(175 days)
The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.
The Focus is a 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms. The device provides functionality for the Electromyography (EMG), Nerve Conduction Studies (NCS), and Evoked Potential (EP) testing for a range of clinical applications and has a fast, intuitive and flexible graphical user interface (GUI) that conforms to a Windows philosophy. The Focus EMG Device consists of a handheld electronic unit, a stimulator unit with steel electrodes and felt pads, and a footswitch.
The TeleEMG Focus EMG Device is intended for use by healthcare providers to perform nerve conduction and EMG studies, and for evoked potentials (EP) studies using electrical or sound stimulus.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a neurodiagnostic testing system (hardware and software) and not an AI/ML device making diagnostic claims, the acceptance criteria are based on compliance with established medical device safety and performance standards rather than specific diagnostic accuracy metrics. The "reported device performance" refers to the successful completion of these compliance tests.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1-1:2000 Medical electric equipment Part 1-1: Safety requirements for medical electrical systems | Successfully tested and meets the requirements. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2001 Medical electric equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | Successfully tested and meets the requirements. |
| Specific Safety for Electromyographs and Evoked Response Equipment | IEC 60601-2-40:1998 Medical electric equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment | Successfully tested and meets the requirements. |
| Photobiological Safety | IEC 62471:2006 Photobiological safety of lamps and lamp systems (specifically for LED goggles) | The TeleEMG Focus EMG Device met IEC 62471:2006. LED goggles luminance is 1,203 cd/m², which is "much less than the admissible level 10,000 cd/m² specified in clause 4.1 of this standard." Therefore, additional spectral calculations were not required. |
| Software Level of Concern | FDA draft software guidance document ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") | The TeleEMG Focus is categorized as a "moderate" level of concern and "meets the requirements set forth in the FDA draft software guidance document for a 'moderate' in the level of concern device." |
| Biocompatibility | Compatibility of patient-contacting surfaces (stainless steel electrodes and felt pads) | The electrodes and pads were previously cleared under the submission of the NC Stat, K060584. This indicates they are considered biocompatible based on prior FDA review. |
| Substantial Equivalence | Demonstrating that the device is as safe and effective as a legally marketed predicate device. | Based on the non-clinical performance testing and comparison to predicate devices, the Focus EMG Device is considered "substantially equivalent" to the cited predicate devices (Nemus System, K073415, and Synergy LT, K981405). The comparison table highlights that the proposed device has comparable intended use, warnings, contraindications, general design, user interface, patient inputs, signal acquisition, trigger features, stimulator types, and application modules to the predicate devices. |
| Functional Performance | Performance evaluation of features described in the user's manual. | "Performance evaluation of the features described in the Focus user's manual has been successfully completed utilizing hardware and software tests and validations." This implies that the device's functions (e.g., amplification, A/D conversion, filtering, stimulation parameters) operate as specified and are comparable to predicate devices as detailed in the "Side-by-Side Comparison of the Proposed Device with Cited Predicate Devices" table. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical testing was conducted to support this submission."
Therefore, there is no test set in the sense of patient data for clinical evaluation, and no data provenance in that context. The testing was non-clinical (hardware, software, and safety standard compliance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical testing was performed, there was no "test set" requiring expert-established ground truth. The acceptance criteria were based on engineering, safety, and performance standards.
4. Adjudication method for the test set
Not applicable. No clinical test set.
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 a diagnostic electromyograph machine, not an AI-assisted diagnostic tool that interprets or analyzes data to improve human reader performance. Its function is to acquire and display electrophysiological data for a healthcare provider to interpret.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware and software system for data acquisition and display, designed for human-in-the-loop use by a healthcare provider. It does not perform standalone diagnostic interpretation.
7. The type of ground truth used
For the non-clinical performance testing, the "ground truth" would be the specifications defined by the relevant international standards (IEC 60601 series, IEC 62471) and the functional specifications and design requirements internally established for the device itself. For example, for noise levels, the ground truth is that the device noise should be less than 0.6 µVrms, or for the LED goggles, the luminance should be below the 10,000 cd/m² admissible limit.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product that relies on a "training set" of data in the conventional sense. Its software performs signal acquisition, processing, and display based on established algorithms and embedded logic, not learned patterns from a large training dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).