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510(k) Data Aggregation
(71 days)
The Stryker Cross-Pinned Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.
The Stryker Cross-Pinned Interference Screw consists of an implant and associated instruments for installation of the implant. The implant consists of two components: an interference screw and a cross pin. The interference screw has a transverse hole in it for receipt of the cross pin. The cross pin is available for optional use by the user, in the event that adjunctive fixation is deemed appropriate. A drill guide provides alignment for drilling a hole coincident with the hole in interference screw and for receiving the cross pin. Both implants will be provided sterile for single-use applications (ASTM 4169). These devices will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 *. The devices are biocompatible per ISO-10993 and G95-1. The material of construction is Ti-6AI-4 V ELI per ASTM F136.
The provided text describes a 510(k) premarket notification for the Stryker Cross-Pinned Interference Screw System, submitted to the FDA. This document focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a detailed study with acceptance criteria in the manner typically seen for new diagnostic algorithms or AI devices.
Therefore, the following information is extracted or inferred from the text, recognizing that it is not a study design for evaluating algorithm performance, but rather a submission for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | "intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patellar tendon-tibial bone graft complex, the semitendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft." | The device is described as having the same intended use as the predicate device. |
| Safety and Efficacy | "equivalent in intended use, safety, and efficacy to the predicate device." | "The cadaver testing showed a significant strength increase of both the yield load and the ultimate load." "Does not raise new issues when compared to the currently marketed predicate device." "It is considered substantially equivalent to the Stryker Wedge Interference Screw System." |
| Sterilization | "sterile for single-use applications (ASTM 4169)", "sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10⁻⁶". | Device will be provided sterile, sterilized by Gamma irradiation or Ethylene oxide, and validated to SAL of 10⁻⁶. |
| Biocompatibility | "biocompatible per ISO-10993 and G95-1". | Device is biocompatible per ISO-10993 and G95-1. |
| Material of Construction | Not explicitly stated as an "acceptance criterion" but a characteristic expected for the device. | Ti-6AI-4 V ELI per ASTM F136. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The text mentions "cadaver testing," but does not explicitly state the sample size (e.g., number of cadavers, number of screws tested).
- Data Provenance: The cadaver testing is presumably laboratory-based testing, not clinical data from a specific country. The study is prospective in the sense that the testing was conducted specifically to evaluate this new device's performance against the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this submission. The "ground truth" for a physical device like an interference screw is its mechanical performance (yield load, ultimate load), not an expert interpretation of data.
4. Adjudication method for the test set
- This information is not applicable. Mechanical testing results (yield load, ultimate load) are quantitative measurements, not subject to expert adjudication.
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 physical medical device, not an AI or diagnostic tool that requires human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the performance evaluation in this context is the mechanical load data (yield load and ultimate load) obtained from cadaveric testing. This is objective, quantitative physical measurement data.
8. The sample size for the training set
- This information is not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- This information is not applicable. This is a physical medical device, not an AI model.
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