(106 days)
The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904, is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg), and lower back due to strain from exercise or normal household and work activities.
The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904, can generate small pulses of electrical current and delivered these pulses pass through the skin and activated underlying nerves.
The provided text describes the 510(k) summary for the HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with acceptance criteria and performance metrics in the way one might expect for a novel AI/medical imaging device.
Therefore, many of the requested sections (sample size, experts, ground truth, MRMC study, training set) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is about an electrical stimulator, not an AI software/imaging device.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical performance study. Instead, it demonstrates performance by comparing its specifications to a predicate device and adhering to recognized electrical safety and performance standards.
| Parameter | Predicate Device (K11-2392) HIVOX | Subject Device (Rapid ReliefTM Pennypad PP-904) |
|---|---|---|
| Mode or Program Name | PP909, PP907, PP904 | Rapid ReliefTM Pennypad PP-904 |
| Indication for Applied Area for pain relieve | Lower Back, Arm and Leg, Lower Back (differs per model) | Arm, Leg, and Lower Back |
| Dimensions | 113L * 70W * 9.7H mm | (Implicitly similar or identical) |
| Waveform | Symmetrical Biphasic | (Implicitly similar or identical) |
| Shape | Rectangular | (Implicitly similar or identical) |
| Maximum Output Voltage @500Ω | 40.0 Vpp | 57.6 Vpp |
| Maximum Output Current @500Ω | 80.0 mApp | 115.2 mApp |
| Pulse Duration | 200µSec (fixed) | 200µSec (fixed) (from Product Specifications) |
| Frequency | 35 Hz | 2, 5, and 40 Hz (Product Specifications) |
| Net Charge (µC) per pulse @500Ω | 0.3200 | 0.2304 |
| Maximum Charge (µC) @500Ω | 16.0 | 23.04 |
| Maximum Current Density (mA/cm², r.m.s.) @500Ω | 1.964 | 2.828 |
| Maximum Average Power Density (W/cm²) @500Ω | 0.078 | 0.163 |
Performance Tests Submitted (Compliance with Standards):
- IEC/EN 60601-1: Medical electrical equipment Part 1. General requirements for safety, 1996.
- IEC/EN 60601-1-2: Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2007.
- IEC/EN 60601-2-10: Medical electrical equipment, Part 2-10: Particular requirements for safety of nerve and muscle stimulators, 2001.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a 510(k) summary for an electrical stimulator, not an AI/software device that would typically involve a specific "test set" of data or cases for performance evaluation. The substantial equivalence relies on device specifications and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, for the same reasons as above.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here is compliance with electrical safety and performance standards for TENS devices, and the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
Not applicable. There is no AI algorithm being trained.
9. How the ground truth for the training set was established:
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).