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The MC Bio Supertack tacks are used for the stabilization of absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area.

The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.

General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.

The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio SUPERTACK system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone.

Gnereral patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.

The MC Bio SUPERTACK System consists of 3mm, 4mm and 5mm bone tacks and associated instrumentation.

The tacks material consist of Titanium alloy, as specified in ASTM F136 STANDARD for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy, anodized blue color.

The devices are provided non-sterile.

This document is a 510(k) premarket notification for a medical device called the "MC BIO SuperTack" tack, which is used for stabilizing absorbable membranes during bone tissue regeneration and repair in the maxillofacial or mandibular area. The document establishes substantial equivalence to a predicate device (SALVIN Bone Tack) rather than presenting a study for acceptance criteria and reported device performance in the typical sense of a diagnostic or AI device.

Therefore, the requested information (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, training set information) is not applicable to this submission, as it is a device clearance based on substantial equivalence, not a performance study as would be seen for a new diagnostic algorithm or a clinical trial.

However, I can extract the information on non-clinical testing performed to establish equivalence:

Non-Clinical Testing and Equivalence Conclusion:

Instead of acceptance criteria and device performance in a clinical or diagnostic context, the submission focuses on demonstrating substantial equivalence to a predicate device (SALVIN Bone Tack 3mm and 5mm) through technological comparisons and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable for this type of submission. The mechanical and biocompatibility tests are conducted on test samples of the device, not a "test set" of patient data. The document does not specify the number of samples used for these non-clinical tests. Data provenance for such tests would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth here is based on engineering standards (ASTM F136), laboratory test results for biocompatibility, and manufacturing specifications, not expert clinical consensus on a patient dataset.

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 or diagnostic device that involves human readers.

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

• Not applicable. This is not an algorithm.

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

• For biocompatibility: Established laboratory test standards (MTT cytotoxicity using cell cultures).
• For sterilization: Validated sterilization cycle aligned with established medical device sterilization standards.
• For mechanical properties: Engineering flexional tests compared against the properties of the predicate device.
• For design/material: Comparison to technical drawings and material specifications (ASTM F136) of the predicate device and the new device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable.

Conclusion from The Document:

The submission concludes that the MC Bio Supertack tacks are "substantially equivalent" to the legally marketed predicate device based on:

• Engineering inspections
• Dimensional and technological comparisons
• MTT cytotoxicity test results
• Sterilization validation
• Flexional test results
• Material (Titanium alloy as specified in ASTM F136 standard)
• Intended Use
• Manufacturing process (anodization for blue color does not modify biocompatibility).

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