(16 days)
Versaclose is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.
The Versaclose implant is comprised of one (1) Peek Optima (LT1) Toggle-anchor, connected to an adjustable 2-0 braided suture loop, made of ultra high molecular weight polyethylene (UHMWPE) force fiber suture. The suture component conforms to USP requirements. The construct is provided sterile and preloaded on a disposable delivery instrument.
Here's an analysis of the provided text regarding the Versaclose™ device, focusing on the acceptance criteria and supporting study information:
Based on the provided document, the Versaclose™ device's regulatory submission (K100572) is primarily focused on demonstrating substantial equivalence to a predicate device (K061386 - Anchor Band Suturing System) rather than proving performance against specific, quantitative acceptance criteria through a clinical or performance study as might be expected for an AI/diagnostic device.
Key takeaway: This document describes a device modification where the primary evidence for meeting acceptance criteria is through design verification and validation activities, specifically tensile testing to confirm compliance with USP suture requirements. It is not a clinical study of the type often associated with AI performance evaluations.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Compliance to USP suture requirements (identified via risk analysis) | "tensile testing was performed to confirm compliance to USP suture requirements." |
Note: The document does not provide the specific numerical values for USP suture requirements (e.g., minimum tensile strength for a 2-0 braided suture) or the specific numerical results obtained from the tensile testing. It only states that compliance was confirmed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "tensile testing" but does not specify the number of samples or lots tested.
- Data Provenance: Not applicable in the context of a retrospective/prospective study with human subjects. The testing described is a physical characterization of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for this type of submission is defined by the USP (United States Pharmacopeia) standards for sutures, which are published material specifications, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. There is no human adjudication process described for the tensile testing or USP compliance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
- No. This type of study (MRMC) is generally performed for diagnostic or AI-assisted interpretation devices to assess the impact on human readers. This submission is for a surgical implant/suturing system, and such a study is not relevant here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
- No. This is not an algorithm or AI device. The described testing is a standalone device performance test in a laboratory setting (tensile testing) to confirm material properties, not an algorithm's classification performance.
7. The Type of Ground Truth Used
- Material Specification / Standard: The ground truth for the "acceptance criteria" is the USP (United States Pharmacopeia) requirements for sutures. These are pre-defined, standardized physical and mechanical properties that sutures must meet.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device submission for a physical medical device. The "training" here would be related to the development and refinement of the device design, which is not described in terms of a data set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set in the AI/diagnostic sense, there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is adherence to general engineering principles, material specifications, and quality systems.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.