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truFlex is indicated to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Strengthening, toning and firming of arms, buttocks, thighs, and calves
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
• To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions

truFlex is an electrical muscle stimulator, which generates electrical impulses that are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. The device contracts muscles rhythmically to achieve the intended use.

truFlex consists of a console with a touchscreen control panel and eight handpiece pairs. All system functions are controlled through the console. During a treatment session, one or more handpiece pairs are secured to the patient using disposable hydrogel pads and transparent silicone belts, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.

The fundamental scientific technology has not changed in the modified device. Changes are solely considered for addition of indication for use. The modified device generates the same stimulation to contract the muscles rhythmically to achieve the intended use.

The clinician can increase or decrease the intensity as per the desired stimulation. While modified device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truFlex device complies with voluntary standards.

The modified device, as described in this submission, have only addition of the indication for use and name the device

The device has two treatment types:

• Classic - In Classic mode, the treatment duration is 45 minutes.
• flex+ - In flex+ mode, the treatment duration is 15 minutes.

For ease of use and operation for the clinicians, we have 3 modes (suggestive):

• PREP mode creates a twisting motion to warm up and stretch the muscles and to slowly build a tolerance to muscle contractions. PREP mode is available for Classic treatments only.
• TONE mode contracts the muscles, holds it, and then relaxes to increase strength and muscle endurance. TONE mode is available for Classic and flex+ treatments.
• SCULPT mode uses fast, sequential contractions of the muscles which lead to toning and firming. SCULPT mode is available for Classic and flex+ treatments

Based on the provided FDA 510(k) Clearance Letter for the truFlex Muscle Stimulator, it's important to clarify that this document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy or performance through a traditional clinical study with defined acceptance criteria for de novo AI/ML devices.

The truFlex device is a Powered Muscle Stimulator, classified as Class II, and uses electrical muscle stimulation (EMS). Its clearance is based on the premise that its safety and effectiveness are "demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device," as stated on Page 4 and Page 9. This means the acceptance criteria are largely met by showing the device performs similarly to or within the established safety and performance parameters of already cleared, similar devices (predicates).

Therefore, the requested information points (1-9) about acceptance criteria, test sets, expert ground truth, MRMC studies, etc., typically apply to the rigorous clinical validation studies for novel medical devices, especially AI-driven ones where performance metrics like sensitivity, specificity, or AUC are critical. For a 510(k) based on substantial equivalence to predicate muscle stimulators, the "study" is often a combination of non-clinical bench testing, electrical safety testing, electromagnetic compatibility (EMC) testing, and comparison of technical specifications to demonstrate that the new device is as safe and effective as the predicate.

Given this context, I will address your points as best as possible based on the provided document, acknowledging where the information is not directly applicable or explicitly stated as it would be for a typical AI/ML clinical validation study.

Acceptance Criteria and Study for truFlex Muscle Stimulator

The acceptance criteria for the truFlex Muscle Stimulator, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved by showing that the truFlex device has the same intended use, similar technological characteristics, and meets recognized safety and performance standards as its predicates, without raising new questions of safety or effectiveness.

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

Since this is a substantial equivalence submission for a traditional medical device (not an AI/ML diagnostic/therapeutic device), the "acceptance criteria" are generally that the device performs within the established safety and effectiveness profiles of the predicates. The "reported device performance" is demonstrated through compliance with voluntary standards and direct comparison of specifications.

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

• Sample Size: Not applicable in the context of a 510(k) clearance for this type of device, which relies on a comparison to predicate devices and adherence to performance standards rather than a clinical study with patient samples. The "test set" would be the device itself undergoing various engineering and safety tests.
• Data Provenance: The document details non-clinical testing for compliance with international standards (e.g., IEC, ISO). This is primarily bench testing, not patient-derived data. The manufacturer is Syrma Johari Medtech Limited, located in Jodhpur, Rajasthan, India. This suggests the testing and engineering data would originate from their facilities or contracted labs.

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)

• Number of Experts/Qualifications: Not applicable. For demonstrating substantial equivalence for a powered muscle stimulator, the "ground truth" is defined by the technical specifications, safety standards, and established performance of the predicate devices. It does not involve expert consensus on clinical findings in a test set, as would be the case for an AI-driven image analysis or diagnostic device.

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

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication of medical findings.

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

• MRMC Study: Not applicable. The truFlex is a physical medical device (muscle stimulator), not an AI-assisted diagnostic or image analysis tool for human readers.

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

• Standalone Performance: Not applicable. This device is an electrical muscle stimulator; it does not operate as a standalone algorithm in the way an AI diagnostic tool would. Its "performance" is its ability to generate specified electrical impulses safely and effectively.

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

• Type of Ground Truth: The "ground truth" in this 510(k) submission is primarily established by:
  • International Consensus Standards: Compliance with recognized IEC and ISO standards (e.g., IEC 60601-1 series for safety, IEC 62304 for software, ISO 10993 series for biocompatibility).
  • Technical Specifications of Predicate Devices: The specific electrical output parameters (voltage, current, waveform, frequency, pulse width), operational modes, and physical characteristics of the legally marketed predicate devices. The new device must demonstrate it meets or is equivalent to these parameters.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The truFlex is a hardware device cleared through substantial equivalence to predicate hardware devices. It does not involve AI/ML models that require a "training set" in the computational sense. The "training" for such devices involves product development, engineering, and manufacturing processes aimed at meeting specifications.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the development and testing of this device (if one were to use that term broadly) derived from engineering requirements, known electrical stimulation principles, and regulatory standards.

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