(224 days)
The TENS and Microcurrent modes of the Trio 300 are indicated for the symptomatic relief of chronic intractable pain. They are also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
The Trio 300 Multi-Mode Electrical Stimulator is a small, portable, battery-powered electrical stimulator device that has four stimulation modes, (1) TENS, (2) EMS, (3) microcurrent, and (4) programmable. The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters. The device is supplied with an AC adaptor for line current operation.
The Trio 300 consists of the pulse generator, A/C power adapter, and the surface electrodes.
The Trio 300 is a dual-channel electrical stimulator with four output modes. The device is equipped with a liquid crystal display (LCD) for communication with the user. The SELECT key allows the user to scroll through the options (e.g., mode) available at a particular point and the SET key allows the selection of the displayed option. The UP-ARROW and DOWN-ARROW keys allow the user to increase or decrease certain selected parameters.
The provided text is a 510(k) summary for the Trio 300 Multi-Mode Electrical Stimulator, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of regulatory submission. This document primarily addresses electrical safety and electromagnetic compatibility, and design qualification to meet internal specifications, not clinical performance against acceptance criteria for an AI/algorithm-based device.
Here's an breakdown of what can be extracted and what information is not available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with EN-60601 electrical safety standard | Ito has certified compliance with EN-60601. Testing to UL 2601 is in progress. |
| Compliance with EN 60601-1-2 standard for electromagnetic compatibility | TUV has issued an Attestation of Conformity for the Trio 300 in regard to the EN 60601-1-2 standard. |
| Meeting design specifications (for design qualification testing) | The design qualification testing demonstrated that the Trio 300 met its design specifications. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The described testing is for electrical safety, electromagnetic compatibility, and design qualification, not for clinical performance using a "test set" in the context of an AI/algorithm study. There's no mention of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical ground truth was established from experts for the stated testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical ground truth adjudication method 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:
- No. This is not an AI-assisted device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a direct electrical stimulator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for the reported tests refers to standards (electrical safety, EMC) and internal design specifications, not clinical outcomes or expert labels.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no training set mentioned.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set.
Summary based on the provided document:
The Trio 300 Multi-Mode Electrical Stimulator is a hardware device. The "acceptance criteria" and "study" described in the 510(k) summary pertain to basic device safety and functionality standards (electrical safety, electromagnetic compatibility, and meeting design specifications). These are not performance criteria related to clinical efficacy or diagnostic accuracy, which would be typical for an AI/algorithm-based medical device where the requested information would be relevant. The document's purpose is to demonstrate substantial equivalence to existing predicate devices based on technological characteristics and intended use, supported by adherence to safety and design standards.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).