(39 days)
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.
| Feature | Predicate Device (POWERTONE, MODEL PT-11) | Modified Device (TORC BODY/TORC PLUS) | Statement of Equivalence/Performance |
|---|---|---|---|
| Output | Two | Two | Equivalent |
| Waveform | Symmetrical Biphasic Square Wave | Symmetrical Biphasic Square Wave | Equivalent |
| Max Output Current (@500Ω) | 102mApp (18.97 mA rms) | 102mApp (18.97 mA rms) | Equivalent |
| Max Output Voltage (@500Ω) | 51 Vpp (9.48 Vrms) | 51 Vpp (9.48 Vrms) | Equivalent |
| Power Density on Electrodes | 0.0089 W/cm² @500Ω | 0.0089 W/cm² @500Ω | Equivalent |
| Max Phase Charge (@500Ω) | 35.7μC | 35.7μC | Equivalent |
| Max Current Density | 0.176 mA/cm² | 0.176 mA/cm² | Equivalent |
| Max Power Density | 0.0089 W/cm² | 0.0089 W/cm² | Equivalent |
| Indications for Use | - Improvement of abdominal tone | - Improvement of abdominal tone | Equivalent |
| - Strengthening, Toning, Firming of | - Strengthening, Toning, Firming of | ||
| abdominal muscles, firmer abdomen | abdominal muscles, firmer abdomen | ||
| - Strengthening, Toning, Firming of | - Strengthening, Toning, Firming of | ||
| buttocks & thighs | buttocks & thighs | ||
| Identification | Powered muscle stimulator with two | Powered muscle stimulator with two | Equivalent |
| outputs, contracting specific muscles | outputs, contracting specific muscles | ||
| Target Populace | Healthy adult men & women for home use | Healthy adult men & women for home use | Equivalent |
| Waveform Type | Symmetrical biphasic square wave | Symmetrical biphasic square wave | Equivalent |
| Humidity | Insulated liquid sprayed on circuitry | Insulated liquid sprayed on circuitry | Equivalent |
| Storage | 32 F to 112 F | 32 F to 112 F | Equivalent |
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.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).