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

The 2cm PCB is an Over-The-Wire (OTW) catheter packaged as sterile and intended for single use in a radiology suite/catheterization laboratory/operating room in conjunction with radiologic equipment for fluoroscopic imaging. The device consists of a double-lumen catheter with a non-compliant balloon attached at the distal tip. One of the lumens connects the Y-Adaptor to the proximal end of the outer shaft and the other connects the Y-Adaptor wire port extending from the wire lumen to the distal end of the balloon. The outer lumen is the balloon inflation lumen and is used to inflate and deflate the balloon during the procedure. The inner lumen is used to pass the catheter over a guidewire. The product is intended to pass a 0.018" (0.46 mm) guidewire. The catheter useable length (effective length) is measured from the distal end of the strain relief to the tip and is available in three sizes - 50 cm, 90 cm and 135 cm. 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 device is coated with MDX 4-4159 silicone coating.

The provided document is a 510(k) Summary for the 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter (K151253) by Boston Scientific Corporation. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a new clinical trial to establish new safety and effectiveness.

Therefore, the acceptance criteria and study information requested in the prompt (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are typically not found in a 510(k) summary for a medical device cleared based on substantial equivalence to existing predicate devices. Such details are usually associated with novel devices requiring clinical trials, de novo submissions, or Pre-Market Approval (PMA) applications, especially for AI/ML-driven devices.

This 510(k) submission primarily relies on bench testing and biocompatibility testing to demonstrate that the proposed device performs as intended and is as safe and effective as its predicate devices.

Here's a breakdown of the information that is available in the document related to performance and acceptance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative format for each test with corresponding performance metrics like one might find in a clinical study report. Instead, it states that the tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised during the testing." This indicates that the device met its internal design specifications and safety requirements, which effectively serve as the acceptance criteria for a 510(k) submission focusing on substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the 510(k) summary. For bench testing, sample sizes would typically be determined by engineering standards or internal quality procedures, but these specific numbers are not publicly disclosed in this type of document.
• Data Provenance: The tests are described as "Bench testing" and "biocompatibility tests," which are conducted in a laboratory setting. There is no mention of country of origin for data; it's assumed to be from Boston Scientific's internal testing facilities or contracted labs. The data is retrospective in the sense that it was generated prior to the submission, but it's not clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. This device is a physical medical device (catheter) and its substantial equivalence is demonstrated through engineering and material performance tests, not through interpretation of medical images or other data requiring clinical expert consensus for "ground truth." Ground truth, in this context, would be the known physical properties and performance characteristics of the predicate device, against which the new device is compared via testing.

4. Adjudication Method for the Test Set:

• Not Applicable. As noted above, this involves engineering and biocompatibility tests, not subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of outputs (e.g., radiologists reading images). This 510(k) is for a therapeutic catheter, not an AI/ML diagnostic aid.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not Applicable. This is a physical medical device, not a software algorithm or an AI/ML product.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating substantial equivalence for this device would be:
  • Predicate Device Performance: The established safety and performance characteristics of the legally marketed predicate devices (K041993 and K070951).
  • Engineering Specifications/Standards: The device must meet predefined engineering specifications, design inputs, and relevant industry standards (e.g., ISO standards for medical devices, specific test methods for balloon catheters).
  • Biocompatibility Standards: Compliance with established standards for biological evaluation of medical devices (e.g., ISO 10993 series).

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As above, no training set for an AI/ML algorithm is involved.

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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 family of Peripheral Cutting Balloon (PCB) Catheters has features of a conventional angioplasty catheter with advanced microsurgical capabilities. The PCB family features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The device is inserted over a guidewire and delivered to the target lesion. When the PCB device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Angioplasty (PTA) with the PCB device allows dilatation of the target lesion with less pressure, minimizing barotrauma.

This document is a 510(k) summary for the Boston Scientific Peripheral Cutting Balloon catheters. It details the device's indications for use, its description, and its substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance Study:

The document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes for the peripheral cutting balloon.

Instead, the submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that the device is considered as safe and effective as the predicate device because it has the same intended use and the same technological characteristics, or, if there are differences in technological characteristics, those differences do not raise different questions of safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:
   This information is not present in the provided 510(k) summary. The summary focuses on showing equivalence rather than meeting pre-defined performance criteria for a new type of device.

2. Sample size used for the test set and the data provenance:
   The document does not describe a specific test set, its sample size, or data provenance for performance evaluation. The substantial equivalence argument relies on the inherent similarity to predicate devices. The "proposed device" in the table (Page 3) is the one under review, which is essentially the same as the "predicate device" with minor labeling changes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable/provided as there is no mention of a test set with ground truth established by experts.

