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The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

The Peripheral Cutting Balloon™ (PCB) has the features of a conventional angioplasty catheter, with advanced microsurgical capabilities. The PCB features a non-compliant balloon with three or four atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The device is inserted over a guidewire and delivered to the target lesion. Upon inflation, the atherotomes score the plaque as the balloon expands and pushes the plaque radially. The scores serve as notches for stress concentration and allow dilatation at lower pressures, minimizing barotrauma.

Three of the PCB devices (1 cm, 2 cm and sPCB OTW) are offerred in Over-the-Wire delivery configuration, the sPCB is also available in Monorail configuration. The OTW devices are attached to a Y-connector at one end, the sPCB MR is attached to a female luer. The OTW catheters feature a co-axial shaft consisting of an inflation lumen and a guidewire lumen; the sPCB MR features a proximal shaft using a single lumen hypotube, which is attached to a coaxial distal section consisting of an inflation and guidewire lumen. The guidewire exit port for the sPCB MR is 24 cm from the catheter tip.

Radiopaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. The sPCB devices are coated with Bioslide at the distal section, the 1 cm and 2 cm PCB are coated with MDX 4-4159.

The Rated Burst Pressure (RBP) for all devices is 10 atm. The devices are available in nominal balloon diameters from 2.0 mm to 8.0 mm and blade lengths of 1 cm to 2 cm (Tables 1-2).

This document is a 510(k) summary for the Boston Scientific Peripheral Cutting Balloon™ (PCB) and primarily focuses on establishing "substantial equivalence" to predicate devices rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test/training sets, ground truth details, expert qualifications, MRMC study, standalone performance) are not directly addressed in the provided text.

However, I can extract the information that is present:

Device Name: Peripheral Cutting Balloon™ (PCB)

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

The document states: "Bench testing and biocompatibility testing 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."

This implies that the acceptance criteria were met by the bench and biocompatibility tests, but the specific criteria and numerical performance results are not provided in this summary.

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

This information is not provided in the document. The summary refers to "bench testing" but does not detail the sample sizes or data provenance for these tests.

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)

This information is not provided as the device's substantial equivalence is based on bench testing and biocompatibility rather than a clinical study requiring expert ground truth establishment.

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

This information is not provided.

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

There is no indication of an MRMC comparative effectiveness study as this is a medical device for angioplasty, not an AI-assisted diagnostic tool.

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

This information is not applicable as this is a physical medical device, not an algorithm. The "performance testing" mentioned refers to bench and biocompatibility tests of the device itself.

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

For the "performance testing" described (bench and biocompatibility), the ground truth would be established by engineering specifications, material standards, and biological safety standards. The document does not elaborate on these specifics.

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set" in the context of this traditional medical device submission.

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

This information is not applicable.

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The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic arteriovenous dialysis fistulae.

The 2 cm Pcripheral Cutting Balloon (2 cm PCB) is a product line extension to the 1 cm Peripheral Cutting Balloon, and uses longer balloons to support 2 cm blades. It is available in nominal balloon diameters of 5.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The catheter body has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire. Radionaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. One end of the catheter is attached to a Y-connector, the other end is attached to the balloon. The Rated Burst Pressure (RBP) of the device is 10 atm. The device is compatible with 0.018" guide wire.

This document is a 510(k) premarket notification for a medical device called the "2 cm Peripheral Cutting Balloon™". It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for an AI/algorithm-based device.

The document discusses substantial equivalence to predicate devices based on design, fundamental technology, intended use, and general performance and biocompatibility testing. It's a regulatory document for a physical medical device, not a software or AI-based diagnostic tool.

Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text.

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