(90 days)
The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is supplied sterile and is intended for one-time use.
The Surgisis® Sling is supplied in sheet form in sizes ranging from 20 cm2 to 140 cm2. The device is packaged in sterile, sealed double pouches.
This document is a 510(k) Summary for the Surgisis® Sling, a surgical mesh device. It does not provide information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or any other quantitative measures typically associated with AI/ML device evaluations.
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: The Surgisis® Sling has the same intended use as its predicates (K980431, K954665, K980483, K963226).
- Technological Characteristics: The device is stated to have the same technological characteristics as the predicate devices.
- Testing for Biocompatibility, Integrity, and Performance: The document states that the Surgisis® Sling "passed the requirements of all tests" in these areas. However, it does not specify what these requirements or performance metrics were, nor does it provide the results of these tests in a detailed manner.
Therefore, I cannot provide the requested information for an AI/ML device as this document pertains to a traditional medical device (surgical mesh) where the evaluation criteria are different. The concept of "acceptance criteria" in this context refers to meeting the standards of biocompatibility, integrity, and equivalent performance to existing devices, rather than statistical performance metrics for an AI algorithm.
Summary of what can be extracted, and what cannot:
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Table of acceptance criteria and reported device performance:
- Acceptance Criteria (Implied): Biocompatibility, Integrity, Performance (in relation to predicate devices).
- Reported Device Performance: "The Surgisis® Sling passed the requirements of all tests." No specific quantitative performance metrics are provided.
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Sample size used for the test set and data provenance:
- Not applicable/Not provided. The document refers to "tests" on the device itself (e.g., material properties), not a "test set" of patient data for an algorithm.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable/Not provided. Ground truth in the context of an AI/ML device would involve annotations by experts on medical data. This document doesn't involve that.
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Adjudication method:
- Not applicable/Not provided.
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Multi-reader multi-case (MRMC) comparative effectiveness study:
- Not applicable/Not performed. This is for evaluating AI assistance to human readers.
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Standalone (algorithm only) performance:
- Not applicable/Not performed. This device is not an algorithm.
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Type of ground truth used:
- Not applicable in the AI/ML sense. The "ground truth" for this device would be established engineering and biological standards for surgical mesh materials.
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Sample size for the training set:
- Not applicable/Not provided. This document describes a physical medical device, not an AI algorithm.
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How the ground truth for the training set was established:
- Not applicable.
In conclusion, the provided document describes a premarket notification (510(k)) for a conventional surgical mesh, focusing on substantial equivalence to existing devices. It does not contain the type of information related to acceptance criteria, test sets, ground truth, or study designs that would be relevant for an AI/ML medical device.
§ 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.