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The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.

The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The Chameleon enables the injection of diagnostic fluids, such as contrast medium or therapeutics fluids through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.

This document is a 510(k) premarket notification for a medical device (Chameleon PTA Balloon Catheter), not a study for an AI/ML medical device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and performance data for an AI/ML-driven diagnostic or assistive technology.

The document primarily focuses on establishing "substantial equivalence" of a new version of the existing Chameleon PTA Balloon Catheter (with new balloon sizes) to a legally marketed predicate device. This type of submission relies heavily on bench testing and simulated use to demonstrate that the physical and functional characteristics of the device remain safe and effective for its intended purpose.

Here's why the requested information cannot be extracted from the provided text:

• No AI/ML Component: The device is a physical medical instrument (a balloon catheter used in angioplasty), not a software or AI/ML algorithm that interprets medical images or data.
• No Diagnostic Performance: The "performance data" mentioned (Section 13) refers to mechanical and physical properties of the catheter (e.g., balloon compliance, burst pressure, fatigue, leakage), not diagnostic accuracy (e.g., sensitivity, specificity) of an AI system.
• No Human Readers/Experts for Interpretation: The context of "human readers" assisting with AI or "expert consensus" for ground truth isn't relevant to a physical catheter's mechanical performance.

However, I can extract what is relevant to the document about its "acceptance criteria" and "study" (bench testing):

Acceptance Criteria and Reported Device Performance (as pertains to this physical device)

The document states: "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." And "The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols."

While specific numerical targets or thresholds for each bench test are not provided in this summary document, the general categories of acceptance criteria and the finding that they were met are clear.

Regarding the specific questions in your prompt, here's why they are largely unanswerable from this document:

1. A table of acceptance criteria and the reported device performance: Partially addressed above for mechanical properties, but no diagnostic performance like an AI would have.
2. Sample sizes used for the test set and the data provenance: Sample sizes for bench tests (e.g., N=X catheters tested for burst pressure) are not detailed. Data provenance is "bench testing and simulated use," implying lab conditions. No patient data is involved for this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical catheter's mechanical properties is derived from engineering specifications and testing methods, not expert human interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI/ML diagnostic studies, not device mechanical testing.
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 for AI/ML diagnostic studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this mechanical device, the "ground truth" for its performance is adherence to engineering specifications and performance benchmarks (e.g., it must not burst below X pressure, it must meet Y compliance).
8. The sample size for the training set: Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional medical device (catheter) and illustrates a "substantial equivalence" pathway, not a submission for an AI/ML-driven medical device requiring clinical performance evaluation of diagnostic accuracy.

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The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.

The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.

This document is a 510(k) premarket notification for the Chameleon PTA Balloon Catheter, and as such, it does not contain the detailed information about acceptance criteria and specific study results that would be found in a clinical study report or a more comprehensive technical document. The FDA 510(k) pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials.

However, based on the provided text, here's what can be extracted and what cannot:

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

The document states: "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." and "The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols."

This indicates that acceptance criteria were established and met, but the specific numerical criteria and the reported device performance values are not detailed in this summary. The summary mentions categories of bench tests performed but does not provide the quantitative acceptance criteria for each or the device's results against those criteria.

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: The document does not specify the sample size for any of the bench tests.
• Data Provenance: The tests described are "bench testing and simulated use test data." This implies the data is prospective in nature (generated specifically for this submission). The country of origin for the testing or data is not explicitly stated, but the manufacturer (AV Medical Technologies Ltd.) is located in Tel Aviv, Israel, suggesting the testing likely occurred there or under their supervision.

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 as the studies described are bench tests and simulated use, not clinical studies requiring expert ground truth for interpretation.

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

This information is not applicable as the studies described are bench tests, not clinical studies involving human interpretation that would require 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:

This is not applicable. The device is a physical medical device (balloon catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance effect size are irrelevant to this submission.

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 an algorithm.

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

For the bench testing, the "ground truth" would be established engineering specifications and applicable standards (e.g., ISO standards for medical devices). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This is not applicable as the device is not an AI/machine learning algorithm that requires a training set. The "Chameleon PTA Balloon Catheter" is an over-the-wire, multi-lumen balloon catheter.

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

This is not applicable for the same reason as above.

Summary of available and unavailable information:

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The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.

This document describes the premarket notification (510(k)) for the Chameleon PTA Balloon Catheter. It outlines the device's characteristics and the nonclinical performance data submitted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

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

The document provides a general statement regarding acceptance criteria and performance rather than a specific table.

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

The document does not specify the sample sizes used for the test sets in the bench tests, biocompatibility tests, or simulated use tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.

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

This document describes technical device performance testing (biocompatibility, bench, and simulated use tests), not clinical studies involving human patients where expert-established ground truth would typically be needed for diagnostic or prognostic accuracy. Therefore, this information is not applicable and not provided in the document.

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

Not applicable, as this document focuses on technical device performance testing, not human-read clinical data.

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 not an AI-assisted device, and the document describes the substantial equivalence of a medical device (PTA balloon catheter), not a diagnostic or AI-driven system.

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

Not applicable. This is not an algorithmic or AI device. The document details the physical and functional performance of a medical device.

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

For the nonclinical performance data (biocompatibility, bench, and simulated use tests), the "ground truth" would be established by:

• Biocompatibility: Adherence to ISO standards and guidelines for biological evaluation of medical devices.
• Bench testing: Engineering specifications, design requirements, and relevant industry standards for balloon catheters (e.g., burst pressure, tensile strength, inflation time, etc.).
• Simulated use testing: Performance against predefined functional criteria in a simulated environment, often mimicking physiological conditions.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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