(57 days)
If any one of "OT", "OPP", and/or "OTE" is mounted for Y or Z.
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
If any one of "OE", and/or "OTE" is mounted for Y or Z.
- Relaxation of muscle spasms.
- Prevention or retardation of disuse atrophy.
- Increasing local blood circulation.
- Muscle re-education.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Maintaining or increasing range of motion.
If any one of "OPE" is mounted for Y or Z.
- Relaxation of muscle spasms.
If any "2IF" is mounted for Y or Z
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
If any "3HV" is mounted for Y or Z
The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.
The GEM-TWIN TENS series, including GM38Y/Z and GM39Y/Z(where Y and Z are any combination of OT/OE/OTE/OPE/OPP/2IF/3HV), are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
The GEM-TWIN TENS series, including GM38Y/Z and GM39Y/Z(where Y and Z are any combination of OT/OE/OTE/OPE/OPP/2IF/3HV), consist mainly of three parts: the TWIN housing, stimulation generators, and electrode. The TWIN housing to mount any two stimulation units, and to provide the connection of supply power and stimulation lead wires. The stimulation generator generates the output current specified as the input of controller. The output electrodes transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.
The stimulation mode for GEM-TWIN TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
The provided text describes a 510(k) submission for the GEM-TWIN TENS Device. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those criteria in terms of measured performance metrics. Instead, the submission focuses on demonstrating "substantial equivalence" to previously cleared predicate devices through compliance with voluntary standards and software verification.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Device Performance
Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against defined acceptance criteria for the new device itself.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | Maintain same safety and effectiveness as cleared device | Pass: "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." |
| Intended Use | Not affect the intended use of the device | Pass: "those engineering difference do not: (1) affect the intended use" |
| Fundamental Technology | Not alter the fundamental scientific technology | Pass: "those engineering difference do not... (2) alter the fundamental scientific technology of the device." |
| Voluntary Standards (Non-Clinical) | Compliance with: | Pass: "Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement." |
| Software Verification | Adherence to FDA software guidance | Pass: "the software verification has been carried out according to the FDA software guidance." |
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical performance data for the device. The "verification and validation tests" mentioned are non-clinical, likely engineering and regulatory compliance tests. No sample size of patients or data provenance is provided.
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. The submission does not detail clinical performance studies using expert-established ground truth. The "ground truth" for this submission refers to compliance with standards and equivalence to predicate devices.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set for performance evaluation is described.
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 TENS/EMS stimulator, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrical stimulator. Its "performance" is primarily defined by its electrical output characteristics and safety, rather than an algorithm's diagnostic accuracy.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is based on:
- Regulatory Standards: Compliance with ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2.
- Software Guidance: Adherence to FDA software guidance.
- Predicate Device Characteristics: The functional and technological characteristics of the previously cleared predicate devices (K032720, K032719, and K032994).
7. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
8. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set" or corresponding ground truth establishment methods.
§ 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).