(65 days)
The device is intended to acquire, store, and transfer biophysical parameters to EEG machines. The device is intended to acquire, store, record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as a diagnostic tool.
The product is comprised of telemetry unit, Electrode junction box and access point to operate with our current commercially available EEG devices. The basic measurement data includes: EEG, EOG, ECG, EMG, respiration, periodic limb movement (PLM), snore, SpO2 and sleep position.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Nihon Kohden Wireless Input Unit (K033475):
Based on the provided text, the device K033475 is a Wireless Input Unit for Electroencephalographs (EEG). The information emphasizes that the device's technological characteristics are the same as the predicate device (Siesta system by Compumedix, K003175) and that it was verified and validated using the same test methods as with the existing device. This strongly suggests that the acceptance criteria are based on equivalence to the predicate device and established performance of existing Nihon Kohden EEG machines, rather than new, independently established performance metrics against a clinical ground truth.
Therefore, the requested information about device performance against specific acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance against pathology/outcomes data is largely not applicable in the traditional sense of a de novo AI/medical device study. This is a 510(k) submission for a device demonstrating substantial equivalence to a predicate.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device (Siesta system by Compumedix, K003175) in acquiring, storing, measuring, and displaying physiological data for EEG and sleep studies.** | The device's technological characteristics are stated to be "the same as predicate." The device's function is to record, measure, and display (EEG, EOG, ECG, EMG, respiration, PLM, snore, SpO2, sleep position) and communicate data to existing cleared Nihon Kohden EEG machines, which have known performance. |
| Intended Use Equivalence to Predicate Device and existing cleared Nihon Kohden EEG-1100A and EEG-9100A. | The intended use for the Wireless Input Unit is stated as "the same intended use as previously cleared for the EEG-1100A, and EEG-9100A (per K992742 and K011204) as well as Siesta system (predicate)." |
| Safety - Non-contact with patient (device itself). | The device "does not directly contact patients." |
| Safety - Patient-contacting accessories (electrodes, sensors) made from same component materials as legally marketed accessories. | "New accessories that contact patients such as the EEG electrodes are made from the same component materials as similar legally marketed accessories." |
| Compliance with design controls and appropriate verification/validation. | "The device was developed in accordance with design controls and operation of the device was appropriately verified and validated using the same test methods as with the existing device." |
Study Details
Given the nature of a 510(k) submission for substantial equivalence based on a predicate and existing devices, the "study" described is primarily one of verification and validation against established engineering and functional specifications, rather than a clinical trial to determine new performance metrics.
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a clinical "test set" in the context of diagnostic performance against a ground truth. The text mentions "operation of the device was appropriately verified and validated." This typically refers to engineering testing (e.g., signal fidelity, wireless range, data transfer integrity, power consumption, software functionality) using test environments and perhaps a limited number of human subjects for usability and basic function checks. No specific number of patient samples is provided for a performance study.
- Data Provenance: Not applicable. The validation would be against technical specifications and existing device performance, not a specific dataset derived from a country of origin. The testing would have been conducted by Nihon Kohden America, Inc. or its affiliates.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable for this type of submission. Ground truth in the sense of expert consensus on clinical diagnoses (e.g., presence of epilepsy, sleep disorders) for a test set is not mentioned, as the device is an input/transfer unit, not a diagnostic algorithm itself. The "ground truth" for its operation would be defined by the technical specifications of the signals it acquires and transmits, and how accurately it correlates with the existing cleared EEG machines.
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Adjudication Method for the Test Set:
- Not applicable. Since there's no mention of a diagnostic performance study against a clinical ground truth, no adjudication method would be required.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- No, an MRMC study was not done. This type of study is relevant for diagnostic algorithms where human readers interpret medical images or data. The Wireless Input Unit is a data acquisition and transfer device; it doesn't involve human interpretation to arrive at a diagnosis.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone technical verification was performed. The phrase "operation of the device was appropriately verified and validated using the same test methods as with the existing device" implies performance testing of the device's technical capabilities (signal acquisition, transmission, storage) independent of a human operator making diagnostic decisions. However, this is for the functionality of the unit, not for a diagnostic algorithm.
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The type of ground truth used:
- Technical Specifications and Performance of Predicate/Existing Cleared Devices: The "ground truth" for this submission is the established and cleared performance characteristics of the predicate device (Siesta system) and other Nihon Kohden EEG machines (EEG-1100A, EEG-9100A) to which this wireless unit connects. The wireless unit is intended to perform identically in terms of data acquisition and transfer fidelity to these existing systems.
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The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI algorithms that require a "training set."
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).