(100 days)
Nihon Kohden's model number MEE-1000 is intended for medical purposes to measure, monitor, record and display the bioelectric signals produced by muscles (EMG), to stimulate peripheral nerves and to monitor, record and display the electrical activities produced by nerves to aid clinicians in the diagnosis and prognosis of neuromuscular disease. The device monitors electric/auditory/visual evoked potential, EEG and EMG. The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.
The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient thru commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation. The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trendgraph with waveforms annotations (events). The acquired waveforms with the measurement data can be saved in a large capacity storage media.
The Neuromaster, MEE-1000A, Neural Function Measuring System model measures and displays electric/auditory/visual evoked potential, and EMG for surgical and diagnostic procedures. For evoked potential, continuous and periodic measurements are available. The acquired waveforms and data can be displayed on the trendgraph with waveforms annotations (events). The acquired waveforms with the measurement data can be saved in a large capacity storage media and printed via any commercially available printer.
The provided text describes a 510(k) notification for the NIHON KOHDEN AMERICA, INC. MEE-1000A Neuromaster. This filing is for substantial equivalence to a predicate device, not for a de novo marketing authorization. Therefore, it does not include typical detailed performance data from a clinical study with acceptance criteria.
The acceptance criteria and performance data for substantial equivalence filings are often demonstrated through conformance to recognized standards, functional testing, and comparison of technical specifications to the predicate device, rather than patient outcome studies with specific numerical performance metrics like sensitivity and specificity.
Based on the provided text, the following information can be extracted/inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for substantial equivalence, the "acceptance criteria" primarily relate to meeting safety and performance standards and being demonstrably similar to the predicate device. The "reported device performance" refers to the device's adherence to these standards and functional capabilities.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Safety & Performance Standards | IEC 60601-1: 1988-12 | Device complies. |
| IEC 60601-1 Amendment 1: 1991-11 | Device complies. | |
| IEC 60601-1 Amendment 2: 1995-03 | Device complies. | |
| IEC 60601-1-1 Second edition: 2000-12 | Device complies. | |
| IEC 60601-2-10: 1987-12 | Device complies. | |
| IEC 60601-2-40: 1998-02 | Device complies. | |
| IEC-60601-1-2 Second edition: 2001-09 | Device complies. | |
| 21 CFR Part 898 (Performance Standard for Electrode Lead Wires and Patient Cables) | Device complies with IEC 60601-1 sub-clause 56.3 as implemented by this CFR part. | |
| Functional/Design Validation | Operation of software and hardware according to design specifications | Design validation confirmed proper operation. |
| Device Operation | Proper operation during electromagnetic, environmental, safety, and performance testing | Tests verified proper operation. |
| Equivalence to Predicate | Functional and technical characteristics comparable to the predicate device (Nihon Kohden MEB-2200A Neuropack) | The new device allows monitoring EMG, EEG and evoked potential responses in similar settings, has more channels (16/32 vs. predicate), and allows saving data on various media, similar to the predicate. |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as a Design Validation process, which included various testing procedures.
"Design validation confirmed the operation of the software and hardware of the device according to the design specifications."
"The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the proper operation of the device."
This indicates a set of engineering and functional tests were performed to ensure the device performs as intended and meets the regulatory safety standards. However, details of specific test plans, protocols, or quantitative results are not included in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable in the context of a typical clinical study with a "test set" of patient data. The "test set" here refers to the device itself being tested for functionality and safety. The document does not specify the number of devices or components tested, but implies that the device (or representative units) underwent the described validation and testing.
- Data Provenance: Not applicable for device functional and safety testing as described. This is internal company testing for design validation and compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This is not a study assessing the diagnostic accuracy of an AI or imaging device where expert ground truth is established for patient cases. The "ground truth" for this device's validation is adherence to technical specifications, safety standards, and functional performance, which is typically assessed by engineers and regulatory experts.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of patient data, which is not the nature of this validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is a clinical study comparing human reader performance, often with and without AI assistance. This document describes a 510(k) for a neural function measuring system, not an AI-powered diagnostic imaging tool, and no clinical comparative effectiveness study involving human readers is mentioned.
6. If a Standalone Study Was Done:
- Yes, in a sense. The described "design validation," "electromagnetic, environmental, safety and performance testing procedures" are assessments of the device's standalone functionality and compliance with standards. There is no mention of a "human-in-the-loop" component in these tests. The device is evaluated on its own functional merits against its specifications and applicable standards.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's validation is its design specifications, international and national safety and performance standards (e.g., IEC 60601 series, 21 CFR Part 898), and the functional equivalence to its predicate device.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a "training set" of data in the common sense for model development. The device's design and engineering are based on established principles of neural function measurement, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set mentioned for this type of device.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).