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The MStim Drop LGT-233 is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. The device electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The MStim Drop LGT-233 may also:

·Prevent/retard disuse atrophy

· Maintain or increase joint range of motion

•Increase local blood flow

The MStim Drop LGT 233 is a wearable foot drop device, which is mainly consist s of stimulator main unit, electrode lead wire, electrodes pad, leg bandage and battery charger. The stimulator main unit can be charge by the battery charger.

The device can control the out stimulation and treatment time setting by APP application provided by the manufacturer, and it can trigger and control the pulse stimulation on and off by detecting the swing phase of gait during walking. The device was design to use FES (Functional Electrical Stimulation) to treat and improve the patient s foot drop and help to improve walking ability. It has two modes: Training mode, Walk mode. Training mode is suitable for muscle training when the patient is seated or lying down (patient lacking active training), which can promote muscle recover, prevent muscle atrophy, improve joint range of motion, and increase local blood flow. Walk mode is walking with the electrical stimulation.

The MStim Drop Model: LGT-233 is an external functional neuromuscular stimulator intended to provide ankle dorsiflexion in individuals with dropped foot due to upper motor neuron injury. It electrically stimulates muscles to improve gait and may also prevent/retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) summary) does not explicitly state "acceptance criteria" in a quantitative, measurable sense for clinical performance. Instead, it demonstrates substantial equivalence to predicate devices through a comparison of technical specifications and an assertion of compliance with various electrical safety and biocompatibility standards. The reported device performance is largely a direct comparison of its technical specifications to those of the predicate devices.

Here's a table summarizing the comparison of key technical elements. "SE" in the remark column indicates "Substantially Equivalent” as claimed by the manufacturer. "Minor difference" remarks are explained in the "Comparison in Detail(s)" section of the document.

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

The document primarily relies on bench testing for safety and performance evaluation against recognized standards (IEC, ANSI, ISO). There is no mention of a human clinical study or "test set" in the context of clinical performance data used for this 510(k) submission. Therefore, sample size and data provenance for a clinical test set are not applicable here.

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, as no clinical test set for performance involving ground truth established by experts is described for this submission. The submission focuses on substantial equivalence based on technical specifications and compliance with safety standards.

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

Not applicable, as no clinical test set requiring adjudication is described.

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 an electrical stimulator, not an AI-powered diagnostic tool requiring reader performance evaluation.

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

Not applicable. This is not an algorithm-only device.

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

For the safety and performance evaluation reported, the "ground truth" used is compliance with various international standards for medical electrical equipment (e.g., IEC 60601 series), battery safety (IEC 62133-2), and biological evaluation (ISO 10993 series). These standards define acceptable limits and testing methodologies for device characteristics. No clinical outcomes data or expert consensus on clinical effectiveness is presented as "ground truth" in this submission.

8. The sample size for the training set

Not applicable. This device does not appear to incorporate machine learning algorithms that require a "training set" in the context of AI model development.

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

Not applicable, as no training set for AI model development is mentioned.

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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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Compression Therapy Device (Model: LGT-2201DVT) is intended to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients.

LGT-2201DVT is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.

Compression Therapy Device LGT-2201DVT a compression therapy device comprised of intermittent pneumatic controller, sleeves and connectable hose. The working principle is the air inflating and deflating the sleeve sequentially to develop the circulating pressure on the human body. Squeezing the proximal and distal of the limbs to promote blood circulation lymphatic system and improve body microcirculation. Besides, prevent thrombus, reduce limbs drops and this kind disease which is related to blood and lymph circulation directly or indirectly.

The provided documentation is a 510(k) premarket notification for a medical device called the "Compression Therapy Device (Model: LGT-2201DVT)". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific clinical performance acceptance criteria through a study involving AI.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or AI performance metrics. The information provided is primarily related to:

• Regulatory clearance: FDA's notification of substantial equivalence.
• Device identification: Trade name, regulation number, product code, etc.
• Intended use/indications for use.
• Comparison to a predicate device: Highlighting similarities and minor differences in specifications (size, weight, input power, battery, pressure range) and noting that these differences do not affect safety or effectiveness.
• Compliance with general safety and performance standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 62133-2.

