(72 days)
POLYPROPYLENE is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
POLYPROPYLENE is a nonabsorbable sterile surgical monofilament suture composed of flexible thread prepared from Long-chain polyolefin polymer known as polypropylene and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYPROPYLENE meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form, it maybe offered undyed or dyed with an FDA listed color additive, either D&C Blue No. 6, (21CFR74.3106) or D&C Blue No. 6 (21CFR74.3106) or [Phthalocyaninato(2-)] copper (21CFR74.3045). It will be offered with or without standard needles attached.
This document describes the safety and effectiveness of the POLYPROPYLENE surgical suture. Due to the nature of the device (a surgical suture), the study criteria and results are focused on physical and material properties rather than AI/software performance. Therefore, many of the requested numbered points, typically applicable to AI/ML-based medical devices, are not relevant or cannot be found in this document.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by U.S.P. Standards) | Reported Device Performance |
|---|---|
| Suture Diameter meets U.S.P. Requirements | Meets U.S.P. Requirements |
| Suture Length meets U.S.P. Requirements | Meets U.S.P. Requirements |
| Knot Pull Tensile Strength meets U.S.P. Requirements | Meets U.S.P. Requirements |
| Needle Attachment Strength meets U.S.P. Requirements | Meets U.S.P. Requirements |
| Material: Long-chain polyolefin polymer known as polypropylene | Long-chain polyolefin polymer known as polypropylene |
| Not absorbed and no significant change in tensile strength retention in vivo | Not absorbed and no significant change in tensile strength retention known to occur in vivo |
| Sterilization Method (Same or equivalent to predicate device) | Gamma Irradiation |
| Packaging (Same or equivalent to predicate device) | Dry packaged in Aluminum Foil and Polyester tear open packaging. |
| Labeling Conformance (CDRH instructions, FDA Guidance documents) | In conformance with CDRH instructions and FDA Guidance documents |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" sample size in the context of typical AI/ML studies. Instead, it refers to non-clinical testing performed to prove conformance to U.S.P. standards. The data provenance would be from laboratory testing of the POLYPROPYLENE suture. The country of origin of the data is not explicitly stated but implies testing was conducted by or for T.CAD International, which is based in Chicago, IL, USA. The testing is prospective in the sense that it was conducted on the manufactured device to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This point is not applicable. For a physical device like a surgical suture, "ground truth" is established by manufacturing specifications and adherence to recognized performance standards (U.S.P. in this case), not by expert human interpretation of data.
4. Adjudication method for the test set
This point is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of medical images or data. For physical product performance, results are based on objective measurements against engineering and material science standards.
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 point is not applicable. The device is a surgical suture, not an AI-assisted diagnostic or decision-support system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable. The device is a surgical suture, not an algorithm.
7. The type of ground truth used
The ground truth for the device's performance is based on United States Pharmacopeia (U.S.P.) standards for Nonabsorbable Surgical Suture. These are widely recognized and established performance benchmarks and specifications for medical devices.
8. The sample size for the training set
This point is not applicable. The device is a physical product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This point is not applicable. There is no training set for this type of device. The specifications and performance requirements are defined by the U.S.P. monograph.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.