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The Intra-Lock Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.

The Intra-Lock International Dental Implant System consists of root form dental implants and restorative components which provide the clinician with screw retained and removable overdenutre This system also includes prosthetic instrumentation, surgical drills, hand type restorative options. instruments, surgical trays and handpiece adapters for use in the surgical procedures. The implants are sterile packaged and include cover screws and a placement instrument. Prosthetic devices are packaged separately to allow the clinician to choose the appropriate means for restoration after osseointegration. Implant bodies are subjected to a surface treatment of blasting with resorbable blast media and then acid passivation to roughen the surface.

The provided text does NOT contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics. Instead, it describes a Special 510(k): Abbreviated 510(k) submission for the Intra-Lock Dental Implant System.

This type of submission relies on demonstrating substantial equivalence to predicate devices and conformity with recognized guidance documents, rather than presenting a standalone performance study with detailed acceptance criteria and reported metrics in the way one might expect for a novel AI/software device.

Here's an analysis of why the requested information cannot be fully provided from the given text:

• Device Type: This submission is for a dental implant system, which is a physical medical device, not a software or AI device. The questions in the prompt (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm only without human-in-the loop performance," "sample size for the training set") are typically relevant for AI/ML-based medical devices.
• Approval Pathway: The "Special 510(k)" pathway focuses on demonstrating substantial equivalence to predicate devices (other legally marketed dental implants) and adherence to recognized consensus standards and FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA"). It does not typically involve the type of clinical performance study with defined, quantitative acceptance criteria and reported device performance metrics in the same vein as an AI/ML device.

Therefore, many of the requested fields are not applicable or cannot be extracted directly from this type of 510(k) summary.

Based on the available information, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance: This information is NOT present. Special 510(k)s typically don't present performance data in this structured way. The "acceptance criteria" here would be conformity to the special controls guidance and substantial equivalence to predicates, not specific quantitative performance metrics like sensitivity/specificity for an AI device.

2. Sample sized used for the test set and the data provenance: Not applicable in the context of this 510(k) for a physical implant system. There's no "test set" in the sense of a dataset for an algorithm. The "testing" would involve bench testing for mechanical properties (not detailed here) and potentially clinical experience with predicate devices or the device itself, but not a defined test set for performance evaluation as with AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant would relate to successful osseointegration, long-term stability, lack of adverse events, etc. This is established through clinical practice and follow-up, not a "test set" with expert adjudication in the AI sense.

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: Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a dental implant, the "ground truth" for proving safety and effectiveness would implicitly be long-term clinical outcomes (e.g., successful osseointegration, lack of infection, stability, patient satisfaction), supported by a history of safe use of predicate devices and adherence to relevant standards for biocompatibility and mechanical properties. This document does not detail specific ground truth data collection for this specific device within a clinical study described here.

8. The sample size for the training set: Not applicable. This is not an AI device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary of what the document does state about proving safety and effectiveness:

• Methodology: The submission is a "Special 510(k): Abbreviated 510(k)," meaning it relies on demonstrating conformity with FDA's guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA."
• Basis for Conclusion: "Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock Dental Implant System has been shown to be safe and effective for its intended use."
• Predicate Devices: The submission references several predicate dental implant systems (Branemark Dental Implant System, Branemark MkII Dental Implants, Lifecore Self Tapping Implants, Lifecore Stage 1 RBM Implants, ITI Strauman One Part Implants). The safety and effectiveness of the Intra-Lock system are established by demonstrating its substantial equivalence to these already-marketed devices.
• Technological Characteristics: The product description details features like "root form dental implants," "screw retained and removable overdenutre options," "surface treatment of blasting with resorbable blast media and then acid passivation to roughen the surface." These characteristics are compared to those of the predicate devices and conform to accepted standards.

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