(73 days)
The TALON™ Anchor Snap-Pak is used for the fixation of non-absorbable braided surgical suture to bone. This product is intended for the following indications:
Cranio/Maxillofacial: Repair and reconstruction or reattachment of tendons and ligaments, muscles and soft tissue flaps to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma and periorbital bones of the skull.
The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.
The provided text describes a medical device, the TALON™ Anchor Snap-Pak, and its clearance process through a 510(k) submission. This document is a regulatory submission for a physical medical device, not a software or AI-powered diagnostic tool. Therefore, many of the requested categories for AI/software device evaluation (like ground truth establishment, training sets, multi-reader studies, effect sizes for human improvement with AI assistance) are not applicable.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance Study for TALON™ Anchor Snap-Pak
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing) | Reported Device Performance |
|---|---|
| Pull-out force (preserved human cadaver skull) | Demonstrated strength comparison against Mitek Micro Anchor (predicate) |
| Strength comparison (TALON vs. Mitek Micro Anchor) | Demonstrated comparable strength to Mitek Micro Anchor (predicate) |
Note: The document states that "safety and performance data has been provided to support substantial equivalence." The specific numerical or statistical acceptance criteria for pull-out force and strength comparison are not explicitly detailed in this summary. The conclusion states that the device was found substantially equivalent based on these data, implying the performance met the thresholds for equivalence to the predicate device.
Regarding the other requested information, the document does not provide details for the following as it pertains to a physical implantable device, not an AI/software device:
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 as this is not an AI/software device. The testing was conducted on "preserved human cadaver skull." No specific sample size for cadavers is given in this summary.
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. This is not an AI/software device requiring expert ground truth for diagnostic accuracy.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for a physical device performance study. The "ground truth" here would be the physical measurement of pull-out force and strength, which are objective engineering measurements.
8. The sample size for the training set
- Not applicable. This concept applies to AI/machine learning models, not physical device testing.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Relevant Information from the Provided Text:
- Device: TALON™ Anchor Snap-Pak (bone fixation staple).
- Purpose of Study: To demonstrate substantial equivalence to predicate devices (K931782 - Mitek LS Anchor, K962511, K982420 - Mitek Micro Anchor).
- Key Performance Tests:
- Pull-out force (using preserved human cadaver skull).
- Strength comparison (TALON vs. Mitek Micro Anchor).
- Conclusion: The device was found to be substantially equivalent based on safety and performance data, similarities in design, operating principle, materials, biocompatibility, and sterilization method. The specific numerical results of the "pull-out force" or "strength comparison" that met the acceptance criteria for substantial equivalence are not provided in this summary.
§ 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.