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REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Device Description

REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).
REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture.

REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).
REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture.

AI/ML Overview

The provided text describes acceptance criteria and the results of a study to demonstrate substantial equivalence for two medical devices: REXLON (nonabsorbable polyamide surgical suture) and REXSIL (nonabsorbable silk surgical suture). Both devices are sutures and their acceptance criteria are based on established USP (United States Pharmacopoeia) and ISO (International Organization for Standardization) standards.

Here's a breakdown of the requested information, focusing on the REXLON and REXSIL devices as described:

REXLON (Nylon Monofilament Suture)

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance (REXLON)
USP 35 <861> SUTURES - DIAMETER	Complies with the diameter requirement
USP 35 <871> SUTURES - NEEDLE ATTACHMENT	Meets the requirements defined
USP 35 <881> TENSILE STRENGTH	Complies with the tensile requirement
USP Nonabsorbable Surgical Suture	Conforms to USP requirements
ASTM F88-09 (Seal Strength)	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
ASTM F1929-98(2004) (Seal Leaks)	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
USP <71> STERILITY TEST	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
USP 36, <151>; Pyrogen Test	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
ISO 11135-1:2007 (Ethylene Oxide Sterilization)	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
USP <85> Bacterial Endotoxin Limit	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
ISO 10993 (Biological Evaluation)	Biocompatible per ISO 10993-1, and other parts of ISO 10993 evaluation completed.
Shelf life stability (Real-time and accelerated aging)	Stable over the proposed shelf life

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each individual test conducted (e.g., how many sutures were measured for diameter or tensile strength). It only states that "REXLON were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing rather than human subject data. There is no information regarding country of origin for the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established standards.

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 a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXLON (and REXSIL) is based on established industry standards and pharmacopoeia monographs, specifically:

United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established

Not applicable.

REXSIL (Nonabsorbable Silk Suture)