(261 days)
The Auto Suture* SurgiStitch** suture passer is indicated for the placement of interrupted sutures for soft tissue approximation in surgical procedures such as cardiovascular and gastrointestinal surgery.
The Auto Suture* SurgiStitch** suture passer is designed to pass either one or both needles of a double armed suture through tissue for the creation of interrupted stitches.
The provided document, a 510(k) summary for the Auto Suture SurgiStitch suture passer, does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary is primarily focused on establishing substantial equivalence to a predicate device (Modified Endoscopic Suturing device K961173) for market clearance. It describes the device, its intended use, and materials, and clarifies the regulatory process.
Therefore, I cannot provide the requested information from the given text.
Here's a breakdown of why each point cannot be answered:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory clearance, not performance metrics.
- Sample sized used for the test set and the data provenance: No performance testing data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is detailed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical tool.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document mainly covers administrative and regulatory aspects for market clearance, not detailed performance studies or AI-related evaluations.
§ 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.