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The Island Biosurgical, Inc. Bladder Neck Suspension Bolster is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation. This bolster is recommended where the possibility of reduced suture and mosh reaction is desired.

A surgically implantable polypropylene mesh bolster with monofilament sutures.

The provided text is a 510(k) summary for the Island Biosurgical Bladder Neck Suspension Bolster. It explicitly states:

"Performance testing: Performance testing was not included in this 510 (k)."

Therefore, based on the provided document, there is no information available regarding acceptance criteria, device performance against such criteria, or any study that proves the device meets acceptance criteria.

As a result, I cannot provide the requested information. This device received substantial equivalence without requiring performance testing to demonstrate its safety and effectiveness.

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The Island Biosurgical, Inc. Bladder Neck Suspension Kit is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation.

A surgical kit including disposable surgical suture carriers and catheter stylet, implantable polypropylene mesh bolsters, a urethral Malecot catheter, surgical drapes, with bone anchors (Kit #2) or without bone anchors (Kit #1).

This document is a 510(k) Summary for the Island Biosurgical Bladder Neck Suspension Kit from 1997. It explicitly states:

"Performance testing: Performance testing was not included in this 510 (k)."

Therefore, based on the provided text, the device did not undergo performance testing to establish acceptance criteria or to prove that the device meets such criteria. Consequently, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth can be extracted from this document.

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Supporting the endopelvic fascia in bladder neck surgery for stress incontinence.
The Island Biosurgical Bolster is indicated for correction of pelvic floor relaxation or herniation at the bladder neck level.

A preformed surgical mesh device with sutures woven along the edges.

This submission is a 510(k) premarket notification for a medical device and therefore does not contain details about acceptance criteria, device performance studies, or ground truth establishment in the way a clinical trial report or a comprehensive performance study would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or performance against specific metrics through new clinical data.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the 510(k) summary. The submission focuses on substantial equivalence based on technological characteristics and intended use matching a predicate device (Marlex polypropylene mesh), rather than specific performance metrics against pre-defined acceptance criteria for a novel device.

2. Sample size used for the test set and data provenance:

This information is not provided. As this is a 510(k) seeking substantial equivalence to a predicate device, it likely did not involve a specific "test set" or clinical study with patient samples. The basis for substantial equivalence is primarily through comparison of materials, design, and intended use with the predicate.

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

This information is not provided. Ground truth establishment for a test set is typically part of a clinical trial or performance study, which is not detailed in this 510(k) summary.

4. Adjudication method for the test set:

This information is not provided. Adjudication methods are relevant for studies involving human assessment of outcomes, which are not described in this document.

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:

This information is not applicable and not provided. This device is a surgical bolster, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

This information is not applicable and not provided. This device is a passive surgical implant, not an algorithm.

7. The type of ground truth used:

This information is not provided. Since there's no mention of a performance study with a "test set," there's no ground truth concept applied in this context. Substantial equivalence relies on comparing the new device's characteristics to a predicate, not against an objective clinical ground truth derived from patient data for performance evaluation.

8. The sample size for the training set:

This information is not applicable and not provided. This device is a physical surgical mesh, not a machine learning model that requires a training set.

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

This information is not applicable and not provided. As mentioned above, there is no "training set" for this type of device.

Summary based on the provided text:

The submission for the Island Biosurgical Bolster is a 510(k) premarket notification. The core of a 510(k) is to demonstrate substantial equivalence to a predicate device already on the market (in this case, Marlex polypropylene mesh). This means showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety and effectiveness.

Therefore, the document focuses on:

• Trade Name: Island Biosurgical Bolster
• Common Name: Surgical Bolster
• Classification Name: Mesh, Surgical, Polymeric
• Intended Use: Supporting the endopelvic fascia in bladder neck surgery for stress incontinence.
• Technological Characteristics: "No differences from the legally marketed polypropylene mesh."
• Predicate Device: Marlex polypropylene mesh

The absence of the requested details about acceptance criteria, performance studies, sample sizes, and ground truth establishment is typical for a 510(k) submission, especially one that claims "no differences from the legally marketed polypropylene mesh" in technological characteristics. These types of studies are more common for novel devices or those seeking PMA approval.

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