(67 days)
IN-SLING is intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence
The IN-SLINGTM is a gelatin-sealed, knitted polyester patch fabric intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
The provided document is a 510(k) summary for the IN-SLINGTM device. It focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the IN-SLING device itself. Therefore, many of the requested elements (acceptance criteria, specific study details, sample sizes, expert qualifications, etc.) are not present in this type of submission.
Here's a breakdown of what can be extracted from the document regarding "acceptance criteria" and "study":
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in the way typically seen for a new device's efficacy or safety study. Instead, the submission focuses on substantial equivalence to predicate devices. The "performance" is implicitly tied to the performance of the predicate devices.
2. Sample sized 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. The document describes the device and claims substantial equivalence, but it does not detail a study with a test set, sample size, or data provenance.
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 no such ground truth establishment is described for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no test set requiring adjudication is described.
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
A MRMC study is not mentioned. The device is a surgical mesh, not an AI or imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable as no performance study requiring ground truth is described.
8. The sample size for the training set
This information is not provided. Since this is a physical medical device (surgical mesh), not an AI algorithm, the concept of a "training set" in this context is not relevant.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
Summary based on the provided document:
The 510(k) submission for the IN-SLINGTM establishes substantial equivalence topredicate devices, specifically Surgical Fabrics' ProteGen™ and Vascutek's Gelseal™.
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Predicate Devices:
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Basis for Substantial Equivalence:
- To Vascutek Gelseal™: The IN-SLING™ is stated to be "identical to the Vascutek Gelseal™ in terms of materials, manufacturing, processing, packaging and sterilization." The only difference is in the size and shape of the fabric.
- To Surgical Fabrics' ProteGen™: The IN-SLING™ is substantially equivalent in terms of "intended use and labeling." Both are used as slings in sling procedures for the treatment of urinary incontinence.
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Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criteria are that the IN-SLING™ performs as safely and effectively as its predicate devices. This is established by demonstrating identical materials, manufacturing, and processing to one predicate, and identical intended use and labeling to another. No new performance studies for the IN-SLING™ itself are detailed in this summary; rather, its performance is considered equivalent to devices already on the market and deemed safe and effective by the FDA.
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Study Proving Acceptance: The document does not describe a standalone performance study for the IN-SLING™. The "proof" is the detailed comparison of its characteristics and intended use to the legally marketed predicate devices, as presented in the 510(k) submission.
§ 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.