(55 days)
CP Medical's synthetic absorbable monofilament is 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 intended to be used for surgical wound closure.
The proposed device is a synthetic absorbable monofilament surgical suture comprised of polydioxanone, trimethylene-carbonate and caprolactone copolymers. These polymers, individually, and as co-formulated herein, are substantially equivalent to other synthetic absorbable monofilament sutures in commercial distribution today.
The provided text is a 510(k) premarket notification summary for a medical device (surgical suture). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the comprehensive study that proves the device meets those criteria in a typical "AI/software device" context.
Therefore, many of the requested sections below cannot be fully answered with the information provided because this document is for a physical surgical suture, not an AI or software-based medical device. The "study" mentioned is conformity to recognized consensus standards for surgical sutures, which is different from a performance study for AI.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (for surgical sutures) | Reported Device Performance |
|---|---|
| Meets recognized consensus standards for surgical suture, United States Pharmacopoeia (USP) | Device meets these standards. |
| Meets ISO 10993 biocompatibility | Device meets these standards. |
| Similar characteristics (chemistry, material, and composition) to predicate devices | The device has similar characteristics as the predicate devices. |
| Manufacturing in compliance with current QSR and ISO quality standards | Manufacturing, including QC testing, is in substantial compliance with current QSR and ISO quality standards. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified, but given it's a physical product, the testing would likely be performed in a lab setting rather than using "data provenance" in the sense of patient data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. "Ground truth" in the context of material science and biocompatibility testing for a surgical suture refers to established scientific/medical standards (USP, ISO) rather than expert consensus on interpretive data as in AI.
4. Adjudication method for the test set
- Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically for human interpretation tasks, not physical material testing.
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 or imaging diagnostic device that would involve human readers or AI assistance.
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
- The "ground truth" for evaluating this device's safety and effectiveness relies on adherence to recognized consensus standards, specifically:
- United States Pharmacopoeia (USP) for surgical suture specifications.
- ISO 10993 for biocompatibility.
- The primary "proof" for this 510(k) submission is also substantial equivalence to an existing legally marketed predicate device (CP Medical's polydioxanone surgical suture) based on its chemistry, material, and composition.
8. The sample size for the training set
- Not applicable. This device is a physical product the subject of material science and manufacturing standards, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.