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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.

Regarding the other points of your request:

• 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.

• 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.

• 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.

• 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.

• 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.

• 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."

• 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.

• 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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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.

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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Z5-TL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-TL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-TL implants are intended for delayed loading.

Z5-TL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for tissue level placement. The dental implants are provided in two endosseous body diameters (4 mm and 5 mm) and each diameter is provided in three endosseous lengths (8 mm, 10 mm, and 12 mm). The corresponding platform diameters are: 4.8 mm platform diameter for 4 mm body diameter, and 6 mm platform diameter for 5 mm body diameter. The dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The system also includes gingiva formers and a temporary abutment manufactured from polyetheretherketone (PEEK). Zirconia abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, zirconia Locator-type abutments are provided in straight and 15° angled designs.

The subject device is compatible with the following components cleared in K190243: a healing cap manufactured from PEEK; Locator-type abutments manufactured from zirconia; and occlusal (abutment) screws manufactured from zirconia and from Ti-6Al-4V alloy conforming to ASTM F136.

The subject device implants are provided sterilized by plasma gas. All other subject device components are to be sterilized by the end user by moist heat (steam).

The provided text describes a 510(k) premarket notification for a dental implant system (Z5-TL) and does not contain information about the acceptance criteria and study design you've requested for typical AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to already-marketed predicate devices, primarily through non-clinical data.

Therefore, I cannot populate the table or provide answers to most of your questions as the information is not present in the provided text.

Here is what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or tabulated performance data for an AI/ML device are provided in this document. The performance data discussed relates to the mechanical properties and sterilization of the dental implant itself.

2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device relying on a test set of data. The "performance data" section refers to non-clinical testing of the dental implant's physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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
No MRMC study was mentioned or performed, as this is not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" would be established by validated test methods and physical measurements according to specified ISO and ASTM standards.

8. The sample size for the training set
Not applicable.

9. How the ground truth for the training set was established
Not applicable.

Summary of relevant performance data (non-clinical, from the document):

The performance data submitted was non-clinical and aimed to demonstrate substantial equivalence of the Z5-TL dental implant device.

• Sterilization Validation: According to ISO 14937 and ISO 17665-1 (referenced from predicate K132881).
• Sterile Product Shelf Life Testing: According to ISO 11607-1, ISO 11607-2, ASTM F1886/F1886M, and ASTM D3078 (referenced from predicate K132881).
• Biocompatibility of PEEK material: According to ISO 10993-3, ISO 10993-12, ISO 10993-10, ISO 19003-11, ISO 10993-18, and USP Class VI testing according to USP 37-NF32 (referenced from predicate K190243).
• Static compression and compression fatigue testing: Of the zirconia implants and abutments according to ISO 14801.
• Assessment of abutment screw loosening and removal torque testing: According to ISO 18130, after insertion and dynamic testing (ISO 14801), including microscopic examination, and comparison to reference devices K063286 and K072642.
• Assessment of wear particles: Associated with the Ti-6A1-V alloy abutment screw used with zirconia implant bodies and abutments after dynamic testing (ISO 14801), including light microscopy and SEM/EDX, and comparison to all-titanium constructs of reference devices K063286 and K072642 (leveraged from K190243).

Conclusion on Performance: The document states that the non-clinical data demonstrated that the device has "sufficient strength for their intended use" and supports substantial equivalence to the predicate devices. No clinical data was included in the submission.

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Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.

Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The subject device includes dental implants provided in one body diameter of 3.6 mm in lengths of 8 mm, 10 mm. The subject device also includes a gingiva former, straight abutments for single-unit cemented restorations, and a 15° angled abutment also for single-unit cemented restorations.

The subject device is compatible with components cleared previously in K190243, including a healing cap, straight abutments for multi-unit cemented restorations, Locator-type abutments for retention of overdentures, and occlusal (abutment) screws.

The subject device dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The subject device abutments are manufactured from Y-TZP zirconia conforming to ISO 13356, or from polyetheretherketone (PEEK).

The subject device implants are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).

The provided text describes a 510(k) premarket notification for a dental implant system (Z5-BL). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The information primarily focuses on non-clinical performance data and a comparison of technological characteristics, rather than reporting on a study demonstrating the device meets specific acceptance criteria in terms of clinical performance or human-AI effectiveness.

Therefore, many of the requested details, such as acceptance criteria for clinical performance, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable or not present in the provided document.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance:

The document does not specify quantitative clinical acceptance criteria for the Z5-BL device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance data and technological characteristics.

The "performance data" section lists the types of non-clinical tests performed and their respective standards. The implied acceptance criterion for these tests is conformance to the referenced international or national standards, which is then used to support the claim of substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Not applicable. This submission did not include clinical data or a "test set" in the context of clinical performance evaluation or AI model validation. The performance data listed are non-clinical, mechanical, and material tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical test set or ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set.

