(25 days)
SAFYRE VS and SAFYRE T are to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.
PROMEDON's Slings, SAFYRE VS and SAFYRE T, are manufactured with biocompatible silicone elastomers and polypropylene. Each sling is a permanent implant and is offered as a single use sterile product. Safyre consists of a monofilament polypropylene mesh between two silicone columns that are made of multiple coneshaped soft tissue anchors. These units are the basis of the self anchoring system. The polypropylene mesh lies on the mid-urethra and the interconnective tissue grows among its pores, between the vaginal flap and the urethra, which leads to integration of the implant without a loss of vascularization between the bladder and the vagina. The two columns are fixed to the abdominal fascia or the obturator muscle. This self . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains.
SAFYRE VS consists of a sling and a pair of single-use surgical instruments to facilitate its vaginal or suprapubic implantation ; while SAFYRE T is made up of the same sling, only varying in length with respect to the model VS, and a needle intended for the transobturator technique. Both are supplied with the surgical instruments to aid implantation.
The provided text describes a 510(k) premarket notification for the SAFYRE Sling System (SAFYRE VS and SAFYRE T) and not a study that proves the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.
510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies with detailed measures like those outlined in the prompt. The "performance testing" mentioned in the document refers to bench testing and biocompatibility testing, which are fundamental safety and efficacy tests for medical devices, but not the type of clinical performance study with AI-specific metrics that the prompt is asking for.
Therefore, most of the information requested in the prompt cannot be extracted from the provided text because it describes a different type of regulatory submission.
Here's an analysis based on the information available in the text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics (e.g., accuracy, sensitivity). The "acceptance criteria" for a 510(k) are typically focused on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety/efficacy.
- Reported Device Performance: The document states "Bench testing and biocompatibility testing was performed on the SAFYRE VS and SAFYRE T." However, no specific performance results (e.g., tensile strength values, biocompatibility study results) are provided in this summary.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable/Not mentioned. The document refers to "bench testing" and "biocompatibility testing," which are not typically associated with clinical test sets in the way implied by the prompt (i.e., for evaluating diagnostic accuracy).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not mentioned. This information would be relevant for a clinical performance study involving expert assessment, which is not described here.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned.
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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/Not mentioned. This device (surgical mesh) is not an AI-powered diagnostic tool, so such a study would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not mentioned.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not mentioned in the context of clinical performance evaluation. For bench testing, the "ground truth" would be engineering specifications or scientific standards.
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The sample size for the training set:
- Not applicable/Not mentioned. This device is not an AI model requiring a training set in the sense implied.
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How the ground truth for the training set was established:
- Not applicable/Not mentioned.
Summary from the provided text:
The document is a 510(k) summary for SAFYRE VS and SAFYRE T surgical mesh, demonstrating substantial equivalence to a predicate device (SAFYRE Sling System - K020007). The performance testing mentioned is "Bench testing and biocompatibility testing," aimed at ensuring the device's safety and fundamental functional properties, rather than clinical efficacy or diagnostic accuracy as might be evaluated for an AI medical device. No specific clinical study or performance data fitting the prompt's criteria (e.g., accuracy, sensitivity, expert review, AI integration) is present.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.