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This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT.

The Sterling IF Screw Eyelet is manufactured from bovine bone processed with the BioCleanse® Tissue Sterilization Process. The Sterling IF Screw Eyelet is 25mm long by 8mm wide with an oval eyelet. The subject Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT cleared via K060253.

This document describes the Sterling® IF Screw Eyelet, a soft tissue graft fixation device. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, not on performance criteria or specific studies.

Therefore, I cannot provide the requested information in the format specified. The information about the Sterling® IF Screw Eyelet is limited to:

• Proprietary Name: Sterling® IF Screw Eyelet
• Common Name: soft tissue graft fixation device
• Product Code: HWC. Orthopedics Panel
• Regulation Number: 21 CFR 888.3040 for Smooth or threaded metallic bone fixation fastener.
• Description: Manufactured from bovine bone, processed with BioCleanse® Tissue Sterilization Process. 25mm long by 8mm wide with an oval eyelet. To be used with Sterling Interference Screw HT.
• Intended Use: Graft fixation (e.g., ligament and tendon) in cruciate ligament reconstruction surgeries.
• Substantial Equivalence: To LinX HT (design/function) and Sterling Interference Screw ST and Sterling Interference Screw HT (materials/function).
• Material Source: Closed herd in the U.S.A.
• Viral Inactivation Study: Worst-case representation of BioCleanse® process showed a reduction of a panel of viruses to below detectable limits.

To address each point of your request directly based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample size used for the test set and the data provenance: Not provided in the text. (The mention of a viral inactivation study doesn't specify a "test set" in the context of device performance, nor does it provide sample size or provenance for general device acceptance.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the text.
4. Adjudication method: Not provided in the text.
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 and not provided in the text. (This is not an AI-assisted device for diagnostic imaging or similar applications.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not provided in the text.
7. The type of ground truth used: Not provided in the text. (The viral inactivation study implies laboratory assay results for "ground truth" on viral reduction, but this is not about overall device performance acceptance criteria.)
8. The sample size for the training set: Not provided in the text.
9. How the ground truth for the training set was established: Not provided in the text.

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