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Torc Body 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 buttocks & thighs.

Torc Body, the Powered Muscle Stimulator, is intended to improve tone and strengthen the muscles of the abdomen, buttocks, and thighs and to firm the abdomen muscles. The modified Torc Body, as described in this submission, is an upgrade from its previous version; which includes User- Friendly GUI, Internal power supply, and a wheeled console allowing clinicians to navigate and operate the device effortlessly. We intend to market this device to clinicians, as a prescription device. For ease of use and operation for the clinicians, we have 3 modes (suggestive): CLASSIC VECTOR, POWER SEQUENCE, DYNAMIC ROTATION. The modified device generates electrical stimulation to contract the muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.

The provided FDA 510(k) summary for the Torc Body device (K192039) primarily focuses on demonstrating substantial equivalence to a predicate device (K131291) through a comparison of technical characteristics and compliance with voluntary standards. It does not contain information about clinical studies with specific acceptance criteria related to device performance in terms of diagnostic accuracy, sensitivity, specificity, or human perception improvement.

Therefore, many of the requested details about acceptance criteria and clinical study design for device performance, especially those related to AI/algorithm performance and human perception, are not available in this document. The Torc Body is a "Powered Muscle Stimulator," and its performance is evaluated based on its electrical output characteristics and safety, rather than complex diagnostic or image interpretation tasks.

However, based on the provided text, I can infer the acceptance criteria by looking at the "Comparison" column in the tables, where the modified device's characteristics are judged against the predicate device. The general acceptance criterion is substantial equivalence, meaning the modified device performs as designed and its changes do not affect safety and effectiveness compared to the predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a powered muscle stimulator demonstrating substantial equivalence, the "acceptance criteria" are generally that the modified device's technical specifications and safety aspects are comparable to or within acceptable deviations from the predicate device, or meet relevant safety standards. The "performance" refers to these technical specifications.

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

The document states "The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared Torc Body device."

• Sample Size: Not specified. This typically refers to the number of physical units subjected to bench testing or the number of measurements taken. The document does not provide these details.
• Data Provenance: The testing appears to be bench testing conducted by the manufacturer (Johari Digital Healthcare Ltd). No information about country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study on human subjects or pre-existing datasets.

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

• Not applicable. This device is a powered muscle stimulator, and its performance is evaluated through engineering and electrical safety bench tests against specifications and voluntary standards, not by expert interpretation of clinical data in the way a diagnostic AI would be.

4. Adjudication Method for the Test Set

• Not applicable. There's no "ground truth" established by experts in the context of a diagnostic decision to adjudicate. The "ground truth" here is adherence to engineering specifications and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not a diagnostic device or a device involving human interpretation of medical cases. No MRMC study was performed.

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

• No. This device is a hardware muscle stimulator with software controls; it's not an algorithm intended for diagnostic interpretation to be evaluated in a standalone performance test in the typical sense of AI/ML. Its performance is inherent in its electrical output and safety characteristics.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence is:

• Predicate Device Specifications: The technical specifications (output voltage, current, pulse width, frequency, etc.) of the legally marketed predicate device (K131291).
• Voluntary Standards: Compliance with international safety and quality standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, ISO 13485, IEC 62366, ISO 15233, and ISO 10993-1.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. No training set was used.

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TORC BODY 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 buttocks & thighs.

TORC BODY is a powered muscle stimulator with two outputs. This battery powered unit is designed for men & women to provide exercise technology. The stimulation is the most comfortable & this technology makes it easier to combine active & passive exercise. The TORC BODY stimulator provides selections of different programs for Bottom Thighs muscles (BTS), Abdominal muscles (ABS) & yet customization of stimulation parameters. Four body areas can be treated simultaneously. The electrical muscle stimulator contracts muscles rhythmically to achieve muscle tone and strength. The belts provided with the device are used to place the electrodes in place on the body area to be treated. The lead wires connect the electrodes with the main stimulator unit. The Torc Body muscle stimulator provides comforting and soothing muscle stimulation to achieve the intended use of strengthening, toning and firming of the muscles of abdomen, thighs and buttocks. The user can increase the intensity to get a stronger stimulation and achieve better results. A touch screen LCD user interface simplifies the selection of the programs and displays the selected program, treatment time and other stimulation parameters. Rechargeable batteries power it. The unit can perform anytime & anywhere. Torc Body is suitable for use by all healthy adults. However as with other form of exercise some care is needed when using them.

The provided text is a Special 510(k) summary for the TORC BODY powered muscle stimulator. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, the POWERTONE, MODEL PT-11 (K062439), rather than presenting a study to prove acceptance criteria for novel claims.

Therefore, many of the requested sections about specific study methodologies, sample sizes, expert qualifications, and ground truth establishment will not be directly derivable from this type of regulatory submission. The document primarily highlights the comparison of technical specifications and intended use to show that the modifications made to the TORC BODY do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, indicating where information is present versus not applicable for this type of submission:

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

The document does not explicitly state acceptance criteria in terms of numerical performance targets (e.g., specific percentages for sensitivity, specificity, accuracy) for a clinical outcome. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device by comparing technical specifications and intended use. The "reported device performance" is essentially the alignment of these specifications with the predicate.

Differences noted (not relevant to performance criteria in this context, but design/user interface changes):

• Design: Predicate uses 4.8 VDC battery; Modified uses 24 VDC. Both are microcontroller-controlled.
• Mechanical Size: Predicate: 3.9"(L) x 1.6"(H) x 4.0(W); Modified: 8.0"(L) x 6.0"(W) x 4.0"(H). (Larger form factor for the modified device).
• User Interface & Display: Predicate: MKB Panel and LCD Display; Modified: Touch Screen LCD User Interface.
• Power: Predicate: Four rechargeable NiMH 1.2 VDC batteries; Modified: 24 VDC battery pack (20 cells of NiMH 1.2 VDC).

The "acceptance criteria" here is that the modified device's core technological parameters and intended uses are identical to the predicate device, thereby not raising new questions of safety or effectiveness. The study demonstrating this is the comparison table itself and the accompanying narrative arguing for substantial equivalence.

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

• Not applicable (N/A) for this type of submission. This is a Special 510(k) focused on engineering changes and demonstrating substantial equivalence to a predicate, not a new clinical trial that would require a test set of data. The "test set" is effectively the set of technical specifications and indications for use that are being compared.
• The data provenance would be from internal engineering documentation and specifications of both the modified and predicate devices.

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)

• N/A. Ground truth in the context of clinical studies (e.g., diagnostic accuracy) is not relevant for this engineering-focused substantial equivalence submission. The "ground truth" for the comparison is the documented specifications of the predicate device and the newly modified device.

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

• N/A. Adjudication methods are used in clinical trials to resolve discrepancies in expert interpretation of data. This is not applicable to a submission demonstrating substantial equivalence through technical specification comparison. The FDA's review process serves as the "adjudicator" for the claim of substantial equivalence.

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

• N/A. This device is a powered muscle stimulator, not an AI-driven diagnostic or assistive technology. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.

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

• N/A. This device is a physical medical device (muscle stimulator), not an algorithm or software. Its performance is intrinsic to its physical and electronic properties, not an "algorithm only" performance.

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

• N/A for clinical ground truth. The "ground truth" in this context is the technical and performance specifications of the predicate device that have already been cleared by the FDA. The justification for equivalence relies on comparing the modified device's specifications to these established (and accepted) predicate specifications.

8. The sample size for the training set

• N/A. There is no "training set" in the context of this device being a physical stimulator. This term is relevant for machine learning algorithms.

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

• N/A. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.

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