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Ultra-Thin SDS Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The proposed Ultra-Thin SDS Balloon Dilatation Catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller.

This document is a 510(k) premarket notification for a medical device called the "Ultra-Thin SDS Balloon Dilatation Catheter". It is a submission to the FDA seeking clearance to market the device by demonstrating its substantial equivalence to a legally marketed predicate device.

Let's break down the requested information:

1. Table of Acceptance Criteria & Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria with numerical targets or a "reported device performance" against those criteria in a tabular format as would be typical for clinical studies or performance testing summaries. Instead, it makes a general statement of compliance.

• Acceptance Criteria (Implicit): Assumed to be "conformance to the requirements for its intended use" and "no new safety or performance issues."

• Reported Device Performance:
  "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen."

  Therefore, a table cannot be constructed with the provided information. The document confirms that testing was done and that the device met the requirements without new issues, but not specific numeric results or thresholds.

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

• Sample Size for Test Set: Not specified. The document mentions "Bench testing and biocompatibility testing" but does not give any details on the number of devices or samples tested.
• Data Provenance: The testing was "performed to support a determination of substantial equivalence." This refers to internal testing conducted by the manufacturer, Boston Scientific Corporation, based in Galway, Ireland. The testing is likely retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.

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

• Not applicable / Not specified. This document describes a 510(k) submission primarily based on bench and biocompatibility testing, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set:

• Not applicable / Not specified. As this document does not describe a clinical study requiring expert adjudication of results, this information is not relevant.

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:

• No. This document describes a medical device (a balloon dilatation catheter), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not applicable.

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

• No. This document describes a medical device (a balloon dilatation catheter), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used:

• Not applicable for clinical ground truth. For the bench and biocompatibility testing, the "ground truth" would be established by specifications and regulatory standards for material properties, mechanical performance (e.g., burst pressure, fatigue), and biological safety.

8. The sample size for the training set:

• Not applicable / Not specified. This is a medical device (catheter) submission, not an AI model. There is no concept of a "training set" in this context.

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

• Not applicable / Not specified. As above, there is no "training set." The performance of the device is assessed against engineering specifications and biocompatibility standards.

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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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