(166 days)
For Transcutaneous Electrical Nerve Stimulation, ezFit Digital Heating TENS (Model No.: HR-661/ UC-101) is intended for · symptomatic relief and management of chronic intractable pain.
For Powered heating therapy , ezFit Digital Heating TENS (Model No .; HR-661/ UC-101) is intended for
- · Temporary relief of minor aches and pains and muscle spasms
ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) ( Transcuntaneus Electrical Nerve Stimulator) is designed for symptomatic relief and management of chronic intractable pain.
ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is of independent two channels output (double output), the user can choose to use a single channel connecting to two electrode pads or using both channels with four electrode pads simultaneously. With large LCD panel. It is powered by 3.6V(1.2V x 3)Ni-H Rechargeable Batteries or AC-DC adaptor.
The ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is a TENS (Transcuntaneus Electrical Nerve Stimulator) that employs a combination application of previously well known electrical and temperature treatment modalities for pain relief and rehabilitation. The system is based on a combination of thermal transfer (Powered heating pads - 21 CFR 890.5740) and conventional TENS - 21 CFR 882.5890) therapy.
When used in either Compress heat function only or Compress heat function plus TENS , An electronically controlled thermoelectric electrode pads can provide automatic thermal control with a Range of 36℃ - 42℃ . The Dual output can be adjusted to provides thermal heat to the skin between 40 and 42 °C for at least 10 minutes as therapeutic heating. This automatic thermal control mechanism also avoid skin from thermal injury.
The provided document is a 510(k) premarket notification summary for the ezFit Digital Heating TENS device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about acceptance criteria, study design, and ground truth establishment is not explicitly detailed in the summary.
General Interpretation of the Document:
The acceptance criteria for a 510(k) submission are generally that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The "study that proves the device meets the acceptance criteria" in this context is the comparison made to the predicate devices and the bench testing performed.
Here's an attempt to extract and infer the requested information based on the provided text, with explicit notes about what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence & Standards) | Reported Device Performance (as stated or inferred) |
|---|---|
| For TENS Function: | |
| Symptomatic relief and management of chronic intractable pain. | Same intended use as predicate TENS devices. |
| Electrical output characteristics (waveform, intensity, frequency). | "Waveform & output Study performed" (Details not provided). |
| Safety standards (electrical, electromagnetic compatibility). | Conforms to IEC 60601-1, IEC 60601-1-2. |
| For Powered Heating Function: | |
| Temporary relief of minor aches and pains and muscle spasms. | Same intended use as predicate heating pads. |
| Automatic thermal control functionality. | Electronically controlled thermoelectric electrode pads provide automatic thermal control. |
| Temperature range. | Range of 36℃ - 42℃. |
| Therapeutic heating maintenance (duration). | Provides thermal heat to the skin between 40 and 42 °C for at least 10 minutes. |
| Avoidance of thermal injury. | Automatic thermal control mechanism also avoids skin from thermal injury. |
| Safety standards (thermal, electrical). | Conforms to IEC 60601-1, IEC 60601-1-2. Also ISO 14971 (risk management). |
| General Device Characteristics: | |
| Software validation. | "Software Validation Study performed." |
| Overall safety and effectiveness. | Bench testing demonstrates no new safety or effectiveness questions compared to predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of a clinical study with human subjects. The studies mentioned are:
- "Software Validation Study"
- "Waveform & output Study"
- "Skin temperature study"
These appear to be bench tests rather than clinical performance studies on human subjects, so a "test set" in the typical AI/medical imaging sense is not applicable here.
The data provenance, if referring to these bench tests, would be internal laboratory data generated by the manufacturer. These would be retrospective data in the sense that the studies were performed prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided as the submission focuses on bench testing and substantial equivalence, not a clinical study involving expert interpretation of data or images. Ground truth, if applicable to these bench tests, would be established by validated measurement equipment and engineering specifications, not human experts.
4. Adjudication Method for the Test Set
This information is not provided as it pertains to human interpretation/adjudication in clinical studies, which are not described here.
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
An MRMC comparative effectiveness study was not done. This device is a TENS unit with heating capabilities, not an AI-assisted diagnostic or therapeutic imaging device involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device itself is a therapy device (TENS and heating pad), not an algorithm or AI system where "standalone" performance would be measured in the typical sense. Its performance is evaluated through bench testing against its specifications and safety standards.
7. The Type of Ground Truth Used
The ground truth for the "Software Validation Study," "Waveform & output Study," and "Skin temperature study" would be based on:
- Engineering specifications and validated measurement equipment for parameters like waveform characteristics, electrical output, and temperature.
- Safety standards (ISO 14971, IEC 60601-1, IEC 60601-1-2) indicating acceptable ranges and performance criteria.
It is not based on expert consensus, pathology, or outcomes data from clinical trials.
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is not an AI/machine learning system that requires a "training set" in the typical sense of data used to train a model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reasons as point 8.
§ 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).