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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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Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES and TENS.

NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance.

TENS is used to:

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

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

The Portable Electro-Stimulation Therapy Device, model LGT-231 is a dual channel stimulator which sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Reha, main unit and electrodes.

The Mobile App MStim Reha provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible device for selecting a pre-programmed output mode, adjusting frequency, pulse width and treatment time. Software operating environment of Mobile App MStim Reha are Android 4.3 or later mobile phone, with 4.0 Bluetooth and iOS 8.0 or later iPhone mobile phone, with 4.0 Bluetooth. Click the MStim Reha Application installation package on the phone to install the application. MStim Reha Application and the device can be connected via Bluetooth.

The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.

The two modes that Portable Electro-Stimulation Therapy Device, model LGT-231 employs are neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS). Neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS) target different nerve groups of the body.

TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Self-adhesive electrodes are placed on the skin close to the area of pain.

NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training: warming up or recovering. The Portable Electro-Stimulation Therapy Device stimulates nerve fibers by means of electrical impulses transmitted by electrical pulses generated by the Portable Electro-Stimulation Therapy Device stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Portable Electro-Stimulation Therapy Device may therefore be considered a technique of muscle training.

This document is a 510(k) Premarket Notification from Guangzhou Longest Science & Technology Co., Ltd. for their Portable Electro-Stimulation Therapy Device, model LGT-231. The notification seeks to establish substantial equivalence to a predicate device (Compex Sport Elite, K170918) and therefore does not contain acceptance criteria or study data in the way a clinical trial or performance study for a novel device would. Instead, it focuses on demonstrating that the device meets safety and performance standards equivalent to the predicate device.

Based on the provided information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" for a specific performance metric of the device in a comparative study against a clinical endpoint. Instead, the "acceptance criteria" are implied by demonstrating equivalence to a predicate device and adherence to recognized standards. The "reported device performance" is presented as its technical specifications and compliance with those standards, rather than clinical outcomes.

Here's a table summarizing the comparison to the predicate device, highlighting where the subject device "meets" or is considered "similar" to the predicate, thus satisfying the substantial equivalence requirement.

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

• Test Set Sample Size: The document does not describe any clinical test set involving human subjects to evaluate the device's therapeutic effectiveness. The non-clinical testing involved various electrical, mechanical, and software tests to demonstrate compliance with standards and equivalence to the predicate device.
• Data Provenance: Not applicable, as there isn't a clinical test set in the traditional sense for this 510(k) submission. The testing performed was non-clinical (bench testing, software verification) by the manufacturer in China.

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

• Not applicable. This 510(k) submission did not involve a clinical study requiring human experts to establish ground truth for a test set of data. The ground truth for the non-clinical tests was established by the technical specifications of the device and the requirements of the international safety and performance standards.

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

• Not applicable. There was no clinical test set requiring adjudication.

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 device is not an AI-powered diagnostic imaging system or similar technology that would involve human readers or AI assistance in interpretation. It is an electro-stimulation therapy device.

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

• Not applicable. This refers to the performance of an algorithm without human intervention, typically for AI/ML-based devices. This device is a hardware electro-stimulation therapy device, not an algorithm.

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

• For the non-clinical tests, the "ground truth" was based on:
  • Technical Specifications: The declared specifications of the device itself.
  • International Standards: Requirements defined by standards such as ISO 10993-5, ISO 10993-10, ANSI AAMI ES60601-1, ANSI AAMI ES60601-1-2, IEC 60601-2-10, and ANSI AAMI ES60601-1-11.
  • Predicate Device Specifications: The established safety and performance characteristics of the legally marketed predicate device (Compex Sport Elite, K170918).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI that would require a "training set" of data.

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

• Not applicable, as there is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states that non-clinical verification testing was performed to demonstrate that the Portable Electro-Stimulation Therapy Device, model: LGT-231 meets its design specifications and is suitable for its intended use. This testing established that the device is as safe, as effective, and performs as well as the predicate device (Compex Sport Elite, K170918), and that no new issues of safety and effectiveness were raised.

