(132 days)
MyEllevate is indicated for use in soft tissue approximation of sub dermis and underlying muscle
The MyEllevate device consists of a Surgical Suture System consisting of synthetic non-absorbable, braided, polyester surgical suture, and a set of instruments designed to efficiently and accurately place the suture for the purpose of performing soft tissue approximation. MyEllevate contains a Skin Marking Tape, a Lancet, a Tunneling Rod, two stainless steel Suturods, and a Light Handle which contains an LED light source. Each Suturod™ has an internal fiber optic "light pipe" which, when connected to the Ligh Handle, illuminates the distal tip of the Suturod™ and permits visual verification of the location and depth of the Suturod™ as it is passed through the subcutaneous space. All components of MyEllevate are provided sterile and are intended for single use only. While the nonabsorbable suture is a Class II device as describes by 21CFR, §878.5000, the remaining instruments are Class I devices exempt from 510(k) requirements. The Lancet, Clearing Device, and Tunneling Rod are manual surgical devices described by 21 CFR §878.4800. The Skin Marking Pen is described in 21 CFR §878.4660, and the fiber optic "light pipe" and Light Handle to illuminate surgical sites, is described in 21 CFR, §876.4530.
The provided document is a 510(k) summary for the MyEllevate device, which is a surgical suture system. This document is a premarket notification for a medical device and therefore does not contain information about an AI/ML-based device.
The document explicitly states:
- "807.92(b)(2) Clinical tests submitted – N/A – No clinical tests submitted" (Page 6), indicating no human performance or clinical studies were conducted for this submission.
- The device being cleared is a "Nonabsorbable Polyester Suture" and associated manual surgical instruments (Suturods, Lancet, Tunneling Rod, Light Handle, Skin Marking Tape). There is no mention of any AI or machine learning component.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets these criteria because the submitted text is a 510(k) for a physical medical device (suture system), not an AI/ML device.
§ 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.