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Intended Use:

The PHYSIQ device is intended in EMS mode for:

Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

and in TENS mode for:

Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

The PHYSIQ is a device provided with 4 handpieces by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.

The PhysiQ consists of :

• an AC/DC power supply unit,
• EMS/TENS driving electronic board
• CPU controller; ●
• user interface with LCD touch screen, . ●
• 4 EMS/TENS handpieces with interconnecting cables ●

EMS or TENS treatment is enabled at the same time on all 4 handpieces. The operator can choose how many handpieces to use and leave the unused ones in the proper holder.

Through the handpieces the electrical energy is delivered to the patient, which repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area.

During TENS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes which are in contact with the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

During EMS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes in contact with the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms, prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.

Handpieces are directly applied on the area to be treated, such as-upper and lower back, abdomen, legs and arms.

The user interface allows to fully control the treatment parameters. The operator can manage Electro Muscle Stimulation (EMS) or Transcutaneous Electrical Nerve Stimulation (TENS) (OFF or ON from 1 to 50, with selection step of 1).

Treatment time can be changed regardless of the suggested one.

The provided text describes a 510(k) premarket notification for the PHYSIQ device, which is a powered muscle stimulator and transcutaneous electrical nerve stimulator. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data rather than extensive clinical studies with acceptance criteria based on patient outcomes.

Therefore, the acceptance criteria and study detailed below will focus on the non-clinical performance benchmarks used to establish substantial equivalence with the predicate device, rather than clinical performance metrics typically found in efficacy trials.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PHYSIQ device are based on demonstrating similar performance characteristics to its predicate device, The InMode System with Tone Applicator (K192249), and compliance with relevant safety standards. The reported device performance aligns with these criteria.

2. Sample size used for the test set and the data provenance

The provided submission does not detail a clinical "test set" in the context of an AI/ML device. Instead, it refers to bench testing for the device's electrical, mechanical, and biological performance.

• Sample size for bench testing: Not explicitly quantified as a "sample size" in terms of subject count. The testing involved physical units of the PHYSIQ device.
• Data provenance: Not explicitly stated as "country of origin." The manufacturing company (DEKA M.E.L.A. srl) and submitter (El.En. S.p.A.) are based in Italy, suggesting the testing was likely conducted in or overseen by entities within Italy or the EU. The data is retrospective in the sense that it evaluates the manufactured device against pre-defined specifications and standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the submission describes a traditional medical device (electro-stimulator), not an AI/ML CADe/CADx device that would create "ground truth" labels from medical images or data. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards and specifications. Engineers and technicians with expertise in medical device testing, electrical safety, and biocompatibility would perform and interpret these tests.

4. Adjudication method for the test set

This is not applicable as there is no "test set" involving human interpretation or labeling that would require an adjudication method (like 2+1 or 3+1). The testing involved objective measurements and compliance assessments against predefined standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The PHYSIQ device is an electro-stimulator, not an AI-powered diagnostic tool, and the submission clarifies that "Clinical Performance Data: None" was provided.

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

No, a standalone algorithm-only performance study was not done. The PHYSIQ is a hardware device with embedded software/firmware for controlling its functions, but it's not described as an AI algorithm that performs an independent diagnostic or predictive task. Its "performance" is its ability to generate specific electrical outputs within defined parameters.

7. The type of ground truth used

For this device, the "ground truth" is established by engineering specifications, recognized national and international consensus standards, and documented biocompatibility assessments.

• Engineering Specifications: The design parameters for output voltage, current, pulse width, frequency, etc.
• Consensus Standards: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, 21 CFR 898, 21 CFR 882.5890 (GZJ), and 21 CFR 890.5850 (IPF). These standards define acceptable safety and performance limits.
• Biocompatibility Assessments: Standardized biological tests (e.g., cytotoxicity, irritation, sensitization) that meet established criteria as "ground truth" for material biological safety.

8. The sample size for the training set

Not applicable. The PHYSIQ device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its functionality is based on direct electrical and mechanical engineering principles.

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

Not applicable. As there is no AI/ML training set, there is no corresponding ground truth establishment process for it.

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