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The Aspiron(TM) Aspiration Catheter is used for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature system.

The Aspiron™ Aspiration Catheter is a dual lumen, rapid exchange catheter consisting of a distal tip, distal shaft, and proximal shaft with luer hub at the proximal end. The smaller of the two lumens is the Guide wire lumen (distal tip) and is compatible with 0.014" (0.36mm) guide wires. The larger diameter lumen is the extraction lumen and when used with the Aspiron™ accessories, allows for removal of thrombus. The extraction lumen is provided pre-loaded with a stylet that resists kinking during delivery. A hydrophilic coating is applied to the distal shaft. The Aspiron™ is compatible with 6F guide catheters and has a working length of 140cm. The Aspiron™ accessories include 30ml suction syringes, a one way stopcock, an extension tube, a flushing needle and 70μm filter caps.

The provided text describes the Aspiron™ Aspiration Catheter and its 510(k) summary, which outlines the device's comparison to a predicate device and its non-clinical performance data. It does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria based on human-in-the-loop performance or diagnostic accuracy metrics.

Here's a breakdown of the information that is available, and what is missing based on your request:

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

The document states: "The Aspiron™ Aspiration catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols." However, it does not provide a table with specific acceptance criteria (e.g., numerical thresholds for performance like extraction rate or tensile strength) or their corresponding individual reported device performance values. It only lists the types of tests performed.

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 provided in the document. The non-clinical performance data describes bench testing, not a clinical test set with 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 provided as the document details non-clinical, bench testing, not studies requiring expert interpretation of medical images or patient data.

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

This information is not provided as the document details non-clinical, bench 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

This information is not provided. The document describes a medical device (aspiration catheter) and its non-clinical performance, not an AI or imaging device that would typically undergo MRMC studies.

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

This information is not provided. The device described is a physical catheter, not an algorithm.

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

For the non-clinical performance tests, the "ground truth" would be the established engineering specifications, standards (like ISO 10993-1 for biocompatibility), and test protocols. The document states the device "met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols."

8. The sample size for the training set

This information is not provided as the document details non-clinical, bench testing, not a machine learning model requiring a training set.

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

This information is not provided as the document details non-clinical, bench testing, not a machine learning model.

Summary of available information related to acceptance criteria and study:

The device is the Aspiron™ Aspiration Catheter. The study described is a series of non-clinical, bench performance tests and biocompatibility tests.

Acceptance Criteria (General Statement):
"The Aspiron™ Aspiration catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols."

Reported Device Performance (General Statement):
"Comparative testing between the Aspiron™ Aspiration Catheter and Export Advance™ Aspiration Catheter found similar performance characteristics with respect to Catheter Extraction Rate, Tensile strength and Radiopacity."

List of Non-Clinical Performance Tests Performed:

• Dimensional verification
• Tensile Strength
• Flexibility and kink
• Torque strength
• Radiopacity
• Catheter Preparation, Extraction and Removal
• Catheter Extraction Rate (Aspiration Rate)
• Aspiration Catheter Leak
• Coating Integrity & Acute Particulate Evaluation

Biocompatibility Testing (in compliance with ISO 10993-1):

• In Vitro Cytotoxicity Study
• Skin Sensitization Study
• Intracutaneous reactivity test
• Acute Systemic Toxicity Study
• In vitro Hemolysis test Study
• Material Mediated Pyrogen Test
• In vitro C3a and SC5b-9 complement activation Test
• In Vivo Thromboresistance

Biocompatibility Testing for Accessories:

• In Vitro Cytotoxicity Study
• Skin Sensitization Study
• Intracutaneous reactivity test
• Acute Systemic Toxicity Study
• In vitro Hemolysis test Study
• Material Mediated Pyrogen Test

Conclusion of the study: The Aspiron™ Aspiration catheter met all predetermined acceptance criteria and no safety and efficacy issues were raised. It was found substantially equivalent to the predicate Export Advance™ Aspiration Catheter.

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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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MESIRE™ - Balloon Sinus Dilatation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

The MESIRE™ - Balloon Sinus Dilatation System consists of following components. It is available as an integrated system or individual components.

• MESIRE™ Sinus Balloon Catheter
• MESIRE™ Guide - Sinus Guide Catheter
• MESIRE™ Illuminus Sinus Light Wire
• MESIRE™ Latch Catheter Holding System

The MESIRE™ - Balloon Sinus Dilatation System is a Class I device and the provided documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with specific performance metrics against acceptance criteria that are typically seen for higher-risk devices or software.

Based on the provided text, the acceptance criteria and the study demonstrating the device meets them can be summarized as follows:

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

The document does not explicitly state numerical acceptance criteria or reported device performance in a comparative table format. Instead, it states that "The following testing demonstrated that Mesire™ Balloon Sinus dilatation System effectively dilated the sinus." It then lists various mechanical tests, biocompatibility tests, sterilization validation, and packaging/shelf life studies. The results are generally described as "demonstrated" or "complies with/meets requirements", implying successful achievement of pre-defined criteria for each test.

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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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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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