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The device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 5.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents.

The Armada 14 XT PTA Catheter is an over-the-wire co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.

The provided text describes a 510(k) summary for the Armada 14 XT PTA Catheter. This document primarily outlines the device's technical characteristics, its substantial equivalence to predicate devices, and the types of performance testing conducted to support this claim. It does not present a study that establishes acceptance criteria and then proves the device meets those criteria in the way a clinical study or a standalone AI performance study would.

Instead, this is a regulatory submission demonstrating substantial equivalence for a medical device (a PTA Catheter) based on bench testing and biocompatibility testing, comparing it to already cleared predicate devices. The "acceptance criteria" here refer to internal engineering specifications and performance benchmarks derived from the predicate devices and general standards for such catheters, not clinical performance metrics in a patient population or AI model performance metrics.

Therefore, many of the requested sections (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone AI performance, training set details) are not applicable to this type of document because it describes a physical medical device submission, not an AI/ML-driven diagnostic or assistive device that would involve such studies.

Here's a breakdown of what can be extracted and what is not applicable:

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)

• Sample Size for Test Set: Not explicitly stated as numbers of patients or images. The "test set" here refers to physical catheter samples tested in a laboratory setting. The typical sample sizes for such bench tests are defined by internal quality control procedures and relevant ASTM/ISO standards, not usually disclosed in a 510(k) summary in terms of a "study sample size" for performance metrics like sensitivity/specificity.
• Data Provenance: Not applicable. This is laboratory bench testing and biocompatibility testing of a manufactured medical device, not a study involving patient data from a specific country or setting.

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. Ground truth, in the context of this device, would be based on established engineering principles, material science, and regulatory standards for mechanical and biological performance. There are no "experts" establishing ground truth in the sense of medical diagnosis or image interpretation for this type of submission. Performance is measured against physical specifications and validated test methods.

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

• Not Applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus is needed. This is a bench study of a physical device.

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. An MRMC study is not relevant to a physical PTA catheter and was not performed. This type of study is for evaluating diagnostic performance, often with AI.

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

• No. This device is a physical medical instrument, not an algorithm. Standalone performance for an algorithm is not applicable.

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

• The "ground truth" for the performance tests listed (e.g., Minimum Balloon Burst Strength, Balloon Compliance) is the pre-defined engineering specifications and regulatory limits derived from predicate devices, recognized standards (e.g., ISO, ASTM), and the device's intended use. For biocompatibility, the ground truth is the absence of cytotoxicity, irritation, etc., as per ISO 10993 standards.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI model. There is no training set in the machine learning sense. The device "training" would be the engineering design, prototyping, and manufacturing process based on established medical device development principles.

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

• Not Applicable. As there is no AI training set, this question is not relevant.

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