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

PROLENETM Polypropylene Suture (clear or pigmented) is a nonabsorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with phthalocyanine blue, Color Index Number 74160) to enhance visibility. PROLENE™ suture, also available as PROLENE™ HEMO-SEAL™ needle suture, is a needle suture combination in which the diameter of the suture swage area has been reduced to facilitate attachment of finer wire diameter needles. The diameter of the suture strand and the needle wire have been more closely aligned to reduce the degree of needle hole bleeding.

This document is a 510(k) Pre-Market Notification for a modified medical device, specifically a suture. The fundamental purpose of this type of submission is to demonstrate that a new device is "substantially equivalent" to an existing legally marketed device (the predicate device) and thus does not require a full Pre-Market Approval (PMA).

Therefore, the "acceptance criteria" for this submission are not performance metrics in the typical sense of a clinical study demonstrating efficacy or accuracy for a diagnostic device. Instead, the acceptance criteria are met by demonstrating substantial equivalence to the predicate device through comparisons of design, materials, manufacturing processes, intended use, and performance testing as required by the relevant standards (in this case, USP monographs).

The "study" that proves the device meets "acceptance criteria" is a series of design verification tests, not a clinical trial or a study assessing algorithm performance.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" for this specific submission: The primary 'acceptance criterion' addressed by the modification is that the proposed device now meets the USP (U.S. Pharmacopeia) monograph requirements for needle attachment force, which the predicate device (specifically the HEMO-SEAL variant) did not fully meet. The submission demonstrates that the modified manufacturing process has achieved this. Other USP requirements (Tensile Strength, Diameter) were also tested to ensure that the modification did not negatively impact these properties.

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

• Sample Size: Not explicitly stated in the provided text, but "Design Verification Testing" was conducted.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by ETHICON, Inc. This is a common practice for device modifications. It is a prospective set of tests on newly manufactured samples.

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 submission. The "ground truth" here is defined by objective, standardized physical performance measurements specified in USP monographs (e.g., specific force in Newtons for needle attachment, diameter in millimeters, tensile strength in Newtons per area). These are not subjective interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective assessments (e.g., by radiologists) to establish a "ground truth" when there's inter-reader variability. Here, the measurements are objective and standardized, directly compared against a numerical standard.

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

This question is not applicable. This submission is for a surgical suture, not a diagnostic device or an AI-powered system that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This is a physical medical device (suture), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for performance testing (design verification) is:

• Objective physical measurements against pre-defined, standardized specifications outlined in the United States Pharmacopeia (USP) Monograph for sutures. This includes:
  • Needle Attachment Force (USP )
  • Tensile Strength (USP )
  • Diameter (USP )

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this physical medical device and its manufacturing modification. The "training" here refers to process adjustments during manufacturing to achieve the desired physical properties.

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

This question is not applicable for the reasons stated above. If interpreting "training set" as the initial manufacturing process development, the "ground truth" for the process adjustments would still be the objective physical measurements against USP standards.

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