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SunStim Peripheral Nerve Stimulator and SunStim Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.

SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load).

The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Double Burst (DBS), Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator models have the same functions with the following exceptions: the SunStim™ Peripheral Nerve Stimulator functions do not include Double Burst and the 50 Hz Tetanus option.

The document provided is a 510(k) summary for the SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator. It describes the device, its intended use, and its substantial equivalence to a predicate device (EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator, K121743).

However, the document does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets such criteria in the way that would typically apply to AI/ML or diagnostic devices.

The "Performance Data" section lists recognized consensus standards that the device underwent tests against, which are primarily related to electrical safety, electromagnetic compatibility, risk management, and software lifecycle processes. These are general standards for medical electrical equipment and software, not performance metrics like accuracy, sensitivity, or specificity that would be expected for an AI system or device requiring clinical performance validation.

Therefore, many of the requested details about acceptance criteria and a study proving performance cannot be extracted from this document because they are not present. This document is focused on demonstrating substantial equivalence based on technological characteristics and adherence to general safety and quality standards, not a specific clinical performance study with defined criteria and results.

Here's an attempt to answer based on the available information, with many points marked as "Not provided in the document."

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The provided document describes the SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator, highlighting its substantial equivalence to a predicate device (K121743) based on its intended use, operating principle, basic design principle, operating modes, and stimulation parameters. The "performance data" section focuses on adherence to general safety, electromagnetic compatibility, risk management, and software lifecycle process standards, rather than specific clinical performance metrics.

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)

Not provided in the document. The testing mentioned refers to conformance with general safety and engineering standards, not a clinical test set with patient data.

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 ground truth or expert review process for a test-set of patient data is described. The "testing" refers to engineering and quality assurance against recognized standards.

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

Not applicable, as no clinical data 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. The device is a peripheral nerve stimulator, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

Not applicable, as the document describes a hardware medical device (peripheral nerve stimulator), not an algorithm or AI system.

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

Not applicable, as the "testing" described is against engineering and safety standards, not based on clinical ground truth.

8. The sample size for the training set

Not applicable, as the document describes a hardware medical device, not a machine learning model requiring a training set.

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

Not applicable.

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This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

SmartTENS is a portable battery powered T.E.N.S. device with a wireless remote control feature for over-the-counter use, mainly operating in home, clinic, or hospital environments.

There are three control buttons on the unit itself: ON/OFF, intensity UP and intensity DOWM. The device is also designed to be controlled wirelessly through Bluetooth 4.0 connection (Frequency: 2402.0 - 2480.0 MHz) by a matched smart phone, which is featuring a mobile application (App) developed by EasyMed Instruments Co., Ltd.

A user entered 6-digit security code ensures the access to the device can only be the user's matched smart phone, thus avoiding unauthorized controls to the device.

There are totally seven (7) modes that are intended for pain relieving treatments to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot. The specifications of each mode will be described in greater details in the User Manual.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the SmartTENS device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the SmartTENS in the form of specific performance metrics (e.g., accuracy, sensitivity, specificity) expected from a clinical study. Instead, it details the technical specifications and performance characteristics of the SmartTENS and compares them to predicate devices, demonstrating substantial equivalence.

The reported device performance is implicitly shown through its compliance with various electrical and medical device safety standards and a usability study.

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

The document mentions that a "usability study was conducted," but it does not specify the sample size for this study or any other test set. The data provenance (country of origin, retrospective/prospective) for any test data is also not mentioned.

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

This information is not provided in the document. The usability study would likely have involved user feedback, but the "ground truth" for a medical device's performance often relates to objective measures of efficacy or safety, which are not detailed here in terms of expert evaluation.

4. Adjudication Method for the Test Set

This information is not provided.

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

A MRMC comparative effectiveness study was not conducted for this device as it is a Transcutaneous Electrical Nerve Stimulator (T.E.N.S.) which directly delivers electrical current, rather than an imaging or diagnostic AI requiring human reader interpretation. The purpose of this submission is to demonstrate substantial equivalence to predicate devices based on technical specifications and safety standards, not a comparative effectiveness study involving human interpretation.

