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The Portable Electro-Stimulation Therapy Device, model LGT-232(US) is used to: Stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

Portable Electro-Stimulation Therapy Device, model LGT-232(US) in TENS mode is used for:

1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities;

2. The symptomatic relief and management of chronic, intractable pain associated with arthritis.

The LGT-232(US) is a lightweight and portable multifunctional electrotherapy device that provides NMES or TENS current. The device consists of the main unit, charging case, charger connector, FDA cleared self-adhesive electrodes (K183154), indicator light, main unit cable, on/off button, decreasing intensity button, and increasing intersity button to complete the function. The device can also be connected to a mobile phone through Bluetooth, and be controlled by the MStim Sport Application on the mobile device to choose the training programs and adjust pulse output intensity. The MSim Sport App can be downloaded from App Store. MStim Sport has up to seven training programs. These include Endurance, Resistance, Strength, Explosive Strength, Potentiation, Training Recovery and Pain Relief programs. The programmed electrical pulses will transfer through electrode plates to the suggested area of the body where the electrodes are placed.

The provided text is a 510(k) summary for a medical device (Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)). It outlines the device's characteristics and compares them to predicate devices to establish substantial equivalence. However, this document does not describe a study involving human subjects or artificial intelligence (AI) performance validation.

The "Test Summary" section [5] refers to lab bench testing according to various safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-10, ISO 10993-10, ISO 10993-5). This type of testing evaluates the device's electrical safety, electromagnetic compatibility, and biocompatibility, as well as its physical output parameters (voltage, current, frequency, pulse width). It does not involve "acceptance criteria" related to diagnostic accuracy, a human-in-the-loop study, or AI performance, as typically seen in submissions for AI/ML-driven medical devices.

Therefore, because the provided text is a 510(k) summary for an electro-stimulation therapy device that relies on established safety and performance standards for comparison to predicates, and not a study validating AI or diagnostic performance, I cannot extract the information required to populate the fields related to acceptance criteria, study design, expert involvement, or AI performance.

The document focuses on demonstrating that the new device is functionally and safely comparable to existing, legally marketed predicate devices, primarily through engineering specifications and adherence to relevant international standards.

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