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Interferential Stimulation

• Symptomatic relief of chronic intractable pain

• Adjunctive treatment for the management of post-traumatic or post-surgical pain

EMS (Electrical Muscle Stimulation)

• Relaxation of muscle spasm

• Increasing local blood circulation

• Muscle re-education

• Prevention or retardation of disuse atrophy

• Prevention of venous thrombosis of the calf muscles immediately after surgery

• Maintaining or increase range of motion

The Flex-MI is a combination EMS and interferential stimulation device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 4.8V Ni- MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours. Flex-MI is compatible and recommended for use with Everlife self-adhesive electrodes (K012463).

The provided document is a 510(k) premarket notification for the Flex-MI device, which is a combination EMS and interferential stimulator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a standalone study with acceptance criteria.

Therefore, the document does not contain the acceptance criteria and the study details as requested in the prompt. This type of FDA submission (510(k)) primarily aims to show that a new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and indications for use, rather than presenting a full efficacy or performance study against pre-defined acceptance criteria for a novel AI device.

Without specific acceptance criteria and a detailed study report, it's not possible to populate the requested tables and information. The document explicitly states: "Clinical Data: Clinical data is not required to support the substantial equivalence to the predicate devices." This further confirms that a study to prove performance against acceptance criteria was not part of this submission.

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As prescribed by a physician for the following:

TENS- Transcutaneous Nerve Stimulation

• Symptomatic relief of chronic intractable pain .
• . Post traumatic and post surgical pain relief

EMS- Electrical Muscle Stimulation

• . Relaxation of muscle spasm
• . Increasing local blood circulation
• . Muscle re-education
• . Prevention or retardation of disuse atrophy
• Prevention of venous thrombosis of the calf muscles immediately after surgery
• . Maintaining or increase range of motion

The Flex-MT + is a combination TENS and EMS device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 700 mAh 4.8V Ni MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.

The provided text is a 510(k) summary for the Flex-MT+ device. It outlines the device's technical specifications and compares them to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the "study" (in this case, performance testing) that proves the device meets them, based on the provided text:

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

The document does not explicitly state "acceptance criteria" for performance, but rather demonstrates substantial equivalence by comparing the Flex-MT+ device's technical characteristics and performance to two predicate devices (K083030 EMSI TENS-EMS-14 (Flex MT) and K021100 EMPI 300 PV). The "Comment" column in the provided tables effectively acts as the "acceptance criteria" by stating whether the subject device's performance is comparable to or within acceptable limits of the predicate devices and relevant standards.

Acceptance Criteria (Derived) and Reported Device Performance (Flex-MT+)

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As prescribed by a physician for the following:

Relaxation of muscle spasm

Increasing local blood circulation

Maintaining or increasing range of motion

Preventing or retarding disuse atrophy

Muscle re-education

Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

The GS 3000 is a High Voltage Pulsed Galvanic Current (HVPGC) Stimulator which delivers stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The device has a twin peak monophasic waveform with a 5 usec fixed duration. The current Amplitude is adjustable from 0-350 Volts (0~190V Max @ 500ohm resistance), with an adjustable pulse frequency range from 2-100 cycles per second.

The GS 3000 is a single channel device, with the option to set the active electrodes (treatment electrode) to either positive or negative polarity in relation to the dispersive electrode (closes patient circuit) and alternating or synchronous treatment mode selection. The device is powered by a 9 volt battery.

It appears this document describes a 510(k) premarket notification for a medical device called the GS 3000, which is a Powered Muscle Stimulator.

However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. The "Discussion of performance testing" section specifically refers to:

• IEC 60601-1: General requirements for safety of medical electrical equipment. This covers electrical leakage current, electrode and lead wire safety, output current, and power density.
• IEC 60601-1-2: Collateral standard for electromagnetic compatibility.

These are engineering and safety performance standards, not clinical performance or efficacy studies. The document states that the device "met all applicable requirements" for these standards, indicating successful electrical and EMC testing.

