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USTOMED Bone Fixation/Bone Augmentation Systems – PIN is intended for fastening membranes during bone regenerative treatment.

USTOMED Bone Fixation/Bone Augmentation Systems – PIN consists of a titanium pin. The Pin can be used to fasten third-party non-absorbable PTFE and titanium-reinforced membranes up to a thickness of 1.0mm cleared by FDA for stabilization and support of bone grafts in dento-alveolar bony defect sites (product code JEY). After fulfilling its supportive function, which is typically achieved within three to nine months, the Pin must be removed, as it is not intended to remain in the body permanently.

The Pin are intended for single use and provided non-sterile for cleaning and sterilization by the user before use.

This 510(k) clearance letter pertains to a Class II medical device, the USTOMED Bone Fixation/Bone Augmentation Systems - PIN. The letter states that the device has been found substantially equivalent to a predicate device (NEOSS Ltd.'s Membrane Tack, K201561).

The information provided in this 510(k) summary focuses primarily on demonstrating substantial equivalence through a comparison of technological characteristics and performance testing to ensure the device meets established safety and performance standards. It does not describe a clinical study of diagnostic performance, but rather engineering and material tests typical for an implantable device with a mechanical function.

However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for each test mentioned (dimensional verification, reprocessing validation, mechanical testing, biocompatibility, cytotoxicity, materials chemical analysis). These are likely engineering and laboratory tests, not clinical trials with patient data. Therefore, "data provenance" in terms of country of origin of patient data or retrospective/prospective is not applicable to these types of tests. The data provenance would be laboratory testing conducted by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable to the types of tests described. These are not diagnostic accuracy studies requiring expert reads of images or clinical assessments to establish ground truth. The "ground truth" for these tests is established by the specifications and standards (e.g., ASTM F543-17, ISO 10993).

4. Adjudication Method for the Test Set

Not applicable. The tests described are laboratory and engineering tests with objective pass/fail criteria based on established standards, not subjective assessments requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance, to assess changes in diagnostic performance. This device is a bone fixation pin and therefore, this type of study is not relevant for its clearance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "performance testing" described (dimensional verification, mechanical testing, biocompatibility, etc.) are all standalone tests of the device's physical and material properties, independent of human interaction during testing, beyond setting up the experiment. This device is not an AI algorithm, so the term "algorithm only" is not directly applicable.

7. The Type of Ground Truth Used

The ground truth for these performance tests is based on engineering specifications, material science standards (e.g., ISO 10993, ASTM F543-17), and documented reprocessing protocols. For example, for dimensional verification, the ground truth is the specified dimensions from the device design. For mechanical testing, the ground truth is the expected mechanical properties as defined by the ASTM standard for a similar device. For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by ISO standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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