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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 tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.

The Stryker Bioabsorbable 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 Bioabsorbable Interference Screw System will be provided sterile for single-use applications (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550) and validated to a sterility assurance level (SAL) of 10 . The device is biocompatible per ISO-10993 and G95-1. The Stryker Bioabsorbable Interference Screw System is equivalent in intended use, safety and effectiveness to other fixation devices in commercial distribution. The material of construction and its overall design are equivalent to currently marketed products.

The provided text describes the Stryker Bioabsorbable Interference Screw System and its substantial equivalence to predicate devices, rather than an AI/ML device that would typically have acceptance criteria, test sets, and ground truth as outlined in your request.

The document is a 510(k) submission summary for a medical device (an interference screw for ACL reconstruction), which relies on demonstrating substantial equivalence to existing legally marketed devices. It does not contain information about:

• Acceptance criteria and reported device performance in the context of an AI/ML model.
• Sample sizes for test sets or data provenance for AI/ML validation.
• Number of experts for ground truth or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone AI algorithm performance.
• Types of ground truth (e.g., pathology, outcomes data pertinent to AI/ML).
• Training set sample sizes or ground truth establishment for a machine learning model.

Instead, the document focuses on:

• Intended Use: Similar to predicate devices.
• Material: Poly(L-lactic Acid), similar to Linvatec BioScrew but different from Stryker Wedge Interference Screw (Titanium).
• Thread design: Similar to both predicate devices.
• Head design: Similar to both predicate devices.
• Shelf life: 24 months, similar to Linvatec BioScrew but different from Stryker Wedge Interference Screw (5 years).
• Geometry (Dimensions): Similar ranges but with minor differences in minimum/maximum diameters and lengths compared to the predicates.
• Design elements: Cannulated, rounded head, non-symmetric/buttress-shaped thread, spiral thread – shared characteristics with predicates.
• Biocompatibility: Stated as per ISO-10993 and G95-1.
• Sterilization: Gamma irradiation or Ethylene oxide, validated to a sterility assurance level (SAL) of 10^-6.

The "study" in this context is the 510(k) submission process itself, where the manufacturer provides documentation to the FDA proving that their new device is "substantially equivalent" to predicate devices already on the market, meaning it is as safe and effective. This is not a clinical performance study in the way one would validate an AI/ML diagnostic or therapeutic device.

Therefore, I cannot provide the requested information from the given text as it pertains to AI/ML device validation. The provided text is about a traditional medical implantable device's regulatory review for market clearance.

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