(112 days)
The CRI Zmachine is a single-channel, EEG acquisition and analysis system, designed for use in the home or clinical environments. This device is intended to be used by qualified healthcare practitioners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.
The CRI Zmachine is a battery-operated, single-channel, EEG acquisition and analysis system. The Zmachine system includes the Zmachine device, disposable EEG sensors, sensor cable, and a wall charger. The device operates on data from the differential-mastoid EEG channel to determine the wake and sleep states (wake, light sleep, deep sleep and REM) of the patient every 30 seconds.
Here's the breakdown of the acceptance criteria and study information for the Zmachine DT-200, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Zmachine DT-200 are implicitly established by demonstrating substantial equivalence to predicate devices, particularly the Sleep Profiler (K120450). The performance metrics used for comparison are P1 (sensitivity) and P2 (positive predictive value) for each sleep stage.
| Sleep Stage | Performance Metric | Zmachine DT-200 (Reported) | Sleep Profiler (Predicate) | Acceptance Criteria (Implicit - "Similar to Predicate") | Meets Criteria? |
|---|---|---|---|---|---|
| Wake | P1 | 0.908 | 0.789 | ≥ 0.789 | Yes |
| P2 | 0.843 | 0.831 | ≥ 0.831 | Yes | |
| Light Sleep | P1 | 0.835 | 0.855 | Similar to 0.855 (0.835 is slightly lower but deemed similar) | Yes |
| P2 | 0.848 | 0.812 | ≥ 0.812 | Yes | |
| Deep Sleep | P1 | 0.738 | 0.757 | Similar to 0.757 (0.738 is slightly lower but deemed similar) | Yes |
| P2 | 0.782 | 0.787 | Similar to 0.787 (0.782 is slightly lower but deemed similar) | Yes | |
| REM | P1 | 0.721 | 0.719 | ≥ 0.719 | Yes |
| P2 | 0.732 | 0.782 | Similar to 0.782 (0.732 is slightly lower but deemed similar) | Yes | |
| Overall | Kappa Agreement | 0.716 | Not reported for Sleep Profiler | Not explicitly defined as a numerical threshold, but implied to be good. | Yes |
Note: "Similar to Predicate" is the implicit acceptance criterion. The document states, "The P1 and P2 values obtained during clinical validation of the Zmachine Algorithm are similar to those obtained by the predicate Sleep Profiler algorithm."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 99 subjects (52 female / 47 male, 18-60 years, median age 32.7 years).
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study subjects included those reporting normal sleep and those with complaints consistent with various sleep disorders. The study is described as "clinical," suggesting it's prospective, but this is not explicitly stated. It is a clinical study in which overnight laboratory polysomnographic (PSG) data was acquired.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Two to four (2-4) certified polysomnographic technologists.
- Qualifications of Experts: Certified polysomnographic technologists.
4. Adjudication Method for the Test Set
- Adjudication Method: Majority voting rule. The individual score files from the 2-4 technologists were combined, on a 30-second epoch basis, using a majority voting rule to generate a single score file per subject ("Human Scores").
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 MRMC comparative effectiveness study was done involving human readers with and without AI assistance. This study focused on the standalone performance of the Zmachine algorithm compared to human consensus.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone study was done. The Zmachine Algorithm's performance was evaluated by directly comparing its output to the "Human Scores" (ground truth). The objective was to assess the algorithm's ability to determine wake and sleep states independently.
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert consensus. The ground truth, referred to as "Human Scores," was established by comparing the Zmachine Algorithm's output against the scores generated by multiple certified polysomnographic technologists using a majority voting rule, based on standard PSG channels. The scoring guidelines used were Rechtschaffen and Kales (R&K) visual sleep staging guidelines.
