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The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion.

The Flash-C PTCA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The device uses a dual balloon design featuring a compliant anchoring balloon, which enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

The provided text describes a medical device, the Flash-C PTCA Balloon Dilatation Catheter, and its performance evaluation for a 510(k) submission. However, it does not include information about AI/ML device performance, acceptance criteria, or a study comparing its performance against predefined criteria using metrics like accuracy, sensitivity, or specificity. The document focuses on regulatory approval based on substantial equivalence to existing devices and standard medical device performance testing, such as biocompatibility and bench testing.

Therefore, many of the requested sections about AI/ML performance, sample sizes for test/training sets, expert adjudication, or MRMC studies cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists various performance bench tests and in-vivo testing, but it does not explicitly state acceptance criteria (e.g., "Balloon Burst Pressure must be > X psi"). It only states that the device "meet the established specifications necessary for consistent performance" and "meets all predetermined design verification and validation acceptance criteria." Without the specific criteria, a comparative table cannot be created.

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

• Test Set Sample Size:
  • In-vitro Bench Testing: Not specified. Standard tests would involve multiple units, but the exact number isn't mentioned.
  • In-vivo Testing: "A swine model" was used. The number of animals in the test and control groups is not specified.
• Data Provenance: Not specified, but a swine model implies animal testing, likely in a controlled laboratory environment. The location of the testing is not mentioned.
• Retrospective/Prospective: The in-vivo study would be prospective in nature, as it involved performing a procedure and observing animals post-procedure.

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 applicable and not provided. The ground truth for the device's performance is established through direct physical/biological measurements and observations in the bench and in-vivo tests, not by expert interpretation as would be the case for an AI/ML diagnostic device.

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

This is not applicable and not provided, as the tests performed are not based on subjective interpretation requiring adjudication.

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 device (catheter), not an AI/ML-driven diagnostic tool that assists human readers.

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

Not applicable. This device is a physical medical device.

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

• For Biocompatibility: Laboratory test results based on established ISO and ASTM standards (e.g., MEM Elution Assay results, Hemolysis Assay results).
• For In-vitro Bench Testing: Direct physical measurements against established engineering specifications (e.g., precise measurements of balloon crossing profile, rated burst pressure tests until failure).
• For In-vivo Testing: Physiological and clinical observations in the swine model post-procedure (e.g., assessment for downstream and cognitive effects).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set.

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The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.

The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The device uses a dual balloon design featuring a compliant anchoring balloon, which enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

The provided text describes a 510(k) premarket notification for the Flash PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a previously cleared device (K102482) and reports on bench testing for product line extensions.

The document does not contain information on acceptance criteria or a study proving the device meets those criteria in a clinical setting. The performance data section exclusively mentions "Bench testing."

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated based on the given document:

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

Explanation: The document states, "All test results demonstrate that the materials, manufacturing process, and design of the Flash PTA Balloon Dilatation Catheter meet the established specifications necessary for consistent performance according to its intended use." This indicates that for each bench test listed, there were pre-defined acceptance criteria (specifications) that the device successfully met. However, the exact numerical or qualitative specifications themselves are not provided in this summary.

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

• Sample size: Not specified. The document only mentions "Bench testing performed."
• Data provenance: Not specified. This was bench testing, not human or animal study data.

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

• Not applicable. This document describes bench testing of a physical medical device, not a diagnostic algorithm that requires expert-established ground truth.

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

• Not applicable. This document describes bench testing of a physical medical device.

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:

• No. This document is for a physical balloon catheter, not an AI or diagnostic imaging device.

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

• No. This document is for a physical balloon catheter.

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

• Not applicable. For physical device bench testing, "ground truth" refers to the established engineering specifications and physical measurements.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set as this is not an algorithm being developed.

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

• Not applicable. There is no mention of a training set.

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The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion.

The Flash-C PTCA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash-C PTCA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon that enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

The Flash-C PTCA Balloon Dilatation Catheter did not undergo a study that would typically involve acceptance criteria and device performance reported in the context of AI/ML or diagnostic devices. Instead, this a medical device (a catheter) with a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" and "device performance" in this context refer to the results of engineering bench testing and pre-clinical in-vivo studies that confirm the device meets established specifications and operates as intended.

Here's an attempt to structure the information based on your request, understanding that it's a different type of device assessment:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a physical medical device (catheter) and not a diagnostic/AI device, the "acceptance criteria" are the established specifications for various physical and performance characteristics of the catheter. The "reported device performance" refers to the results from the specific tests against these specifications.

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

• Test Set (In-Vivo): "test and control groups" in a swine model. The exact number of animals in each group is not specified in the summary.
• Data Provenance: Pre-clinical, in-vivo animal study (swine model). Country of origin is not specified, but typically conducted in a controlled laboratory setting. Retrospective or prospective is not explicitly stated, but animal studies are generally prospective.

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

• Not Applicable. This is a physical device where "ground truth" refers to objective measurements against engineering specifications and observation of physiological effects in an animal model, not expert interpretation of data or images. The evaluation would be performed by qualified laboratory personnel and veterinarians overseeing the animal study, not "experts" in the context of establishing diagnostic ground truth from images or clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is not a study involving human interpretation or subjective assessments that would require an adjudication method like 2+1 or 3+1. Performance is based on objective measurements and observations in controlled environments.

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

• No, an MRMC study was NOT done. MRMC studies are relevant for diagnostic devices where human readers interpret medical images or data, especially when comparing AI assistance to unassisted reading. This device is a therapeutic catheter, not an interpretive diagnostic tool.

6. If a Standalone Performance Study Was Done

• Yes, in essence. The in-vitro performance bench testing and biocompatibility testing represent "standalone performance" in that they assess the device's intrinsic characteristics against predetermined specifications. The in-vivo swine model also assesses the device's standalone performance and safety in a biological system, comparing it to a control device (Sterling PTA Balloon Dilatation Catheter). The simulated use testing specifically compared the Flash-C to the predicate device, Maverick XL.

7. The Type of Ground Truth Used

• Engineering Specifications and Physiological Observations. For the in-vitro tests, "ground truth" is defined by established engineering and material specifications (e.g., burst pressure limits, diameter tolerances, fatigue cycles). For biocompatibility, it's the lack of toxic or sensitizing reactions per ISO 10993 standards. For the in-vivo study, it's direct physiological observations in the animal model and the absence of pre-defined adverse events.

8. The Sample Size for the Training Set

• Not Applicable. This device uses conventional engineering design and manufacturing processes, not AI/ML algorithms that require training data.

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

• Not Applicable. As there is no AI/ML component, there is no training set and therefore no ground truth established for it.

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