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510(k) Data Aggregation
(50 days)
The Stryker Wedge 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 femoral and tibial bony attachments of the patella bone-patellar tendon-tibial bone graft complex, the semi-membranosus tendon grafts, and the semi-tendinosus tendon grafts, or fixation of the allograft techniques such as ACL allografts and Achilles tendon allografts.
The Stryker Wedge Interference Screw System is intended for use in the surgical reconstruction of the anterior cruciate ligament deficient knee to provide interference fixation of the femoral and tibial bony attachments of the patellar tendon-tibial bone graft complex, the semi-membranosus tendon grafts, and the semi-tendinosus tendon grafts, or fixation of the allograft techniques such as ACL allografts and Achilles tendon allografts. The Stryker Wedge Interference Screw System will be provided sterile for single-use applications (ASTM 4169). This device is validated for EtO (AAMI ST27) and gamma (AAMI ST32) sterilization methods, as well as autoclave steam sterilization for re-sterilization (AAMI ST37 and SSSA), with a minimum SAL of 10-0. The material of construction (ASTM F136) and its overall design are equivalent to currently marketed products. The device material has been found to be biocompatible per ASTM F136, ISO-10993, and G95-1 standards.
The provided document is a 510(k) premarket notification for a medical device, the Stryker Wedge Interference Screw System. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than presenting a performance study with acceptance criteria in the way a novel AI/software device would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) are not applicable to this type of regulatory submission for a physical orthopedic implant.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance for Stryker Wedge Interference Screw System
Context: The Stryker Wedge Interference Screw System is a physical orthopedic implant intended for ACL reconstruction. Its approval is based on demonstrating substantial equivalence to existing, legally marketed predicate devices, not on meeting specific, quantifiable performance metrics from a novel clinical study as would be seen for an AI or software-as-a-medical-device (SaMD).
| Acceptance Criteria Category | Description (as applicable to a 510(k) for an implant) | Reported Device Performance/Evidence |
|---|---|---|
| 1. Acceptance Criteria | The primary acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to an existing predicate device regarding intended use, safety, and effectiveness. This involves showing that the new device is as safe and effective as the predicate, and does not raise new questions of safety or effectiveness. | The summary states: "The Stryker Wedge Interference Screw System is equivalent in intended use, safety and effectiveness to other fixation devices in commercial distribution." and "The screw system does not raise any new safety and efficacy concerns when compared to other devices currently on the market. Therefore, the Stryker Wedge Interference Screw System is substantially equivalent to other ACL fixation devices." The FDA concurred with this assessment. |
| 2. Device Intended Use | The device must be intended for the same fundamental use as the predicate device(s). | Intended Use: "The Stryker Wedge 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 femoral and tibial bony attachments of the patella bone-patellar tendon-tibial bone graft complex, the semi-membranosus tendon grafts, and the semi-tendinosus tendon grafts, or fixation of the allograft techniques such as ACL allografts and Achilles tendon allografts." This use is consistent with existing ACL fixation devices. |
| 3. Device Materials | Materials of construction must be safe, biocompatible, and either identical or equivalent to those in legally marketed predicate devices. | "The material of construction (ASTM F136) and its overall design are equivalent to currently marketed products. The device material has been found to be biocompatible per ASTM F136, ISO-10993, and G95-1 standards." This indicates that the materials meet established standards for medical implants and are similar to those used in predicate devices. |
| 4. Sterilization | The device must be provided sterile (or sterilizable by the user) and validated to achieve appropriate sterility assurance levels (SAL). | "The Stryker Wedge Interference Screw System will be provided sterile for single-use applications (ASTM 4169). This device is validated for EtO (AAMI ST27) and gamma (AAMI ST32) sterilization methods, as well as autoclave steam sterilization for re-sterilization (AAMI ST37 and SSSA), with a minimum SAL of 10-0." This confirms proper sterilization validation. |
| 5. Biocompatibility | The materials must be demonstrated to be biocompatible. | "The device material has been found to be biocompatible per ASTM F136, ISO-10993, and G95-1 standards." |
| 6. Labeling/Regulatory Compliance | Labeling must be accurate, compliant with FDA regulations, and include appropriate warnings. The device must comply with general controls (e.g., GMP). | FDA letter outlines specific labeling requirements: prominent statement of intended use, prohibition against promoting for pedicular screw fixation, and a warning if screws meet certain size criteria regarding pedicular use. A substantial equivalence finding assumes compliance with Good Manufacturing Practice (GMP) requirements. |
Remaining Requested Information (Not Applicable for this 510(k) Device)
The following information pertains to clinical or performance studies that generate quantified metrics, often used for AI/SaMD or higher-risk devices requiring PMA. This 510(k) submission for a physical orthopedic screw system does not involve such studies.
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not describe a clinical test set or data provenance for performance evaluation in the context of an AI/software device. The submission relies on equivalence to predicate devices, not de novo clinical data comparing the device itself against a specific outcome measure in human subjects for performance.
2. 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)
- Not Applicable. There was no "ground truth" derived by experts for a test set in the context of a performance study for this device. The assessment was a regulatory review of equivalence.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or related adjudication method was used for performance assessment.
4. 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 is a physical implant, not an AI or imaging device involving human readers or interpretation.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant; there is no algorithm or standalone performance in the context of AI/software.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No explicit "ground truth" was established for performance metrics in the way it is for an AI/software device. The "truth" for this submission is based on the safety and effectiveness profile of the predicate devices and the physical/biocompatibility characteristics of the new device.
7. The sample size for the training set
- Not Applicable. There is no training set for an AI/software model.
8. How the ground truth for the training set was established
- Not Applicable. No training set exists for this device.
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