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CP-Fiber is indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries.

CP-Fiber is a synthetic non-absorbable suture composed of a braided polyblend. As with all surgical sutures, CP-Fiber is a single-use device. This submission expands the indications for use to include orthopedic surgeries.

The provided document is a 510(k) summary for a medical device (CP-Fiber suture). While it describes the device's intended use and substantial equivalence to predicate devices, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

This document focuses on regulatory approval based on demonstrating equivalence to existing products rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, nor its data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document states: "Testing activities demonstrate that the product complies with USP requirements for nonabsorbable sutures." This is a general statement about compliance with a standard, but it doesn't provide the detailed acceptance criteria or study results that you're asking for.

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