(220 days)
TENS (TENS 1 and TENS 2)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PMS (STIM1 STIM2 STIM3 and STIM4)
To stimulate healthy muscles in order to improve and facilitate muscle performance.
The Electrical Stimulator System delivers electric pulses to the user's body areas in shoulder, waist, back, arm, and leg. The portable and compact device has multiple modes frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electical Muscle Stimulation (EMS). It includes the operating elements of an M button, intensity increase button, intensity decrease button, and can be attached and detached to electrodes.
The provided document is an FDA 510(k) Premarket Notification review, not a study report. It states that no clinical test data was used to support the decision of substantial equivalence (Section 12). Therefore, the document does not contain the information requested about acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies for a device performance study.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, performance specifications, and compliance with recognized standards through non-clinical bench tests.
Based on the information provided in the document, here's what can be extracted, and what cannot be answered as it pertains to a clinical performance study:
Information NOT available from this document regarding a device performance study:
- A table of acceptance criteria and the reported device performance for a clinical study. (No clinical study performed)
- Sample sizes used for the test set and the data provenance. (No clinical study performed)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts. (No clinical study performed)
- Adjudication method for the test set. (No clinical study performed)
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done. (No clinical study performed)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (Not applicable, this is a hardware stimulator, not an AI/algorithm-based device)
- The type of ground truth used. (No clinical study performed)
- The sample size for the training set. (Not applicable, not an AI/ML device that requires a training set)
- How the ground truth for the training set was established. (Not applicable)
Information available from this document regarding the basis for market clearance:
The acceptance criteria and "study" proving the device meets these criteria are primarily based on non-clinical testing and comparison to predicate devices, rather than a clinical performance study involving human patients.
1. Acceptance Criteria and Reported Device Performance (Non-Clinical / Bench Testing)
The document primarily relies on compliance with a set of international and FDA-recognized standards as its acceptance criteria for device safety and performance. The "reported device performance" refers to the successful testing to these standards and the comparison of technical specifications to predicate devices.
| Acceptance Criteria (Compliance with Standards) | Reported Performance (Compliance Demonstrated) | Specific Tests Mentioned |
|---|---|---|
| Electrical Safety | Device demonstrated electrical safety. | IEC 60601-1:2012+A2:2020 Medical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance. |
| Electromagnetic Compatibility (EMC) | Device demonstrated EMC. | IEC 60601-1-2:2014 /AMD1:2020 Medical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests. |
| Basic Safety and Essential Performance (General & Home Healthcare) | Device meets basic safety and essential performance requirements. | IEC 60601-1-11:2020: General Requirements For Basic Safety And Essential Performance - Collateral Station of Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment. |
| Specialized Safety (Nerve & Muscle Stimulators) | Device meets specific safety requirements for stimulators. | IEC 60601-2-10:2012 +A1:2016+A2:2023 medical electrical equipments for the basic safety and essential performance of nerve and muscle stimulators. |
| Usability | Device meets usability requirements. | IEC 60601-1-6 :2010+A1:2013+A2:2020 Medical Electrical Equipment For Basic Safety And Essential Performance -Collateral Standard: Usability. |
| Software Verification and Validation | Software verified and validated. | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Software Contained in Medical Devices." (Software deemed "Moderate" level of concern). |
| Biocompatibility | Device materials are biocompatible with human contact. | ISO 10993-1:2009 Biological evaluation of medical devices-Parts 1: Evaluation and testing. |
| ISO 10993-10:2021 Biological evaluation of medical devices-Parts 10: Tests for skin sensitization. | ||
| ISO 10993-23:2021 Biological evaluation of medical devices-Parts 10: Tests for irritation. | ||
| Functional Performance (Output Characteristics vs. Predicate Range) | Device's functional parameters are within acceptable ranges of predicates. | Bench tests were conducted to verify parameters such as waveform, stimulation parameters (maximum output voltage, current, etc.), and current distribution on electrodes against the characteristics of legally marketed predicate devices. (Specific quantitative results compared in Table 1 and 2 of the document). |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The "test set" here refers to the physical device prototypes undergoing non-clinical bench testing, not a dataset of patient cases. The number of physical units tested is not specified but is assumed to be standard for device verification.
- Data Provenance: The tests were conducted by the manufacturer (Gymmax Technology Shenzhen Co., Ltd.) or contracted labs in China, as indicated by the company's address and the application correspondent's company (IMD Medical & Drug Technology Services Institutions) also based in China. The data provenance is from non-clinical bench testing, not from human subjects, and therefore is not retrospective or prospective in the clinical sense.
3. Number of Experts and Qualifications:
- Experts: Not applicable for establishing ground truth as no clinical ground truth was established by human experts for device performance. Ground truth would be defined by the measurement standards of the bench tests themselves.
- Qualifications: Not applicable.
4. Adjudication Method:
- Method: Not applicable. No human interpretation or adjudication of test results, beyond standard engineering and quality control procedures, is mentioned for the bench tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No. The document explicitly states "No clinical test data was used to support the decision of substantial equivalence" (Section 12). This type of study is relevant for AI/ML diagnostic interpretation devices, not for a physical stimulator.
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only):
- Was it done? Not applicable. This device is an Electrical Stimulator System, a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used:
- For Non-Clinical Tests: The ground truth is established by engineering specifications, international consensus standards (e.g., IEC, ISO), and the performance characteristics of legally marketed predicate devices. The device needs to demonstrate that its electrical outputs, safety features, and material properties are compliant with these standards and comparable to accepted devices.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Method: Not applicable.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).