(268 days)
The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The ePTFE suture contained within StitchKit® is indicated for use in all types of soft tissue approximation, including use in cardiovascular surgery and dura mater repair. It is recommended for use where reduced suture line bleeding during cardiovascular anastomotic procedures is desired.
The StitchKit® device is a sterile, single-use plastic canister that is pre-loaded with six strands of non-USP ePTFE suture, (diameter approx. 0.294 mm
Here's an analysis of the acceptance criteria and study information for the StitchKit® device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the types of performance testing conducted but does not explicitly state quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a high-level summary that "This testing has demonstrated that the StitchKit® device meets its design input requirements."
Therefore, the table below will list the types of performance testing conducted and the general statement regarding their fulfillment, as specific thresholds and results are not available in this document.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material & Product Properties | |
| Biocompatibility | Meets design input requirements (implied acceptable) |
| Shelf-life testing | Meets design input requirements (implied acceptable) |
| Packaging validation | Meets design input requirements (implied acceptable) |
| Sterilization validation | Meets design input requirements (implied acceptable) |
| Suture testing (USP methods) | Suture's key characteristics unaffected by cutting, packaging, sterilization; includes knot-pull, diameter, needle attachment |
| Suture length | Meets design input requirements (implied acceptable) |
| Device physical dimensions (weight, size) | Meets design input requirements (implied acceptable) |
| Functional Performance | |
| Suture dispensing force | Meets design input requirements (implied acceptable) |
| Tensile evaluation of key components (foam pullout, suture-holder base pull-out, disposal compartment cover pull-out) | Meets design input requirements (implied acceptable) |
| Retrieval string tensile strength | Meets design input requirements (implied acceptable) |
| Hinge strength | Meets design input requirements (implied acceptable) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each performance test (e.g., number of devices tested for hinge strength, number of suture strands for knot-pull).
It also does not provide information about the country of origin of the data or whether the studies were retrospective or prospective. The nature of these tests (e.g., biocompatibility verification, mechanical testing) typically implies laboratory-based, prospective testing conducted by the manufacturer or contracted labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the StitchKit® device as described. The testing performed involves objective physical and mechanical measurements and validations (e.g., tensile strength, dimensions, sterilization efficacy, biocompatibility). These do not rely on expert interpretation in the way, for example, a diagnostic imaging study would require radiologists to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used for subjective assessments where multiple experts might disagree, which is not the case for the physical and mechanical performance tests described for the StitchKit®.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic or AI-powered devices to assess the impact of the device on human reader performance, which is not relevant for this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was not conducted. The StitchKit® is a medical device (suture delivery canister with pre-loaded suture) that facilitates surgical procedures; it is not an algorithm or an AI-powered system that would have a "standalone performance" in the sense of an algorithm operating independently of human interaction for interpretation or decision-making. Its performance is assessed through its physical and functional attributes.
7. Type of Ground Truth Used
The "ground truth" for the StitchKit® device's performance tests is based on pre-defined design input requirements, industry standards (e.g., USP methods for suture testing), and objective physical and mechanical measurements. For example, for tensile evaluations, the ground truth would be a specific force threshold that the component must withstand, measured objectively. For suture diameter, the ground truth is the specified diameter range. For sterilization, it's the demonstration of sterility per established protocols.
8. Sample Size for the Training Set
This information is not applicable. The StitchKit® is a physical medical device (suture delivery canister and suture), not an AI/ML algorithm or software that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device.
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.