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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 Intuit Medical, LLC, DK-PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The DK-PTCA Balloon Catheter is a torqueable, rapid-exchange, percutaneous transluminal coronary angioplasty catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 6F guide catheters (MIN inner diameter of 0.074"). Catheter working length is approximately 142cm.

The distal end of the catheter has a semi-compliant balloon that expands to known diameters and lengths at specific pressures. The balloon has two radiopaque markers to assist with positioning. The proximal end of the device is a common PTCA catheter design consisting of a hypo-tube connected to a plastic hub and strain relief and which assists with torque transmission. The hub is used to inflate the balloon and the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The DK-PTCA Balloon Catheter is supplied sterile and intended for single use.

This document describes the DK-PTCA Balloon Catheter, a device intended for balloon dilatation of coronary artery or bypass graft stenosis. It's a 510(k) submission, meaning the manufacturer is demonstrating that its device is "substantially equivalent" to an already legally marketed predicate device.

Hence, the acceptance criteria and study information provided here are not for an AI/ML algorithm or a new novel device proving its standalone accuracy against a ground truth. Instead, these are performance criteria for a physical medical device (a balloon catheter) to demonstrate its safety and effectiveness through engineering and biological testing, showing it performs comparably to existing, approved devices.

Given this context, I will adapt the requested information structure to fit the provided document's content.

Device: DK-PTCA Balloon Catheter
510(k) Number: K123264

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

The document lists performance tests conducted, implying these tests are designed to meet established acceptance criteria for PTCA catheters. However, the specific numerical acceptance criteria for each test (e.g., maximum allowable balloon burst pressure, minimum bond strength) and the exact quantitative reported performance for each test are not explicitly detailed in this summary. The summary states that "No new questions of safety or effectiveness were identified during device testing," which indicates the device met its internal acceptance criteria.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each performance test. The data provenance is internal testing conducted by Intuit Medical, LLC, likely on manufactured samples of the DK-PTCA Balloon Catheter. The data would be prospective in the sense that the tests were designed and executed specifically for this 510(k) submission. There is no information on country of origin of the data beyond the manufacturer being in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the typical AI/ML context. For a physical medical device like a balloon catheter, "ground truth" is established by adherence to engineering standards, validated test methods, and regulatory guidelines (e.g., ISO, FDA guidance). The "experts" involved would be engineers, material scientists, and biomedical experts responsible for designing, conducting, and interpreting these physical performance and biocompatibility tests. Their qualifications are not specified but are implied by their roles in a medical device company and adherence to regulatory standards.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods are typically used for expert consensus in clinical data or image interpretation. For physical device testing, results are typically objective measurements against pre-defined specifications. Any discrepancies would involve re-testing, calibration, or review of test methodology, not "adjudication" in the clinical sense.

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 question is not applicable. An MRMC study is relevant for diagnostic AI/ML devices involving human readers. The DK-PTCA Balloon Catheter is a therapeutic physical device.

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

This question is not applicable. This is a physical medical device, not an algorithm. The "standalone performance" refers to the device's physical and biological performance as measured by the tests listed.

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

For this physical device, the "ground truth" is based on:

• Engineering Specifications and Standards: (e.g., material properties, dimensional tolerances, force requirements).
• Biocompatibility Standards: (e.g., ISO 10993-1, FDA Bluebook Memorandum G-95) which dictate acceptable levels of biological response.
• Performance Requirements: Established by predicate device characteristics and regulatory guidance for PTCA catheters.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a physical medical device. The device's design and manufacturing processes are refined through engineering development and iterative testing, but not in the "training set" sense of machine learning.

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

This question is not applicable for the same reasons as #8.

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