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The Cirona™ 6100 system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments.

The Cirona™ 6100 deep vein thrombosis prevention system is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition. The Cirona'''' 6100 system consists of a pump, a pair of single patient reusable soft compression garment(s) (sleeves), and the extension tubing set for calf and calf-thigh. The device will alternatively inflate the two garments and mimic the natural walking pace in order to enhance circulation. The device supplied compression provides a 60-second automatically timed cycle consisting of an approximately 12-second inflation period followed by a 48-second period of relaxation. A pressure of 40mm Hg is used for both the calf and calf-thigh treatments. This pressurization enhances venous flow and fibrinolytic activity in order to ultimately prevent early blood clotting.

The provided 510(k) summary describes a pneumatic compression device (Cirona™ 6100) for deep vein thrombosis prevention. The study conducted for this device is focused on showing its substantial equivalence to predicate devices through performance testing, rather than a clinical study evaluating its effectiveness in patients.

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

1. Table of Acceptance Criteria and Reported Device Performance

This device's performance testing is primarily based on functional standards and safety. The acceptance criteria are essentially that the device passes specific bench and laboratory tests, ensuring it meets its specifications and conforms to relevant safety standards.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state a specific "test set" in terms of patient data. The testing described is bench and laboratory testing of the device itself.

• Sample Size for Test Set: Not specified for individual tests, but implies a sample sufficient to perform the listed performance tests (e.g., "all sleeves tested" for the bladder burst test).
• Data Provenance: Not applicable as it's not a clinical study with patient data. The data is generated from engineering/performance testing of the device hardware and software.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for engineering and performance tests is typically established by engineering specifications, regulatory standards, and established test protocols, not by clinical experts.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of expert opinions. The performance tests yield objective results (pass/fail, measurements against specifications).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of an MRMC comparative effectiveness study, nor would it be relevant for this type of device (a pneumatic compression system) seeking 510(k) clearance based on substantial equivalence to predicate devices through performance testing. The purpose of this submission is to show the device functions safely and effectively as intended, not to compare its efficacy against a control arm in a clinical setting or to evaluate human reader performance with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a hardware-based medical device, not an AI/algorithm-based diagnostic or assistive system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests is derived from:

• Engineering Specifications: The design and operating parameters the device is intended to meet (e.g., 40mmHg pressure, 12-second inflation, 48-second relaxation).
• Regulatory Standards: Conformance to recognized international and national standards for medical electrical equipment, risk management, and biological evaluation (e.g., IEC 60601-1, ISO 14971, ISO 10993 series).
• Predicate Device Characteristics: Ensuring the Cirona™ 6100 has "very similar components" and "very similar principles of operation" to its predicates.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model.

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