(69 days)
The ReSolve ™ QuickAnchor is used for the fixation of absorbable monofilament polydioxanone surgical suture to bone. This product is intended for the following indications:
Cranio/Maxillofacial:
Repair, reconstruction or reattachment of tendons, 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 document describes a medical device, the ReSolve™ QuickAnchor, and its 510(k) premarket notification. It outlines performance data related to its safety and mechanical characteristics, rather than diagnostic or AI-driven performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable as they relate to studies of diagnostic accuracy or AI system performance.
Here's an analysis of the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Testing |
|---|---|
| Sufficient pullout force for intended use | Pullout force testing (preserved human cadaver skull) |
| Comparable strength to predicate devices | Strength comparison (ReSolve vs. Mitek Micro Anchor) |
| Appropriate for skull thickness | Skull thickness measurements |
| Biocompatibility | Not explicitly detailed in the performance section, but mentioned as having "similarities" to predicate devices, implying compliance. |
| Sterilization method | Not explicitly detailed in the performance section, but mentioned as having "similarities" to predicate devices, implying compliance. |
| Design and Operating Principle | Mentioned as having "similarities" to predicate devices, implying compliance. |
| Materials | Mentioned as having "similarities" to predicate devices, implying compliance. |
Study Proving Acceptance Criteria:
The study conducted to prove the device meets acceptance criteria involved several mechanical and material tests.
1. Table of Acceptance Criteria and Reported Device Performance (as above)
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "preserved human cadaver skull" for pullout force testing but does not provide the number of specimens or tests conducted.
- Data Provenance: The pullout force testing was conducted on "preserved human cadaver skull," indicating the use of human anatomical specimens, likely from the country where the testing was performed (not specified). This is a prospective study in terms of testing the device, but the cadaver material itself is "retrospective" in the sense that it's from deceased individuals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a mechanical implant, not a diagnostic tool or AI algorithm. Ground truth, in this context, would be established by physical measurements and engineering standards, not expert interpretation of outputs.
4. Adjudication method for the test set:
- Not Applicable. As this is a mechanical device being tested for physical properties, there is no "adjudication method" in the sense of reconciling subjective expert interpretations. Results would be based on quantitative measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not a diagnostic device or AI system that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the performance testing of this device is derived from direct physical measurements and mechanical properties. For example:
- Pullout force: Measured by applying a force until the anchor disengages, compared against established biomechanical requirements for similar devices or anatomical structures.
- Strength comparison: Directly comparing measured forces/strengths of the ReSolve™ QuickAnchor against those of predicate devices.
- Skull thickness measurements: Direct physical measurements of skull bone thickness to ensure the device is compatible with the intended anatomical sites.
- It is based on objective, quantifiable engineering and biomechanical principles, not expert consensus, pathology, or outcomes data in the traditional sense of diagnostic validation.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is a physical device, not an AI algorithm.
§ 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.