The "study" or evidence provided includes:

• Comparison to a Predicate Device (K170918 Compex Sport Elite): Detailed tables comparing the technological characteristics and output specifications of the subject device to the predicate device. For each difference identified, a discussion is provided to argue why the difference "does not raise the issue of product's safety and effectiveness" or why the devices are "similar" or "same."
• Compliance with International Standards: The device underwent testing to demonstrate compliance with a list of recognized consensus standards:
  • ISO 10993-5:2009 (Biological evaluation - Cytotoxicity)
  • ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization)
  • ANSI AAMI ES60601-1:2005+A1:2012 (Medical electrical equipment - General requirements for basic safety and essential performance)
  • ANSI AAMI ES60601-1-2:2014 (Medical electrical equipment - Electromagnetic compatibility)
  • IEC 60601-2-10:2012 (Particular requirements for the safety of nerve and muscle stimulators)
  • ANSI AAMI ES60601-1-11:2015 (Medical electrical equipment - Home healthcare environment)
• Internal Verification and Validation: The document states the device was "designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing."

Conclusion from the Submission:

The manufacturer concluded that "bench and non-clinical testing were sufficient to demonstrate that Portable Electro-Stimulation Therapy Device, model: LGT-231 is as safe and effective as the predicate device." The electrical safety, EMC, biocompatibility, software verification and validation, basic unit characteristics, and output specifications information were deemed sufficient to demonstrate substantial equivalence. Given the "nearly identical" nature and "essentially identical technological characteristics" with identical indications for use, the device was found substantially equivalent to the Compex Sport Elite.

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Portable Electro-Stimulation Therapy Device, model LGT-235 is indicated for the Symptomatic relief of chronic intractable pain, Post-traumatic pain and Post-surgical pain of the arms and legs.

The Portable Electro-Stimulation Therapy Device, model LGT-235 is a stimulator which sends gentle electrical current to underlying nerves via electrodes (Knee brace or self-adhesive electrode) applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Arth, main unit and electrodes (Knee brace and self-adhesive electrode).

The Mobile App MStim Arth provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible mobile device for selecting a pre-programmed output mode and treatment time.

The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.

The two modes that Portable Electro-Stimulation Therapy Device, model LGT-235 employs are transcutaneous electrical stimulation (TENS) and Microcurrent (MCR).

TENS and MCR are both specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS and MCR use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS and MCR do not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Knee brace is placed on the leg or arm close to the area of pain.

The provided text describes the Portable Electro-Stimulation Therapy Device, model LGT-235, and its substantial equivalence to a predicate device (Sonicator Plus 920, Model ME 920), which implies that it meets certain performance criteria. However, the document does not explicitly list quantitative acceptance criteria for the device's performance in terms of clinical efficacy or diagnostic accuracy. Instead, it focuses on demonstrating equivalence through technical specifications and compliance with recognized safety standards.

Therefore, many of the requested fields cannot be filled as they relate to clinical studies or performance metrics that are not detailed in this 510(k) summary.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria for clinical performance (e.g., pain reduction percentage, accuracy). Instead, it compares the technical characteristics and output specifications of the subject device to the predicate device, with the implicit acceptance criterion being "similar" or "same," meaning the differences do not raise new questions of safety or effectiveness.

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

This information is not provided in the document. The submission focuses on non-clinical (engineering, safety, and performance) testing, and does not describe a clinical test set or its provenance.

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)

This information is not applicable/not provided. The document describes non-clinical testing and equivalency to a predicate device, not a study involving expert-established ground truth for a test set.

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

This information is not applicable/not provided. There is no described clinical test set with ground truth requiring adjudication.

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

This information is not applicable/not provided. The device is an electro-stimulation therapy device for pain relief, not an AI-assisted diagnostic or interpretative device that would typically involve human "readers" or MRMC studies for AI improvement.

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

This information is not applicable/not provided. The device is a therapy device, not an algorithm, and its performance is assessed against electrical and safety standards, not standalone diagnostic accuracy.

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

This information is not applicable/not provided. The "ground truth" for the non-clinical tests involved comparing the device's measured electrical outputs and safety characteristics against established international standards (ISO, ANSI, IEC) and the specifications of the predicate device.

8. The sample size for the training set

This information is not applicable/not provided. As this is a 510(k) for a physical medical device (electro-stimulation therapy), not an AI/ML algorithm, there is no "training set" in the conventional sense.

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

This information is not applicable/not provided. See response to point 8.

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