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510(k) Data Aggregation
(227 days)
Transcutaneous Electrical Nerve Stimulation:
- For symptomatic relief and management of chronic pain
- For adjunctive treatment in the management of post-surgical and post-traumatic pain
- 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 and normal household and work activities
Powered Muscle Stimulator
- To temporarily increase local blood circulation in healthy muscles
- For muscle conditioning by stimulating healthy muscle in order to improve or facilitate muscle performance
The HBOTC is an OTC electrical nerve and muscle stimulator indicated for symptomatic relief and management of chronic pain as well as muscle conditioning and increasing local blood flow. The HBOTC consists of a portable battery-operated electrical stimulation device with two channels, two sets of lead wires, six packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons for selecting the desired frequency and a dial to control the intensity of the signal. The stimulator is also supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display.
The HBOTC Muscle and Nerve Stimulator is a Class II device (product codes NUH and NGX), and its 510(k) summary (K160255) primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and compliance with relevant safety and performance standards.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance in terms of sensitivity, specificity, or other outcome metrics that would typically apply to diagnostic AI/ML devices. Instead, the "acceptance criteria" are implied by the demonstration of compliance with recognized electrical safety and performance standards, and by showing that the technological characteristics of the HBOTC device are substantially equivalent to those of legally marketed predicate devices.
The "reported device performance" is framed within the context of these non-clinical tests and the comparison to predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (2012) | Device passed tests demonstrating basic safety and essential performance. |
| Compliance with IEC 60601-1-11 (2015) | Device passed tests for safety in home healthcare environment. |
| Compliance with IEC 60601-2-10 (2012)/Amendment 1 2001 | Device passed tests for safety of nerve and muscle stimulators. |
| Substantial equivalence in technological characteristics to predicates (e.g., power source, output modes, channels, waveform, electrical parameters, materials) | Comparisons made in the 510(k) summary (table spanning pages 5-9) indicate that the HBOTC's characteristics are either identical or have minor differences that do not impact safety and effectiveness when compared to K131910, K112485, K103738, and K102051. For example, similar Ni-MH rechargeable batteries (7.2V), 2 output channels, alternating synchronous, galvanic isolation, biphasic spike with exponential decay waveform, similar max output voltage/current, pulse width, net charge, max phase charge, max current density, and max power density. Minor differences such as the Pain Buddy predicate using disposable AAA cells and having a different frequency range (8-80 Hz vs 1-70 Hz) and pulse width (160 μs vs 5 ms) were acknowledged but deemed non-impactful. |
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 study with a test set of patient data. The device under review is an electrical nerve and muscle stimulator, and the approval is based on non-clinical performance tests and substantial equivalence claims to existing devices, not on a study involving patient data. Therefore, this information is not applicable and not provided in the document.
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)
As no clinical study or test set involving patient data is described, there is no mention of experts establishing ground truth. The evaluation relies on engineering and regulatory assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set or adjudication process for ground truth 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. This device is an electrical stimulator, not an AI-assisted diagnostic tool or a device that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware electrical stimulator, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as there are no clinical trials or patient data used in the submission to establish a "ground truth" for diagnostic or predictive performance. The "ground truth" for device safety and performance here refers to compliance with established electrical safety standards and the demonstrated equivalence of its technical specifications to similar, already approved devices.
8. The sample size for the training set
Not applicable, as this device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this device is not an AI/ML algorithm that requires a training set or ground truth establishment for training.
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