(29 days)
MONODERM™ (PGA-PCL) suare is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Monoderm™ (PGA-PCL) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-carpolactone. The Monoderm™ (PGA-PCL) suture is available dyed and undyed in Size 1 through Size 6-0.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Monoderm™ (PGA-PCL) Surgical Suture, structured according to your request:
Acceptance Criteria and Study for Monoderm™ (PGA-PCL) Surgical Suture
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must conform to) | Reported Device Performance (How the device met the criteria) |
|---|---|
| USP monograph for absorbable sutures | Conforms to the USP monograph for absorbable sutures |
| Performance requirements for substantial equivalence to predicate device | Demonstrates substantial equivalence to the predicate device, including in vitro post-hydrolysis tensile testing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in terms of individual sutures tested. The reference is to "performance testing" being conducted. The data provenance is implied to be from non-clinical laboratory testing conducted by the company, Surgical Specialties Corporation, likely in the USA (given the company's address and FDA submission). The nature of the testing suggests it is prospective in the sense that the new Monoderm™ (PGA-PCL) suture was manufactured and then subjected to these tests to evaluate its properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for suture performance is typically established by physical and chemical properties measured against established standards (like the USP monograph), rather than expert human interpretation of images or other subjective data. Therefore, expert consensus in the traditional sense is not directly applicable here.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for human review of subjective data, typically in diagnostic imaging or clinical trials where expert consensus is needed. For product performance testing of a physical device like a suture, the assessment is based on measured physical properties against predefined specifications, not human adjudication of subjective findings.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This submission is for a physical surgical suture, not an AI device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone study (in the context of an algorithm) was not done. This submission is for a physical surgical suture.
7. The Type of Ground Truth Used
The ground truth used for evaluating the suture's performance is based on:
- Established standards and specifications: Specifically, the USP monograph for absorbable sutures.
- Comparative data against a legally marketed predicate device: "in vitro post-hydrolysis tensile testing" to demonstrate substantial equivalence. This implies that the predicate device's performance characteristics served as a reference "ground truth" for comparison.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This submission is for a physical medical device (suture) and does not involve an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable as there is no training set for an algorithm in this context.
§ 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.