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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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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 dental implants are provided in body diameters of 4 mm and 5 mm, and each diameter is provided in 8, 10, and 12 mm lengths. The dental implants are manufactured from Y - TZP zirconia conforming to ISO 13356. The system also includes a healing cap, gingiva formers, and a temporary abutment manufactured from polyetheretherketone (PEEK). Zircoma 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. Occlusal (abutment) screws are provided in Ti-6Al-4V alloy conforming to ASTM F136 and in zirconia.

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

The provided text is a 510(k) summary for the Z5-BL dental implant. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data. However, it does not contain information about acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, or MRMC studies).

The document explicitly states: "No clinical data were included in this submission." This means there is no performance data related to human-in-the-loop studies, standalone AI performance, or any studies that would involve establishing ground truth from expert consensus or pathology for evaluating AI model performance.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria from the provided text, as it describes a traditional medical device submission for dental implants, not an AI/ML-driven device.

To answer your specific questions in the context of an AI/ML device, I would need a different type of document that describes performance data related to an AI/ML algorithm.

Ask a specific question about this device