Search Results

The resorbable IMTEC BioPin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment mechanism.Its use is intended to avoid a second stage surgery required to remove nonresorbable tacks and pins.

The IMTEC BioPin is a bioresorbable pin designed to fixate and stabilize bioresorbable barrier membranes in the oral cavity during the healing process following dental surgery. The pin provides an anchoring mechanism to resident and adjacent bone at the surgical site. The pin is fabricated from a bioresorable copolymer of L and DL lactide. The pin has a low profile, round, lens shaped head an a shaft with two circular ribs. It is provided in a sterile vial.

This 510(k) premarket notification for the IMTEC BioPin focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a study with acceptance criteria and a detailed performance report. Therefore, much of the requested information regarding acceptance criteria and study specifics is not available directly from the provided text.

The submission primarily establishes that the IMTEC BioPin has similar design, materials, configuration, sterilization methods, and technological characteristics to already marketed predicate devices, and is intended for the same indications for use. This approach is common for 510(k) submissions where a new device is compared to a legally marketed predicate device.

Here's a breakdown of the available and unavailable information based on your request:

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

• Acceptance Criteria: Not explicitly stated or provided in a quantitative form within the document. The "acceptance criteria" for a 510(k) submission like this is primarily the demonstration of substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
• Reported Device Performance: No specific quantitative performance data (e.g., success rates, complication rates, degradation times) for the IMTEC BioPin itself are reported in this document. The submission relies on the established performance and safety profiles of the predicate devices.

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 / Not provided. This 510(k) submission does not describe a clinical or performance study with a "test set" in the sense of a controlled experiment. Instead, it relies on comparison to existing predicate devices.

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 / Not provided. As no specific "test set" study is described, there's no mention of experts establishing ground truth for such a study.

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

• Not applicable / Not provided.

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 bioresorbable pin, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

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

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

• Not applicable / Not provided. Since no specific performance study is detailed, there's no mention of how "ground truth" would have been established. The "ground truth" for a 510(k) in this context is implicitly the regulatory acceptance and safe/effective use of the predicate devices.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" described, as this is not an algorithm-based device.

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

• Not applicable / Not provided.

Summary of Approach for K982951:

The core of this 510(k) submission, as presented, is the demonstration of substantial equivalence to predicate devices. This means:

• Indications for Use: The IMTEC BioPin is intended for the same use as predicate devices: to stabilize bioresorbable guided tissue regeneration membranes during healing, specifically to avoid a second surgery for removal of non-resorbable pins.
• Technological Characteristics: The manufacturer asserts that the IMTEC BioPin is "similar" to predicate devices in terms of design, material (bioresorbable copolymer of L and DL lactide), configuration, and sterilization method. The material, PURASORB PL, is specified, and its molecular weight is given.
• Safety and Effectiveness: By demonstrating similarities to legally marketed predicate devices, the submission implicitly argues that the IMTEC BioPin will be as safe and effective as those already approved devices. The FDA's letter (K982951) confirms this determination of substantial equivalence.

In essence, for this type of device and 510(k) submission, the "acceptance criteria" are met by successfully arguing to the FDA that the new device is sufficiently similar to existing approved devices that it raises no new questions of safety or effectiveness. No new clinical performance study data would typically be required to prove this for a straightforward substantial equivalence pathway.

Ask a specific question about this device