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The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit With Bone Anchors is intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.

The Laparotomy Bladder Neck Suspension Kit With Bone Anchors is comprised of a template assembly, suture retriever, suture cutter, bone anchors and suture pulling loop. 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) summary for a medical device (Laparotomy Bladder Neck Suspension Kit With Bone Anchors). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel high-risk device might.

Therefore, many of the requested details about acceptance criteria, study design, expert qualifications, adjudication methods, and sample sizes for training/test sets are not present in this document. The FDA 510(k) process for this type of device typically relies on a comparison of technological characteristics to existing devices and performance testing that demonstrates safety and effectiveness without necessarily involving large-scale clinical outcome studies in the same way.

Here's what can be extracted based on the provided text, with clear indications where information is not available:

Acceptance Criteria and Device Performance

1. Table of acceptance criteria and the reported device performance:

This document does not contain a table of explicit acceptance criteria with numerical performance targets for the device itself. The 510(k) summary asserts substantial equivalence to predicate devices based on technological characteristics and intended use. Performance data is not detailed in a quantitative manner here.

General Statement on Equivalence (as the primary "acceptance"):

Study Details (or lack thereof)

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

Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of evaluating performance metrics against ground truth. The submission is based on demonstrating substantial equivalence to pre-existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. This information is relevant for studies that establish ground truth (e.g., image-based diagnostic AI models). This 510(k) summary does not detail such a study.

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

Not applicable/Not provided. As there is no described test set or ground truth establishment process involving experts, adjudication methods are not mentioned.

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:

Not applicable/Not provided. This type of study (MRMC for AI assistance) is not mentioned in the 510(k) submission. The device is a surgical kit, not an AI diagnostic tool that assists human readers.

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

Not applicable/Not provided. The device is a surgical kit for use by a surgeon, not a standalone algorithm.

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

Not applicable/Not provided. No explicit "ground truth" (in the sense of a definitive diagnostic or outcome label) is discussed in relation to a study for this device within the given text. Substantial equivalence relies on comparing the device's characteristics and intended use to approved predicate devices.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a "training set" as would be used for machine learning models.

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

Not applicable/Not provided. As there is no training set, this information is not relevant or available.

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

The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, and suture cutter and suture placement system. 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 suture placement system that is offered is the Laurus Medical Disposable Suture Placement System.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit.

Unfortunately, the provided document does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the requested table and the subsequent points about sample sizing, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training set information cannot be extracted from this document as they are not present.

The document primarily covers:

• Sponsor/Applicant information
• Device name
• Identification of predicate devices
• Device description
• Intended use
• Comparison of technological characteristics to predicate devices
• FDA's letter of clearance based on substantial equivalence.

Key takeaway: This 510(k) focuses on regulatory clearance via substantial equivalence, not on a detailed performance study with defined acceptance criteria.

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