In summary, none of the requested information regarding acceptance criteria, study design for proving device performance (especially in the context of AI), sample sizes for test/training sets, expert ground truth establishment, or MRMC studies is present in this document. This device is a physical, non-AI medical device, and its clearance process relied on demonstrating equivalence to an existing device through bench testing and standard compliance, not a clinical performance study with AI.

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Compression Therapy Device LGT-2200SP is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas, it can simulate kneading and stroking of tissues by using an inflatable garment.

Compression therapy device LGT-2200SP is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller, 4-chamber sleeves covered with Polyether Nylon Fabric, and a connectable hose for connecting the device to the sleeves. The case of main unit body is made from ABS plastic. The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 4-chambers and different applicable body areas, such as the Arm/ Leg/ Waist, hip and thigh/ Calf and foot. The sleeves can be inflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit. The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas.

The provided text is a 510(k) Summary for the Compression Therapy Device Model LGT-2200SP. It asserts substantial equivalence to predicate devices and focuses on technical specifications and adherence to safety standards.

Here's an analysis of the provided text in relation to your request:

The document does not include detailed acceptance criteria or a study that rigorously proves the device meets those criteria in a clinical performance context. Instead, it focuses on demonstrating safety and effectiveness through compliance with recognized standards and comparison to predicate devices.

Let's break down your specific points based on the available information:

1. A table of acceptance criteria and the reported device performance:
   The document doesn't provide a typical "acceptance criteria" table for device performance in a clinical sense (e.g., accuracy, sensitivity, specificity). Instead, it compares the subject device's technical specifications and features to predicate devices, and asserts that differences do not raise new questions of safety or effectiveness.

   Here's a table summarizing the comparison of the device's technical specifications and features to the predicate devices, which act as a form of "acceptance" by demonstrating substantial equivalence:

   Elements of Comparison	Subject Device (LGT-2200SP)	Predicate Device (Primary: NormaTec Pulse/Pro)	Predicate Device (II: Rapid Reboot System)	Predicate Device (III: Senyang Pt 1002)	Verdict (Equivalence Claim)
   Classification Name	Powered inflatable tube massager	Powered inflatable tube massager	Powered inflatable tube massager	Powered inflatable tube massager	Substantially Equivalent (SE)
   Regulation Class	2	2	2	2	SE
   Regulation Number	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650	SE
   OTC & Rx	OTC	OTC	OTC	Rx	Minor different (Noted in Remarks below)
   Indications for Use	Temporary relief of minor muscle aches and pains, temporary increase in circulation. Simulates kneading/stroking.	Temporary relief of minor muscle aches/pains, temporary increase in circulation.	Temporary relief of minor muscle aches/pains, temporary increase in circulation in healthy people. Simulates kneading/stroking.	Treating primary lymphedema, edema, venous insufficiencies, lymphedema (Rx use).	Minor different (Noted in Remarks below)
   Power Source	AC100-240V, Battery 11.1V, 6500mAh	12 VDC via IEC 60601-1 PSU, Optional rechargeable battery	110 V, 60Hz	110 V, 60Hz	Minor different (Noted in Remarks below)
   Power Consumption	90VA	14W	30W	30W	Minor different (Noted in Remarks below)
   Dimensions (WHD)	270148129mm	4"*5" *9"	10" x 6.5" x 5"	260170130mm	Minor different (Noted in Remarks below)
   Weight	2.0 Kg (4.4 pounds)	3.6 pounds	5.8 pounds	5.8 pounds	Minor different (Noted in Remarks below)
   Housing Materials	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	SE
   Number of Chambers	4-chamber	5 or less	4 Chambers	4 Chambers	SE
   Sleeve Materials	Polyether Nylon Fabric	200 denier nylon with polyurethane laminate/extrusion	Nylon with a Polyurethane laminate	Thermoplastic Urethane	Minor different (Noted in Remarks below)
   Mode of Compression	Sequential	Sequential	Sequential	Sequential	SE
   Device Pressure Range	30-150mmHg	30-110 mmHg	0-200 mmHg	0-250mmHg	Minor different (Noted in Remarks below)
   Treatment Time	1min-99min, default 30min, step of 5min	Stays on until user turns off or 10mins to continuous	10, 20, or 30 minute, with option to add 10 minutes	0 - 30mins	Minor different (Noted in Remarks below)
   Work Mode	6 modes (SEQUENTIAL, SQUEEZE, FLUSH, FLOW, RELEASE, WAVE)	Sequential, Zone pulses (2 modes)	Model A, Model B (2 modes)	Model A, Model B (2 modes)	Minor different (Noted in Remarks below)
   Patient Contact	Non-conductive appliances	Non-conductive appliances	(Image of Predicate II)	(Image of Predicate III)	SE
   Software/Firmware/Microprocessor Control	Microprocessor	Microprocessor	Microprocessor	Microprocessor	SE
   Technology	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	SE
   FDA-Recognized Standards	ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133, ISO 10993-5, ISO 10993-10	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	IEC 60601-1:2014, IEC 60601-1-2:2014, EN ISO 10993-5:2009, EN ISO 10993-10:2010	IEC 60601-1, IEC 60601-1-2, ISO10993-5, ISO10993-10	Minor different (Noted in Remarks below)

