(163 days)
HIVOX OTC Electrical Stimulator, SEM44 -
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
HIVOX OTC Electrical Stimulator, SEM44-1 -
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
HIVOX OTC Electrical Stimulator - SEM44 and SEM44-1, falls into the electro stimulation device category.
SEM44 provides two basic functions, TENS/EMS; SEM44-1 provides one basic function, TENS:
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Electrical stimulation of nerve tracts (TENS)
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Electrical stimulation of muscle tissue (EMS)
The two models also feature two independent stimulation channels and four adhesive electrodes which FDA cleared k number is K132588. For TENS, SEM44 and SEM44-1 are designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities .; For EMS, SEM44 is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. For these purposes, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
The principle of electro stimulation units is based on the imitation of impulses in our bodies that are transferred to nerve and muscle fibers with electrodes via our skin. The electrodes can be applied to many parts of the body. In certain applications the user will merely notice a slight tingling or vibrating sensation. For SEM44, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves, nerve centers and muscle groups in the application area; for SEM44-1, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves and nerve centers in the application area.
The provided document is a 510(k) summary for the HIVOX OTC Electrical Stimulator (Models SEM44 and SEM44-1). It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device. Instead, it details a substantial equivalence determination based on non-clinical testing for an electrical stimulator.
Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for an AI/algorithm device is not applicable or cannot be extracted from this document.
However, I can extract the information relevant to the non-clinical testing performed and the comparison with predicate devices.
Here's a breakdown of the available information based on your request, with a note where information is not present:
Acceptance Criteria and Device Performance Study for HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets for each parameter. Instead, it states that "All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices."
The comparison tables (pages 7-10 and 13-16) describe various technical specifications of the subject device and the predicate devices. For each difference, the document states: "Different but does not adversely impact safety and effectiveness of subject device." This implicitly indicates that the subject device's performance, despite differences, falls within an acceptable range for safety and effectiveness as determined by comparison to the predicate.
Non-Clinical Testing & Performance Summary
| Test Category | Reported Device Performance | Implicit Acceptance Criteria / Comparison Basis |
|---|---|---|
| Shelf Life | Met requirements | Pre-defined acceptance criteria, comparable to predicate devices. |
| Biocompatibility | Met requirements | Pre-defined acceptance criteria, comparable to predicate devices. |
| Software Validation | Met requirements | Pre-defined acceptance criteria, comparable to predicate devices. (Both subject and predicates use software/firmware) |
| Electromagnetic compatibility (EMC) & Electrical Safety | Met requirements (Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO10993-5/10, 21 CFR 898-7) | Compliance with listed international and national standards. |
| Function Test | Met requirements | Pre-defined acceptance criteria, comparable to predicate devices. |
| Primary Output Parameters (e.g., Voltage, Current, Frequency, Pulse Duration) | Varied slightly from predicates but deemed not to adversely impact safety/effectiveness. | Within acceptable ranges for safe and effective transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS), as demonstrated by predicate devices. |
| Physical Characteristics (Weight, Dimensions) | Slightly different from predicates but deemed not to adversely impact safety/effectiveness. | Within acceptable ranges for design and handling, as demonstrated by predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document describes non-clinical engineering and performance testing of a physical device, not an AI/algorithm using a test set of data.
- Data Provenance: Not applicable. The tests performed are laboratory-based non-clinical tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI/algorithm study requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/algorithm study involving adjudication of results.
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 document is for an electrical stimulator, not an AI-assisted diagnostic or treatment device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to an AI algorithm. The device here is an electrical stimulator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For the non-clinical tests, the "ground truth" or reference standards are the specifications and requirements defined by the relevant international and national safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, 21 CFR 898-7).
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/algorithm device.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Non-Clinical)
The study supporting the HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)'s safety and effectiveness for its intended use is a series of non-clinical tests as detailed in section 5.8 of the 510(k) summary. These tests covered:
- Shelf Life: To ensure the device maintains its performance over its intended lifespan.
- Biocompatibility: To confirm that the materials used in the device are safe for contact with the human body.
- Software Validation: To verify that any embedded software functions correctly and safely. (Both the subject device and predicate devices utilize software/firmware/microprocessor control, as noted in the comparison tables).
- Electromagnetic compatibility and electrical safety: To ensure the device operates safely in its electromagnetic environment and meets electrical safety standards. The document explicitly lists compliance with:
- IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests)
- IEC 60601-2-10 (Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)
- ISO 10993-5/10 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, and Part 10: Tests for irritation and skin sensitization)
- Compliance with 21 CFR 898-7 (Radiation protection regulations for diagnostic X-ray systems) - Note: This standard appears to be an error in context for an electrical stimulator, as 898-7 typically pertains to X-ray systems. It's likely an oversight in the document or a misstatement.
- Function test: To confirm the device operates as intended in terms of its electrical stimulation outputs (TENS and EMS modes), power delivery, and user controls.
The conclusion of these tests (Section 5.8) states: "All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices."
The entire submission is based on demonstrating substantial equivalence to legally marketed predicate devices (K130802 and K150386). The tables provided in the document (pages 7-10 and 13-16) meticulously compare the subject device's features and specifications against those of the predicate devices. For any differences, the rationale is provided that these "do not adversely impact safety and effectiveness of subject device," thereby supporting the claim of substantial equivalence.
No clinical test data was used to support the decision of substantial equivalence (Section 5.9).
§ 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).