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

The SmartTENS is a physical medical device, not an algorithm in the context of AI. Therefore, a standalone (algorithm only) performance study as typically understood for AI/software devices was not performed or is not applicable. Its performance is assessed through its output characteristics and compliance with electrical and safety standards.

7. Type of Ground Truth Used

For the SmartTENS, the "ground truth" for its performance is established through:

• Compliance with recognized electrical and medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 60601-1-6, IEC 62304). This demonstrates that the device operates within established safe and effective parameters for TENS devices.
• Usability Feedback: The usability study inherently uses user experience (ease of use, safety observation) as a form of "ground truth" to determine if users can correctly and safely operate the device.

8. Sample Size for the Training Set

The SmartTENS is a hardware device with embedded software (for control and modes), but not an AI/machine learning model in the sense that would require a "training set" of data for learning and prediction. Therefore, a training set sample size is not applicable and not mentioned.

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

As there is no "training set" for an AI/machine learning model, this question is not applicable. The "ground truth" for the device's design and functionality is based on established engineering principles, regulatory standards, and the performance characteristics of predicate devices.

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TENS stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is used to provide symptomatic pain relief for chronic, acute or post operative pain.

PMS/EMS stands for Powered Muscles Stimulator/Electrical Muscles Stimulator. This PMS/EMS system is indicated for:

• 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 increasing range of motion

For the TENS function A portable TENS device for pain relief.
For the EMS function A portable EMS device for the re-education of muscles.
Features:
· Innovative design
· Large LCD display
• Dual output channels
• 2 AA Alkaline Batteries
· Adjustable frequency, pulse width, and timing parameters
• 9 different modes
• Timer option
• Doctor lock/unlock facility
· Open circuit detectors
• Non-volatile

The EasyMed EMS/TENS Model NMS-28 is a medical device that combines the functions of a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief and a Powered Muscle Stimulator (PMS) or Electrical Muscle Stimulator (EMS) for muscle re-education.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary for the EasyMed EMS/TENS Model NMS-28, which means it aims to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the same way a clinical trial would for a novel device. Therefore, a direct table of acceptance criteria and device performance based on quantitative metrics is not explicitly provided in the document.

Instead, the document asserts substantial equivalence based on:

• Identical intended use and indications for use as predicate devices.
• Technological comparison:
  • For TENS function: The software for the TENS function is a "subset" of the predicate EasyMed TENS Unit TN-28C (K040253). The new device shares the same enclosure, circuit diagram, PCB layout, components, and working principle.
  • For EMS function: The software for the EMS function is "very similar" to the predicate TensCare Ultima NMS/EMS Model XL-A3 (K023997), applying "similar control methods for muscle contraction-relaxation."
  • Safety and reliability considerations from the TN-28C are incorporated into the EMS function.
• Safety information:
  • Design complies with relevant safety and recognized consensus standards.
  • Output energy is "well controlled" within safety and effectiveness ranges specified by FDA guidance.
  • "Detailed and strict" testing has been carried out.
  • Risk Analysis and FMEA (Failure Modes and Effects Analysis) show the unit is "safe with no any hazard."
  • Mechanical integrity ensures only one function (TENS or EMS) can be selected at a time.
• Post-market experience (Europe): The device has been on the European market for two years, and a review of customer complaints, returned products, and post-market feedback demonstrated it "performed as Intended, to its Specified Requirements."

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

The document does not describe a specific clinical test set in terms of sample size or data provenance (e.g., country of origin, retrospective/prospective). The evidence supporting safety and effectiveness appears to be primarily based on:

• Bench testing and engineering analysis to verify compliance with standards and equivalence to predicate devices.
• Existing clinical evidence/regulatory filings for the predicate devices.
• Post-market surveillance data from the European market.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided as the submission relies on demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than establishing a new ground truth through an independent expert panel for a novel clinical claim.

4. Adjudication Method for the Test Set:

This information is not applicable/provided, as no clinical test set requiring expert adjudication for ground truth is described.

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

An MRMC study is not mentioned in the document. This type of study (evaluating human reader performance with and without AI assistance) is typically performed for AI-driven diagnostic or screening tools. The EasyMed NMS-28 is a physical electrical stimulation device, not an image-based diagnostic AI, so an MRMC study would generally not be relevant to its regulatory submission.

