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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(TM) 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(TM) NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

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 coaxial dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium markers 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 2.00mm to 4.50mm and lengths varying from 8mm to 38mm.

This document describes the Mozec™ NC – Rx PTCA Balloon Dilatation Catheter. The information needed to address the user's request, specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria, is limited to the non-clinical performance data provided. There is no mention of an AI-based device or a comparative effectiveness study involving human readers. The document pertains to a medical device approval through a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing, rather than extensive clinical efficacy trials.

Here's a summary of the available information based on the provided text, with many fields indicated as "Not Applicable" or "Not Provided" due to the nature of the device and the submission document:

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

The document states: "The Mozec™ NC – Rx PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols." However, the specific quantitative acceptance criteria and the detailed reported device performance values are not explicitly provided in this summary. The summary lists the types of tests performed, which implies these tests had corresponding acceptance 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 used for the test set: Not provided. The document mentions "performance testing," but does not specify the number of devices or components tested for each category.
• Data provenance: Not explicitly stated, but assumed to be internal testing conducted by Meril Life Sciences Private Limited, which is based in India. The testing is non-clinical/bench testing.

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)

• Not Applicable. This request is relevant for AI/diagnostic devices where expert ground truth is established. This document describes a PTCA Balloon Dilatation Catheter, for which ground truth is typically established through engineering and biological testing against established standards, not expert consensus on interpretations.

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

• Not Applicable. See point 3.

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 is not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant to this device.

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

• Not Applicable. This is not an algorithm or AI device. Performance is assessed through engineering and biocompatibility testing of the physical catheter.

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

• Type of ground truth: For the non-clinical performance testing, the "ground truth" refers to established engineering standards, FDA guidance documents (e.g., "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and ISO standards (e.g., ISO 10993-1 for biocompatibility). The device's performance is compared against these predetermined specifications and accepted norms for safety and function.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. See point 8.

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