8. The Sample Size for the Training Set
- The document does not provide information regarding the sample size used for the training set for the Zmachine DT-200. It focuses on the clinical performance testing sample.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for any training set was established for the Zmachine DT-200.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2015
Consolidated Research Of Richmond, Inc % Richard Kaplan President 26250 Euclid Ave Suite 709 Euclid. Ohio 44132
K142825 Re:
Trade/Device Name: Zmachine DT-200 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ, OLV, OMC Dated: December 15, 2014 Received: December 19, 2014
Dear Dr. Kaplan,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142825
Device Name Zmachine DT-200
Indications for Use (Describe)
The CRI Zmachine is a single-channel, EEG acquisition and analysis system, designed for use in the home or clinical environments. This device is intended to be used by qualified healthcare practitioners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Zmachine® 510(k) Notification Consolidated Research of Richmond, Inc.
| 510(k) Owner | Consolidated Research of Richmond, Inc. |
|---|---|
| Address | 26250 Euclid Avenue, Suite 709Euclid, Ohio 44132Phone: (216) 289-2331Fax: (216) 393-0079 |
| Contact Person | Richard F. Kaplan, Ph.D., PresidentPhone: (216) 289-2331 Extension 1001E-mail: kaplan@cri-systems.com |
| Date Prepared | December 16, 2014 |
| Trade Name | Zmachine® DT-200 |
| Common Name | Sleep monitoring system |
| Classification Name | Electroencephalograph21 CFR 882.1400 |
| Product Codes | OLZ, OLV and OMC |
| Indications for Use | The CRI Zmachine is a single-channel, EEG acquisition and analysissystem, designed for use in the home or clinical environments. Thisdevice is intended to be used by qualified healthcare practitioners tomonitor the wake and sleep states of adult patients and as an adjunct totheir diagnosis of sleep disorders. |
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| DeviceDescription | The CRI Zmachine is a battery-operated, single-channel, EEGacquisition and analysis system. The Zmachine system includes theZmachine device, disposable EEG sensors, sensor cable, and a wallcharger. The device operates on data from the differential-mastoidEEG channel to determine the wake and sleep states (wake, light sleep,deep sleep and REM) of the patient every 30 seconds. |
|---|---|
| SubstantialEquivalence | The Zmachine DT-200 is substantially equivalent to the Zmachine DT-100 (K101830) by Consolidated Research of Richmond, Inc., sharingthe same indications for use, the same primary wake/sleep detectionalgorithm, and the same hardware platform. The firmware ofZmachine DT-200 has been upgraded to further subdivide epochsdetected as sleep by the primary wake/sleep detection algorithm intolight sleep (stages N1 and N2), deep sleep (N3) and REM. The furthersubdivision of sleep stages are substantially equivalent to the SleepProfiler algorithm (K120450) by Advanced Brain Monitoring, Inc. |
The table below summarizes the technological characteristics of the Zmachine DT-200 in comparison to the predicate devices.
| Zmachine DT-200(New) | Zmachine DT-100(K101830) | Sleep Profiler(K120450) | |
|---|---|---|---|
| ManufacturerName | ConsolidatedResearch ofRichmond, Inc. | ConsolidatedResearch ofRichmond, Inc. | Advanced BrainMonitoring, Inc. |
| 510(k) Number | This 510(k) | K101830 | K120450 |
| ClassificationRegulation | 882.1400 | 882.1400 | 882.1400 |
| Product Code | OLZ, OLV andOMC | OLV and OMC | OLZ |
| Zmachine DT-200 | Zmachine DT-100 | Sleep Profiler | |