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

A standalone performance study focused on an algorithm's performance is not described. As mentioned, this is an electrical stimulation device, not an AI algorithm in the typical sense. The "software" mentioned as part of the technological comparison refers to the embedded firmware controlling the device's electrical output, not a diagnostic or decision-making AI. The "performance" assessment focuses on the device's electrical output parameters and safety through engineering tests and comparison to predicate devices.

7. Type of Ground Truth Used:

The "ground truth" for the submission is based on the established safety and effectiveness of the predicate devices (EasyMed TENS Unit TN-28C and TensCare Ultima NMS/EMS Model XL-A3) and the assertion that the new device is technologically similar and meets relevant safety standards.

8. Sample Size for the Training Set:

This information is not applicable/provided. The device does not employ a machine learning model that requires a "training set" in the conventional sense. The "software" referred to is programmed control logic, not a learned algorithm.

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

This information is not applicable/provided, as there is no training set for a machine learning model described.

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T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.

T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
We do not feel pain until a coded message travels to the brain where it is decoded, analyzed and responded to. The pain message travels from the affected area along small nerve fibers leading into the spinal cord. Here the message is relayed to different nerves that travel up the spinal cord to the brain.
The kind provided to you by your personal Transcutaneous Electrical Nerve Stimulator, TN-28C T.E.N.S. Unit consists of sending small electrical pulses through the skin to the body's nervous system. According to the " gate " theory for pain control, the stimulation of large nerve fibers may result in the blocking of pain transmission.

This 510(k) summary for the EasyMed TN-28C T.E.N.S. Unit does not describe a study involving acceptance criteria and device performance in the way a clinical study for an AI/ML device would. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (FDTENS 2010), primarily through a comparison of design principles, power sources, and electrical output parameters.

Therefore, many of the requested fields cannot be filled as they pertain to a type of study not conducted or reported in this document.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable (N/A). The document does not describe specific quantitative acceptance criteria and corresponding measured device performance data. The basis for equivalence is a qualitative and parametric comparison to a predicate device.

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

N/A. No test set or associated data provenance is described for performance evaluation in the context of efficacy for pain relief in a human population. The comparison is based on device specifications.

3. Number of Experts Used to Establish Ground Truth and Qualifications

N/A. This document does not describe a study that required expert consensus for ground truth.

4. Adjudication Method

N/A. No adjudication method is described.

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

N/A. An MRMC study was not conducted or reported for this Transcutaneous Electrical Nerve Stimulator (TENS) unit. These studies are typically relevant for diagnostic imaging or AI-assisted interpretation, which is not the function of a TENS device.

6. Standalone Performance Study

N/A. While the document describes the technical specifications and operational principles of the device, it does not present a standalone performance study in terms of its clinical effectiveness or diagnostic accuracy. The equivalence is established on technical similarity, not a standalone clinical outcome study for the new device.

7. Type of Ground Truth Used

N/A. No ground truth is described, as the submission focuses on substantial equivalence based on technical specifications and intended use matching a predicate device.

8. Sample Size for the Training Set

N/A. This TENS device is not an AI/ML device, and thus, there is no "training set."

9. How Ground Truth for the Training Set Was Established

N/A. Not applicable as there is no training set mentioned.

Summary of the K040253 Submission:

The EasyMed TN-28C T.E.N.S. Unit obtained 510(k) clearance by demonstrating substantial equivalence to a previously legally marketed device, the FDTENS 2010 (K994266). The submission emphasizes that:

• Their circuits design are based on the same principle.
• Both devices use two 1.5V AA batteries and have two output channels.
• Their output electrical parameters (frequency, pulse width, intensity, etc.) are very similar substantially.
• The intended use of providing symptomatic pain relief for chronic, acute, or post-operative pain is the same as the predicate device.

This type of 510(k) submission, especially for a well-established device type like a TENS unit, typically relies on comparing technical specifications and intended use to a predicate device rather than conducting extensive new clinical performance studies with acceptance criteria as one might see for novel AI software or high-risk devices. The FDA's letter explicitly states that the determination of substantial equivalence allows the device to be marketed, subject to general controls.

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