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Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.

TEVDEK® II NextStitch® and 'silky' II POLYDEK® NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.

Deknatel Polyester Surgical Sutures (i.e. Dacron®, Polydek, and Tevdek) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

The Deknatel® Polyester Surgical Suture is a non-absorbable surgical suture composed of twisted or braided Polyethylene Terephthalate fibers. Deknatel® Polyester Surgical Suture is available undyed (white) or dyed (green) and is offered in a variety of cut lengths, with or without needles, and with or without pledgets. Product labeling carries the following specific information on the suture: material (including color, number and length of sutures in the package); USP size (diameter, including any difference in diameter); the number, profile and size of any attached needles; and the number, size and density of pre-attached pledgets.

The Deknatel® Polyester Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) for tensile strength, diameter and needle attachment, except for suture size 7-0 which differs from USP in diameter only.

Deknatel® Polyester Surgical Suture is available in USP sizes 7-0 to 9 in the following configurations:

• . 'cottony' II: Uncoated (Not PTFE impregnated)
• "silky II" or Polydek®: Lightly coated (PTFE impregnated) .
• Tevdek® II: Heavily coated (more PTFE impregnated than "silky")) .

The Deknatel® Polyester Surgical Sutures are also available in the following productspecific configurations with or without needles, and with or without pledgets:

• Surgical Suture Tape as uncoated 'cottony' II in flat braid sizes of 1/8", 1mm, 2 mm, ● 3mm, 4mm and 5mm.
• . NextStitch® Cardiovascular Valve Suture is comprised of "silky" II POLYDEK and/or TEVDEK II polyester suture. NextStitch is a continuous chain of linked sutures designed to provide an alternative suturing technique for cardiovascular valve replacement procedures. NextStitch Sutures are available in USP Sizes 4-0, 3-0, 2-0 and 0 (metric sizes 1.5 through 3.5).
• Readi-Cut TEVDEK® II Bulk Non-Sterile Polyester Surgical Suture is bulk, non-● sterile Tevdek® II polyester suture available in USP Size 2.

This document is a 510(k) Premarket Notification for a surgical suture device (K192490) and primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not describe a study involving an AI/Machine Learning device. Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI device is not available in these provided pages.

However, I can extract information related to the device's performance criteria as established by the United States Pharmacopeia (USP) for surgical sutures, which serves as the "acceptance criteria" for this conventional medical device.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for the non-clinical testing (diameter, tensile strength, needle attachment). It generally states "all sizes" meet the requirements. It also does not provide details on data provenance (country of origin, retrospective/prospective) for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a surgical suture, and its performance is evaluated against established physical and chemical standards (USP, ISO) using laboratory testing, not by expert interpretation of data like in an AI study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is a surgical suture, and its performance is evaluated against established physical and chemical standards using laboratory testing.

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 document pertains to a surgical suture, not an AI or imaging device involving human readers.

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

Not applicable. This device is a surgical suture.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" or reference standards for the device's performance are:

• United States Pharmacopeia (USP) Standards: Specifically, USP <861> for diameter, USP <881> for tensile strength, and USP <871> for needle attachment. These are objective, published physical and mechanical test standards.
• ISO 10993-1: For biocompatibility.
• Ethylene Oxide (EO) Sterility Method, SAL 10-6: For sterility.

8. The sample size for the training set

Not applicable. This document describes a surgical suture, which is a physical device, not an AI device that requires a training set.

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

Not applicable. There is no training set for this type of medical device submission.

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