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STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from the polyester, poly (pdioxanone). The empirical molecular formula of the polymer is (C+HgO3). The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is dyed with D&C Violet No. 2.

STRATIX™ Symmetric PDS™ Plus Knotless Tissue Control Device consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. Polydioxanone has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HgO3)x. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral PDS™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDSTM Plus Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDS™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.

STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE® MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360ug/m. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1mm.

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is a monofilament. synthetic absorbable device prepared from a copolymer of glycolide and e-caprolactone. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Device is designed to anchor with a closed loop at one end and unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Device reduces tensile strength relative to non-barbed suture material of the same size, tving of knots in non-barbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1mm.

The provided document is a 510(k) Summary for several STRATAFIX™ Knotless Tissue Control Devices. It primarily discusses substantial equivalence to predicate devices based on technological characteristics and proposed labeling changes.

Crucially, this document states: "Summary of Technological Characteristics: The technological characteristics of the subject devices are identical to their predicate devices, therefore performance data are not necessary to establish substantial equivalence."

This means that the FDA determined that the applicant did not need to conduct new studies to prove the device met acceptance criteria because the device's technical characteristics, materials, and performance were considered identical to previously cleared predicate devices. The submission focuses on explaining the equivalence and justifying minor labeling changes.

Therefore, for the information requested in your prompt, the answer is largely that no new studies or performance data were deemed necessary or provided in this 510(k) submission to establish acceptance criteria for the device itself. The acceptance criteria are implicitly met by the substantial equivalence to the predicate devices, which would have undergone their own testing.

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

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

   • Acceptance Criteria: Not explicitly stated as new, independent criteria for this submission. The device is considered to meet the acceptance criteria of its predicate devices due to substantial equivalence. The document highlights that the subject devices are "identical to their respective predicate devices with respect to functionality, technological characteristics, intended uses, and indications." Performance specifications are also stated as unchanged.
   • Reported Device Performance: No new performance data is reported as no new studies were deemed necessary. The performance is presumed to be equivalent to the predicate devices. The document explicitly states: "performance data are not necessary to establish substantial equivalence."

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

   • Not applicable. No new test set data was generated or submitted for this 510(k) as the devices were found to be substantially equivalent to predicates without new performance studies.

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. No new test set requiring expert ground truth was generated or submitted.

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

   • Not applicable. No new test set requiring adjudication was generated or submitted.

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 device is a surgical suture, not an AI-assisted diagnostic tool.

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

   • Not applicable. This device is a surgical suture, not an algorithm.

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

   • Not applicable. No new ground truth was established for this submission. The ground truth for the predicate devices would have been established through their original clearance processes, likely involving physical and mechanical testing, biocompatibility, and potentially animal or clinical studies to support their indicated uses.

8. The sample size for the training set

   • Not applicable. This device is a surgical suture, not a machine learning model requiring a training set.

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

   • Not applicable. This device is a surgical suture, not a machine learning model.

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STRATAFIX™ Symmetric PDS™ Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

STRATAFIX Symmetric PDS Plus Devices are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . STRATAFIX Symmetric PDS Plus Devices will contain IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg /m. STRATAFIX Symmetric PDS Plus Devices are dyed with D&C Violet No. 2 (21CFR§ 74.3602) at a maximum of 0.15% w/w. STRATAFIX Symmetric PDS Plus Devices consists of an absorbable monofilament thread with unidirectional barbs, with a surgical needle attached at one end and a fixation tab at the other. The barbs and fixation tab design allow for tissue approximation without the need to tie surgical knots.

This document describes a 510(k) premarket notification for the STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device. The information provided is sufficient to answer some, but not all, of your specific questions.

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

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

The document states: "STRATAFIX Symmetric PDS PLUS Devices met all testing criteria to demonstrate substantial equivalence to the predicate device." However, specific numerical acceptance criteria and reported device performance values are not provided in this summary. The performance data section describes what was tested, but not the quantitative results or the specific criteria for "adequacy" or "integrity."

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

• Sample sizes for the test set: Not provided. The document states "performance testing-bench models" and "performance testing-animal models" but does not specify the number of samples, animals, or human users involved in these tests.
• Data provenance:
  • Country of origin of the data: Not specified.
  • Retrospective or prospective: Not specified. The nature of the "Preclinical Survival Study" suggests it was prospective, but this is not explicitly stated for all tests.

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

Not applicable. This device is a surgical suture, not an AI/CAD diagnostic device that typically relies on expert interpretation for ground truth. The "ground truth" for its performance would be derived from physical measurements (strength, cyclic loading) and biological observations (wound healing in animal models), not expert consensus on images or diagnoses. No experts are mentioned for establishing ground truth in this context.

4. Adjudication method for the test set

Not applicable. As above, this is not an AI/CAD diagnostic device. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting data, which is not relevant to the described performance testing of a physical medical device.

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 physical surgical device, not an AI diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant.

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

Not applicable. This is a physical surgical device. "Standalone performance" in the context of an algorithm is not relevant here.

7. The type of ground truth used

For the performance tests mentioned, the "ground truth" implicitly would be:

• Physical measurements: For Tissue Holding Strength, Initiation Strength, and Cyclic Compression. This would involve calibrated instruments measuring force, displacement, etc.
• Biological observations: For the Preclinical Survival Study, ground truth would be based on direct observation and potentially histological analysis of wound approximation and healing in the animal models.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.

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