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PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.

PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.

The provided text describes the submission of a 510(k) premarket notification for a new surgical suture device named PREMIO®. The purpose of this submission is to demonstrate that PREMIO® is substantially equivalent to a legally marketed predicate device, PRONOVA™. The document focuses on comparing the new device to the predicate device, particularly regarding their technological characteristics and intended use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that non-clinical laboratory testing was performed. However, it does not specify the sample size used for this testing. The data provenance is also not detailed beyond mentioning "non-clinical laboratory testing." It does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be based on laboratory testing against established pharmacopoeia standards (USP and EP) rather than expert review of cases or outcomes.

4. Adjudication Method for the Test Set

Since there is no mention of experts or a test set requiring adjudication in the context of human review, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or mentioned. The submission focuses on demonstrating substantial equivalence through technological and performance comparisons against established standards and a predicate device, not on assessing human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the device being described. PREMIO® is a physical surgical suture, not a software algorithm or AI-powered system designed for standalone performance or human-in-the-loop assistance.

7. Type of Ground Truth Used

The ground truth used for evaluating PREMIO® appears to be the established standards and specifications outlined in the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for non-absorbable surgical sutures. The biocompatibility of the raw material is also cited as "proven," likely referring to existing literature or prior regulatory approvals for the material.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission. PREMIO® is a physical medical device, not a machine learning model that requires a training set. The evaluation is based on laboratory testing and comparison to a predicate device and monograph standards.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.

5. 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.

6. 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.

7. 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.

8. The sample size for the training set: Not applicable/provided. The device is not an AI/ML model that requires a training set.

9. 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.*

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