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The Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.

Needle-Point Suture Passer Instrument Set

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device (Carter-Thomason Needle-Point Suture Passer Instrument Set), confirming its substantial equivalence to a predicate device.

While it mentions the device's intended use ("to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery"), it does not include any specifics regarding:

• Acceptance criteria: No performance metrics or thresholds are listed.
• Device performance data: No study results, sensitivity, specificity, accuracy, or other performance indicators are provided.
• Sample sizes: No information about test sets, training sets, or data provenance.
• Ground truth establishment: No details on experts, adjudication methods, or the type of ground truth used.
• Comparative effectiveness studies (MRMC) or standalone algorithm performance: These concepts are not applicable to the type of device described (a surgical instrument, not an AI/software device).

The document is a regulatory approval, not a technical report detailing the device's validation study. Therefore, I cannot populate the requested table or answer the specific questions based on the given input.

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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. Vaginal Suturing Kit for Laparobomy Bladder Neck Suspension is indicated for urethropexy procedures for bladder neck suspension to correct incontinence due to urethral hypermobility.

The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, suture cutter 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 document K971791 is a 510(k) Pre-Market Notification for a medical device submitted to the FDA in 1997. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically seen for novel devices.

Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what the document does provide:

• Acceptance Criteria and Study Data: The 510(k) pathway for medical device regulation in 1997 (and largely today) focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate). This typically involves comparing device design, materials, intended use, and technological characteristics. It does not generally require de novo clinical trials with predefined acceptance criteria and performance metrics like sensitivity, specificity, or outcomes data, unless there's a significant difference in technology or intended use that raises new questions of safety and effectiveness.

Instead, the document provides the following relevant information for a 510(k) submission:

• Identification of the Predicate Devices:

  • Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076)
  • Laurus Medical Suturing System (K932553)
  • "several surgical techniques that have been performed for over forty years."

• Statement of Substantial Equivalence: The document states that the Vaginal Suturing Kit For Laparotomy Bladder Neck Suspension is substantially equivalent to the aforementioned predicate devices. The basis for this claim is similarity in:

  • Intended use (bladder neck suspension for female stress incontinence due to urethral hypermobility).
  • Technological characteristics: Both the subject device and predicates include kit components for delivering bone anchors and/or sutures for bladder neck suspension, use a method or component for positioning sutures, and use a standard scissors or suture cutter for cutting sutures.

• FDA Determination: The FDA reviewed the 510(k) notification and determined that the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This determination allows the sponsor to market the device.

In summary, because this is a 510(k) pre-market notification from 1997, it relies on demonstrating substantial equivalence to existing devices rather than presenting novel clinical study data with specific acceptance criteria.

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

The Laparoscopic 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 in the kit is the Laurus Medical Disposable Suture Placement System.

I am sorry, but the provided text primarily consists of a 510(k) summary for the "Louisville Laboratories, Inc. Laparoscopic Suspension Kit." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific study that proves the device meets acceptance criteria through performance data.

Therefore, the document does not contain the information necessary to fill out a table of acceptance criteria and reported device performance or answer the specific questions about study design, sample sizes, expert ground truth, adjudication, or MRMC comparative effectiveness. The text highlights:

• Intended use: Bladder neck suspension for female stress incontinence due to urethral hypermobility.
• Device description: Comprised of a template assembly, suture retriever, suture cutter, and suture placement system.
• Technological characteristics comparison: States similarity in components and method of positioning sutures to predicate devices.
• Predicate devices: Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076) and Laurus Medical Suturing System (K932553).

The 510(k) process typically relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often by showing similar technological characteristics and intended use, rather than requiring extensive clinical trials with specific acceptance criteria and performance metrics for the new device as would be seen in a PMA or De Novo submission.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device