(451 days)
truSculpt flex 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.
truSculpt flex 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 of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.
truSculpt flex 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 provided text describes a 510(k) premarket notification for the truSculpt flex device, a powered muscle stimulator. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Torc Body, K192039) through a comparison of technological characteristics and non-clinical bench testing.
However, the document does not contain any information about clinical studies that would involve a test set, human subjects, expert consensus for ground truth, or MRMC studies demonstrating improvement with AI assistance. It explicitly states:
"The device safety and efficacy was demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device." (Page 6)
"The information and testing presented in this traditional 510(k) demonstrate that the truSculpt flex device performs as designed and intended, and is substantially equivalent to the predicate device (K192039). The changes made do not affect the safety and effectiveness of the device." (Page 16)
The submission details non-clinical bench testing to demonstrate compliance with various standards (e.g., IEC, ISO, CFR 820), reliability testing, and a comparison of output specifications between the modified and predicate devices. It emphasizes that fundamental scientific technology has not changed and reported differences in individual mode parameters are within acceptable limits as per regulatory guidance.
Therefore, an exhaustive answer to your request, based only on the provided text, would indicate the absence of information for many of your criteria concerning clinical performance studies.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance in the way one might expect for an image-based diagnostic AI device. Instead, the acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (Torc Body, K192039) through:
- Identical Indications for Use: "Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. Strengthening, toning and firming of buttocks & thighs." (Page 6)
- Identical Fundamental Scientific Technology: "The fundamental scientific technology has not changed in the modified device." (Page 4) and "There are no changes to the indications for use, fundamental scientific principles, performance specifications, or operation of the device." (Page 16)
- Compliance with applicable voluntary standards and regulations: (IEC 60601-1, IEC 60601-1-2, IEC60601-2-10, ISO 14971, ISO 13485:2016, 21CFR820, IEC 62366, ISO 15233, ISO 10993-1). (Page 16)
- Bench testing demonstrating safety and performance: "The truSculpt flex device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared device. No new safety or performance issues were raised during testing." (Page 16)
- Output specifications within acceptable limits: Minor differences in mode parameters are noted but are deemed to be "within the limits as per 'Guidance Document for Powered Muscle Stimulator 510(k)s', issued on June 9, 1999, ANSI/AAMI NS4:2013 (R2017) standard for electrical stimulators." (Page 16)
Since this is a substantial equivalence claim based on technical characteristics and bench testing, there are no reported "device performance" metrics in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) from a clinical study on a test set. The performance is implied by its adherence to safety standards and comparable electrical output to the predicate.
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. The document describes non-clinical bench testing and a comparison to a predicate device, not a clinical study involving human test subjects or a "test set" of patient data for performance evaluation in the context of an AI/diagnostic device.
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)
Not applicable. No clinical test set or human-established ground truth is mentioned for this device's 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is mentioned.
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
Not applicable. No MRMC study was performed as this is not an AI/diagnostic imaging device and is not described as involving human "readers" or AI assistance in clinical interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical powered muscle stimulator, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of a clinical test set. The "ground truth" for this 510(k) submission is primarily based on:
- Engineering specifications and measurements: Comparing the electrical output parameters (voltage, current, pulse width, frequency, etc.) of the modified device to the predicate device and ensuring they fall within acceptable ranges as per relevant standards (e.g., ANSI/AAMI NS4:2013).
- Compliance with recognized voluntary standards: Meeting the requirements of standards like IEC 60601-1, ISO 14971, etc., which are inherently designed to ensure basic safety and performance.
8. The sample size for the training set
Not applicable. The document does not describe the use of machine learning or AI models with training sets.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
§ 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).