(124 days)
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.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.