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510(k) Data Aggregation
(122 days)
The DePuy Mitek RIGIDFIX® CURVE Cross Pin System is indicated for femoral fixation of autograft or allograft anterior cruciate ligament (ACL) soft tissue grafts.
The DePuy Mitek RIGIDFIX® CURVE Cross Pin System consists of instruments and Cross Pins designed for use with the RIGIDFIX® CURVE Cross Pin Instrumentation. The Soft Tissue (ST) Cross Pin material is PEEK™ (polyetheretherketone), a radiolucent high strength thermoplastic or PLA (Poly-Lactic Acid). Repair requires two (2) DePuy Mitek RIGIDFIX® CURVE Cross Pins.
The provided documentation describes a 510(k) submission for the DePuy Mitek RIGIDFIX® CURVE Cross Pin System. This system is a medical device designed for femoral fixation of ACL soft tissue grafts.
The submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI or diagnostic devices, is not applicable to this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: The PLA implant should be identical in material and design to the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant. | |
| The PEEK implant should use the same PEEK material as the predicate DePuy Mitek Gryphon PEEK Anchor and have the same dimensional specifications as the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant. | The proposed RIGIDFIX CURVE ST ACL PLA Cross Pin System implant is identical in material and design to the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant. |
| The proposed RIGIDFIX CURVE ST ACL PEEK Cross Pin System implant is manufactured out of the same PEEK material as the predicate DePuy Mitek Gryphon PEEK Anchor and has the same dimensional specification as the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant. | |
| Functional Equivalence (Instruments): The proposed instruments should be similar to those offered for the predicate RIGIDFIX System, with material similarity (stainless steel and radel) and the redesign allowing for fully adjustable femoral cross pin implantation. | The proposed disposable and reusable instruments are similar to those currently offered for use with the predicate RIGIDFIX System. The proposed and predicate disposable instruments are made of similar materials: stainless steel and radel. The proposed disposable instruments have been redesigned to allow the capability of being fully adjustable for desired angle of femoral cross pin implantation, which is an improvement over the predicate's 0-degree insertion limitation. |
| Safety and Performance: Product Design Verification activities (e.g., In-Vitro Break Strength Testing and Real-Time Break Strength Testing) should demonstrate that the proposed devices are substantially equivalent to the predicate devices in terms of performance and safety. | Results of performance and safety testing (In-Vitro Break Strength Testing and Real-Time Break Strength Testing) have demonstrated that the proposed devices are substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The testing mentioned (In-Vitro Break Strength Testing and Real-Time Break Strength Testing) would involve physical samples of the device and likely would not have a "test set" in the sense of patient data.
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)
This information is not applicable as the submission relies on physical and material testing, not expert-derived ground truth from patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as there is no mention of a test set requiring adjudication in the context of expert review.
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
This information is not applicable. This is a submission for a surgical implant system, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the performance and safety profiles of the legally marketed predicate devices, as established through their prior 510(k) clearances and the manufacturer's own design verification activities (e.g., break strength testing). The goal is to show that the new device meets or exceeds these established benchmarks.
8. The sample size for the training set
This information is not applicable as this is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI or machine learning device requiring a training set.
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