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The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.

The Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is comprised of a template assembly, suture retriever, and suture cutter. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray.

The provided text is a 510(k) premarket notification for the Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data with acceptance criteria for the new device.

Therefore, many of the requested elements about acceptance criteria, detailed study design, ground truth, and expert involvement are not present in the provided text.

Based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as specific performance metrics. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to a legally marketed predicate device. This means the device performs as intended and is as safe and effective as the predicate.
• Reported Device Performance:
  • Technological Characteristics: "The technological characteristics are similar in that they include several kit components for delivering bone anchors and/or sutures for bladder neck suspension. Both the Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension and the predicate devices are similar in design in that they both use a method or a component for positioning the sutures to the appropriate anatomical site. Both the Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension and predicate products are similar in that they use a standard scissors or a suture cutter for cutting the sutures."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not contain any information about a specific test set, its sample size, or data provenance. This is typical for a 510(k) submission where equivalence is often argued based on design, materials, and intended use, rather than a new clinical performance study.

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)

• The document does not report on any ground truth establishment for a test set by external experts. The ground truth for the claims of substantial equivalence is based on the previously cleared predicate devices and general knowledge of surgical techniques.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• The document does not describe any adjudication method for a test set.

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

• The device described is a surgical kit, not an AI or diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• This is a surgical kit, not an algorithm. Therefore, "standalone" performance in this context is not applicable and was not performed. Its "standalone" function is its physical components performing their intended mechanical function during surgery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness of the predicate devices (Louisville laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076), Microvasive Percutaneous Bladder Neck Suspension Kit) and the longstanding surgical techniques for bladder neck suspension (over forty years). No new clinical outcomes data or pathology review for the new device is presented in this document to establish novel ground truth.

8. The sample size for the training set

• No training set data is mentioned, as this is a physical medical device, not a machine learning algorithm.

9. How the ground truth for the training set was established

• As there is no training set, this question is not applicable.

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