(243 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, 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.
| Characteristic | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (Modified Device, K192039) |
|---|---|---|
| Intended Use | Identical to Predicate (Improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen; Strengthening, toning and firming of buttocks & thighs) | Identical |
| Fundamental Scientific Principles | Identical to Predicate | Identical |
| Safety and Effectiveness | Changes do not affect safety and effectiveness. | Demonstrated via compliance with voluntary standards (IEC 60601-1, IEC 60601-1-2, IEC60601-2-10, ISO 14971, ISO 13485:2016, 21CFR820, IEC 62366, ISO 15233, ISO 10993-1) and comparison of technical characteristics. "No new safety or performance issues were raised during testing." |
| Output Waveform | ||
| (Classic Vector Mode) | Symmetrical Biphasic, comparable maximum output voltage/current, pulse width, frequency, phase duration, net charge, current density, power density. | Waveform: Symmetrical Biphasic (Identical) |
| Shape: Step Sine Wave (Modified from Square Wave, functionally equivalent) | ||
| Max Output Voltage: S.6 Vpp @ 500Ω (± 10%), 62.4 Vpp @ 2KΩ (± 10%), 66 Vpp @ 10KΩ (± 10%) (Negligible difference) | ||
| Max Output Current: 103.2 mA pp @ 500 Ohm, 31.2 mA pp @ 2K Ohm, 6.6 mA pp @ 10K Ohm (Negligible difference) | ||
| Pulse Width: 124.7 μS (± 10%) @500Ω (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength) | ||
| Frequency: 4010 Hz (± 10%) @500Ω, Resultant: 1 – 100 Hz (Higher, but resultant frequency is virtually identical due to interferential effect) | ||
| Phase Duration: 124.7 μS (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength) | ||
| Net Charge: 0 μC @500Ω (Identical) | ||
| Max Phase Charge: 6.435 μC (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength) | ||
| Max Current Density: 1.15 mA/cm² (Negligible difference) | ||
| Max Power Density: 0.0295 W/cm² (Negligible difference) | ||
| Output Waveform | ||
| (Power Sequence Mode) | Symmetrical Biphasic, comparable maximum output voltage/current, pulse width, frequency, phase duration, net charge, current density, power density, ON/OFF times. | Waveform: Symmetrical Biphasic (Identical) |
| Shape: Square Wave (Identical) | ||
| Max Output Voltage: 50.8 Vpp @ 500Ω (± 10%), 64 Vpp @ 2KΩ (± 10%), 65.6 Vpp @ 10KΩ (± 10%) (Negligible difference) | ||
| Max Output Current: 101.6 mA pp @ 500 Ohm, 32 mA pp @ 2K Ohm, 6.56 mA pp @ 10K Ohm (Negligible difference) | ||
| Pulse Width: 350 μS (± 10%) @ 500Ω (Identical) | ||
| Frequency: 99.91 Hz (± 10%) @ 500Ω (Negligible difference) | ||
| Phase Duration: 350 μS (± 10%) (Identical) | ||
| Net Charge: 0 μC @500Ω (Identical) | ||
| Max Phase Charge: 35.56 μC @ 500 Ω Load (Negligible difference) | ||
| Max Current Density: 1.13 mA/cm² (Negligible difference) | ||
| Max Power Density: 0.0287 W/cm² (Negligible difference) | ||
| ON Time: 6 seconds (Virtually identical to 5.5s) | ||
| OFF Time: 4 seconds (Virtually identical to 5.5s) | ||
| Output Waveform | ||
| (Dynamic Rotation Mode) | Symmetrical Biphasic, comparable maximum output voltage/current, pulse width, frequency, phase duration, net charge, current density, power density. | Waveform: Symmetrical Biphasic (Identical) |
| Shape: Modulated Sine Wave (Modified from Square Wave, functionally equivalent) | ||
| Max Output Voltage: 51.2 Vpp @ 500Ω (± 10%), 63.2 Vpp @ 2KΩ (± 10%), 65.6 Vpp @ 10KΩ (± 10%) (Negligible difference) | ||
| Max Output Current: 102.4 mA pp @ 500 Ohm, 31.6 mA pp @ 2K Ohm, 6.56 mA pp @ 10K Ohm (Negligible difference) | ||
| Pulse Width: 124.9 μS (± 10%) @ 500Ω (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength) | ||
| Frequency: 4002 Hz (± 10%) @ 500Ω, Resultant: 1 – 100 Hz (Higher, but resultant frequency is virtually identical due to interferential effect) | ||
| Phase Duration: 124.9 μS (± 10%) (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength) | ||
| Net Charge: 0 μC @500Ω (Identical) | ||
| Max Phase Charge: 6.4 μC (Less than predicate, but sinewave with 50% duty cycle implies similar stimulation strength) | ||
| Max Current Density: 1.14 mA/cm² (Negligible difference) | ||
| Max Power Density: 0.0291 W/cm² (Negligible difference) | ||
| Other Device Features (e.g., Power source, Display, Console, Class) | Comparable or enhanced without adverse impact. | Power source: Internal medical grade power supply (Modified from AC/DC adaptor & rechargeable battery; tested to be safe). |
| Display: 12" LCD (Modified from 5.7" LCD; improved visual/wide angle view). | ||
| Console: Wheeled console (Modified from non-wheeled; enhanced navigation/operation). | ||
| Prescription/OTC: Prescription (Modified from OTC; change in marketing, not performance). | ||
| Weight/Dimension: Increased due to wheeled console (Modified, but functional). | ||
| Compliance with Voluntary Standards: YES (Identical). |
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.
§ 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).