(63 days)
I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.
I-STOP is a sterile, single use kit consisting of knitted monofilament polypropylene, two to four stainless steel needles and two polycarbonate handles. The kit is designed to be used with any of the surgical approaches to position the sling.
The provided text describes a medical device called I-STOP, a surgical mesh intended for the treatment of female urinary incontinence. However, it does not contain specific acceptance criteria, reported device performance metrics in a quantifiable way, or details of a study that proves the device meets those criteria in the format requested.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria through clinical studies with quantitative outcomes.
Here's a breakdown based on the information provided, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. For a medical device, these would typically involve specific quantifiable targets for safety and effectiveness (e.g., success rate, complication rates, tensile strength, erosion rates).
- Reported Device Performance: Not provided in a quantifiable manner. The summary mentions "Mechanical tests, biocompatibility tests in compliance with ISO 10993 and chemical tests" and "One multicenter retrospective study on a large population, published on Urology (January 2000) and one march and published soon." However, no specific results, success rates, or complication rates are reported from these studies to compare against acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document mentions "one multicenter retrospective study on a large population." "Large population" is not a specific sample size.
- Data Provenance: "One multicenter retrospective study" is mentioned. The country of origin is not specified but the submitter is based in France. The study is explicitly stated to be retrospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not provided. The retrospective study mentioned would have involved patient outcomes as "ground truth," but details about expert involvement in establishing this are absent.
4. Adjudication Method for the Test Set:
- This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study is mentioned. This device is a surgical implant, not an imaging or diagnostic AI-assisted device, so an MRMC study in the typical sense (comparing human readers with and without AI assistance for interpretation) would not be applicable.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical surgical implant, not a software algorithm.
7. Type of Ground Truth Used:
- Based on the context of a retrospective clinical study for a surgical implant, the ground truth would typically be patient clinical outcomes (e.g., resolution of urinary incontinence, occurrence of complications) as observed and recorded in patient medical records over time.
8. Sample Size for the Training Set:
- Not applicable/provided. There is no mention of an algorithm or AI model requiring a training set. The clinical study described is for evaluating the implant's effectiveness in patients, not for training a model.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not contain the detailed performance metrics, acceptance criteria, or specific study designs (like MRMC or AI training/testing details) that would be expected for a software-as-a-medical-device (SaMD) or an AI-enabled device. The "Summary of clinical tests" section is very brief and lacks quantitative results.
§ 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.