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Ultra-Thin SDS Balloon Dilatation Catheters are indicated for stent deployement/optimization of the J&J Palmaz® Biliary Storit and for the treatment of obstructive lesions of biliary strictures.

an over-the-wire catheter designed to be placed over an over the which have outer diameters of .035" or smaller.

The provided document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, which would typically be found in studies for AI/software devices. This document describes a medical device, the Ultra-Thin SDS Balloon Dilatation Catheter, and its 510(k) premarket notification process for substantial equivalence to a predicate device.

Instead, the document focuses on:

• Substantial Equivalence: The primary "acceptance criteria" and "study" are related to demonstrating substantial equivalence to a legally marketed predicate device (Boston Scientific Corporation -- Marshal Balloon Dilatation Catheter, K973008) in accordance with FDA regulations.
• Bench Testing and Biocompatibility: The "study" performed involved "Functional and integrity bench testing and biocompatibility" according to FDA guidance (ODE Blue Book Memorandum #G95-1, May 1, 1995) and ISO-10993 standards. The data from these tests "supported the substantial equivalence."

Given the nature of the provided text, I cannot provide an answer that directly addresses the specific requested points related to AI/software device performance criteria such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. These types of studies are not described in the provided 510(k) summary for this balloon dilatation catheter.

Summary of available information related to acceptance criteria and "study":

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable/not defined in the provided document, as the "study" primarily involved bench testing and biocompatibility assessments, not clinical or image-based test sets with associated data provenance in the context of AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not defined. Ground truth in this context would relate to physical and biological properties assessed through testing, not expert interpretation of data.

4. Adjudication method for the test set: Not applicable/not defined. Adjudication methods are relevant for subjective interpretations, which are not described here.

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. This device is a physical medical instrument (balloon catheter), not an AI system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument (balloon catheter), not an AI system. Its performance is inherent to its physical properties and function.

7. The type of ground truth used: For functional and integrity bench testing, the "ground truth" would be established by validated measurement standards and physical/material properties. For biocompatibility, it would be compliance with biological safety standards through specific assays.

8. The sample size for the training set: Not applicable. This device is a physical medical instrument (balloon catheter), not an AI system that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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