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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 autografts and allografts, 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 device is provided sterile and intended for single-use only.

The Stryker Bioabsorbable Interference Screw System is made as a single unit from an absorbable polymer derived from Poly L-lactic acid (ASTM 4169). This device will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN 550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The material, molding process, sterilization process for the line extension is equivalent to the predicate device, the Stryker Bioabsorbable Interference Screw System.

The provided text describes a 510(k) premarket notification for a medical device (Stryker Bioabsorbable Interference Screw System) and focuses on demonstrating substantial equivalence to a predicate device. It addresses the device's materials, design, intended use, safety, and efficacy. However, it does not contain the kind of information typically found in a study demonstrating a device meets acceptance criteria, particularly for an AI/ML-driven device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study that proves the device meets them, specifically because these elements are designed for evaluating AI/ML performance, which is not applicable to the Stryker Bioabsorbable Interference Screw System as described in this document.

Here's why and what the document does provide:

• No AI/ML Component: The Stryker Bioabsorbable Interference Screw System is a physical medical device (an absorbable screw for ACL reconstruction), not an AI/ML software or system. Therefore, the concepts of "test set," "training set," "ground truth," "expert consensus," "MRMC study," "human readers improve with AI," or "standalone performance" are not relevant to its evaluation.
• Substantial Equivalence: The document's primary purpose is to establish "substantial equivalence" to a predicate device (Stryker Bioabsorbable Interference Screw System, #K993166) already on the market. This is a regulatory pathway for many non-novel, traditional medical devices.
• Performance Metrics for Substantial Equivalence: For this type of device, performance is typically assessed through:
  • Material Equivalence: The document states, "The material... is equivalent to the predicate device."
  • Molding Process Equivalence: "The material, molding process... is equivalent to the predicate device."
  • Sterilization Process Equivalence: "The sterilization process... is equivalent to the predicate device."
  • Mechanical Testing: "When comparing insertion torque and pullout test results, the line extension device has substantially equivalent performance to the predicate device."

To directly answer your numbered points based on the provided text, while acknowledging the mismatch in evaluation paradigms:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, the acceptance criterion implicitly is "substantially equivalent performance" to the predicate device in key mechanical tests.

   Acceptance Criteria (Implicit)	Reported Device Performance
   Substantially equivalent material of construction to predicate device.	"The material... is equivalent to the predicate device."
   Substantially equivalent molding process to predicate device.	"The molding process... is equivalent to the predicate device."
   Substantially equivalent sterilization process to predicate device.	"The sterilization process for the line extension is equivalent to the predicate device."
   Substantially equivalent insertion torque to predicate device.	"insertion torque... has substantially equivalent performance to the predicate device."
   Substantially equivalent pullout test results to predicate device.	"pullout test results... has substantially equivalent performance to the predicate device."
   Validated sterility assurance level (SAL) of 10⁻⁶.	"sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN 550)... and validated to a sterility assurance level (SAL) of 10⁻⁶."

2. Sample sized used for the test set and the data provenance: Not applicable. Performance是以與predicate device作比較，而非透過獨立測試一個"test set"來評估。The mechanical tests mentioned (insertion torque and pullout) would have involved a sample size of manufactured screws, but the specific numbers are not provided in this summary. The data provenance would be laboratory testing conducted by Stryker.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is objective mechanical testing results against a benchmark (the predicate device), not expert interpretation of outputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical performance, the "ground truth" is the objective results of physical material and mechanical tests (e.g., insertion torque values, pullout strength values), compared directly to the predicate device's known performance.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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