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To help prevent Deep Vein Thrombosis (DVT)

The Flowtron ACS800 pump is a pneumatic pump that supplies compressed air to inflate compression garments that are attached to patient's limbs.
It is designed to work with the ArjoHuntleigh ranges of DVT calf/thigh compression garments, Foot compression garments and Tri Pulse calf/thigh compression garments.
The pump automatically senses the type of compression garment connected and adjusts the pressure/time cycle accordingly.
Each garment is compressed alternately, applying pressure to the patient's limb. to help prevent deep vein thrombosis.

This device, the Flowtron ACS800 Pump and Tri Pulse Garments, is a pneumatic pump system designed to help prevent Deep Vein Thrombosis (DVT). Its clearance is based on demonstrating substantial equivalence to predicate devices: the Flowtron Universal AC600 (K010744) for the pump and the STS garments (K012008) for the Tri Pulse garments.

The provided document describes various tests performed to demonstrate this equivalence, primarily focusing on bench testing of the device's functionality and performance rather than clinical studies with human subjects.

Here's an analysis of the available information against your requested points:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to predicate devices through various tests. The reported performance refers to the satisfactory outcomes of these tests.

Study Details:

Based on the provided document, the regulatory submission relies heavily on bench testing and comparison to predicates rather than a primary clinical study with a test set of patient data.

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not applicable in the context of human subjects or patient data. The "test set" here refers to physical prototypes of the device components (pump, Tri Pulse garments, DVT garments, Foot garments) undergoing various engineering and performance tests.
   • Data provenance: Not applicable. The data is generated from laboratory bench tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for bench testing is defined by engineering specifications, international standards (e.g., IEC, EN, ISO), and performance of predicate devices. This type of evaluation does not typically involve human expert consensus for "ground truth" as it would for image interpretation or diagnosis.

3. Adjudication method for the test set: Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies with human evaluations (e.g., blinded reading of medical images). For bench testing, results are typically determined by instrument readings against predefined pass/fail criteria or direct comparison to predicate device performance.

4. 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 device is a mechanical pump and garment system, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself "stands alone" in its automated function (pump delivering compression to garments). The tests described (functionality, performance, life testing) assess this standalone performance against specified criteria and predicate devices. There is no "algorithm only" component in the sense of a software-based diagnostic or AI tool being evaluated separately from a human operator.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is established through:

   • Engineering specifications: Predefined performance parameters (e.g., pressure, timing, durability).
   • International standards: Compliance with recognized safety and performance standards (IEC 60601-1, EN 60601-1-2, ISO 10993 series).
   • Predicate device performance: Directly comparing the new device's performance to that of previously cleared devices to establish equivalence in function and safety.

7. The sample size for the training set: Not applicable. This submission does not involve machine learning or AI models that require training sets.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.

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