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The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased blood flow. It is intended for use under the oversight of a healthcare professional.

The Pure Flow External Counter-Pulsa-tion device is a mechanical device used to increase aortic pressure during early native heart diastole to augment myocardial perfusion, and to decrease aortic pressure during early native heart systole to reduce ventricular workload and vascular afterload.

The PureFlow consists of a main unit, and applied parts (computer monitor, keyboard, flexible tubes which connect to fabric cuffs, inside each cuff is an inflatable plastic balloon), EKG wires, and SpO2 sensors.

PureFlow works on the basis of external counter pulsation. The pressure is created by inflating a series of cuffs (similar to blood-pressure cuffs) that squeeze the extremities (calf's, thighs, buttocks) forcing blood back up to the heart on each heart cycle. This process ultimately restores (by force) sufficient blood flow to parts of the heart that is lacking oxygen. The treatment process generally spans for a period of 1 hour each day for a period of 35 total treatments. ECP Treatment is proven to develop existing pathways of oxygenated blood back to the heart muscle. In other words, External Counterpulsation Therapy restores pathways for adequate & necessary blood flow back to heart through vessels that already exist.

The device also utilizes the following cleared components: Cable/Lead wire (ECG/EKG, SpO2, and Invasive Blood Pressure): K120010 LNCS/M-LNCS Oximetry Sensor: K101896

This document, a 510(k) Summary for the Pure Flow External Counter-Pulsation Device (K173483), describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, not a study designed to prove the device meets acceptance criteria for a new clinical application or algorithm performance. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided text in relation to your request:

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 (Test Set): For the Pressure Control Timing Measurement Test and Pressure Accuracy Test, "Three models were tested."
• Data Provenance: Not specified, but the tests are non-clinical, likely internal laboratory testing. Country of origin not mentioned. The tests are prospective in the sense that they were designed to evaluate the physical device's performance.

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 document describes non-clinical performance testing of a physical device, not an AI/algorithm-based diagnostic or prognostic tool that would require expert-established ground truth. The "ground truth" for these tests refers to the expected physical performance of the device as measured by calibrated equipment against established engineering standards.

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

• Not applicable. This relates to an external counter-pulsation device, not an AI diagnostic/imaging system. No human reader studies are mentioned.

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

• Not applicable. This is a hardware medical device with some software control, not a standalone algorithm. Software verification and validation were done, but this refers to the robust operation of the device's control software, not a standalone algorithmic output.

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

• Non-clinical-specific ground truth: For the Pressure Control Timing Measurement Test and Pressure Accuracy Test, the "ground truth" was established by reference standards (JIS T0601-2-204), which define acceptable ranges for device performance. These are engineering standards, not medical ground truths like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This document describes the testing of a physical device, and therefore does not involve a "training set" in the context of machine learning or AI models.

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

• Not applicable. See point 8.

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