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The Prodigy System endosseous implants may be used in the mandible and maxilla for fixed single tooth replacement or as abutments for fixed bridgework and denture retention.

The Prodigy System dental implants are machined titanium, screw-form implants supplied in 3.5mm, 4mm, 5mm, 6mm diameters across lengths of 9mm, 10.5mm, 12mm and 15mm. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications. The devices are further processed by roughening the surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM F 1185, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants, to promote implant fixation. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 108, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization. The Prodigy System is a comprehensive system consisting of dental implants and surgical components.

This document is a 510(k) premarket notification for a dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria for a new device. Therefore, a direct answer to your request in the format you provided is not fully possible.

However, I can extract the relevant information and explain why certain sections of your request cannot be fulfilled based on the provided text.

Here's a breakdown of what can be inferred and what is missing:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report device performance in the way a clinical study would for a new medical device. Instead, it argues for substantial equivalence to existing predicate devices.

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

Not applicable. This is a 510(k) submission, not a clinical study report. There is no "test set" of patient data or clinical outcomes in the provided text. The "test" for the 510(k) is demonstrating that the characteristics of the new device are substantially equivalent to those of legally marketed predicate devices.

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. As this is not a clinical study involving diagnostic accuracy or treatment outcomes, there is no "ground truth" established by experts in this context.

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

Not applicable. No test set or expert adjudication process is described.

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 medical device (dental implant) and not an AI/imaging device, so MRMC studies or AI assistance are irrelevant to this submission.

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

Not applicable. See point 5.

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

Not applicable. See point 3.

8. The sample size for the training set

Not applicable. This is not a study involving a training set for an algorithm.

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

Not applicable. See point 8.

Summary of Device Comparison (from the provided text):

The core of the 510(k) submission is to demonstrate that the Prodigy System™ Dental Implants are substantially equivalent to BioHorizons The Maestro™ System dental implants. The rationale for equivalence is based on:

• Identical fundamental scientific technology: "The fundamental scientific technology of the device is identical to the referenced predicate devices."
• Identical materials: "All materials... remain the same as for the predicate BioHorizons Maestro System endosseous implants." (Raw material: titanium alloy as specified in ASTM F 136; HA coating conforming to ASTM F 1185).
• Identical packaging and sterilization methods: "packaging and sterilization methods remain the same as for the predicate BioHorizons Maestro System endosseous implants." (Minimum sterility assurance level of 10⁻⁶, validated in compliance to ANSI/AAMI/ISO 11137).
• Substantially equivalent design: "The BioHorizons Prodigy System device... and its specifications are substantially equivalent to all features of the products in design, material and intended use."
• Identical intended use: "The intended use of The Prodigy System endosseous implants may be used in the human mandible and maxilla for single tooth replacement or as abutments for fixed bridgework and denture retention." This matches the predicate's intended use.
• Similar physical characteristics: The document lists various diameters (3.5mm, 4mm, 5mm, 6mm) and lengths (9mm, 10.5mm, 12mm, 15mm) and surface treatments (tricalcium phosphate blast media or hydroxylapatite coating), which are presented as comparable to the predicate.

Conclusion from the document: The FDA letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This "substantial equivalence" is the "acceptance criteria" and "proof" in the context of a 510(k) submission.

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