene oxide residuals covered by predicate (K093595). |
| Material Properties | Made of Y-TZP zirconia based on ISO 13356. | Confirmed as Y-TZP zirconia, identical to primary predicate. |
| Mechanical Performance | Fatigue testing according to ISO 14801. | Testing results demonstrated that the CeraRoot TL implant system meets existing requirements and acceptance criteria, like the predicate devices. |
| Sterilization | Compliance with ISO 11135 (Sterility Assurance Level ≤ 10⁻⁶), ISO 11607-1, ISO 11607-2 (packaging integrity). For non-sterile components, ISO 17665 (end-user sterilization). | Sterility assurance level of ≤ 10⁻⁶ proven. Packaging validated for 5 years accelerated aging. End-user sterilization validated. Processes identical to predicate. |
| Design/Manufacture | Equivalent design and manufacturing process (Milling and Sintering, Acid Etching surface finish) to predicate and reference devices, with differences substantiated by reference devices. | Demonstrated through detailed comparison tables (Section 5 & 6) and substantial equivalence discussion (Section 7), showing that any differences are covered by legally marketed reference devices. |
Regarding the other points of your request:
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2. Sample sized used for the test set and the data provenance:
- For biocompatibility and mechanical testing (e.g., fatigue), specific sample sizes are used as defined by the relevant ISO standards (e.g., ISO 14801). The document does not specify these exact numbers, but indicates that the testing was performed "like the predicate devices" and "according to ISO 14801."
- Data Provenance: The studies are bench tests (laboratory performance testing) rather than clinical studies with human patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" patient data are not applicable. The data provenance is the testing facility/laboratory where the bench tests were conducted.
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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 device being tested against engineering and biological performance standards, not a diagnostic or AI device requiring expert interpretation of data to establish ground truth.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication relates to resolving discrepancies in human expert interpretations, which is not part of dental implant performance testing.
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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/ML-enabled diagnostic or assistance device.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm or human-in-the-loop component for this physical medical device.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is compliance with established international engineering and biocompatibility standards (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility) and demonstrated substantial equivalence to predicate devices. There is no "pathology" or "outcomes data" ground truth directly from this 510(k) summary, as human clinical testing was explicitly stated as "Not applicable."
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8. The sample size for the training set:
- Not applicable. There is no "training set" for a physical dental implant. This term applies to machine learning models.
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9. How the ground truth for the training set was established:
- Not applicable. No training set for this device.
In summary, this 510(k) clearance is for a conventional dental implant, and the requested details about AI/ML device validation are not relevant to the information provided in this document. The "proof" of meeting acceptance criteria for this device rests on rigorous bench testing against established performance standards and a thorough comparison to legally marketed predicate devices to demonstrate substantial equivalence.
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(209 days)
The Strauman® PURE Ceramic Implant is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw.
The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
The Straumann® PURE Ceramic Implants (Tissue Level Monotype and Tissue Level two-piece design) are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding instruments and prosthetic parts. The Straumann® PURE Ceramic Implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched (ZLA® surface). The implants have a 1.8 mm high machined transmucosal neck. The Straumann® PURE Ceramic Implant has a two -piece design with internal connection based on features of the Straumann® Tissue Level Standard Plus and Straumann® Bone Level Implants. The Straumann® PURE Ceramic Implant Monotype features a monotype design where the ceramic abutment for final restoration is already built in.
This document, a 510(k) summary for the Straumann® PURE Ceramic Implants, does not contain information about an AI/ML device or a study proving its performance against acceptance criteria in the way a typical AI/ML medical device submission would.
The document describes a dental implant (a physical medical device) and its equivalence to previously cleared predicates. The nonclinical testing mentioned (dynamic fatigue, biological assessment, sterilization validation, packaging stability, MRI compatibility, surface features) are standard tests for physical implants to ensure their safety and effectiveness.
Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from this document. The concepts of "test set," "ground truth experts," "adjudication," "MRMC study," "standalone performance," "training set," and "how ground truth for training set was established" are not applicable to the non-AI/ML device described in this 510(k) summary.
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(176 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. Healing,
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement- or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.
The PEEK CR Abutment is indicated to be used on Neodent Implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.
The Zirconia Abutments subject of this submission are similar to devices already approved in previous submissions of Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Zirconia Abutments with new dimensions of gingival height for Zirconia Healing Abutments, Zirconia Bases, CR Abutments for Zirconia and PEEK CR Abutments for Zirconia, to provide more treatment options to the customers. All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method. The new transmucosal heights are 3.5mm and 4.5mm.
