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Tufflex™ Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Tufflex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Tufflex™ sutures are braided for optimal handling properties.

The provided text describes the 510(k) submission for the Tufflex™ polyester suture, which is a medical device. The information primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with detailed performance metrics like those for diagnostic AI devices.

Instead of "acceptance criteria," the document refers to compliance with USP requirements and equivalence to predicate materials for specific physical properties of the suture.

Here's an analysis based on the provided text, structured to answer your questions where applicable. Please note that many of your specific questions are designed for AI/diagnostic device studies and are not directly addressed by this type of 510(k) for a physical medical product like a suture.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The text does not specify the exact sample sizes used for testing suture diameter or knot tensile strength. It only states that "summaries of studies were conducted to evaluate the suture diameter and knot tensile strength as specified in the FDA Guidance Document."

• Data Provenance: Not explicitly stated, but typical for physical medical device testing, it would likely be laboratory-generated data from manufacturing lots. There is no mention of country of origin of data, nor whether it was retrospective or prospective in the clinical sense (as it's a materials test, not a patient outcome study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to this type of device. "Ground truth" in the context of a physical medical device like a suture refers to established physical standards (USP requirements). No human experts are used to "establish" this ground truth in the way described for AI/diagnostic devices. The testing is objective against published standards.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous "result" that requires adjudication by experts, as the testing is against defined physical parameters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating observer performance with diagnostic or AI-assisted interpretation, which is not relevant for a surgical suture.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI or algorithm-based device. The "performance" is based on the physical properties of the suture itself.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Tufflex™ polyester suture's performance against the "acceptance criteria" (USP requirements) is objective physical standards and specifications for surgical sutures. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary of the Study and Acceptance Criteria:

The "study" cited in the 510(k) submission for the Tufflex™ polyester suture was a series of tests performed to demonstrate that the device complies with the United States Pharmacopeia (USP) requirements and is equivalent to predicate devices for key physical properties.

• Acceptance Criteria: Compliance with USP requirements for suture diameter and knot tensile strength, and equivalence to the sterilization process of predicate devices. These criteria are established by regulatory guidance ("Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" - June 23, 2003) and industry standards (USP).
• Study That Proves Meets Criteria: The manufacturer "conducted summaries of studies" to evaluate these properties. The data from these studies "demonstrate that the Tufflex™ polyester suture satisfied the USP requirements and was equivalent to the predicate materials."

In essence, for this type of medical device, "acceptance criteria" are met by demonstrating adherence to established material specifications and manufacturing equivalency, rather than through clinical performance studies involving patient outcomes or expert interpretation.

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