(90 days)
The MICROFIX QUICKANCHOR Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below: Hand: Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal), DIP (distal interphalangeal) and MCP (metacarpal interphalangeal) joints for all digits. Skull: Soft tissue attachment to the parietal, temporal ridge, frontal, mandible, maxilla, zygoma, and periorbital bones of the skull.
The MICROFIX QUICKANCHOR Plus is a bioabsorbable polymer implant designed for reattachment of soft tissue to bone. Similar to the currently marketed MICRO Anchor, the implant is mounted on a disposable inserter assembly and placement of the implant is facilitated via use of a sterile, disposable drill bit. There have been no modifications to the drill bit for use with the MICROFIX QUICKANCHOR Plus device.
Here's the analysis of the provided text regarding the acceptance criteria and study for the MICROFIX QUICKANCHOR Plus device:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document (K024115) is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not a study detailing specific acceptance criteria and performance against those criteria. In these types of submissions, the "acceptance criteria" are implied by demonstrating substantial equivalence to existing, legally marketed devices.
Therefore, the "acceptance criteria" is that the device must be shown to be substantially equivalent to the predicate devices in terms of technological characteristics, safety, and performance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (MICRO Anchor, ReSolve QuickAnchor, BIOFASTIN RC suture anchors) in: | The MICROFIX QUICKANCHOR Plus has similar technological characteristics, design, and configuration compared with the predicate devices. |
| - Technological Characteristics | - Testing demonstrated that it is substantially equivalent to the predicate devices. |
| - Design and Configuration | - Suitable for its intended use. |
| - Safety and Performance Data | - Similarities in design, operating principles, biocompatibility, and sterilization method. |
| - Operating Principles | |
| - Biocompatibility | |
| - Sterilization Method | |
| Suitability for Intended Use (fixation of soft tissue to bone for specified indications) | - Testing demonstrated that it is suitable for the intended use specified. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission does not describe a clinical study with a "test set" of patients in the typical sense. The evaluation was primarily non-clinical.
- Data Provenance: Not applicable. No clinical data was used or generated for this submission. The "testing" mentioned is non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical test set was used, no experts were needed to establish ground truth from patient data. The ground truth, in the context of a 510(k), is implicitly established by the predicate devices being legally marketed and deemed safe and effective.
4. Adjudication method for the test set:
- Not applicable. No clinical test set or human interpretation was involved that would require an adjudication method.
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 bioabsorbable polymer implant (suture anchor), not an AI-based diagnostic tool. No MRMC study or AI component is mentioned.
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:
- The "ground truth" for this 510(k) submission is the established safety and efficacy profile of the predicate devices (MICRO Anchor, ReSolve QuickAnchor, and BIOFASTIN RC suture anchors). The new device is evaluated against these predicates through non-clinical testing to demonstrate similar performance and characteristics.
8. The sample size for the training set:
- Not applicable. This submission does not involve machine learning or AI, and therefore no "training set" in that context. The "training" in the context of device development would refer to the iterative design and testing process, but not a dataset for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned in the context of AI/ML, there is no ground truth established for it. The comparison is based on the known properties and regulatory approval of the predicate devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.