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

Enhanced External Counterpulsation Device Plus OM-A is a computer-controlled system that applies external pressure via cuffs to the patient's lower extremities in synchronization with the patient's cardiac cycle. When the heart is in its relaxed state (diastole), pressure is applied sequentially; distal to proximal, from the lower legs (calves) to the lower thighs and then the upper thighs and buttocks, to propel blood back to the heart. The consequence is an increase in arterial blood pressure during diastole (diastolic augmentation) resulting in increased coronary perfusion pressure and coronary blood flow. Compression of the extremities also results in an increase in venous return to the heart. Just before the heart ejects blood (systole), air is released rapidly from all the cuffs simultaneously to release the externally applied pressure, allowing the compressed vessels to recover to their normal shape, thereby reducing vascular impedance. As a result, arterial pressure during systole is reduced (systolic unloading), as is cardiac workload. The patient's calves, lower thighs and buttocks are wrapped with cuffs containing air bladders. The patient's ECG is monitored via conventional, high-quality electrodes and detection of the R-wave is used to signal the System when to command sequential inflation of the cuffs. The start and duration of inflation, as well as the start of deflation, are adjustable by the Operator, within limits determined by the System. An algorithm is used to prevent the start of inflation during ejection of blood from the heart and to end inflation and begin deflation prior to the occurrence of the next heartbeat. The pressure applied by the cuffs is also adjustable by the Operator from 150mmHg to 300mmHg (for a patient with a heart rate of 60 bpm). The device also utilizes the following cleared components: ECG/EKG and SpO2: K123711

The provided document is a 510(k) summary for the "Enhanced External Counter Pulsation Device Plus Omay-A." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a new device meets specific performance acceptance criteria for an AI or imaging diagnostic tool.

Therefore, many of the requested categories for describing an AI/imaging device study (e.g., acceptance criteria for diagnostic performance, sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable to this document.

This document describes a medical device called an "Enhanced External Counter Pulsation Device," which is a therapy device, not a diagnostic AI or imaging device. The performance data provided are related to safety and efficacy standards (biocompatibility, electrical safety, EMC), and comparative functional features, not diagnostic performance metrics.

Specifically addressing your points based on the provided text:

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

• Acceptance Criteria: The document does not define specific "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it is a therapeutic device, not a diagnostic tool utilizing AI or advanced image analysis. The "acceptance" here is for market clearance based on substantial equivalence to an existing predicate device, primarily by meeting safety and performance standards (IEC 60601-1, IEC 60601-1-2) and demonstrating similar functional characteristics.
• Reported Device Performance:
  • Biocompatibility: Passed Cytotoxicity, Sensitization, and Irritation tests according to ISO 10993-5 and ISO 10993-10.
  • Non-clinical (Safety & EMC): Passed tests according to IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012 (General requirements for basic safety and essential performance) and IEC 60601-1-2:2014 (Electromagnetic compatibility).
  • Functional Comparison to Predicate (K130439 P-ECP/TI):
    • Triggering Mechanism: Same (R-Wave trigger)
    • Microprocessor: Same (Windows Based)
    • Emergency System Power-down: Same (Red)
    • Pressure Setting: Subject device range (5mmHg to 350mmHg, Error: ± 10mmHg) is within predicate device range (1kPa~50kPa, Error: ± 2kPa)
    • Treatment Time: Subject device range (1min45min) is within predicate device range (1min60min)
    • Cuff System: Same (Three parts: calf, thigh, buttocks)
    • Major Components: Same (Base Unit, Air-Tubes, ECG/SPO2, three Cuffs)
    • Operating Environment: Same (10°C 30°C; Relative humidity: <85%; Atmospheric pressure: 70kPa106kPa)
    • Safety and EMC Standards: Same (IEC 60601-1, IEC 60601-1-2)
    • Biocompatibility Standards: Same (ISO 10993-5, ISO 10993-10)

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

• Not applicable. This is a therapeutic device clearance, not a diagnostic AI study. The "test sets" here refer to samples for electrical safety, EMC, and biocompatibility testing, not patient data for diagnostic performance evaluation.

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

• Not applicable. Ground truth as understood in diagnostic AI is irrelevant here. The ground truth for electrical safety or biocompatibility is derived from established international standards and validated testing methodologies.

4. Adjudication method for the test set

• Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This type of study is for evaluating human reader performance with and without AI assistance, which is not relevant for this therapeutic device.

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

• No. This concept applies to diagnostic algorithms. The device operates under the oversight of a healthcare professional as a therapeutic tool.

7. The type of ground truth used

• Not applicable in the context of diagnostic performance. The "truth" for this device's clearance is its compliance with recognized safety and performance standards for medical devices and its substantial equivalence to an existing predicate device based on functional and safety characteristics.

8. The sample size for the training set

• Not applicable. This device is not an AI model that requires a training set in the machine learning sense.

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

• Not applicable.

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