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The Alpha-Bio Bone Fixation Screw System® is used to stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.

The Alpha-Bio Bone Fixation Screw System consists of titanium alloy Gr-5 screws with 1.2mmd and 1.6mmd diameter, and with 4mm-12mm lengths. This system includes drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure

The provided document is a 510(k) premarket notification for a medical device, the Alpha-Bio Tec® Bone Fixation Screw System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is largely not applicable to this type of submission.

Here's an explanation based on the provided text:

1. Table of acceptance criteria and reported device performance: Not applicable. For a 510(k) submission, especially for a device like a bone fixation screw system, "acceptance criteria" are generally related to demonstrating substantial equivalence in terms of materials, intended use, and mechanical performance, rather than clinical performance metrics. The document states "No performance standards have been established for such devices under Section 514 of the Federal Food, Drug, and Cosmetic Act." and instead refers to compliance with recognized standards for biocompatibility, materials, and resistance (see point 1 below for details).

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 submission does not describe a clinical study with a "test set" in the context of AI/diagnostic device evaluation. The "performance and safety testing" mentioned (Section J) refers to bench testing to demonstrate physical properties and biocompatibility, not clinical outcomes from patient 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): Not applicable. No clinical "ground truth" or expert review of clinical data is described in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical "test set" requiring adjudication 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 device is a bone fixation screw system, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a device like this relates to its physical and biological properties.

8. The sample size for the training set: Not applicable. There is no AI component or "training set" for this device.

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

However, the document does contain information relevant to the device's "acceptance" based on recognized standards and equivalence to a predicate device:

Here's a breakdown of the relevant information from the provided text, re-framed to address the spirit of the request where possible:

1. Table of "Acceptance Criteria" (Standards Compliance) and Reported Device Performance (as implied by equivalence):

Summary of the Study (or Basis for Acceptance):

The "study" presented here is a 510(k) Premarket Notification designed to demonstrate substantial equivalence to legally marketed predicate devices, not to prove meeting specific clinical performance acceptance criteria in the manner of an AI diagnostic device.

• Basis for Acceptance: The device is accepted because it has been shown to be substantially equivalent to predicate devices (Straumann K050515; K011698) in terms of intended use, indications for use, technological characteristics (Titanium alloy Gr-5, specific diameters and lengths), and performance. This equivalence is supported by compliance with recognized international and ASTM standards for biocompatibility, material composition, and instrument durability, as well as general "safety and performance testing" (likely bench testing) that confirmed comparable physical and mechanical properties.
• Key points from the submission:
  • Device Description: Consists of titanium alloy Gr-5 screws (1.2mmd and 1.6mmd diameter, 4mm-12mm lengths) and a drill instrument for fixation in oral cavity bone regeneration procedures.
  • Intended Use/Indications for Use: Stabilize and fixate bone grafts, bone filling materials, and/or barrier membranes for bone regeneration in the oral cavity.
  • Predicate Devices: Straumann K050515; K011698.
  • Equivalence Justification: No unique applications, indications, materials, or specifications compared to the predicate. Intended use and indications were previously cleared for the predicate. Technical characteristics are similar. Safety and performance testing (bench-level) was conducted.
  • Conclusion: The Alpha-Bio Tec® is substantially equivalent to its predicate devices and "raises no new safety and/or effectiveness issues."

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