(231 days)
The PSG-1100 Sleep Diagnostic System is intended to record the physiological data required for EEG and sleep studies (Polysomnography or PSG). These data may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid. This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional.
The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies. The device consists of an amplifier box (head box) and main interface unit. The head box operates with commercially available sensors and interfaces with a main unit which connects to and communicates with computer hardware/ software via Ethernet connection.
The Nihon Kohden PSG-1100 Sleep Diagnostic System is a polysomnograph intended to record electrical activity of the brain (EEG) and other biopotential signals as an aid in diagnosing sleep disorders, epilepsies, and other disorders.
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
The submission primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant industry standards. The acceptance criteria are implicitly defined by matching or exceeding the specifications of the predicate devices and adhering to safety and performance standards for medical electrical equipment.
| Acceptance Criteria Category | Specific Criteria (from Predicate/Standards) | Reported Device Performance (Nihon Kohden PSG-1100A) |
|---|---|---|
| Functional/Technical | Number of Channels: 32 (JE-912A) | 34 |
| Input Impedance: 100 M ohm | 100 M ohm | |
| Calibration Check: Step square or Sine wave, 2 to 1000 uV (9 steps) | Step square, 50 uV (1 step) | |
| Impedance Check: All inputs with Screen and Input box readout | All inputs with Screen and Input box readout | |
| Common-Mode Rejection Ratio (CMRR): 105 dB or more | 105 dB or more | |
| Noise Level: 1/25) | 50 or 60 Hz (rejection ratio > 1/25) | |
| Sensitivity: OFF, 1 to 200 uV/mm (15 steps) DC: OFF, 10 to 200 mV/mm (10 steps) | OFF, 0.1 to 200 uV/mm (20 steps) DC: OFF, 10 to 200 mV/mm (10 steps) | |
| A-D Conversion: 16 bits | 16 bits | |
| Sampling: All channels, 100, 200, 500 Hz | All channels, 200, 250, 500, 1000, 2000 Hz | |
| Display Resolution: N/A, 1600 x 1200 | 1600 x 1200 | |
| Power: 120 V +/- 10%, 50/60 Hz, 750 VA (incl PC and display) | 100-240 V +/- 10%, 50/60 Hz, 42 VA (Main unit only) | |
| Environmental | Operating Temperature: 10 to 35 C | 10 to 35 degree C |
| Operating Humidity: 30 to 80 % | 30 to 80 % | |
| Safety and Effectiveness | Equivalent in safety and effectiveness to predicate devices; no new questions of safety or effectiveness. | Confirmed by verification/validation testing in compliance with Design Control requirements and risk analysis. |
| Standards Compliance | IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-26, CAN/CSA-C22.2 No. 601.1-M90 and related amendments | Confirmed by compliance testing with all listed standards. |
| Labeling | Equivalent to predicate devices | Confirmed by verification/validation testing. |
Study Proving Acceptance Criteria:
The study described is a design control and verification/validation testing process rather than a traditional clinical study with human subjects to evaluate diagnostic accuracy. The primary method used to prove the device meets acceptance criteria is a demonstration of substantial equivalence to legally marketed predicate devices.
- Study Type: Design Control and Verification/Validation Testing for Substantial Equivalence.
- Methodology: Comparative analysis of technical characteristics, performance specifications, and compliance with recognized consensus standards.
2. Sample Size for the Test Set and Data Provenance
This submission does not involve a "test set" in the sense of a clinical dataset of patient recordings for diagnostic accuracy evaluation. Instead, the "test set" refers to the device itself and its components undergoing engineering and performance testing.
- Sample Size for Test Set: Not applicable in the context of diagnostic accuracy, as this is a device performance and safety evaluation. The "sample" would be the manufactured device units undergoing verification/validation.
- Data Provenance: The data arises from internal company testing (Nihon Kohden Corporation) and compliance with international and national safety and performance standards. No specific country of origin for clinical retrospect/prospective data is mentioned because it's not a clinical diagnostic performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth for this type of submission is established by engineering specifications, performance standards, and regulatory requirements, not by expert interpretation of patient data for diagnostic accuracy.
- Qualifications of Experts: The "experts" involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists at Nihon Kohden, along with the standard bodies and regulatory agencies (like the FDA) whose criteria the device must meet.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable for a traditional diagnostic accuracy adjudication. The "adjudication" in this context is the process of verifying that the device's technical specifications and performance meet the established design requirements, predicate device specifications, and relevant standards. This is typically done through documented testing procedures, review by quality assurance, and compliance checks against standards by certified bodies or internal personnel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence, not on the improvement of human reader performance with or without AI assistance. This device is an amplifier and diagnostic system, not an AI-driven image analysis or interpretation tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Not applicable. This device is a measurement and recording system; it does not contain a standalone algorithm for diagnosis that would operate without human interaction. Its function is to acquire and present physiological data to a clinician.
7. Type of Ground Truth Used
- Ground Truth: The "ground truth" for this device's acceptance is based on:
- Engineering Specifications: The design parameters and performance targets set by Nihon Kohden.
- Predicate Device Performance: The established specifications and performance of the legally marketed predicate devices (JE-912A PSG Input Box, JE-921A junction Box, EEG-1200A Series Neurofax).
- Consensus Standards: Compliance with international and national standards for medical electrical equipment (e.g., IEC 60601 series, CAN/CSA-C22.2 series).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware system for signal acquisition and display, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.
§ 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).