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The PulseFlowDF™ is designed to enhance blood circulation in the venules and arterioles in patients with diabetic foot ulcers of the lower extremities.

PulseFlowDF is intended for patients in the home who would benefit from increased blood flow to:

• · Treat and assist healing of cutaneous ulceration (wounds)
• · Reduce wound healing time
• · Enhance arterial circulation (blood flow)
• · Prevent venous stasis (slowing of blood flow)
• · Reduce compartmental pressures
• · Reduce edema (swelling)
• · Reduce post-operative pain and swelling
• Reduce the need for anticoagulant medications (medications that thin the blood) and
• · Prevent Deep Venous Thrombosis (DVT) (blood clots in the deep veins).

PulseFlowDF is an off-loading boot with a built in air bladder in the insole for intermittent plantar compression therapy. One active boot and one matched height inactive boot is provided. PulseFlowDF is designed to protect a diabetic wound during healing by (1) stimulating blood flow to the wound (and throughout the foot and leg) by means of cyclic inflation of an air bladder under the arch of the foot (primary action), (2) providing a protective cover for the wound which is bandaged and shielded inside the boot) and (3) stabilizing the foot and lower leg with an "off-loading design" that holds the foot and lower leg in a fixed position to reduce pressure on the sole of the foot (secondary action). PulseFlowDF allows the user to walk and move while wearing the boot. PulseFlowDF is worn for up to 10 to 15 hours per day for 12 weeks, after which time it can be converted to standard footwear.

The FDA 510(k) summary for the PulseFlowDF device mentions several performance tests but does not explicitly define acceptance criteria prior to reporting results. Instead, it describes the outcome of these tests, generally stating "pass" or "statistically significantly improved" to indicate that performance objectives were met.

Here's an attempt to extract the implied acceptance criteria and reported performance based on the provided text, along with other requested study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • Summative Usability Testing: 10 diabetic patients (under treatment for active or healed diabetic foot ulcers) and 2 healthcare professionals.
  • Measurement of Blood Flow Study: 8 volunteer subjects.
• Data Provenance: The document does not specify the country of origin for the clinical or usability studies. The manufacturing company is located in the UK. The studies appear to be prospective as they describe specific tests and measurements performed with the device.

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

• Experts for Usability Testing: Two (2) healthcare professionals were involved in the summative usability testing. Their specific qualifications (e.g., specialty, years of experience) are not specified in the provided text.
• Experts for Blood Flow Study: No information is provided regarding experts establishing ground truth for the blood flow measurements. The measurements were taken using Near-Infrared Spectroscopic technique and a Doppler flowmeter, implying objective measurements rather than expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• The document does not mention any adjudication method for establishing ground truth in any of the described tests. The tests appear to rely on objective measures (e.g., electronic sensors, quantitative blood flow measurements) or direct observation during usability testing.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (a compressible limb sleeve) and not an AI-driven diagnostic or interpretative tool that would typically involve human readers or AI assistance in a clinical setting.

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

• This question is not applicable as the PulseFlowDF is a physical medical device, not an algorithm, and its performance inherently involves interaction with a human (the patient). The firmware monitors wear time, but there's no "algorithm-only" performance in the sense of a diagnostic AI.

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

• For Blood Flow Measurement: The ground truth for the efficacy claim (improved blood flow) was established using objective physiological measurements from a Near-Infrared Spectroscopic technique (for calf blood flow) and a Doppler flowmeter (for microvascular perfusion).
• For Usability Testing: Ground truth related to usability was established through direct observation that "no safety issues occurred" and "performance of essential tasks was demonstrated," likely based on predefined criteria and user feedback.
• Other Bench/Safety Tests: Ground truth was based on compliance with established engineering and safety standards (e.g., IEC 60601-1, IEC 62133:2012) and pre-defined performance specifications (e.g., disabling at 1000 hours, inflation pressure).

8. The sample size for the training set

• The document does not mention any "training set." This term is typically used for machine learning or AI models. The studies described are for a physical medical device and involve performance verification and validation rather than model training.

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

• This question is not applicable as there is no mention of a training set for this device.

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