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"Myolift QT" is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

The MyoliftQT is a microcurrent, handheld, and mobile application-based device which is easy to operate. The mobile application used in the device supports both types of users (iPhone®/Android™). The user has to download the application via Google Play™ store (Android) /App Store® (IOs) and connect the device via Bluetooth of their phone. The users can thereafter make their profiles accordingly.

The purpose of this device is to lift and tone the face and neck. It is a battery-powered device used with conductive gel. The conductive gel is used to reduce the impedance between the electrodes and the skin of the user.

Myolift QT has one channel and two output ports. One output is through the applicator ball and the other output is through the lead wire via the USB port connected through the charging port.

The Lead wire is connected to the device via USB. And electrodes are connected through the lead wire to give skin treatment to the user. The Metal balls and the electrodes are in contact with the user/patient maximum of 60 min, therefore the Surface-contacting, less than 24hour duration.

The Sphere shape applicator balls made up of stainless steel in this device are designed to gently roll over the skin to deliver low-level electrical impulses in the face and neck region. The device delivers current in the range of 350 microamperes and low 160-microampere current.

Note: During treatment, only one output port works.

In skin treatment, the device minimize the fine lines and wrinkles on the skin.

This device delivers two types of waveforms (Erase and Educate) for effective skincare treatment.

It is intended to be used by multiple users (multiple applications). The device can be switched ON|OFF by simple touch on the power button.

The device offers multiple LED indications (Visual) to indicate the different states of the device.

• -A flashing blue LED light indicates that the device is ON|OFF and when the device is connected to Bluetooth, the flashing blue light becomes steady.
• -A Red LED indicates battery low while A Green LED indicates the chagrining of the device

lt is a portable device having dimensions 6.65″ x 1.49″ [ L X B X H ]. Its outer case is made up of thermoplastic resin. The device comes with a C-type USB cable for the charging of the device. The device is automatically turned off if it is not connected via Bluetooth or not operated for more than 10 minutes.

This document is a 510(k) Summary for the Myolift QT device, which is a Transcutaneous Electrical Nerve Stimulator for cosmetic use. The summary focuses on demonstrating substantial equivalence to a predicate device (ZIIP+ Device, K212342) rather than presenting a performance study with acceptance criteria in the typical sense for an AI/ML medical device.

Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or not provided in this document. The "acceptance criteria" here are based on meeting various electrical safety, biocompatibility, and quality standards, and demonstrating technological characteristics similar to the predicate device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed through its adherence to various regulatory and safety standards, and by comparing its electrical output parameters to those of the predicate device. The "acceptance criteria" are implied by compliance with these standards and the demonstration of substantial equivalence.

• IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)
• IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests)
• IEC 60601-1-11 (Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
• IEC 60601-2-10 (Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators) | Compliant with IEC 60601-1, 60601-1-2, 60601-1-11. (Specific results like patient leakage current, overload/no-load trip described as within limits based on circuit design). |
  | Quality Management Systems:
• ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes)
• 21 CFR 820 (Quality System Regulation) | Covered by the manufacturer's quality system. |
  | Risk Management:
• ISO 14971 (Medical devices – Application of risk management to medical devices) | Compliant with ISO 14971. |
  | Usability Engineering:
• IEC 62366 (Medical devices – Application of usability engineering to medical devices) | Compliant with IEC 62366. Ergonomic handheld design noted. |
  | Biocompatibility:
• ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) | Biocompatible materials used, identical to predicate device. |
  | Wireless Capability:
• 47 CFR Part 15 FCC requirements of the Equipment Authorization - RF Device | Compliant with 47 CFR Part 15 FCC requirements. Uses Bluetooth Low Energy (BLE). |
  | Functional Equivalence to Predicate Device:
• Indications for Use: "facial and neck stimulation and… over-the-counter cosmetic use."
• Mechanism of Action: Microcurrent electrical therapy.
• Power Source: Internal Rechargeable Lithium-Ion Battery.
• Output Parameters (Mode: Erase):
  • Waveform: Symmetrical Biphasic Square wave
  • Max Output Voltage: 175 mV @500Ω, 684 mV @ 2KΩ, 3.20V @ 10KΩ
  • Max Output Current: 350μΑ @ 500Ω, 342μΑ @ 2ΚΩ, 320μΑ @ 10ΚΩ
  • Max Phase Charge: 17.5 μC @ 500Ω
• Output Parameters (Mode: Educate):
  • Waveform: Symmetrical Biphasic Square wave
  • Max Output Voltage: 175 mV @500Ω, 640 mV @ 2KΩ, 3.2V @ 10KΩ
  • Max Output Current: 350mA @ 500Ω, 320mA @ 2KΩ, 320mA @ 10KΩ
  • Max Phase Charge: 5.25 μC @ 500Ω
• Other features: Mobile application, auto shut-off, patient override control, LED indicators. | Identical indications for use.
  Identical mechanism of action.
  Identical power source.
  Output parameters for both "Erase" and "Educate" modes were presented and compared to the predicate device. While specific values differ (e.g., maximum output voltage/current, maximum phase charge), the document concludes these "minor differences… do not raise any questions regarding the safety and effectiveness" and that "The electrical values are within the limits as per the "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 9, 1999, ANSI/AAMI NS4:2013 (R2017) standard for electrical stimulators." |

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

This document describes a 510(k) submission for a physical device, not an AI/ML model. Therefore, "test set" and "data provenance" in the context of an AI/ML study are not applicable. The device undergoes "non-clinical bench testing" to demonstrate compliance with standards and equivalence. No patient data is involved in this described testing.

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. This is not an AI/ML device requiring human expert annotation for ground truth.

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

Not applicable. No expert adjudication for a test set 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. This is not an AI/ML device that assists human readers.

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

Not applicable. This is a standalone physical device, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness is established through its compliance with recognized electrical safety standards (IEC 60601 series), biocompatibility standards (ISO 10993-1), and quality management systems (ISO 13485, 21 CFR 820), as well as demonstrated similarity in technological characteristics and intended use to a legally marketed predicate device. There is no "ground truth" derived from patient outcomes or expert consensus for AI model training/testing.

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. This is not an AI/ML device that requires a training set with ground truth.

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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.

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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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