(137 days)
NUVANCE* Facial Rejuvenation System is intended to fixate subdermal tissue in an elevated position in plastic and reconstructive surgery. The device may be used in areas such as the forehead, midface, jowls and neck.
NUVANCE For Face is a sterile implant typically used in minimally invasive face-lift and facial contouring procedures. It consists of a bi-directionally barbed polymer strand with a short and a long straight steel introducer attached at the ends. The device may be pigmented to enhance visibility.
The strand has barbed upper and lower anchoring sections with unbarbed smooth sections adjacent to the steel introducers. Upper and lower anchoring sections are barbed in opposite directions with a small unbarbed section between them. Two sizes and various lengths are available.
The provided text describes a 510(k) premarket notification for the NUVANCE* Facial Rejuvenation System, a nonabsorbable polypropylene surgical suture for fixating subdermal tissue. However, the document does not contain specific acceptance criteria, a detailed study report proving device performance against those criteria, or information on reader studies, ground truth establishment for a training set, or sample sizes for test and training sets in the context of AI/ML device evaluation.
The document states:
- Performance Data: "Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements."
Based on the provided text, I cannot complete the requested tables and information fields as they pertain to detailed performance criteria and study methodologies, particularly in the context of AI/ML device evaluation. The document is a regulatory submission for a physical medical device (suture) and focuses on substantial equivalence to predicate devices, biological reactivity, and general functional performance, not on demonstrating performance against specific AI/ML metrics.
To directly answer your request based on the absence of the specific information you asked for:
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Table of acceptance criteria and reported device performance: Not provided in the document. The document vaguely states "meets or exceeds all functional requirements" but does not define these requirements or provide specific quantitative performance metrics.
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Sample sized used for the test set and the data provenance: Not provided. The document mentions "bench and animal testing" but no details on sample sizes or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This device is a surgical suture, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
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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/provided. This is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/provided. This is a physical surgical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/provided in the context of an AI/ML device. For material reactivity, ground truth would be established by ISO 10993-1 standards; for functional performance, it would be established by engineering specifications and physical test results from bench and animal studies.
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The sample size for the training set: Not applicable/provided. The device is not an AI/ML model that requires a training set.
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How the ground truth for the training set was established: Not applicable/provided.
In summary, the provided regulatory document for the NUVANCE Facial Rejuvenation System lacks the specific details regarding acceptance criteria, study methodologies, and data provenance as requested for an AI/ML device. The performance data mentioned relates to biological reactivity and functional testing, not to the types of studies typically conducted for AI/ML device evaluation.*
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.