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Model SM9187:

TENS (Mode 1, 3, 4, 5, 6):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Model SM9180L & SM9180S:

TENS (Mode 1. 3. 4. 5. 6):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.

PMS (Mode 1, 2, 3, 4, 5, 6):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Sunmas TENS & PMS (Model SM9187, SM9180L & SM9180S) is a portable battery powered device with a wireless feature for over-the-counter use, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. Sunmas TENS & PMS has totally 6 modes, applying electrical current to electrodes on a patient's skin to relieve pain or build up muscle. Due to different electrode shapes and sizes, Model SM9187 can be used on the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (legs), while Model SM9180L and SM9180S can be used on the shoulder, back and abdomen. Model SM9187 is designed to be controlled by a mobile phone application program (APP) named “Dr.Stim”, through Bluetooth 4.0 technology (Frequency: 2402.0 - 2480.0MHz). The APP is developed by Hong Qiangxing (Shenzhen) electronics Limited. SM9187 consists of a round main unit, two sets of self-adhesive electrode pad, a mobile application (APP), an AC charger and a USB cable. Model SM9180L and SM9180S both have a butterfly-shaped main unit (Frequency: 2450MHz) and can be remotely controlled through wireless technology. SM9180L has a black remote control with an electronic display screen which is powered by two AAA alkaline batteries, while Model SM9180S has a white remote control powered by a CR2032 coin battery. The radio frequency of remote control (both black and white) is 2405.0 - 2470.0MHz. Model SM9180L and SM9180S consists of a unit, two pairs of electrode gels, a remote control (black or white), an AC charger and a USB cable.

This document is a 510(k) Pre-Market Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) device. The purpose of this notification is to demonstrate that the new device, Sunmas TENS & PMS (Models SM9187, SM9180L, SM9180S), is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies, as requested:

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

The provided document doesn't explicitly present a table of "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, it compares the technical specifications and safety standards compliance of the new device with those of its predicate devices to demonstrate substantial equivalence. The implicit "acceptance criteria" are that the new device's specifications and safety performance are comparable to or meet the standards of the predicate devices.

Below is a table summarizing key comparative performance metrics, drawn directly from the "Substantial Equivalence to Predicate device" tables (Table 1 and Table 2) within the document. The "Reported Device Performance" for the new device is its own specifications, and the "Acceptance Criteria" are implied by the predicate device's specifications and the statement that the new device is "safe and effective as the predicate devices cited above."

Note: The table for models SM9180L & SM9180S showed similarly comparable specifications to their predicate devices, with particular attention to wireless control and power sources. For brevity, only the first new device model (SM9187) is fully detailed above, but the same principle of demonstrating comparable specifications applies across all models.

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 does not describe a clinical test set or patient data for performance evaluation. The evaluation is based on a comparison of technical specifications and compliance with recognized safety standards. There is no mention of a "sample size" in terms of patients or data, nor the provenance of such 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)

Since there was no clinical test set or patient data involved in a performance evaluation requiring expert interpretation or "ground truth" establishment, this information is not applicable and not provided.

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

As no clinical test set or patient data requiring adjudication was used, this information is not applicable and 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

The device described is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). It is a physical therapy device and does not involve AI assistance for "human readers" or image interpretation. Therefore, an MRMC comparative effectiveness study in this context is not applicable, and no such study was reported.

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

This device is not an algorithm or AI system. It is a physical medical device that delivers electrical stimulation. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

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

Given the nature of the device and the submission type (demonstrating substantial equivalence through technical specifications and safety standards compliance), no "ground truth" in the context of clinical disease manifestation or diagnostic interpretation was used. The "truth" in this submission lies in compliance with electrical safety standards and the device's physical and electrical properties matching established safe and effective parameters of predicate devices.

8. The sample size for the training set

As this is not an AI/ML device, there is no "training set" in the conventional machine learning sense.

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

Since there is no training set, this information is not applicable.

Study Proving Acceptance Criteria:

The "study" demonstrating that the device meets "acceptance criteria" (understood as achieving substantial equivalence to predicate devices and complying with relevant safety standards) is a series of technical tests and evaluations against recognized voluntary standards. The document explicitly lists the following standards to which the new device has been tested and found compliant:

• ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
• IEC 60601-2-10 Edition 2.1 2016-04 - Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators.
• ANSI AAMI IEC 60601-1-2:2014 - Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests.
• IEC 62133 Edition 2.0 2012-12 - Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications.
• IEC 60601-1-11 Edition 2.0 2015-01 - Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment.
• FCC 47 CFR Part 15 - Radio Frequency Devices.
• AAMI TIR69: 2017 - Technical Information Report Risk Management Of Radio-Frequency Wireless Coexistence For Medical Devices And Systems.
• ANSI IEEE C63.27-2017 - American National Standard For Evaluation Of Wireless Coexistence.

These tests likely involved engineering evaluations, bench testing, and potentially electromagnetic compatibility (EMC) testing to ensure the device's electrical safety, functional performance within specified parameters, and safe operation in its intended environment, similar to the predicate devices. The successful completion of these tests provides the evidence that the device meets the implied acceptance criteria for safety and performance as a TENS/PMS device.

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