(77 days)
The Membrane Tack is a titanium alloy, machined, miniature nail designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The guided tissue regeneration membranes are intended for use in wrapping bone or cartilage, or in soft tissue defects when bony or soft tissue ingrowth and attachment is required Guided tissue regeneration membranes are also appropriate for augmentation of slight tissue deficiencies. These are medical devices currently cleared by FDA and commercially available for sale in the United States. While not yet classified by FDA, the FDA Dental Advisory Panel has recommended a Class II Classification for guided tissue regeneration devices, both resorbable and non-resorbable.
The IMZ Membrane Tack System consists of components and instruments designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The Membrane Tack is fabricated of titanium alloy and has a thin low profile head and a barb at the tip for stabilization.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IMZ Membrane Tack System:
Summary of Acceptance Criteria and Device Performance (from the Provided Text):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull Force (Membrane Stabilization) | Membrane material does not possess the strength to pull the implanted Tack out of the bone without compromising itself in the process. |
Detailed Study Information:
-
A table of acceptance criteria and the reported device performance:
(See table above) -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The text only mentions "Pull Force testing of the IMZ Membrane Tack was performed using membrane material tacked into cortical and cancellous bone." The number of samples (tacks, membrane pieces, bone samples) is not provided.
- Data Provenance: Not explicitly stated. This appears to be a laboratory-based non-clinical test. No information about country of origin or whether it was retrospective/prospective is given.
-
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):
- This document describes a non-clinical, physical performance test. Therefore, there were no human "experts" establishing a ground truth in the context of diagnostic interpretation. The "ground truth" was the physical outcome of the pull force test – whether the tack remained in place or the membrane failed first.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was a non-clinical physical performance test, not a human reader study requiring adjudication.
-
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 document describes a non-clinical test for a physical medical device (a bone tack), not an AI/software device. No MRMC study was performed or mentioned.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm or AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this non-clinical test was the direct mechanical observation of failure mode during the pull force testing. Specifically, the observation was that the membrane failed before the tack was dislodged, indicating sufficient retentive force of the tack.
-
The sample size for the training set:
- Not applicable. This is a physical medical device undergoing non-clinical testing, not an AI/machine learning model that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm was used.
Conclusion based on the provided text:
The provided 510(k) summary focuses on the non-clinical functional performance of the IMZ Membrane Tack. The only acceptance criterion and corresponding performance mentioned relates to the tack's ability to retain the membrane under pull force. The study conducted was a direct mechanical pull force test. The document lacks details on the specific methodology of this test, such as the number of samples, precise force applied, or detailed quantitative results beyond the qualitative statement of the membrane failing before the tack.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.