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The FA100 SCCD is indicated for use in:

• Increasing local blood circulation,
• . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
• Preventing or retarding disuse atrophy
• Edema reduction

The FA100 SCCD is a portable, battery powered, hand-held 4-channel electrical stimulator (single unit) intended to provide continuous, sequential stimulation of the calf muscles. The FA100 SCCD designed to be user friendly and simple to use, with a large liquid crystal display (LCD) screen that displays the treatment mode currently in use and the selected intensity level for the patient to select a comfortable therapy session as recommended by the patient's healthcare provider.
The FA100 SCCD system provides three preset treatment programs, which enable the patient to choose among three pulse frequencies:

• 1. 4 Hz (program AA)
• 2. 9 Hz (program VE - the default setting of the device)
• 3. 14 Hz (program PA)
     Pulse frequency is the only difference between the three programs and is selected for patient comfort during the treatment as recommended by the patient's healthcare provider. The stimulation provided by the FA100 SCCD rotates in a continuous, sequential pattern through the four channels. The rotation through the channels is directly related to the frequency setting, i.e., slowest for the 4 Hz program and fastest for the 14 Hz program. All programs effectively contract the muscles and increase blood flow. The only other parameter that can be varied is the stimulus intensity, which is set by the user to achieve the maximum tolerable contraction. Otherwise, the pulse shape (rectangular, symmetrical, bi-phasic), pulse width (500 µsec), and stimulation pattern (sequential channel activation) are the same for all three programs.

The provided document is a 510(k) Summary for the FlowAid Medical Technologies, Corp. FA100 SCCD (Sequential Continuous Contraction Device). This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not detail specific acceptance criteria or an explicit study proving the device meets those criteria in the typical sense of a diagnostic or screening algorithm. Instead, the "acceptance criteria" are implied by the performance standards for powered muscle stimulators and the "study" is a clinical study supporting the device's indications for use.

Here's an attempt to extract the requested information based on the provided text, while acknowledging that some aspects (like expert ground truth and MRMC studies) are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied by the electrical and functional specifications that demonstrate substantial equivalence to legally marketed powered muscle stimulators and the successful results of a clinical study for specific indications.

Study Information

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

   • Sample Size: 15 patients.
   • Data Provenance: Retrospective or prospective is not explicitly stated, but the description of the study design ("FA100 SCCD was used in the home on the same leg for 2 hours daily for 30 days. The compression device was used for the same length of time on the other leg.") suggests a prospective clinical trial. The study was published in "J Vasc Med & Surg 2016", indicating an academic or clinical setting. Country of origin is not specified.

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

   • This question is not applicable to this type of device (a powered muscle stimulator). The "ground truth" for its effectiveness is clinical outcome measures (leg circumference reduction) rather than expert interpretation of images or other data. The clinical study measured physical changes directly.

3. Adjudication method for the test set:

   • This is not applicable. The outcome measures (leg circumference) were objective physical measurements, not subjective interpretations requiring adjudication.

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:

   • This is not applicable. The FA100 SCCD is a therapeutic/rehabilitative device, not an AI-powered diagnostic or screening tool that would involve human readers.

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

   • This is not applicable. The device is a physical medical device, not a standalone algorithm. Its performance is evaluated through its direct physiological effect on patients.

6. The type of ground truth used:

   • Clinical Outcome Data: Specifically, objective physical measurements of leg circumference reduction at the ankle and calf.

7. The sample size for the training set:

   • This is not applicable as the device is a hardware product, not a machine learning algorithm requiring a "training set." The clinical study involved 15 patients, which serves as the effectiveness data.

8. How the ground truth for the training set was established:

   • This is not applicable for the same reasons as above. The clinical study measured objective physical changes directly.

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