(58 days)
The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing.
Monotex® PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. Monotex® PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. Monotex® PTFE suture is provided sterile as a single use device.
StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles.
The provided text does not describe the acceptance criteria, reported device performance, or any study that proves the device meets specific acceptance criteria regarding a medical device that utilizes artificial intelligence.
The document is a 510(k) Premarket Notification from the FDA for a device called "StitchKit® Suture Deliver Canister with PTFE Surgical Suture." The review is for a change to an existing legally marketed device, specifically:
- Alternate source for suture
- Choice of finish on stainless steel needle
- Longer shelf life based on real-time age testing
The document lists performance data that was collected to support these changes. However, these are standard engineering and material tests for sutures and their components, not studies evaluating AI-driven performance or diagnostic accuracy.
Therefore, I cannot provide the requested information from the given text. The text does not contain:
- A table of acceptance criteria and reported device performance (for an AI device).
- Sample size used for a test set or its provenance.
- Number/qualifications of experts for ground truth.
- Adjudication method.
- Details of an MRMC comparative effectiveness study or effect size of AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (for an AI device).
- Sample size for a training set.
- How ground truth for a training set was established.
§ 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.