(86 days)
The SuperStitch 5F, 12F & EL sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SuperStitch 5F, 12F & EL are not intended for blind vascular closure.
The SuperStitch 5F, 12F & EL versions are hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, a pre-loaded guidewire, a KnotPusher accessory for advancing the knot to the wound site, and a KwiKnot accessory.
The provided text is a 510(k) summary for a medical device (SuperStitch® 5F, 12F & EL Vascular Suture Delivery Device). This document is a regulatory submission to the FDA for market clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results or acceptance criteria in the manner typically seen for novel AI/software as a medical device (SaMD) products.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not present in this type of document because the device relies on existing technology and a predicate device.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/present in this document. The 510(k) focuses on demonstrating substantial equivalence, not meeting specific performance metrics from a detailed clinical study with pre-defined acceptance criteria. The claim is that the device has "the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the currently marketed SuperStitch," with only minor modifications in diameter or length. This implies the performance is expected to be equivalent to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a manual surgical suturing device, not an AI/software device that would typically have a "test set" in the context of AI performance evaluation. The submission relies on the established safety and effectiveness of its predicate device, the original SuperStitch Vascular Suturing Device, without presenting a specific clinical "test set" for the new iterations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth establishment, in the context of expert consensus, is typically for evaluating diagnostic or prognostic algorithms. This device is a surgical instrument.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. MRMC studies are typically for evaluating the impact of AI on diagnostic performance of human readers. This device is a surgical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/algorithm-only device.
7. The Type of Ground Truth Used
Not applicable. For this type of device, safety and effectiveness would be demonstrated through bench testing, biocompatibility, sterilization validation, and potentially animal or limited human use data, all aimed at showing that the device performs its intended function safely and effectively, similar to its predicate. The concept of "ground truth" as used in AI evaluation does not directly apply here.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of what is available in the document regarding how the device meets acceptance criteria (through the lens of substantial equivalence):
The device (SuperStitch 5F, 12F & EL) gained market clearance based on its substantial equivalence to a previously cleared predicate device, Sutura's SuperStitch Vascular Suturing Device.
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Acceptance Criteria (Implied by Substantial Equivalence): The device is considered to meet acceptance criteria if it:
- Has the same intended use.
- Has the same indications for use.
- Has the same principles of operation.
- Has fundamental technological characteristics that are equivalent.
- Any differences do not raise new questions of safety or effectiveness.
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Study Proving Acceptance Criteria (Demonstration of Substantial Equivalence):
- The "study" here is the 510(k) submission itself, which argues for substantial equivalence.
- The document explicitly states: "The SuperStitch 5F, 12F & EL has the same intended use and indications for use, principles of operation, and fundamental technological characteristics as the currently marketed SuperStitch, except that the SuperStitch 5F, 12F & EL provide the option of diameter or lengths for use by the physician. This minor modification to the SuperStitch does not raise any new questions of safety or effectiveness. Thus, the SuperStitch 5F, 12F & EL are substantially equivalent."
In essence, for this specific K062125 submission, the "acceptance criteria" were met by demonstrating that the new devices are essentially minor variations of an already cleared and accepted device, and therefore share its established safety and effectiveness profile. No new clinical trials or performance studies specific to these minor modifications were required or presented in this summary document.
§ 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.