(90 days)
The Crystal Monitor® Model 16 is intended for wireless monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.
The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Crystal Monitor Model 16 is an eight-channel, programmable, wireless data acquisition system intended to monitor and record physiological signals. Any channel can be programmed to monitor any physiological signal. Harnesses connect electrodes or sensors from the patient to the patient unit. The patient unit, worn by the patient, acquires, amplifies, and digitizes physiological signals. These signals are then transmitted by radio frequency to a computer unit connected via a serial port to a personal computer (PC). The data is then displayed in real-time and can be stored on the PC.
The Crystal Monitor Model 16 incorporates state-of-the-art wireless technology for viewing and recording physiological signals such as EEG, EKG, EMG, and EOG. This 8channel monitor is the most unobtrusive, flexible, and convenient way of measuring and transmitting physiological signals. Subjects can now be untethered during studies while real time data is collected and displayed. The Crystal Monitor Model 16 wireless physiological signal monitor consists of a Transmitter (also called the Patient Unit), a Receiver Assembly (a Receiver [also called the Computer Unit], receiver cable, and power supply), accessories (Universal Differential Harness, mounting band, electrolyte gel, screwdriver, batteries, and Test Pack), and a PC Operator Interface Software program.
The Patient Unit collects signals from electrodes attached to the subject, performs analogto-digital conversion, encoding, formatting, and transmitting of all signals. The signals are transmitted via a radio transmitter. The Computer Unit receives the transmitted data packets, performs extensive error detection and correction, and then sends the data through a Receiver cable to the PC Operator interface where the data can be stored, monitored in real time, or analyzed at a later time.
The Crystal Capture program consists of several software components that allow the user to acquire, store, and view physiological data as acquired by the Crystal Monitor Transmitter. The software provides a simple graphical interface for setting up and managing data acquisition. The Crystal Configuration Wizard allows customization of the number of input channels (1-8), ranges (micro- to millivolts), and sampling rate. Configurations can be saved allowing the user to program the Crystal Monitor for numerous applications.
The provided text describes a 510(k) premarket notification for the Crystal Monitor Model 16, an 8-channel wireless data acquisition system for physiological signals. It details the device's technical characteristics, intended use, and substantial equivalence to existing devices. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or accuracy of physiological signal measurement against a ground truth.
Instead, the document focuses on regulatory compliance and technical specifications. The "acceptance criteria" discussed are primarily related to safety, electromagnetic compatibility, and adherence to voluntary standards.
Here's an analysis based on the information provided and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Safety and EMC Standards: | The device was subjected to the following voluntary standards: |
- FCC Part 15.109, Class B digital device
- FCC Part 15.249, Intentional radiator, FCC ID#N9Y0007
- IEC 60601-1-2 Medical Electrical Equipment, Part 1 General requirements for safety
- EN 61000-4-2: 1995 Electrostatic discharge immunity test
- EN 61000-4-3: 1995 Radiated, radio-frequency, electromagnetic field immunity test
- EN 61000-4-4: 1995 Electrical fast transient/burst immunity tests
- EN 61000-4-6: 1996 Immunity to conducted disturbances induced by radio-frequency fields
- EN-55011 Electromagnetic Emissions
- IEC 601-2-26 (environmental conditions: 10° to 50° C, 25-95% humidity) |
| Functional Equivalence to Predicate Devices: | "The Crystal Monitor Model 16 is technically the same as the Crystal-EEG Model 15 with the exception of software, labeling, and production company." It states they have "the same hardware, board designs, drawings, and all available accessories." |
| Wireless Signal Transmission (Implicit Functionality): | Acquires, amplifies, and digitizes physiological signals, then transmits them by radio frequency to a computer for display and storage. Performs "extensive error detection and correction" upon reception. |
| Programmability (Implicit Functionality): | 8-channel, programmable (number of channels 1-8, ranges micro- to millivolts, sampling rate). |
| Real-time Display and Storage (Implicit Functionality): | Data is "displayed in real-time and can be stored on the PC." |
Missing Information: It's crucial to understand that this document does not present clinical performance acceptance criteria such as accuracy of EEG readings, signal-to-noise ratio, or agreement with a gold standard for physiological signal interpretation. The "reported device performance" above is a summary of capabilities and compliance with safety/EMC standards, not clinical efficacy.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- None provided. The document describes regulatory compliance testing (e.g., EMC, electrical safety) but does not detail human subject testing or clinical performance evaluation with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set or ground truth established by experts is described for clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or 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 such study was done or described. This device is a physiological signal monitor, not an AI-based diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm" as typically referred to in AI/diagnostic studies. The device's primary function is data acquisition and display, not automated interpretation or standalone diagnostic decision-making beyond what an electroencephalograph intrinsically does (i.e., record signals). The "software components" described are for acquiring, storing, and viewing, not for AI-driven standalone analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the safety and EMC standards, the "ground truth" is compliance with the specifications of those standards (e.g., does it emit below a certain level, does it withstand a certain electrostatic discharge).
- For functional equivalence, the "ground truth" is the established performance and design of the predicate device (Crystal EEG Model 15).
- No clinical ground truth (expert consensus on EEG readings, etc.) is mentioned.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no described training set, there is no discussion of how its ground truth was established.
Conclusion:
The provided 510(k) summary for the Crystal Monitor Model 16 focuses on technical specifications, regulatory compliance with safety and EMC standards, and substantial equivalence to a predicate device. It does not present a clinical study with acceptance criteria related to physiological signal accuracy, diagnostic performance, or a "ground truth" derived from patient data interpreted by experts. The "study" referenced in the prompt's question is essentially the device's submission to and compliance with various engineering and safety standards, and its comparison to a previously cleared predicate 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).