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To help prevent Deep Vein Thrombosis (DVT)

The Flowtron ACS900 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 deen vein thrombosis.

The provided document is a 510(k) summary for the Flowtron ACS900, a pneumatic pump designed to prevent Deep Vein Thrombosis (DVT). The document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in a way typical for diagnostic or AI-driven devices. Instead, it lists various "Testing conducted" with a binary "Result" (Passed or Complies with Standard). The acceptance criteria are implicitly defined by compliance with established medical device standards and the functional validation of the pump's software/hardware.

Here's the information parsed into a table format as requested, interpreting "acceptance criteria" as the tests performed and "reported device performance" as the outcome:

• Garment detection
• Therapy delivery | Passed |
  | Performance testing garments – Pressure cyclic test:
• with Tri Pulse garments
• with Foot garments
• with DVT garments | Passed |
  | Electrical Testing to Standard AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 | Complies with Standard |
  | EMC testing to Standard IEC 60601-1-2, 2007 | Complies with Standard |
  | Environmental Stability testing:
• Storage / Distribution Test
• Operational Temperature / Humidity Test | Passed |

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

The document does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) relating to clinical performance or patient data. The tests described are primarily engineering and hardware/software validation tests, not clinical efficacy trials with patient populations.

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

Not applicable. The tests described are for a physical medical device (a pneumatic pump and its associated garments) and involve engineering validation and standard compliance, not interpretation of clinical data by experts to establish ground truth for a diagnostic output.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication as the tests performed are primarily objective engineering and performance evaluations against predefined standards or functional specifications.

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. The Flowtron ACS900 is a physical medical device (a pump for DVT prevention), not an AI-driven diagnostic tool that would involve human readers or MRMC studies.

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

Not applicable. This device is not an algorithm, but a hardware product.

7. The type of ground truth used

The "ground truth" for this device's evaluation is defined by:

• Functional specifications: Ensuring the pump correctly detects garments and delivers therapy as designed.
• Performance specifications: Ensuring the compression garments maintain specific pressure cycles.
• Regulatory standards: Compliance with electrical (AAMI / ANSI ES60601-1) and EMC (IEC 60601-1-2) standards.
• Environmental stability requirements: The device's ability to withstand storage, distribution, and operational conditions.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device requiring data for model training.

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

Not applicable, for the same reason as point 8.

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