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ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

ANKYLOS® C/X Implants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

The ANKYLOS® C/X Implant 6.6 mm represents a line extension of the currently marketed ANKYLOS® C/X Dental Implant System. It is an endosseous dental implant with a length of 6.6 mm and an internal tapered implant-abutment connection. The ANKYLOS® C/X Implant 6.6 mm is machined from Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67 -Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The ANKYLOS C/X 6.6 mm implants are provided in the diameters 3.5 mm, 4.5 mm, and 5.5 mm.

This looks like a 510(k) premarket notification for a dental implant system. Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The application states that the new device, the ANKYLOS® C/X Implant 6.6 mm, is a line extension of an already cleared device and has largely similar characteristics to its predicate device (K083805 - ANKYLOS® C/X Dental Implant System). The primary acceptance criteria for this type of submission are typically demonstrating substantial equivalence to a legally marketed predicate device, especially in terms of safety and effectiveness.

Here's a table based on the provided "Similarities and Differences" section and the described non-clinical performance data to outline the criteria and the device's performance against them:

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many implants were used for fatigue testing or CAD analysis. It simply states "Fatigue testing was conducted on the subject ANKYLOS® C/X Implant 6.6 mm in comparison to the predicate device" and "surface area and bone to implant contact have been calculated by CAD data for the ANKYLOS® C/X Implant 6.6 mm and the predicate device, respectively." For a 510(k) submission, especially for a line extension, the focus is often on representative samples demonstrating conformance to standards rather than large statistical cohorts typical of clinical trials.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of mechanical testing (fatigue, CAD), it's highly likely this was laboratory-based, prospective testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This type of submission focuses on non-clinical performance (mechanical testing and CAD analysis). Therefore, no external experts or clinicians were explicitly used to establish ground truth for a "test set" in the way one might for a diagnostic AI device. The ground truth is established by an international standard (ISO 14801) for fatigue testing and engineering principles for CAD analysis, performed by the manufacturer's qualified personnel.

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

• None. As explained above, this is a non-clinical, engineering-focused evaluation based on established standards and calculations rather than subjective assessment requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is a dental implant, which is a physical medical device, not a diagnostic AI system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable and was not performed.

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

• No. This is a physical dental implant, not an algorithm or AI system.

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

• The ground truth for the non-clinical performance data (fatigue, surface area, bone-to-implant contact) is derived from engineering standards (ISO 14801) and CAD calculations based on the device's design specifications for the implant and comparison to the predicate. The "ground truth" for the FMEA is based on risk analysis methodologies.

8. The sample size for the training set

• Not applicable. This device is a physical dental implant. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering principles, material science, and testing, not through training data in the AI sense.

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

• Not applicable. As there is no training set for an AI/algorithm, there is no ground truth established for one. The "truth" about the device's functionality is established through its design, material properties, and adherence to performance standards.

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