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

The STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable single-use surgical suture device composed of a copolymer of glycolide and (epsilon) s-caprolactone. The device contains IRGACARE®: MP (triclosan), a broad-spectrum antibacterial agent, at no more than 2360 ug/m. The colorant employed is D&C Violet No.2, in

This document describes a 510(k) premarket notification for a medical device, specifically a surgical suture. It does not contain information about an AI/ML medical device, which would typically include acceptance criteria, study details (sample size, data provenance, ground truth establishment, expert qualifications, etc.), or details of human reader studies (MRMC).

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as the provided text pertains to a traditional medical device (surgical suture) and not an AI/ML device. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than the detailed clinical validation studies common for AI/ML products.

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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™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device are indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is a monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-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 a 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.

The 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 2360 µg/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.

The provided document is a 510(k) summary for a medical device (STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device), which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a standalone study with defined metrics.

Therefore, the specific quantitative acceptance criteria and the detailed study proving the device meets those criteria, as typically seen in an AI/ML medical device submission, are not explicitly present in this document. The document primarily describes equivalence through performance data relative to USP monographs and comparison to predicate devices.

However, I can extract the relevant information where applicable and indicate when a specific aspect is not detailed in the provided text.

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

Since this is a 510(k) for a surgical suture, the "acceptance criteria" are largely based on meeting existing USP (United States Pharmacopeia) monograph requirements for absorbable surgical sutures and demonstrating comparable performance to predicate devices. The document states:

"Non-clinical laboratory performance testing was performed demonstrating that STRATAFIX™ Spiral MONOCRYLTM Knotless Tissue Control Devices and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Devices conforms to the current USP Monograph for absorbable surgical sutures, except for diameter."

The table below summarizes the performance characteristics mentioned, with the understanding that "meets USP requirements" implicitly serves as an acceptance criterion.

2. Sample size 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 (number of sutures, number of animals, etc.) for each non-clinical test (bench and animal testing). It also does not explicitly state the country of origin of the data or whether the animal studies were retrospective or prospective, though animal studies are typically prospective.

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)

This document pertains to a physical medical device (surgical suture), not an AI/ML algorithm that requires expert ground truth labeling. Therefore, this information is not applicable and not provided. Performance is evaluated through physical and biological testing.

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

Not applicable, as this is not an AI/ML algorithm requiring human adjudication of classifications or segmentations.

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, as this is a physical medical device and not an AI-assisted diagnostic/treatment planning tool.

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

Not applicable, as this is a physical medical device and not an AI algorithm.

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

For a surgical suture, "ground truth" is established through standardized physical measurements (e.g., tensile strength testing equipment, caliper measurements for diameter) and biological assays/animal studies that assess tissue reaction, absorption, and wound healing, often against established scientific norms or predicate device performance. It is not based on expert consensus for interpretative tasks.

8. The sample size for the training set

Not applicable, as this device does not involve an AI/ML algorithm that requires a training set.

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

Not applicable, as this device does not involve an AI/ML algorithm that requires a training set.

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