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The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.

The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.

The provided FDA 510(k) Clearance Letter for the Aperta NSE PTA Balloon Dilatation Catheter describes a device that is substantially equivalent to a predicate device. This document does not contain acceptance criteria for performance of the device in a clinical setting (e.g., success rates, complication rates) nor does it describe a study proving such performance.

Instead, the document focuses on demonstrating substantial equivalence through non-clinical testing (bench testing, biocompatibility, and packaging) in comparison to the predicate device. The acceptance criteria described are for these non-clinical tests.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, MRMC study, ground truth type, training set size) are not applicable to this document as it does not report on clinical performance or AI algorithm development.

Here's the information that can be extracted based on the provided document:

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

The document states that non-clinical testing was performed "After meeting all acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test or the detailed numerical "performance" results. It primarily indicates that the tests passed.

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

This information is not applicable as the document describes non-clinical (bench and lab-based) testing, not a clinical study on a test set of 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)

This information is not applicable as the document describes non-clinical testing.

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

This information is not applicable as the document describes non-clinical 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

A MRMC comparative effectiveness study was not reported. This document is for a medical device (a catheter), not an AI-powered diagnostic tool.

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

This information is not applicable as the document is for a medical device (a catheter), not an AI algorithm.

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

For the non-clinical tests, the "ground truth" would be established by the expected performance characteristics based on engineering specifications, regulatory standards (e.g., ISO, ASTM), and the predicate device's performance. For biocompatibility, it's based on established biological safety endpoints. The document does not specify the exact methods for establishing these "truths" for each individual test, but implies adherence to the FDA Guidance Document titled "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters issued on April 14, 2023."

8. The sample size for the training set

This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm requiring a training set.

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

This information is not applicable as the document describes non-clinical testing of a physical medical device, not an AI algorithm.

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The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.

The Aperta NSE™ PTA Balloon Dilatation Catheter (Aperta NSE PTA) is an over-the-wire (OTW) type catheter used for percutaneous transluminal angioplasty of lesions in peripheral arteries and obstructive lesions of arteriovenous dialysis fistula. The Aperta NSE PTA catheter is designed with protruding polymer elements parallel to the balloon to aid dilatation of stenotic lesions that are difficult to expand with a conventional balloon.

This document is a 510(k) premarket notification for a medical device called the Aperta NSE PTA Balloon Dilatation Catheter. It is important to note that this submission does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML device. The device described is a physical medical device (a balloon catheter), and the studies mentioned are non-clinical (bench and animal testing).

Therefore, I cannot provide the information requested in the format of AI/ML device acceptance criteria and study details. The document does not describe an AI/ML device or its associated performance metrics, test sets, ground truth, or human-in-the-loop studies.

Instead, the document details the non-clinical testing performed for the physical medical device to demonstrate its substantial equivalence to a predicate device. If you are interested in the "acceptance criteria" and "study" as presented in this specific document for the physical device, here's an interpretation:

The acceptance criteria are implicitly defined by the successful completion of the listed non-clinical tests in accordance with relevant FDA guidance and standards. The "study" refers to the entire body of non-clinical testing.

Here's a breakdown of what is available in the document regarding the physical device's non-clinical studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical tests performed. The "reported device performance" is summarized by the statement: "After meeting all acceptance criteria, non-clinical testing has demonstrated that the Aperta NSE PTA is substantially equivalent to the predicate." This implies that the device successfully passed all specified tests according to predefined thresholds (acceptance criteria), though the specific numerical thresholds for each test are not explicitly detailed in this summary.

2. Sample Size for Test Set and Data Provenance:

• Bench Testing: Sample sizes are not specified in this summary. The tests are typically conducted in a laboratory setting.
• Animal Testing: A "porcine peripheral artery model" was used for acute (Day 0) and chronic (Day 30) safety evaluation. The number of animals (sample size) is not specified. This is prospective data generated for the submission. The "country of origin of the data" is not specified but would be from the performing lab/facility.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:
Not applicable. For a physical device, "ground truth" typically refers to established engineering specifications, material properties, and biological responses observed in animal models, rather than expert consensus on data interpretation.

4. Adjudication Method for the Test Set:
Not applicable. This is typically used for clinical trials or image interpretation studies, not for bench and animal testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is relevant for AI/ML diagnostic tools with human readers, which is not what this device is.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is based on:

• Established engineering specifications and design tolerances for physical properties and dimensions.
• Industry standards and FDA guidance for biocompatibility.
• Observed biological responses and safety endpoints in an animal model.

8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set for an AI/ML algorithm.

In summary, the provided document is a 510(k) summary for a physical medical device (balloon catheter) and outlines its non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than the acceptance criteria and study details for an AI/ML product.

Ask a specific question about this device

Ask a specific question about this device