(160 days)
The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic arteriovenous dialysis fistulae.
The Peripheral Cutting Balloon (PCB) is available in nominal balloon diameters of 5.0 mm to 8.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The proximal end of the balloon is equipped with a stainless folding spring to enhance balloon refold. The spring consists of a collar, proximal to the balloon cone; and four fingers that extend across the balloon cone and terminate before the pads that hold the atherolomes to the surface of the balloon. 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. 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 provided text describes the 510(k) summary for the Boston Scientific Peripheral Cutting Balloon. It includes information on performance testing (bench and biocompatibility) and a clinical study (Cutting EDGE trial). However, the information provided focuses on the substantial equivalence to predicate devices rather than specific acceptance criteria thresholds the device had to meet. The study's primary purpose was to compare the Peripheral Cutting Balloon to conventional angioplasty, not to prove the device met predetermined acceptance criteria against a specific numerical benchmark.
Therefore, I cannot populate all the requested fields as the document does not explicitly state "acceptance criteria" for the device's performance in the way a traditional validation study might. Instead, it presents comparative efficacy and safety data against a control group (conventional angioplasty) and references general guidelines (KDOQI) for expected patency rates.
However, I can extract information related to the clinical study and its findings.
Here's the information based on the provided text, with "N/A" for criteria not explicitly stated:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (Peripheral Cutting Balloon - PCB) |
|---|---|
| Primary Patency (6 months) | 47.9% PCB vs. 40.5% PTA (p=0.37) |
| For stenosed grafts | 51.3% PCB vs. 46.9% PTA (p=0.84) |
| For thrombosed grafts | 43.1% PCB vs. 32.0% PTA (p=0.15) |
| Procedural Success | Not significantly different from PTA (p=0.24) |
| Hemodialysis Access Circuit Patency (6 months) | Not significantly different from PTA (p=0.45) |
| Mean Number of Target Lesion Reinterventions (6 months) | Not significantly different from PTA (p=0.22) |
| For thrombosed grafts | 0.7 PCB vs. 1.0 PTA (marginally significant, p=0.06) |
| Device-Related Adverse Events (Dissections) | 1.7% (3/173) PCB vs. 0% PTA |
| Device-Related Adverse Events (Perforations) | 2.9% (5/173) PCB vs. 0% PTA |
| Overall Safety and Effectiveness | Not significantly different from conventional angioplasty |
Notes on Acceptance Criteria:
- The document implies that "not significantly different from conventional angioplasty in overall safety and effectiveness" was a key criterion for demonstrating substantial equivalence.
- For patency rates, the document references KDOQI guidelines as benchmarks for "achievable" or "typical" rates, suggesting these were considered relevant for comparison. For example, for stenosed grafts, KDOQI suggests ~50% at 6 months, and the PCB achieved 51.3%. For thrombosed grafts, KDOQI suggests ~40% at 3 months and 20% at 6 months; the PCB's 43.1% at 6 months was noted as "more than double the expected rate."
- For complication rates, the document compares the PCB's perforation rate (2.9%) to literature-based expected rates of 2% to 4%, indicating that falling within this range was acceptable.
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: 340 patients (173 in Peripheral Cutting Balloon arm, 167 in PTA arm).
- Data Provenance: The study was a "prospectively randomized clinical trial," and data was collected from "27 centers in the US."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated for specific ground truth establishment.
- Qualifications of Experts: An "Adverse events were adjudicated by a CEC" (Clinical Events Committee), and a "DSMB reviewed safety information throughout the enrollment portion of the study." Specific qualifications of CEC or DSMB members are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- "Adverse events were adjudicated by a CEC" (Clinical Events Committee). The specific method (e.g., 2+1) is not provided.
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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:
- This was a clinical trial comparing a device (Peripheral Cutting Balloon) to another medical intervention (conventional angioplasty - PTA), not an MRMC study involving human readers or AI. So, N/A.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information pertains to an AI/algorithm. This device is a physical medical device. So, N/A.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The study used outcomes data, specifically "primary patency through 6 months post-procedure," "access circuit primary patency," "procedural success," "number of target lesion reinterventions," and "occurrence of adverse events."
- Adverse events were "adjudicated by a CEC."
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The sample size for the training set:
- This document describes a clinical trial for substantial equivalence, not a machine learning study. Therefore, there's no "training set" in the context of an algorithm. So, N/A.
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How the ground truth for the training set was established:
- As there is no training set for an algorithm, this question is N/A.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).