(146 days)
StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the StitchKit® device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.
StitchKit® COMBO is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a disposal compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile in a foil pouch. Each StitchKit® version contains strands of existing legallymarketed Suturing Materials, cleared for use within the StitchKit®.
This looks like a 510(k) summary for a medical device called "StitchKit® COMBO Suture Delivery Canister". Based on the provided text, the device is explicitly a suture delivery system and not an AI or imaging device, so the requested information about AI performance, ground truth, expert adjudication, etc., is not applicable.
Here's a breakdown of why the requested information cannot be provided given this document:
- No AI component: The document describes a "suture delivery canister which facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing." There is no mention of artificial intelligence, machine learning, image analysis, or any diagnostic capabilities.
- Physical device, not a diagnostic algorithm: The device handles physical sutures and needles. The performance data listed (knot-pull tensile testing, diameter, needle attachment, biodegradation testing, pyrogen testing, physico-chemical analysis, stability evaluations) are all related to the physical properties and safety of the surgical sutures and the delivery system itself, not to the performance of a software algorithm.
Therefore, since the device is not an AI/ML medical device, the following points from your request are not applicable and cannot be found in the provided text:
- A table of acceptance criteria and the reported device performance (The "performance data" mentioned refers to physical product testing, not AI performance metrics)
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
In summary, this document describes a traditional medical device (suture delivery system) and does not provide any information relevant to the performance or validation of an AI/ML component.
§ 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.