Therefore, I cannot fill in the requested table and sections related to clinical acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text.

The document primarily focuses on establishing "substantial equivalence" to a predicate device based on technological characteristics (output specifications, device design, waveforms) and safety standards, rather than clinical performance outcomes against defined acceptance criteria.

Based on the provided text, here is what can be extracted, and where limitations exist:

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

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

• No information provided. The performance tests mentioned (IEC 60601-1 and IEC 60601-1-2) are engineering and safety tests, not clinical studies involving patients or a "test set" in the context of diagnostic or clinical outcome performance.

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

• Not applicable. There is no "test set" and no ground truth established by experts for clinical performance in this document.

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

• Not applicable. There is no "test set" and no adjudication method 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

• No. An MRMC study was not done. The device is a "Powered Muscle Stimulator," not an AI-powered diagnostic or assistive tool.

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

• No. This is not an algorithm-based device. "Standalone performance" in this context would refer to the device's electrical output characteristics and safety, which were tested against IEC standards as mentioned.

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

• Not applicable for clinical performance. For the engineering and safety tests, the "ground truth" would be the specifications and limits defined by the IEC standards themselves.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

• Not applicable. This device does not involve a "training set."

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Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as interferential devices, galvanic devices, TENS, etc. and a patient's skin for the delivery of electrical stimulation.

The EMSI Garment Electrodes are a cloth type device weft knitted of a continuous fiber made up of 77% Nylon and 23% Silver. Each device is flexible, and is available in a range of sizes to ensure good patient contact. A male snap connector is placed within the fabric weave and is connected via the female snap connector to a short lead wire, The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The entire fabric is made up of conductive material to provide uniform current distribution when connected to a stimulator.

The provided text describes the 510(k) summary for the "EMSI Garment Electrodes." This device is a Class II medical device, product code GXY (Cutaneous Electrodes), intended for use as reusable cutaneous, flexible, conductive garment/fabric electrodes for electrical stimulation.

Based on the provided information, the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove novel performance against specific acceptance criteria. Therefore, most of the requested fields related to a performance study will not be applicable or cannot be extracted from this document, as a typical clinical performance study with AI algorithms is not described.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that are typically associated with AI-based diagnostic or prognostic devices. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence through specific tests.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document describes bench testing and biocompatibility testing, not a clinical study on a patient test set using an AI algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Not applicable. This device is an electrode garment, not an AI algorithm. Its performance is related to its physical and electrical properties, not an algorithmic output.

7. Type of Ground Truth Used

For the bench tests and substantial equivalence claims, the "ground truth" (or reference standard) would implicitly be:

• Biocompatibility: Adherence to established biocompatibility testing standards (e.g., ISO 10993).
• Impedance/Resistance: Measurements against electrical engineering principles and comparison to the predicate device's measured values.
• Durability: Functional testing after wash cycles, likely comparing pre-wash and post-wash electrical characteristics and structural integrity to predefined specifications or those of the predicate.

8. Sample Size for the Training Set

Not applicable. This is not an AI device with a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI device with a training set.

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TENS- Transcutaneous Nerve Stimulation

• . Symptomatic relief of chronic intractable pain
• Post traumatic and post surgical pain relief .

EMS- Electrical Muscle Stimulation

• . Relaxation of muscle spasm
• . Increasing local blood circulation
• . Muscle re-education
• . Prevention or retardation of disuse atrophy
• . Prevention of venous thrombosis of the calf muscles immediately after surgery
• . Maintaining or increase range of motion

The TENS-EMS-14 is a combination TENS and EMS device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 4 AA batteries. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.

This document is a 510(k) premarket notification for the EMSI TENS-EMS-14, a combination Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS) device. The purpose of this notification is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a de novo study with acceptance criteria and performance data in the typical sense of a medical diagnostic or AI-powered device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for devices that require extensive performance validation (e.g., diagnostic accuracy for AI algorithms).

