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The Membrane Tack is indicated for use as a means of membrane fixation in Guided Bone Regeneration (GBR) procedures.

The Membrane Tack is a barrier membrane fixation tack used in oral/maxillofacial surgical procedures for stabilizing membranes in Guided Bone Regeneration (GBR) or Guided Tissue Regeneration (GBR) procedures or other clinical situations that require membrane use/fixation. The Membrane Tack is used to fixate commercially available resorbable and nonresorbable barrier membranes. The Membrane Tacks are made of LactoSorb® which are composed of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and Polylactic/polyglycolic acid copolymer glycolic acids. degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body.

The provided text is a 510(k) summary for a medical device called "Membrane Tack." It focuses on establishing substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with detailed performance metrics. Therefore, explicit information required to fill out the table and answer all questions about acceptance criteria and a detailed study is not available in the given document.

However, I can extract the information that is present and indicate where information is missing.

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

The document does not explicitly define acceptance criteria in terms of quantitative performance metrics (e.g., specific thresholds for strength or resorption rates that differentiate success from failure). Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.

The reported performance is qualitative and comparative:

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

• Sample Size for Test Set: Not specified. The document primarily refers to prior studies or general knowledge about the material (LactoSorb®) and comparisons to a predicate device. There is no new test set described for the Membrane Tack itself in this summary.
• Data Provenance: Not specified for any new testing. References are made to "animal studies" for LactoSorb® and "prior marketing" of LactoSorb® devices, implying historical data. No country of origin is mentioned.

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. The document does not describe a study involving expert assessment to establish ground truth for a test set for this device. The assessment is based on material properties, prior use of the material, and comparison to a predicate device.

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

Not applicable. No expert-adjudicated test set 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 physical medical device (a tack for membrane fixation), not an AI diagnostic or assistance tool. Therefore, an MRMC study related to interpretation by human readers is irrelevant.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" for the claims in this submission is derived from:

• Material Science Data: Properties of LactoSorb® concerning degradation, resorption, and biocompatibility.
• Pre-clinical (Animal) Studies: Mentioned for LactoSorb®'s biocompatibility.
• Clinical Experience/Outcomes Data (Indirect): Reference to LactoSorb® devices being "marketed for over two years" and found "both safe and effective" in other applications.
• Comparison to a Predicate Device: The primary method for proving substantial equivalence. The predicate device's established safety and effectiveness serve as a benchmark.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set in the machine learning sense.

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

Not applicable. As above, this is not an AI algorithm.

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