(56 days)
Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
This looks like a 510(k) summary for a medical device (Monoswift™ Synthetic Absorbable Suture), which is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
The provided document does not contain the kind of detailed study information (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) that would be present for evaluating a diagnostic AI/ML device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design verification and USP requirements for needle attachment tensile strength.
Therefore, for this specific input, the requested information cannot be fully provided because it pertains to a different type of device evaluation (e.g., for AI/ML diagnostic software) than what is presented here.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with USP requirements for needle attachment tensile strength. | "The testing and verification activities performed for this product demonstrate that the product complies with USP requirements for needle attachment tensile strength." |
| Breaking strength retention consistent with predicate PGCL sutures. | "Breaking strength retention is consistent with the predicate PGCL sutures." |
| Overall performance similar to other PGCL sutures (monofilament, synthetic, absorbable, comprised of poly(glycolic co-caprolactone), may be dyed with D&C Violet #2). | "Monoswift™ performance for the intended use is similar to that of other PGCL sutures in that it is a monofilament, synthetic absorbable surgical suture comprised of poly(glycolic co-caprolactone) and may be dyed with D&C Violet #2." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The manufacturer is CP Medical, Portland, OR, USA. The testing was likely conducted in the US.
- Retrospective or Prospective: Not specified.
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 information is not applicable and not present for this type of device (surgical suture). Ground truth in the context of diagnostic AI/ML refers to diagnoses or classifications established by human experts or definitive tests. For a surgical suture, the "ground truth" relates to its physical and biological performance characteristics, measured through various laboratory and potentially in-vivo tests, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable and not present for this type of device. Adjudication methods are relevant for resolving discrepancies in expert interpretations in diagnostic studies.
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. MRMC studies are used to evaluate the performance of diagnostic imaging devices (often with AI assistance). This device is a surgical suture.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" or reference standard for verification is based on USP (United States Pharmacopeia) requirements for needle attachment tensile strength and comparison of breaking strength retention with predicate devices. This involves laboratory testing and performance metrics of the suture material itself, rather than expert interpretation of patient data or outcomes in the traditional sense of diagnostic devices.
8. The sample size for the training set:
- Not applicable. This device does not use a training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. This device does not use a training set.
In summary, the provided document outlines a 510(k) submission for a surgical suture, where "acceptance criteria" are related to physical and performance characteristics of the material (e.g., tensile strength, absorbability) as measured against established standards (like USP) and comparison to predicate devices, rather than the diagnostic performance metrics typically associated with AI/ML devices.
§ 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.