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 document describes a dental implant and does not involve AI or human reader improvement studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This document describes a dental implant and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical performance data, the "ground truth" is established by adherence to the respective international and national standards (e.g., ISO, ASTM, USP) for material properties, sterility, biocompatibility, and mechanical performance. These standards define the accepted methods and criteria for evaluating device properties.

8. The sample size for the training set:

• Not applicable. No training set for an AI model is mentioned.

9. How the ground truth for the training set was established:

• Not applicable. No training set for an AI model is mentioned.

In summary, this 510(k) submission for the Z5-BL dental implant relies on demonstrating substantial equivalence through comprehensive non-clinical testing according to established standards. It explicitly states, "No clinical data were included in this submission" (page 5). Therefore, the requested information pertaining to clinical studies, AI performance, ground truth, and expert evaluation for a test or training set is not present.

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SDS2.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations.

SDS2.2 dental implants are a two-piece implant system to fit a synthetic root replacement into the human jaw. The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. The SDS2.2 dental implant system with its included components is used to fix the prosthetic restoration and is suitable for patients with an intolerance to metal. The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS2.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined. SDS2.2 implants are provided in different length/ diameter combinations and with 2 different shoulder designs (standard shoulder and oval shoulder). The implants are provided sterile in sterile packaging and are intended for single use. The sterile packaging also includes the SDS2.2 cover screw made of PEEK (Polyetheretherketone), which can be used to protect the implant interface during the healing phase up to 180 days. SDS2.2 standard implant posts are made of Y-TZP and are attached to SDS 2.2 dental implants by cementation. During cementation, the implant posts are screw retained with the SDS2.2 standard PEEK screw to ensure implant post is fixed at final position. The SDS2.2 standard PEEK screw is removed before the cement is completely cured. After attachment to the SDS2.2 implant, standard implant posts enable cementation of prosthetic restorations. SDS2.2 standard implant posts are available in different designs. The SDS2.2 standard implant posts and SDS2.2 standard PEEK screws are provided non-sterile.

The document is a 510(k) premarket notification for the SDS2.2 dental implant system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices. The information provided heavily emphasizes physical and mechanical properties, material composition, manufacturing processes, and sterilization validation rather than AI/ML algorithm performance.

Therefore, many of the requested bullet points for describing AI/ML device acceptance criteria and study details cannot be directly answered from this document. The document describes a traditional medical device (dental implant) and its non-clinical testing for safety and effectiveness.

Here's an analysis based on the provided document, addressing what can be inferred and stating what cannot:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present acceptance criteria in a formal table with values for an AI/ML algorithm's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it discusses the device meeting "existing requirements and acceptance criteria" based on various regulatory standards and non-clinical tests.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. This document describes testing for a physical medical device (dental implant), not an AI/ML algorithm. The "test set" in this context refers to physical implants subjected to various lab tests (e.g., fatigue testing, material analysis). The sample sizes for these specific physical tests are not provided in this summary document.
• Data Provenance: Not applicable for AI/ML dataset. The "data" refers to the results of bench testing and physical-chemical characterization of the implant. There is no mention of country of origin or retrospective/prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth, in the context of AI/ML, refers to human annotations or confirmed diagnoses used to train and evaluate an algorithm. For a dental implant, "ground truth" is established through engineering and material science standards and confirmed by accredited lab testing, not by expert physicians interpreting images or data for AI.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers to resolve discrepancies in annotations or diagnoses for AI/ML ground truth. This is not relevant to the physical testing of a dental implant.

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:

No. An MRMC study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. This document describes a physical medical device and its non-clinical performance, not an AI/ML diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This concept is specific to AI/ML algorithm testing. The device is a physical implant; its "performance" is inherently "standalone" in mechanical terms, but it's not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for evaluating this device's performance is based on established engineering and material standards for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility) and the successful outcome of physical bench tests and material analyses. It's not based on clinical imaging, pathology, or outcomes data in the sense used for AI/ML.

8. The sample size for the training set:

Not applicable. There is no AI/ML training set discussed in this document.

9. How the ground truth for the training set was established:

Not applicable. There is no AI/ML training set discussed in this document.

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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.

