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The Marshal™ Balloon Dilatation Cutheter is indicated for deployment of the Palmaz™ and the Palmaz-Shatz™ Balloon-Expanded Stents for the Biliary system
Marshal Gatheters are not indicated for use in coronary arteries or the neurovasculature.

The Marshal™ Balloon Dilatation catherer is an over-the-wire catherer designed to be placed over guidewires which have outer diameters of .035" or smaller.

This document appears to be a 510(k) premarket notification for the Marshal™ Balloon Dilatation Catheter, filed by Boston Scientific Corporation. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical trials with specific acceptance criteria as you might see for a de novo device or a PMA.

Therefore, the requested information regarding acceptance criteria, specific trial details (sample size, experts, adjudication, MRMC, standalone performance), and ground truth establishment is not present in the provided text, as this type of information is generally not required or included in a 510(k) submission for this class of device.

Here's an analysis based on the information provided, explaining why certain sections are not applicable:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The document explicitly states: "Functional and integrity bench testing and biocompatibility testing... were performed, and the data supported the substantial equivalence of the Marshall™ Balloon Dilatation Catheter to the Courier and PEMT-5 Balloon Dilatation Catherer."
• This indicates that the "acceptance criteria" were tied to demonstrating performance comparable to the predicate devices through bench testing and biocompatibility testing, rather than pre-defined clinical performance metrics (e.g., success rates, complication rates) with specific thresholds. No numerical performance data or acceptance criteria are presented.

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

• Not Applicable. No clinical test set data (human or animal studies) is reported. The "testing" mentioned refers to bench and biocompatibility testing. Therefore, there is no information on sample size, data provenance, or study type (retrospective/prospective) for a clinical test set.

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)

• Not Applicable. As no clinical test set is described, there's no mention of experts or ground truth establishment for such a set.

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

• Not Applicable. No clinical 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

• Not Applicable. This device is a balloon dilatation catheter. It is a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not Applicable. This is not an algorithm or software device.

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

• Not Applicable. For a medical device like a balloon catheter, "ground truth" in the sense of comparing diagnostic accuracy isn't relevant. The "truth" in this context would be the physical properties (e.g., burst pressure, fatigue life) confirmed by engineering tests, and biological response confirmed by biocompatibility tests, all compared against predicate devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. This is not an AI/machine learning device. The testing describes functional, integrity, and biocompatibility bench tests, not a data-driven training process.

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

• Not Applicable. No training set.

Summary of what the document does state:

• Device: Marshal™ Balloon Dilatation Catheter
• Indication for Use: For deployment of the Palmaz™ and Palmaz-Shatz™ Balloon-Expanded Stents for the Biliary system.
• Safety and Performance Basis: Functional and integrity bench testing, and biocompatibility testing (according to FDA guidance and ISO-10993).
• Conclusion: The data from these tests "supported the substantial equivalence of the Marshall™ Balloon Dilatation Catheter to the Courier and PEMT-5 Balloon Dilatation Catherer."
• Predicate Devices: BSC -- PEMT-5 Balloon Dilatation Catheter and BSC -- Courier 1 Balloon Catheter.
• Regulatory Outcome: FDA found the device "substantially equivalent" to predicate devices, allowing it to proceed to market.

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Courier ST Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the Iliac, Femoral and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Courier ST Catheters are not indicated for use in coronary arteries or the neurovasculature.

The proposed Courier™ ST Balloon Dilatation catheter is an over-the-wire catheter with three lumens. The Courer™ ST Balloon Dilatation catheters are recommended for percutaneous transluminal angioplasty of the Iliac, Femoral and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The provided document, a 510(k) premarket notification for the Medi-tech Courier™ ST Balloon Dilatation Catheter, describes the acceptance criteria and performance testing conducted. However, it does not contain information typically associated with studies proving device performance against acceptance criteria in the context of diagnostic or AI-assisted devices as outlined in your request.

This document is for a medical device (a balloon dilatation catheter) and focuses on "functional tests" and "biocompatibility tests" rather than diagnostic performance metrics like sensitivity, specificity, or AUC, or studies involving human readers and AI assistance.

Here's an analysis of the provided text in relation to your specific questions:

1. A table of acceptance criteria and the reported device performance

The document lists the types of tests performed, but it does not specify quantitative acceptance criteria (e.g., "Burst pressure > X psi") or the exact numerical results for each test. Instead, it broadly states that "The following in vitro functional tests were performed" and "The following biocompatibility tests were performed."

The conclusion states: "Based on the Indications for Use, technological characteristics and safety and performance testing, the Courier® ST Balloon Dilatation Catheter has been shown to be safe and effective for its intended use." This implies the device met the unstated acceptance criteria for these tests.

2. Sample sized used for the test set and the data provenance

The document does not specify sample sizes (e.g., number of catheters tested) for any of the functional or biocompatibility tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, as these are typically not relevant for in vitro functional and biocompatibility testing of a physical medical device.

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

This question is not applicable to the type of device and testing described. Functional and biocompatibility tests for a balloon catheter do not involve expert interpretation or ground truth establishment in the way diagnostic imaging or AI devices do. The "ground truth" for these tests would be objective measurements (e.g., pressure readings, material analysis).

4. Adjudication method for the test set

Not applicable. There's no human interpretation or subjective assessment that would require an adjudication method.

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 (a catheter), not a diagnostic AI or imaging device that would involve human readers or AI assistance in a diagnostic capacity.

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 and does not involve an algorithm.

7. The type of ground truth used

For the functional tests, the ground truth would be based on objective physical measurements (e.g., burst pressure, inflation/deflation times, bond strength). For biocompatibility tests, the ground truth would be based on standardized laboratory assays and toxicology principles to assess the material's interaction with biological systems.

8. The sample size for the training set

Not applicable. This device does not use an "algorithm" or a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI or diagnostic application. Therefore, many of the questions regarding AI performance criteria, expert adjudication, MRMC studies, and training/test sets are not relevant to the information presented. The document confirms that standard functional and biocompatibility tests were performed and concluded that the device is safe and effective, implying it met the necessary (though unspecified) acceptance criteria for those tests.

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