(79 days)
The RAPIDLOC-PDS Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).
The RAPIDLOC-PDS Meniscal Repair System consists of a two piece (polydiaxonone tophat and polylactic acid backstop) bioabsorbable meniscal tissue fixation implant mounted on a 2/0 pre-knotted PANACRYL braided long-term absorbable suture. It is applied using a cannulated needle and arthroscopic pusher.
The provided text describes a 510(k) premarket notification for the Mitek RAPIDLOC-PDS Meniscal Repair System. This is a medical device, not a software algorithm or AI. Therefore, the questions related to acceptance criteria, study details for AI/software performance, ground truth, sample sizes for training/test sets, MRMC studies, and standalone algorithm performance are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and shared technological characteristics.
Here's a summary of the relevant information provided:
Device: Mitek RAPIDLOC-PDS Meniscal Repair System
Device Type: Biodegradable Fixation Fastener for meniscal repair.
Intended Use: Arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).
Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (RAPIDLOC Meniscal Repair System and Mitek "H"-Fix Meniscal Fastener) | "Testing conducted to characterize performance of the RAPIDLOC-PDS Meniscal Repair System has demonstrated that it is substantially equivalent to the predicate devices and is suitable for the intended use specified." |
| Similar technological characteristics, design, and configuration to predicate devices. | "The proposed device has similar technological characteristics and is similar in design and configuration compared to the predicate devices." |
| Safety and performance acceptable for intended use. | "Based on 1) safety and performance data, and 2) similarities in design, operating principles, biocompatibility and sterilization method, The Mitek RAPIDLOC-PDS Meniscal Repair System has been shown to be substantially equivalent to predicate devices..." |
Study that Proves the Device Meets Acceptance Criteria:
A "Summary of Non-clinical Test" was conducted. The document states: "Testing conducted to characterize performance of the RAPIDLOC-PDS Meniscal Repair System has demonstrated that it is substantially equivalent to the predicate devices and is suitable for the intended use specified."
Regarding AI/Software Specific Questions:
- Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device, not an AI/software. No specific "test set" in the AI sense is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" for a physical device like this would be its physical and mechanical properties, biocompatibility, and functional performance, which are assessed through non-clinical testing.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Clinical Data:
The document explicitly states: "Clinical Data: Not Applicable". This indicates that the device's substantial equivalence and suitability for its intended use were established through non-clinical testing and comparison to predicate devices, without requiring new human clinical trials for this 510(k) submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.