The restorative materials Polycon ae, N!ce and IPS e.max CAD LT were not presented in previous submissions of Zirconia Implant System and are being included in the scope of Zirconia Bases indication.
The provided document is a 510(k) summary for the Neodent Implant System - Zirconia Implant System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with defined performance metrics, sample sizes, and expert adjudication as might be seen for novel AI/software as a medical device (SaMD) products.
Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving performance, sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment methods for training sets.
The performance testing section (pages 14-15) describes:
- Bench Testing:
- Dynamic fatigue testing: Conducted according to FDA guidance and ISO 14801. The results demonstrated the subject devices do not introduce a new worst case compared to predicate and reference devices.
- Torsion tests: Performed to evaluate screw strength, and results proved adequate torsion strength according to installation torque.
- Biocompatibility Testing:
- Assessment performed according to ISO 10993-1 and FDA guidance. No new issues were raised and no additional testing was required because the subject devices are identical in material and manufacturing processes to predicate and reference devices.
- Sterilization Validation and Packaging:
- Ethylene Oxide (EO) sterilization validated to SAL of 10-6 per ISO 11135:2014. EO residuals verified per ISO 10993-7. The packaging and sterilization are identical to predicate devices.
- Steam sterilization validated per ISO 17665-1, using parameters identical to predicate devices.
- Pyrogen limit specifications met via LAL Endotoxin Analysis (testing limit 20 EU/device) for blood contacting and implanted devices.
In essence, the study presented is a non-inferiority or equivalence-based assessment against previously cleared devices, focusing on engineering and biocompatibility characteristics, not clinical performance metrics or AI algorithm validation metrics.
Therefore, I cannot provide the requested table and details because the information is not present in the provided text. The document describes a traditional medical device (dental implants and abutments) clearance, not a software or AI device that would have the specific performance study criteria outlined in your request.
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(201 days)
Indications for Use for Zirconia Implants, Cover Screw and Healing Abutment:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with singlestage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.
Indications for Use for Zirconia Bases:
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
- Intended for single use;
- Zirconia implants provided sterile via Ethylene Oxide; Zirconia Base abutments are provided sterile but require end user sterilization via moist heat following cementation of the restoration and before use
- All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide), except for the Zirconia Implant Cover Screw and the Basal Screw, which is manufactured of titanium alloy according to ASTM F136 standard;
- ZiLock prosthetic interface with internal indexer;
- Apically tapered implant with trapezoidal thread profile;
- Implant provided with sand-blasted, acid etched surface finish to facilitate osseointegration.
- The final finished Zirconia Base abutments are two-piece abutments composed of a zirconia base bottom-half bonded to a CAD-CAM zirconia top-half.
The provided text describes a medical device submission (K201491) for the Neodent Implant System - Zirconia Implant System to the FDA. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance results for a new AI/software device.
Therefore, the requested information about acceptance criteria, detailed device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies cannot be extracted from this document as it pertains to a different type of medical device submission (dental implants and their components) and regulatory pathway (510(k) for substantial equivalence).
The document details the comparison of the subject device (Neodent Implant System - Zirconia Implant System) to predicate and reference devices in terms of indications for use, technological characteristics, and performance data from various tests. However, these are evaluations against established standards and comparisons to existing devices, not metrics of an AI's performance.
Here's what can be extracted, though it doesn't directly answer the detailed questions about AI performance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of acceptance criteria for software performance in the typical sense (e.g., sensitivity, specificity, AUC). Instead, it presents a comparison of technological characteristics and states that the "tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices" in mechanical testing.
Here's a summary of the performance data presented, which implies meeting an "equivalent" performance to predicates rather than specific numerical acceptance criteria for a new software.
