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The Micro Medical Solutions PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including anterior tibial, posterior tibial, and pedal. Not for use in coronary arteries.

The Micro Medical Solutions PTA Balloon Catheter is a single lumen catheter with a balloon located at the distal tip. As the MMS PTA Balloon Catheter is not an Over-The-Wire device. The catheter consists of a single lumen for balloon inflation and deflation.. Inscribed on the proximal strain relief of the catheter is the balloon diameter (mm) and balloon length (mm). Platinum/Iridium marker bands are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy.

The provided text describes a 510(k) summary for the MMS PTA Balloon Catheter, focusing on its substantial equivalence to a predicate device. This document primarily details non-clinical performance testing for a medical device and does not include information about AI/ML algorithm performance studies or clinical studies with human readers. Therefore, I cannot provide details on questions related to AI-specific criteria, human reader performance, or multi-reader multi-case studies.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Product testing was completed and met all of the acceptance criteria." However, it does not explicitly list the acceptance criteria for each test or detail the specific results. It only lists the tests performed.

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

• Non-Clinical Testing: The document does not specify the sample size for the mechanical, physical, or chemical non-clinical tests (e.g., how many catheters were tested for burst pressure). It mentions testing was done on "sterile final product" and "baseline (non-aged) and aged products," but no specific numbers are given.
• Animal Testing: The document mentions "Animal testing was conducted to assess the simulated clinical performance" but does not specify the number of animals or the type of animal used.
• Cadaver Experience: "Cadaver testing was conducted using the vasculature below the knee" but does not specify the number of cadavers.
• Data Provenance: The studies are non-clinical (bench testing, animal, cadaver). The country of origin for this data is not specified but is presumed to be internal testing by Micro Medical Solutions, Inc., a US-based company. These are retrospective tests performed to support premarket notification.

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

This information is not applicable. The device is a physical medical device (balloon catheter), and the "ground truth" for its performance is established through objective, non-clinical tests (mechanical, physical, chemical, biocompatibility, animal studies, cadaver studies), not through expert interpretation of data like images or clinical outcomes that would require human experts to establish ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the studies described are non-clinical performance evaluations of a physical device, not an AI/ML diagnostic algorithm that requires expert adjudication of results.

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 such study was conducted or reported in this 510(k) summary. This document pertains to a physical medical device (balloon catheter), not an AI/ML diagnostic or assistive device.

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

No standalone algorithm performance study was done. This document is for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

• Objective Material and Mechanical Standards: Such as those defined by ISO 10993 for biocompatibility, and internal specifications for physical properties like burst pressure, dimensions, flexibility, etc.
• Animal Models: For simulated clinical performance.
• Cadaver Models: For simulated clinical use in specific anatomical contexts (below the knee vasculature).

8. The Sample Size for the Training Set

This is not applicable to a physical medical device. There is no AI/ML algorithm involved that requires a training set.

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

This is not applicable to a physical medical device. There is no AI/ML algorithm involved that requires a training set.

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The MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.

The MMS Guide Catheter is a small diameter tubular device. It is inserted into the vasculature using standard access techniques and advanced over a guidewire to the physician desired location. The MMS Guide Catheter can be used as a pathway for other diagnostic or therapeutic devices to enter the vasculature. The distal end has a standard luer fitting.

This appears to be a 510(k) summary for the MMS Guide Catheter, making a case for substantial equivalence to a predicate device (Marksman Catheter, K111490). The document describes non-clinical testing to demonstrate performance, not diagnostic performance of an AI/ML device. Therefore, a direct answer to the request regarding "acceptance criteria and reported device performance" in the context of an AI/ML device is not applicable for this document.

However, I can extract the general acceptance criteria and performance reported for the MMS Guide Catheter as presented in the document, treating "acceptance criteria" as the planned tests and "reported device performance" as the outcome of those tests.

Here's an analysis based on the provided text, adapted to the closest interpretations:

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

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

This document does not specify sample sizes for mechanical or biocompatibility tests. It briefly mentions "Animal testing" and "Cadaver testing" but provides no details on the number of animals or cadavers used, let alone their provenance or whether the studies were retrospective or prospective.

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 device is a guide catheter, not a diagnostic AI/ML system requiring expert ground truth for its performance evaluation (e.g., image interpretation). The "ground truth" for this device's performance would be engineering specifications and biological reactions, evaluated through laboratory and preclinical tests.

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

Not applicable. This is not a study involving human interpretation or adjudication. Performance is assessed against predetermined engineering and biological 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 is not an AI/ML device, nor does it involve human readers in a diagnostic context. This is a medical device clearance submission for a guide catheter.

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.

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

For the MMS Guide Catheter, the "ground truth" for demonstrating its performance relies on:

• Engineering Specifications: Defined physical and mechanical properties (e.g., dimensions, tracking, flex/kink, torque, tensile strength).
• Biocompatibility Standards (ISO 10993): Established tests for biological safety.
• Simulated Clinical Performance: Performance in animal models and cadaveric vasculature against expected functionality.
• Predicate Device Comparison: Establishing substantial equivalence by comparing technological characteristics and intended use to an already cleared device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML system 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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