(40 days)
The STRATASISTM Sling Kit is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The STRATASISTM Sling Kit is composed of a strip of SIS material with TEVDEK® suture attached to each end. Two stainless steel ligature carriers are also included.
The provided text describes a 510(k) premarket notification for the STRATASIS™ Sling Kit. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria with quantitative performance metrics. Therefore, the information typically requested in your prompt (e.g., specific performance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader studies, ground truth types) is not present in the provided document, as it is generally not required for a 510(k) summary focused on substantial equivalence based on materials, construction, and intended use.
However, I can extract information related to the "tests" performed and the "conclusions drawn," which are the closest equivalents to demonstrating criteria satisfaction in this context.
Here's a breakdown of what can be extracted and an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility requirements met | The STRATASISTM Sling Kit met the requirements of all tests. |
| Disinfection requirements met | The STRATASISTM Sling Kit met the requirements of all tests. |
| Performance characteristics met | The STRATASISTM Sling Kit met the requirements of all tests. |
| Substantial equivalence to predicate devices in terms of indications for use, materials, and physical construction. | The STRATASISTM Sling Kit is similar in terms of substantial equivalence to predicate devices (SUROISIS Sling, SIS Hernia Repair Device, Tension Free Vaginal Tape) with respect to indications for use, materials, and physical construction. |
Explanation: The 510(k) summary only states that the device "met the requirements of all tests" for biocompatibility, disinfection, and performance characteristics. It does not provide specific quantitative acceptance thresholds or detailed performance outcomes for these tests. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. 510(k) summaries for devices like surgical meshes typically do not include clinical study details of this nature unless a de novo classification or complex performance data is required. The "tests" mentioned are likely bench tests and material characterization, not patient-based test sets.
3. 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)
This information is not provided as there is no mention of a clinical test set or ground truth established by experts. The "tests" refer to laboratory and material evaluations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a clinical test set or adjudication process.
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
This information is not applicable/provided. The device is a surgical sling, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a surgical sling, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. For a surgical mesh, ground truth is typically assessed through detailed material testing, biocompatibility studies, and in some cases, animal model or clinical trial outcomes to demonstrate safety and efficacy. However, for a 510(k) of this nature, detailed outcomes data acting as "ground truth" for a performance study is usually not the primary focus, especially when substantial equivalence to well-established predicates is the claim.
8. The sample size for the training set
This information is not applicable/provided. The device is a physical surgical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. The device is a physical surgical implant, not an AI model.
In summary: The provided document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" of the STRATASISM Sling Kit to existing predicate devices based on its intended use, materials, and physical construction. It confirms that the device underwent and met requirements for biocompatibility, disinfection, and performance characteristics through un-detailed "tests." It does not contain the kind of detailed performance data, clinical study specifics, or AI-related information requested, as that is not typically part of a 510(k) premarket notification for a device of this type in 2002.
§ 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.