(27 days)
The SPARC™ Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The SPARC™ Sling System is a sterile, single use procedure kit consisting of:
- Two stainless steel, curved, 22-cm long, needle passers (also called insertion . tools).
- One piece of AMS Polypropylene sling mesh with attached dilating . connectors. The AMS Polypropylene sling mesh is constructed of polypropylene monofilament that is precut to 1.0 cm width x 50cm length. A fixed blue polypropylene anchoring suture runs through the middle of the sling mesh. Two plastic sheaths that overlap in the center of the sling mesh, cover the sling mesh and protect it during placement.
Dilating connectors are attached to either end of the plastic sheaths. The dilating connectors are used to attach to the vaginal ends of the SPARC™ needle passers during the procedure to facilitate sling placement. - Two blue colored plastic cystoscopy aids are included in the kit in order to facilitate cystoscopic viewing of the bladder. The use of these cystoscopy aids is optional. The proposed device that is the subject of this 510k will not include the cystoscopy aids.
The provided text describes a 510(k) submission for the SPARC™ Sling System, a surgical mesh device for treating female stress urinary incontinence. The submission focuses on comparing a modified version of the device to a previously cleared predicate device.
Based on the provided text, it is not possible to describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.
Here's why and what information can be extracted:
- No Acceptance Criteria or Performance Metrics: The document states, "A risk analysis of the proposed modification and bench test data reported in this 510(k) application substantiate equivalence to the predicate and did not raise any new questions of safety or effectiveness." It concludes, "The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance." This implies that the device was evaluated against the predicate's established safety and effectiveness, rather than specific numerical acceptance criteria being explicitly defined and reported for the modified device.
- No Clinical Study Details: The submission refers to "bench test data" but does not provide any details about specific studies, their methodology, sample sizes, or results that could be used to fill out the table or answer the detailed questions about ground truth, expert opinions, or MRMC studies. This is a common characteristic of 510(k) summary documents, which often refer to detailed data that would be in the full submission, but not in the public summary.
- Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove efficacy and safety through new, large-scale clinical trials with defined acceptance criteria for a new clinical claim.
Therefore, the requested table and detailed answers cannot be fully populated from the provided text.
However, I can provide a summary of what is mentioned in relation to the device's assessment:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate device (K011251, K01335) in: | The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance. |
| - Intended Use | (Not explicitly stated but implied that the intended use is the same as the predicate and remains "The SPARC™ Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.") |
| - Technological Characteristics | Bench test data and risk analysis indicated no new questions of safety or effectiveness, supporting equivalence. Specific changes include: modified, permanently attached, and ergonomic needle passer handle with added texture; change from double Tyvek pouch to double tray system; removal of cystoscopy aids; sling mesh width increased from 1.0 cm to 1.1 cm. |
| - Performance (Safety and Effectiveness comparable to predicate) | Bench test data and risk analysis indicated no new questions of safety or effectiveness, supporting equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: "Bench test data" is mentioned, implying laboratory or engineering testing. Country of origin and retrospective/prospective nature are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set or ground truth established by experts is described in this summary.
4. Adjudication method for the test set:
- Not applicable as no clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a surgical sling, not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical sling, not an algorithm.
7. The type of ground truth used:
- Not applicable as no clinical ground truth is described. The assessment relied on "bench test data" and "risk analysis" to demonstrate equivalence to a predicate device.
8. The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth for it is mentioned.
§ 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.