Search Results

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.

Ask a specific question about this device