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The FOXTROT™ NC PTCA Balloon Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. FOXTROT™ NC PTCA Balloon Catheters are also indicated for the post-delivery expansion of balloon expandable stents.

The FOXTROT NC PTCA Balloon Catheter device is a sterile, single-use, rapid exchange percutaneous transluminal coronary angioplasty catheter. The design is an integrated shaft system with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. Two radiopaque markers aid in positioning the balloon catheter under fluoroscopy during the procedure. The distal portion of the shaft is coated with a hydrophilic coating to provide lubrication. The effective length of the FOXTROT NC device is 145 cm and it is compatible with a 0.014" guide wire. The FOXTROT NC PTCA balloon catheter is available with balloon diameters of 2.5-4.0 mm and balloon lengths of 10 mm and 15 mm.

This document describes the FOXTROT™ NC PTCA Balloon Catheter and its non-clinical testing to demonstrate substantial equivalence to a predicate device.

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

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance values. Instead, it lists the types of tests performed and states that the data supports the safety of the device and that mechanical testing results demonstrate it performs as intended.

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

The document does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that mechanical testing was performed on "both the subject device and the predicate device."

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

This information is not applicable. The study described is entirely non-clinical bench testing and biocompatibility testing. There are no human experts involved in establishing ground truth in the context of diagnostic interpretation for this type of device submission.

4. Adjudication method for the test set

This information is not applicable. As stated above, this is a non-clinical study.

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 applicable. The device is a PTCA Balloon Catheter, not an AI diagnostic device. No MRMC study was mentioned.

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 PTCA Balloon Catheter, not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for this submission is based on established industry standards and regulatory guidance for medical device testing. For biocompatibility, it's the outcome of standardized biological tests. For bench testing, it's the performance against predefined physical and mechanical specifications as outlined in the "FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 2010)." The ultimate "ground truth" for demonstrating substantial equivalence is that the new device performs comparably to the predicate device in these tests.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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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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