| Performance Area | Reported Device Performance |
|---|---|
| Biocompatibility | Representative samples of each device subjected to tests per ISO 10993-1, ISO 10993-5, ISO 10993-12, and ISO 10993-18. (Implied acceptance is successful completion according to these standards). |
| Mechanical Testing | Dynamic Fatigue Test (per ISO 14801): "exhibit a level of performance equivalent to that reviewed for the predicate devices." |
| Wear Assessment (Titanium/Ceramic contacting pieces): "concluded of comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection." | |
| Torsion Test: Performed to evaluate static torsional loading. (Implied acceptance is meeting design specifications and being comparable to predicates). | |
| Insertion Test: Performed to evaluate insertion torque in sawbones materials (bone type I, II, III, IV). (Implied acceptance is meeting design specifications and being comparable to predicates). | |
| Sterilization | Achieved a "Sterility Assurance Level of 1x10⁻⁶" via Ethylene Oxide per ISO 11135-1. Residuals according to ISO 10993-7. Not represented as "pyrogen free." |
| MRI Testing | Done according to documents presented in K182620 (a previously cleared device for MRI compatibility). (Implied acceptance is being MRI compatible as per the reference device). |
| Shelf Life | 5 years. Packaging assessment per ISO 11607-1, with maintenance of sterile barrier and sealing integrity confirmed by Dye Penetration, Sealing Strength, and Bubble Test after Accelerated Aging. |
No information is available regarding points 2-9 as they are specific to AI/software device studies to establish performance against a ground truth. This document is a 510(k) summary for a physical dental implant system and components, establishing substantial equivalence to existing devices.
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(90 days)
TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.
TAV Medical's W Zirconia Implants are dental implants, composed of the following implant models: W One Piece - monotype implant with integrated abutment. W Two Piece – implant for screw retained Abutment. The implants are tissue level designed and includes a body portion and a neck (1.8mm). The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone level. TAV Medical's W Zirconia Implants are made of Yttria stabilized tetragonal zirconia (Y-TZP). This material conforms with ISO 13356:2015 standard for Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The Titanium abutments are going through anodizing process using an electrolytic process that adjusts the oxide level of the metal surface. This adjustment changes the spectrum of light, resulting in perceived color. By controlling the surface oxide level, an entire range of colors can be achieved. The Subject Device includes the following dimensions: W One-Piece implants: Diameter of 3.6mm for lengths of 8mm, 10mm, 12mm and 14mm and; Diameters of 4.1mm and 4.8mm for length of 14mm. W Two-Piece implants: Diameters of 4.1mm and 4.8mm for lengths of 8mm, 10mm, 12mm and 14mm. Cover Screw are screwed into the implant to protect the inner configuration of the implant during the healing phase in cases of submucosal healing protocol. Cover screws are made of Titanium alloy Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Titanium Healing Caps are intended to protect the 2-piece implants during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. The healing caps are available in different geometrical features such as height and diameter. The Titanium Healing Caps manufactured from Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Each diameter is provided with height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Healing Caps are designed to protect the two-piece implant during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. Peek healing caps are available in different geometrical features such as height and diameter and available in 2 different designs, one design for the one-piece implant and second design for the two-piece implant. Both designs are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK healing caps are available in diameters of 4.1mm and 4.8mm and height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Temporary Caps serves as a basis for temporary restoration. TAV Medical temporary restoration caps available in two configurations, temporary Cap for Crown and Temporary Cap for Bridge. The caps are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK temporary caps are available in diameter of 3.6mm. Titanium Abutments for the W Two Piece Zirconia Implants are intended for use as an adapter between the implant and the crown. The abutments are characterized by distinct geometrical features such as length and angulation. The titanium abutments are manufactured from ASTM F136-13 compatible Titanium Ti 6Al 4V ELI & Anodize. TAV Medical abutments are intended to be connected to 2-piece W Zirconia implants with titanium screw, to provide support for prosthetic reconstructions. The abutments are available in the following dimensions: Length of 5.0mm and 6.0mm and Angles of 0°, 5°, 10° and 15°. The 0º serves also for bridges.
The provided document is a 510(k) Premarket Notification for the TAV Medical Ltd. W Zirconia Implants. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set and ground truth in the way one might evaluate a diagnostic AI system.
However, I can extract the information related to performance testing that supports the claim of substantial equivalence.
