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The Ebony® .035 PTA Catheter is intended for the dilation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries.

The Ebony® .035 PTA Catheter is not for use in coronary arteries or neuro-vasculature.

The Ebony® PTA .035 Peripheral Dilatation Catheter is a standard Over the Wire (OTW) PTA Catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing tight stenoses.

It is a double lumen catheter, one lumen for the guide wire used for inflation/deflation of the balloon and one lumen for the guide wire used to access to the distal tip of the catheter (max/0.035″). A luer lock fitting allows the connection with an inflation device (Y hub). The balloon has two radiopaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel.

The distal catheter, proximal to the balloon, is covered with a hydrophilic coating to improve the trackability and pushability characteristics.

The balloon material expands to a known diameter at specific pressure defined in a compliance chart supplied with the catheter. The device is available in balloon. diameters of 5, 6, 7, 8, 9, 10 or 12 mm, balloon lengths of 20, 40, 60, or 80 mm and catheter lengths of 80, 130, or 150 cm.

lt will be supplied sterile and is intended for one time use.

This is a 510(k) premarket notification for a medical device, the Ebony® PTA .035 Peripheral Dilatation Catheter, not a typical AI/ML device, therefore the information you requested like samples size for the test set, provenance of data, number of experts, adjudication method, effect size of human readers with AI assistance, standalone performance, training set size and ground truth for training set are not available in the provided document. The study described focuses on nonclinical, bench-top testing to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy studies.

Here's the available information presented in the requested format:

Acceptance Criteria and Device Performance Study for Ebony® PTA .035 Peripheral Dilatation Catheter

This submission refers to non-clinical bench testing to demonstrate substantial equivalence, rather than a clinical study with human patients. As such, many of the typical acceptance criteria and study details relevant to AI/ML device performance or clinical trials are not applicable or not provided in this document.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally understood to be met if the device performs equivalently to the predicate device in a series of in vitro bench tests. The document states that the subject device met all predetermined acceptance criteria.

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

• Sample Size: Not specified in the provided document. The tests are "in vitro bench tests and analyses."
• Data Provenance: The data is generated from in vitro bench tests conducted by Natec Medical Ltd. or its contracted laboratories. No country of origin for the data is specified beyond the company's location in Mauritius. These are experimental, non-clinical tests rather than retrospective or prospective patient data.

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

• Not Applicable. For this type of submission involving physical device performance, "ground truth" is established through engineering specifications, validated test methods, and comparison to a predicate device's known performance, rather than expert human interpretation of data.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or data. This submission focuses on objective physical and chemical properties of a medical device.

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

• No. An MRMC study is not relevant for this type of device submission. This pertains to evaluating the effectiveness of a diagnostic tool or intervention with human readers, which is not the purpose of this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Engineering specifications, validated test methods, and performance of a legally marketed predicate device (ADMIRAL XTREME™ PTA Catheter). The "ground truth" for the tests is adherence to predefined engineering specifications and demonstrating performance comparable to the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This submission does not involve an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal dilatation balloon. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 40cm, 80cm and 120cm. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter includes additional balloon lengths of 150 mm, 200 mm, 250 mm and 300 mm. The modified ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is manufactured from the same materials as the predicate ADMIRAL XTREME™ PTA Catheter and has the same Intended Use.

This is a 510(k) summary for a medical device, the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter. It's important to understand that this document describes a submission for regulatory clearance, not a scientific study proving clinical effectiveness or diagnostic accuracy in the way an AI algorithm study would.

Therefore, many of the requested categories related to AI performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this type of device submission. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through engineering performance testing.

Here's an breakdown of the available information based on your request, with clarifications on why certain categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Verification testing of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter demonstrated that the device met the acceptance criteria." While the specific numerical acceptance criteria values are not provided in this summary, the types of tests performed indicate the areas of acceptance.

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

• Sample Size for Test Set: This document does not specify the exact sample sizes used for each of the verification tests. These would typically be determined by engineering and statistical principles relevant to device testing (e.g., number of units tested for burst strength, fatigue, etc.).
• Data Provenance: The testing appears to be internal verification testing performed by the manufacturer (Invatec S.p.A.). The country of origin of the data would therefore be Italy (where Invatec S.p.A. is located). This is prospective testing, as it was conducted specifically for this submission to verify the performance of the modified device.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus, as typically applied to AI or diagnostic image analysis, is not relevant here. The "ground truth" for these engineering tests are established physical standards, measurements, and specifications.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is physical device testing, not a clinical study requiring expert adjudication of outcomes or diagnostic findings. The results are based on objective measurements against predefined engineering specifications.

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 submission is for a physical medical device (PTA balloon catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effectiveness metrics are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• Not Applicable. As above, this is not an AI algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Standards: The "ground truth" for this device's performance is based on established engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and regulatory requirements. For example, balloon burst strength is measured against a specified pressure value, and dimensions are checked against design blueprints.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI algorithm that requires a "training set."

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

• Not Applicable. As above, this is not an AI algorithm.

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