| Indications for Use | (New)The CRI Zmachineis a single-channel,EEG acquisition andanalysis system,designed for use inthe home or clinicalenvironments. Thisdevice is intended tobe used by qualifiedhealthcarepractitioners tomonitor the wakeand sleep states ofadult patients and asan adjunct to theirdiagnosis of sleepdisorders. | (K101830)The CRI Zmachineis a single-channel,EEG acquisition andanalysis system,designed for use inthe home or clinicalenvironments. Thisdevice is intended tobe used by qualifiedhealthcarepractitioners tomonitor the wakeand sleep states ofadult patients and asan adjunct to theirdiagnosis of sleepdisorders. | (K120450)Sleep Profiler isintended for thediagnosticevaluation by aphysician to assesssleep quality inadults only. TheSleep Profiler is asoftware-onlydevice to be usedunder thesupervision of aclinician to analyzephysiologicalsignals andautomatically scoresleep study results,including thestaging of sleep,detection ofarousals andsnoring. |
| Patient Population | Adults | Adults | Adults |
| Type of Device | EEG-based sleepmonitor | EEG-based sleepmonitor | EEG-based sleepstaging software |
| No. of EEGChannels | 1 | 1 | 1 |
| ElectrodePlacement | Mastoid | Mastoid | Frontal |
| Analyzes EEGData in Real Time | Yes | Yes | Yes |
| SleepClassification | Wake and N1+N2(light sleep). N3(deep sleep), andREM | Wake and Sleep | Wake and N1, N2,N3, and REM |
| EEG AnalysisMethodology | Proprietaryalgorithm usingtime and frequencydomain features | Proprietaryalgorithm usingtime and frequencydomain features | Proprietaryalgorithm usingtime and frequencydomain features |
| Zmachine DT-200(New) | Zmachine DT-100(K101830) | Sleep Profiler(K120450) | |
| ProvidesInformation toAssist theHealthcareProvider inEvaluation ofTreatmentEfficacy? | Yes | Yes | Yes |
| CalculatesSummary SleepStatistics? | Yes | Yes | Yes |
| Battery Powered? | Yes | Yes | Yes |
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Performance Testing - Clinical
A clinical study was conducted in which overnight laboratory polysomnographic (PSG) data, and data from the differential-mastoids (A1-A2), were acquired from 99 subjects (52F/47M, 18-60 years, median age 32.7 years), including those reporting normal sleep and those reporting complaints consistent with various sleep disorders.
The standard PSG channels were scored independently by two to four certified polysomnographic technologists, using the Rechtschaffen and Kales (R&K) visual sleep staging guidelines. The individual score files were then combined, on a 30-second epoch basis, using a majority voting rule, to generate a single score file per subject ("Human Scores"). EEG data acquired from A1-A2 was processed by the Zmachine Algorithm which determines wake, light sleep (N1&N2), deep sleep (N3) and REM on a 30-second epoch basis.
The performance of the Zmachine Algorithm was evaluated by comparing against the Human Scores for stages wake, light sleep (N1&N2), deep sleep (N3) and REM. Overall, kappa agreement between Zmachine Algorithm and Human Scores for 85,206 epochs is 0.716, with P1 (the probability that Zmachine will correctly assign an epoch when the PSG Consensus assigns the epoch to a particular stage) and P2 (when the Zmachine assigns an epoch to a particular stage, the probability of such assignment is correct) for each stage summarized in the table below.
| Zmachine DT-200 | ||||
|---|---|---|---|---|
| Wake | Light Sleep | Deep Sleep | REM | |
| P1 | 0.908 | 0.835 | 0.738 | 0.721 |
| P2 | 0.843 | 0.848 | 0.782 | 0.732 |
Using the performance data published in K120450 (44 subject study) of the predicate Sleep Profiler algorithm, stages N1 and N2 were combined into Light Sleep for both the
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algorithm and scorers (to permit a direct comparison with the Zmachine Algorithm) with a resulting P1 and P2 for each stage summarized in the table below.
| Sleep Profiler | ||||
|---|---|---|---|---|
| Wake | Light Sleep | Deep Sleep | REM | |
| P1 | 0.789 | 0.855 | 0.757 | 0.719 |
| P2 | 0.831 | 0.812 | 0.787 | 0.782 |
The P1 and P2 values obtained during clinical validation of the Zmachine Algorithm are similar to those obtained by the predicate Sleep Profiler algorithm, which was validated using its own data set.
Conclusion
This submission demonstrates that the Zmachine is substantially equivalent to the predicate devices based on descriptive information and clinical performance testing.
§ 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).