Here's a breakdown of why the requested information is absent and what the document does discuss:

1. A table of acceptance criteria and the reported device performance: This is not present. The document focuses on demonstrating substantial equivalence to predicate devices, which means showing that its technological characteristics, intended use, and safety/effectiveness are similar to devices already cleared by the FDA. The "Discussion of performance testing" section mentions general safety testing (electrical leakage current, electrodes, leads, output current, power density) in accordance with IEC 60601-1-2, but does not provide specific acceptance criteria or quantitative performance results for each.

2. Sample size used for the test set and the data provenance: Not applicable/not provided. This type of information is relevant for studies involving data analysis (e.g., image analysis, diagnostic algorithms), which is not the nature of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.

4. Adjudication method for the test set: Not applicable/not provided.

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 a TENS/EMS stimulator, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided in the context of device performance. The "ground truth" here would relate to the physical and electrical safety standards it passed.

8. The sample size for the training set: Not applicable/not provided.

9. How the ground truth for the training set was established: Not applicable/not provided.

Summary of what the document does provide:

• Intended Use: Details the specific medical conditions for which the TENS and EMS functions are intended.
• Safety Testing: Mentions that safety testing was performed in accordance with IEC 60601-1-2 (Medical Electrical Equipment, Part 1: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility- Requirements and Test), and the device "passed all of the applicable test." However, no specific pass/fail criteria or quantitative results are elaborated.
• Substantial Equivalence: States that the device's output specifications, design, waveforms, and programmability demonstrated it to be substantially equivalent to a predicate device. This is the primary "proof" in a 510(k) submission for this type of device.

In conclusion, the 510(k) summary for the EMSI TENS-EMS-14 does not include the detailed performance study information with explicit acceptance criteria, sample sizes, and ground truth establishment methods that would be pertinent to a device requiring such validation, especially one involving AI or diagnostic interpretation. Instead, it relies on demonstrating adherence to general safety standards and substantial equivalence to a predicate device already on the market.

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Symptomatic relief of chronic intractable pain
Adjunctive treatment for the management of post-traumatic or post-surgical pain

The TENS/IF 14 is a combination TENS and Interferential device which delivers nerve stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device may be powered by either 4 AA batteries or by an AC adapter, that when plugged into a wall outlet provides 6 VDC to the unit. A patient compliance timer can memorize 60 sets of operation records; the total record time is 999 hours.

Here's an analysis of the provided 510(k) summary for the TENS/IF 14, focusing on acceptance criteria and the supporting study information:

Summary of Acceptance Criteria and Device Performance:

Study Information Pertaining to Acceptance Criteria:

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

   • The document does not specify a sample size for a test set in the context of clinical or performance data. The testing primarily involved engineering performance and safety testing in accordance with IEC 60601-1-2.
   • Data Provenance: The standard testing (IEC 60601-1-2) would typically be conducted by the manufacturer or a certified testing laboratory. The document doesn't specify a country of origin for any "data" beyond the manufacturing and submission location. This is not a study involving patient data.

2. 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 device's clearance is based on engineering and safety performance testing against a recognized standard (IEC 60601-1-2) and demonstration of substantial equivalence to predicate devices, not on a clinical test set requiring expert ground truth for diagnostic accuracy or treatment efficacy.

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

   • Not applicable. As stated above, this was not a clinical or comparative performance study that would involve expert adjudication of results. The "adjudication" was effectively by the testing laboratory confirming compliance with the technical standard.

4. 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 a transcutaneous nerve stimulator, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance is not relevant.

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

   • Not applicable. This is a physical medical device (nerve stimulator), not an algorithm or software-as-a-medical-device (SaMD). Its performance is inherent in its electrical output and safety, not in an algorithmic assessment.

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

   • For the safety and performance testing, the "ground truth" was compliance with the technical specifications and safety limits defined by the IEC 60601-1-2 standard. There was no clinical ground truth (like pathology or outcomes data) being established for this type of submission.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable. There is no training set for this device.

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