(90 days)
STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional 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. The device is available in a dyed and undyed version. The pigment for the dyed version is D&C Violet No. 2. 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 Bidirectional Device Design consists of barbed suture material, armed with a surgical needle on each end. The device also contains an unbarbed center transition zone that facilitation of the device use. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs allow for tissue approximation without the need to tie surgical knots.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides specific acceptance criteria for "Tensile Strength." For other characteristics, it broadly states conformance to the USP Monograph for absorbable surgical sutures, with an exception for diameter, and mentions other tests performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Strength | |
| USP Device Size 0 Minimum Knot Tensile Strength (kgf) | 3.90 |
| USP Device Size 2-0 Minimum Knot Tensile Strength (kgf) | 2.68 |
| USP Device Size 3-0 Minimum Knot Tensile Strength (kgf) | 1.77 |
| USP Device Size 4-0 Minimum Knot Tensile Strength (kgf) | 0.95 |
| EU Pharmacopoeia Device Size 3.5 Minimum Knot Tensile Strength (N) | 39.0 |
| EU Pharmacopoeia Device Size 3 Minimum Knot Tensile Strength (N) | 26.3 |
| EU Pharmacopoeia Device Size 2 Minimum Knot Tensile Strength (N) | 17.4 |
| EU Pharmacopoeia Device Size 1.5 Minimum Knot Tensile Strength (N) | 9.32 |
| Other Criteria | |
| Suture Diameter | Conforms to USP Monograph, except for diameter (actual diameter of non-barbed section is one size greater than designated size with a maximum overage of 0.1 mm) |
| Needle Attachment Strength | Conforms to the current USP Monograph for absorbable surgical sutures |
| In Vitro Breaking Strength | Conforms to the current USP Monograph for absorbable surgical sutures |
| Ex Vivo Wound Closure Strength | Conforms to the current USP Monograph for absorbable surgical sutures |
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 sample sizes used for the test sets (e.g., number of sutures, number of measurements for each test). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) submission for a medical device and the tests are non-clinical laboratory performance tests, the data would typically be generated in a controlled laboratory environment, likely within the manufacturer's R&D facilities or contracted labs, rather than from human patients.
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 section is not applicable to the provided document. The "ground truth" for this type of device (surgical suture) is established through objective, quantifiable physical and chemical properties and performance characteristics, as defined by standard monographs (like USP and EU Pharmacopoeia) and engineering test methods. It does not rely on expert interpretation or consensus in the way, for example, an image analysis AI would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human evaluators and subjective assessments, particularly when establishing ground truth for AI algorithms or clinical endpoints. The studies described here are bench and ex vivo performance tests.
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
This section is not applicable. The device described is a physical surgical suture, not an AI software or a device that assists human readers in diagnostic tasks. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on established industry standards and objective physical measurements. Specifically:
- USP Monograph for absorbable surgical sutures: This serves as the primary standard for characteristics like suture diameter (with an noted exception), needle attachment strength, in vitro breaking strength, and ex vivo wound closure strength.
- EU Pharmacopoeia: Also referenced for device size and tensile strength.
- Defined Tensile Strength values: Specific numeric criteria for minimum knot tensile strength are provided in Table 2, which are objective quantitative targets.
8. The sample size for the training set
This section is not applicable. The device is a physical product (surgical suture) and not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable, as there is no AI algorithm training set involved. The "ground truth" for the performance of the suture itself is established by the methods described in point 7.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.