4. Adjudication method for the test set:
   This information is not applicable/provided as there is no mention of a 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:
   This is not applicable. The device described is a medical device (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This is not applicable. The device is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   This information is not applicable/provided as there is no specific performance study requiring ground truth in this submission. The "ground truth" for substantial equivalence is the historical safety and effectiveness data of the predicate devices.

8. The sample size for the training set:
   This information is not applicable/provided. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established:
   This information is not applicable/provided. No training set for an algorithm is mentioned.

Summary of the Document's Content Regarding Equivalence:

The core of this 510(k) submission is the assertion of substantial equivalence based on the following:

• Identical Intended Use: The "Indications for Use" for the proposed device (Peripheral Cutting Balloon catheters for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae) are the same as those of its predicate devices.
• Identical Technological Characteristics (with minor changes): The document states: "There are no changes in design, composition, function or indication of any of the proposed PCB devices compared to their respective predicates." The only change being proposed is "adding a new contraindication and a new warning in the DFU (Directions For Use)." Such labeling changes are generally considered minor and do not alter the fundamental safety and effectiveness of the device itself, thus maintaining substantial equivalence.

Therefore, for this specific 510(k) submission, the "study" demonstrating that the device meets criteria is the comparison to predicate devices, showing that it is fundamentally the same and incorporates only minor, non-performance-altering changes.

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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 PCB: small MR and OTW features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the PCB device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Angioplasty (PTA) with the PCB device allows dilatation of the target lesion with less pressure, minimizing barotrauma.

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 Rated Burst Pressure (RBP) is 12 atm. The devices are available in nominal balloon diameters from 2.0 mm to 4.0 mm and 1.5 cm length.

The OTW devices are attached to a Y-connector at one end; the MR is attached to a female luer. The catheter body for the PCB: small OTW has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire.

The proximal shaft for the PCB:small MR is a hypotube. This hypotube contains the balloon inflation lumen. The distal shaft is made of Pebax material and has a lumen for balloon inflation as well as a guidewire lumen. The guidewire lumen is colored green for case of guidewire insertion. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchange of the catheter. The PCB:small MR and OTW are coated with Bioslide BL at the distal section.

This document is a 510(k) summary for a medical device called the "Peripheral Cutting Balloon (PCB): small Monorail and Over-the-Wire Delivery systems". It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The document does not describe the acceptance criteria and a study that proves the device meets specific acceptance criteria in the way you've outlined. Instead, it describes a submission seeking substantial equivalence to predicate devices based on bench testing and biocompatibility testing. This is a different regulatory pathway than proving performance against specific clinical efficacy or safety endpoints using a standalone or comparative effectiveness study.

Therefore, many of the requested fields cannot be directly extracted from this document, as the information is not present. Here's what can be inferred or stated based on the provided text:

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

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for a diagnostic or AI device. It mentions "Performance Testing" which consists of "Bench testing and biocompatibility testing" to support substantial equivalence. The specific results or defined acceptance criteria for these tests are not detailed.

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

Not applicable. The submission is based on bench testing and biocompatibility testing, not a clinical test set with patient data.

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. Ground truth as typically understood for diagnostic performance is not relevant to bench and biocompatibility testing of a physical medical device.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic performance.

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 is a physical device (a catheter) and not an AI or diagnostic imaging device involved in human interpretation or a MRMC study.

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

Not applicable. This is a physical device, not an algorithm.

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

For the "Performance Testing" mentioned (bench and biocompatibility), the "ground truth" would be established by standard engineering and biological testing protocols and criteria. Specific details are not provided in this summary.

8. The sample size for the training set

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

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

Not applicable. See point 8.

Summary based on the document:

This document describes a 510(k) submission for a medical device (a peripheral cutting balloon catheter) seeking to establish substantial equivalence to legally marketed predicate devices.

• Acceptance Criteria & Device Performance: The document states that "Bench testing and biocompatibility testing support a determination of substantial equivalence." No specific quantitative acceptance criteria or performance metrics are provided in this summary. The device's performance is, implicitly, "substantially equivalent" to the predicate devices in terms of design, fundamental technology, and intended use.
• Study Type: The "study" mentioned for demonstrating equivalence involved "Bench testing and biocompatibility testing." These are laboratory-based evaluations rather than clinical trials with patient data.
• Purpose: The goal was to show that the new device is as safe and effective as pre-existing devices, not to establish novel efficacy or superior performance through clinical trials.

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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 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

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

1. 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."

2. 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.

3. 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.

4. 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.

5. 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.

6. 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."

7. 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.

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

   • As there is no training set for an algorithm, this question is N/A.

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