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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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The geko(TM) Plus R-2 is intended for:

• Increasing local blood circulation; and
• Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

The geko™ Plus R-2 Neuromuscular Stimulator (geko™ Plus R-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casinq, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The geko™ Plus R-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow.

The provided text describes a 510(k) premarket notification for the Geko™ Plus R-2 Neuromuscular Stimulator. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria with detailed performance metrics as would be found for an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.

Here's a breakdown of the information that can be extracted and where the document falls short for AI/ML specific criteria:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) for the device's intended use (increasing local blood circulation, preventing venous thrombosis). Instead, it establishes substantial equivalence based on technical specifications and safety standards compared to a predicate device.

The table on pages 6-8 is a comparison of design parameters between the predicate device (geko™ T-2) and the proposed device (geko™ Plus R-2). It highlights technical specifications rather than clinical performance acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission relies on design validation activities (electrical safety, EMC, hardware/firmware testing) rather than a clinical study with a "test set" in the context of AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable, as no clinical "test set" and ground truth establishment by experts for AI/ML performance are described. The focus is on device specifications and adherence to standards.

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

This information is not provided and is not applicable, as no clinical "test set" with expert adjudication is described.

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

This information is not provided and is not applicable. The device is a neuromuscular stimulator, not an AI diagnostic or assistance tool for human readers.

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

This information is not provided and is not applicable. The device is a physical stimulator.

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

This information is not provided and is not applicable. The assessment is based on physical device specifications and compliance with safety standards, not on "ground truth" for clinical outcomes as validated in AI studies. The "conclusion" on page 9 states that the device "performs as designed and intended," which is validated through engineering tests.

8. The sample size for the training set

This information is not provided and is not applicable, as this is not an AI/ML device requiring a training set.

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

This information is not provided and is not applicable, as this is not an AI/ML device requiring a training set and its ground truth.

Summary of Device Performance and Substantial Equivalence:

The Geko™ Plus R-2 Neuromuscular Stimulator demonstrates substantial equivalence to its predicate device, the Geko™ T-2, primarily through a comparison of technical specifications and an affirmation that its design has been validated against relevant safety and performance standards.

• Key Differences and Their Justification: The main change is the option for stronger stimulation, achieved by higher constant current (54 mA vs 27 mA) and a higher maximum pulse width setting (560 µs vs 400 µs). This change is justified by stating that the higher current and pulse width settings do not raise new safety or effectiveness concerns. The maximum voltage remains the same, and the maximum current density and power density remain well below established limits by IEC 60601-2-10:2012 and FDA guidance, respectively. The longer pulse width for the new device is also comparable to a previous predicate (geko™ T-1).

• Design Validation Activities:

  • Electrical Safety and Electromagnetic Compatibility Testing: The device was certified to comply with IEC 60601-1:2005 (General Safety), IEC 60601-2-10:2012 (Nerve and Muscle Stimulators), and IEC 60601-1-2:2007 (EMC).
  • Hardware/Firmware Testing: Verification of output waveform characteristics (via oscilloscope tracings at different impedance levels) and validation of all hardware and firmware functionality were performed.
  • Results: All test results demonstrated that the geko™ Plus R-2 meets the predefined device technical and functional requirements specifications.

In essence, the study presented here is a set of engineering verification and validation tests to ensure the device meets its design specifications and complies with regulatory safety standards, supporting the claim of substantial equivalence to its predicate. It is not a clinical study designed to measure diagnostic performance or AI effectiveness.

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The geko™ T-2 Neuromuscular Stimulator is intended for:
-Increasing local blood circulation; and
-Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

The geko™ T-2 Neuromuscular Stimulator (geko™ T-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The geko™ T-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow.

The stimulus intensity varies with the pulse width, which can be set to one of seven levels for the geko™ T-2. The asymmetric biphasic waveform results in a net charge of zero to the patient during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking.

Electrical contact is made with the patient through a hydrogel layer applied during manufacture to the integrated electrode. The patient contacting materials have been previously tested per the requirements of ISO 10993-1 and shown to be biocompatible for prolonged (up to 30 days) contact with intact skin. There are no separate electrode leads or electrodes.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and study information for the geko™ T-2 Neuromuscular Stimulator.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with detailed acceptance criteria and standalone performance metrics. Therefore, some requested information, particularly regarding specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC) and a multi-reader multi-case (MRMC) comparative effectiveness study, is not explicitly stated in this type of regulatory submission. The assessment here is based on the information available within the given text.

Acceptance Criteria and Device Performance for geko™ T-2 Neuromuscular Stimulator

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Usability Evaluations: "healthy volunteers" - Not specified numerically.
  • Clinical Evaluations (Efficacy): "patients immediately post-operative following elective total hip replacement" - Not specified numerically. This sounds like a small pilot or verification study rather than a large-scale clinical trial given the context of a 510(k) summary.
• Data Provenance:
  • Usability Evaluations: Not specified.
  • Clinical Evaluations (Efficacy): "at a hospital in the United Kingdom" - Prospective.

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

• Not Applicable / Not Explicitly Stated. The verification and validation activities described are largely engineering and performance testing (comparing outputs, waveforms) and basic clinical assessment of "adequate stimulation" (calf and foot twitches). There is no indication of a "ground truth" adjudicated by multiple experts in the sense you might expect in an AI diagnostic study. The "ground truth" for the clinical evaluation would simply be the observed presence of calf and foot twitches.

4. Adjudication Method for the Test Set

• Not Applicable / Not Explicitly Stated. Since the evaluation methods are primarily focused on
  • Compliance with standards (pass/fail for certificates).
  • Physical measurements (waveform, current).
  • Observation of a physiological response (twitches).
    There is no indication of a need for a multi-expert adjudication method like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a neuromuscular stimulator, not an AI-powered diagnostic imaging tool. The comparison is between the new geko™ T-2 and its predicate, the geko™ T-1, focusing on physical and electrical characteristics and basic clinical capability. There is no AI component involved in the "assistance" to human readers.

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

• Not Applicable. This is a hardware device with embedded software controlling its stimulation functionality. Its "performance" is inherent in its electrical output and the resulting physiological response, not in an independent algorithmic "reading" or classification that could be considered "standalone."

7. The Type of Ground Truth Used

• For Biocompatibility: Compliance with ISO 10993-1, likely through laboratory testing and material analysis.
• For Electrical Safety/EMC: Compliance with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 standards, validated by accredited testing bodies.
• For Hardware/Firmware: Measured electrical characteristics (e.g., output current, waveform patterns), internal functional tests.
• For Clinical Efficacy (Stimulation): Direct observation of physiological response (calf and foot twitches) in patients.

8. The Sample Size for the Training Set

• Not Applicable / Not Explicitly Stated. This device does not use machine learning that requires a "training set" in the conventional sense of AI models (e.g., for image recognition or predictive analytics). The embedded software controls the device's electrical output based on fixed parameters and user input, not on learned patterns from a dataset.

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

• Not Applicable. As there is no "training set" for an AI algorithm in this context, there is no ground truth established for it. The device's operation is based on established electrophysiology and engineering principles.

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