W Zirconia Implants are suitable for one or two stage endosseous form of dental implants. One Piece and Two-Piece implants are available. The abutments are used in conjunction with the endosseous dental implant in order to support in the prosthetic rehabilitation. The implantation procedure can be accomplished, for the One-piece implant in a one stage and for the two piece implant in a one or two stage surgical procedures. TAV Medical's W Zirconia Implants are composed of the following implant models: W One Piece – monotype implant with integrated abutment. W Two Piece –implant for screw retained Abutment. In both implants the endosteal region is provided with a roughness with a Ra value of 2.3 µm. The implants and abutments are tissue level designed and includes a body portion (implant body diameter 4.1 mm with a 4.8 mm platform, and implant body diameter 4.8 mm with a 6.0 mm platform) 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). Each Two piece implant is accompanied with a standard titanium cover screw.

This document, K172668, describes the substantial equivalence determination for TAV Medical's W Zirconia Implants. It is a 510(k) Premarket Notification to the FDA, which means the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device. This is not a de novo application or a PMA, and therefore, the study information described below primarily focuses on non-clinical testing to demonstrate equivalence, rather than extensive clinical efficacy studies to establish new performance criteria.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices. The "reported device performance" demonstrates that the new device meets those equivalent characteristics through non-clinical testing. The document highlights various aspects, but direct quantifiable acceptance criteria with a single reported value for "reported device performance" are not presented in a concise table format in the provided text for all features.

However, based on the non-clinical testing section (5.19.3 Performance Testing) and the substantial equivalence tables (5.18), we can infer some key comparisons.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify exact sample sizes for the non-clinical bench testing (e.g., number of implants tested for fatigue). It generally states that "testing and evaluation" were performed and "validation results have demonstrated" adherence to standards.
• Data Provenance: All testing appears to be non-clinical bench testing performed by or for TAV Medical Ltd. The country of origin of the data is not explicitly stated beyond TAV Medical Ltd. being located in Israel. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts

• Not Applicable. Since no clinical studies were performed (Section 5.21), there was no "ground truth" established by human experts in a clinical setting for the performance of the device on patients. The "ground truth" for the non-clinical tests is established by the specified ISO/ASTM standards and the performance of the predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. As there were no clinical studies involving human readers or expert consensus, no adjudication method was employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. The submission states: "No clinical studies were performed" (Section 5.21) and "No Animal studies were performed" (Section 5.20).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device is a physical medical implant (dental implant), not a software algorithm or AI device. Therefore, the concept of "standalone algorithm performance" is not relevant here.

7. The Type of Ground Truth Used

• Standards-Based and Predicate Device Equivalence: The primary "ground truth" or reference for evaluating the W Zirconia Implants is compliance with recognized international and national standards (e.g., ISO 14801 for dynamic fatigue, ISO 10993-1 for biocompatibility) and demonstrated substantial equivalence to legally marketed predicate devices through comparable material properties, design features, and validated non-clinical performance.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Z5m(t) is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). It has a tapered implant body, a double thread design in the coronal third of the implant and a self-tapping apex. The Z5m(t) endosseous surface is laser modified, identical to the Z5m surface cleared under K120793. Z5m(t) and Z5m utilize the same prosthetic components. Z5m(t) is designed for single or multiple tooth restorations and provided in two diameters (4.0, and 5.0 mm), each in three lengths (8. 10, and 12 mm). The Z5m(t) implant system is suitable for patients with metal allergies and the chronic diseases resulting from them.

This document is a 510(k) Pre-market Notification for a dental implant system called Z5m(t). It does not describe an AI medical device or a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, AI performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and standalone AI performance cannot be extracted from this document.

However, I can extract the general "performance data" that was submitted for this non-AI device:

Performance Data for Z5m(t) Dental Implant System (Non-AI device)

This device is not an AI/ML device, so much of the requested information (AI performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies) is not applicable. The document describes performance data for the dental implant itself, focusing on physical and biological aspects, not a diagnostic or prognostic AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (dental implant) and not an AI algorithm, the "acceptance criteria" are related to product standards and validation rather than diagnostic performance metrics. Similarly, "reported device performance" refers to the validation results against these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of typical AI/ML test sets. The tests mentioned (sterilization, biocompatibility, mechanical) involve specific numbers of device units or biological assays per standard, but are not usually referred to as "test sets" in the AI sense.
• Data Provenance: Not applicable in the context of this type of device submission. The data would be generated in laboratories according to international standards (ISO).

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 device that requires expert-established ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI device that requires expert adjudication for a ground truth dataset.

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 device, and no human reader comparative effectiveness studies are mentioned.

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 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 and biological measurements against regulatory and industry standards (e.g., a device is sterile if it meets the SAL, it is biocompatible if it passes ISO 10993 tests, it is mechanically sound if it passes ISO 14801 fatigue tests).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm. No training set is used.

9. How the ground truth for the training set was established

Not applicable. This is a physical device, not an AI algorithm. No training set or ground truth for a training set is relevant.

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