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The Mozec - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm) is also indicated for post delivery expansion of balloon expandable stents.

The Mozec NC – Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post delivery expansion of balloon expandable stents.

Mozec - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a semi-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec balloon's working length (2.00 mm to 4.50 mm sizes) or the centre of the balloon's working length (1.50 mm size). The Mozec balloons are offered in diameters ranging from 1.50 mm to 4.50 mm and lengths varying from 9 mm to 41 mm.

Mozec NC - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a non-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec NC balloon's working length. The Mozec NC balloons are offered in diameters ranging from 2.00 mm to 4.50 mm and lengths varying from 8 mm to 38 mm.

The provided document is a 510(k) premarket notification for PTCA (Percutaneous Transluminal Coronary Angioplasty) Balloon Dilatation Catheters. It describes the device, its intended use, and non-clinical performance data to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document does not contain information related to an AI/ML medical device, nor does it discuss acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance. Instead, it refers to standard engineering and performance tests for medical devices like balloon catheters.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this text. The questions posed in your prompt (e.g., sample size for test set/training set, number of experts for ground truth, MRMC study, standalone performance) are specific to the validation of AI/ML algorithms, which is not the subject of this document.

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The Mozec™ - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec™ - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm to 4.50mm) is also indicated for post-delivery expansion of balloon expandable stents.

Mozec™ - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a semi-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec ™ balloon's working length (2.00 mm to 4.50 mm sizes) or the center of the balloon's working length (1.50 mm size). The Mozec"™ balloons are offered in diameters ranging from 1.50mm to 4.50mm and lengths varying from 9mm to 41mm.

The provided document describes the Meril Life Sciences Mozec™ - Rx PTCA Balloon Dilatation Catheter and its conformity to acceptance criteria through non-clinical performance data.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was subjected to performance testing as recommended in the "Guidance for Industry and FDA Staff- Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010)."

Conclusion: The document explicitly states: "The Mozec™ - Rx PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols. No safety and efficacy issues were raised during the testing program."

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 describes non-clinical performance data, which typically refers to laboratory testing and does not involve human subjects or clinical data. Therefore, terms like "test set sample size," "country of origin," "retrospective or prospective" are not applicable in this context. The tests were performed on the device itself.

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. For non-clinical performance testing of a medical device like a balloon catheter, "ground truth" is typically established by engineering specifications, validated test methods, and regulatory standards rather than expert medical consensus.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation where multiple human experts assess the same cases and a method is needed to resolve discrepancies. The provided document describes non-clinical, laboratory-based 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 multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to the Mozec™ - Rx PTCA Balloon Dilatation Catheter. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would be evaluated for its impact on human reader performance.

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

This information is not applicable. The device is a physical balloon catheter, not an algorithm.

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

For the non-clinical performance tests conducted, the "ground truth" would be established by engineering specifications, regulatory standards, and validated test methods. For example, the rated burst pressure has a defined specification, and the test method measures if the device meets that specification. Biocompatibility tests rely on established ISO standards.

8. The sample size for the training set

This information is not applicable. The document describes the testing of a physical medical device, not a machine learning model, and therefore there is no "training set."

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

This information is not applicable, as there is no training set for a physical medical device.

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