   Remarks on "Minor different" Verdicts:

   • Indications for Use: The document states, "Although there is a little difference about the indication for use, the meanings are the same. This difference does not affect the safety and effectiveness." (Note 1)
   • Power Source, Consumption, Dimensions, Weight: "Although the subject device design and specification parameter between the predicate are different, they are both complied with ANSI/AAMI ES60601-1. So the minor differences on such parameters do not affect the safety and effectiveness." (Note 2)
   • Sleeve Materials, Sleeves (dimensions/types): "Although the device provides four kind sleeves which have minor difference about size and appearance, the sleeve chamber number are the same and the applicable body areas are included in the predicate... the biocompatibility of sleeves is also complied with ISO 1099-5 and ISO 10993-10. Therefore, the difference would not raise adversely impact on safety and effectiveness." (Note 3)
   • Device Pressure Range: "Although the pressure range of subject devices, the range is smaller and contained by the predicate device (1), so the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 4). (There seems to be an error in the text where it ambiguously says "range is smaller and contained by the predicate device (1)" when for PD(II) and PD(III) the subject device's range is within a larger range.)
   • Treatment Time: "Although the treatment time range of subject device is to 99mins, which seems to be longer than the predicated with is suitable for daily use. And the treatment time is optionally set by user with 5mins step, which is more exact to the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 5). (There seems to be an error in the text where it mentions "difference of pressure range" instead of treatment time range).
   • Work Mode: "Although the subject device provides six kinds of work mode, the SEQUENTIAL and FLUSH mode are the same with the other work modes of subject device just have different about the different chambers. The treatment pressure range are the same under different work modes, so the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 6).
   • FDA-Recognized Standards: "The subject device references more sufficient safety standards than the 'safety of the safety' of the device is verified via tests." (Note 7 - this implies the subject device meets or exceeds the standards referenced by predicates, further supporting SE).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document explicitly states: "Clinical performance is not deemed necessary." (Section 7. Summary for clinical test). Therefore, there is no test set, sample size, or data provenance regarding clinical performance. The evaluation was based on bench testing and comparison to predicates.

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):
   As no clinical test set was used, there were no experts establishing ground truth in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   As no clinical test set was used, there was no adjudication method.

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 device is a physical therapy device (compression therapy device), not an AI imaging or diagnostic algorithm. Thus, an MRMC study and AI assistance effectiveness are not applicable and were not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This is a physical therapy device. The concept of "standalone algorithm performance" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   As no clinical studies were performed, there was no clinical ground truth established (such as expert consensus, pathology, or outcomes data). The "ground truth" for demonstrating substantial equivalence was adherence to recognized safety standards and functional comparison to legally marketed predicate devices.

8. The sample size for the training set:
   As no machine learning or AI component is mentioned, there is no training set, and therefore no associated sample size.

9. How the ground truth for the training set was established:
   As there is no training set for an AI/ML model, this question is not applicable.

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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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