Here's an analysis of the "acceptance criteria" (which are more akin to performance benchmarks against predicate devices and regulatory standards in this context) and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are implicitly meeting the performance of predicate devices and adherence to relevant ISO standards and FDA guidance documents. The document doesn't explicitly list numerical acceptance criteria with pass/fail thresholds in the same way a diagnostic AI study would. Instead, it states that the subject device's performance was "substantially equivalent" to the predicate devices and conformed to standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Conformance | Material (Yttria stabilized tetragonal zirconia, Y-TZP) conforms with ISO 13356:2015. |
| Biocompatibility | Established through identical manufacturing methods, facility, raw materials as the primary predicate device (K172668), |
| and compliance with ISO 10993-1, 10993-5 and FDA Guidance for Use of ISO 10993-1. No additional tests were conducted, as it was concluded biocompatibility was already established. | |
| Sterilization (Implants) | Validation leveraged from primary predicate K172668, conducted in accordance with ANSI/AAMI/ISO 11137-2:2013. Achieved SAL of 10^-6. |
| Sterilization (Abutments) | Steam heat sterilization validation performed in compliance with FDA Guidance (Jan 21, 2016) and ANSI/AAMI/ISO 17665-1:2006. Achieved SAL of 10^-6. |
| Shelf Life | Accelerated aging applied to final packaging, followed by real-time aging validating implants packaging. (No specific duration or results reported in this summary, but implies positive validation). |
| Mechanical Performance (Fatigue Testing) | Performed according to FDA guidance (May 2004) and ISO 14801:2016. Results indicated substantial equivalence to the primary predicate device. |
| Mechanical Performance (Implant-to-Abutment Connection Wear) | Bench tests conducted after fatigue testing to assess wear of implant body, abutment, and fixation screw, and screw loosening. Data concluded 'comparable behavior' to reference devices. |
| Overall Equivalence | Same intended use, indications for use, mode of operation, materials, manufacturing technology, and body contact as predicate devices, demonstrating substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (dental implants), not an AI algorithm. Therefore, the concept of a "test set" for an AI model (like images with ground truth labels) does not directly apply.
- Mechanical Testing: While not explicitly stated as "sample size," mechanical tests (like fatigue testing and wear assessment) would involve a certain number of physical implant samples. This information is typically detailed in the full test reports, which are not included in this 510(k) summary. The summary only states that tests were performed according to ISO standards, which define methodologies including sample numbers.
- Data Provenance: Not applicable in the context of an AI test set. The provenance of the device components (materials, manufacturing) is Israel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as this is a physical medical device, not a diagnostic AI system requiring expert-established ground truth for a test set. Evaluation relies on established engineering principles, material science, and bio-compatibility standards through laboratory testing.
4. Adjudication Method for the Test Set
Not applicable for a physical medical device. Decisions are based on objective measurements against engineering standards.
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 diagnostic 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
For a physical medical device, "ground truth" refers to established scientific and engineering principles, validated test methodologies, and regulatory standards.
- Material Properties: Conformance to ISO 13356:2015.
- Biocompatibility: Demonstrated through adherence to ISO 10993-1, 10993-5, and FDA guidance.
- Sterilization: Demonstrated through adherence to ANSI/AAMI/ISO 11137-2:2013 and ANSI/AAMI/ISO 17665-1:2006, and FDA guidance.
- Mechanical Performance: Demonstrated through adherence to FDA guidance (May 2004) and ISO 14801:2016. Testing involved objective measurements of fatigue life, wear, and screw loosening.
The underlying "ground truth" is that the device must meet the performance and safety requirements outlined in these standards and guidance documents, demonstrating substantial equivalence to legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable as this is a physical medical device.
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(90 days)
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann implants.
The Straumann® Retentive System (to which PUREloc belongs) is designed for the use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The Straumann® Retentive System consists of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in different sizes and angles to fit individual patient needs. Straumann® PUREloc abutments are used exclusively on the Straumann PURE Ceramic Implants, are available in 6 heights (1 mm, 2 mm, 3 mm, 4 mm, 5 mm, and 6 mm) and made of Yttrium-stabilized zirconia ceramic (ISO 13356 - Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)). The Straumann® PUREloc abutments are non-engaging and the implant-to-abutment connection is provided for by the basal screw. The basal screw is manufactured from Titanium Grade 4 and is identical to the basal screw cleared under K180477.
This is a 510(k) premarket notification for the Straumann® PUREloc abutments. It describes the device, its intended use, and compares its technological characteristics to predicate and reference devices. However, this document does not contain acceptance criteria for an AI/ML device or a study demonstrating the device meets such criteria.
The information provided in this document pertains to traditional medical device clearance, focusing on:
- Substantial Equivalence: Comparing the proposed device to legally marketed predicate devices.
- Performance Testing: Bench testing (dynamic fatigue, snapping force, dynamic force), sterilization validation, and biocompatibility evaluations.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, MRMC study, or standalone algorithm performance) related to an AI/ML device from this document. The document describes criteria for dental implant abutments, not an AI/ML system.
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