(145 days)
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders.
The device is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional.
The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
The device or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system.
The device or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
The device or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.
The Polysmith Sleep System, Model NTI6600 is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The device consists of a compatible amplifier, head box, PC, patient sensors, and may include optional external devices, USB DC Box, and audio/video input devices.
Compatible amplifiers may use commercially available sensors and electrodes, an internal SpO2 module, and internal pressure transducers to collect, digitize, and send physiological signals to the host PC.
The Polysmith software may record from video, speaker and microphone equipment. The Polysmith software may also record auxiliary signals from compatible amplifiers or USB DC Box which allow for data inputs from compatible sources.
Polysmith records and displays the data for online or offline review. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders.
Here's a breakdown of the acceptance criteria and study details for the Polysmith Sleep System, Model NTI6600, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as separate performance thresholds the device must meet. Instead, it presents the "Automated Analysis Agreement" as the device's performance, which is then compared against "Average Human Scoring Agreement." Assuming the implied acceptance is substantial equivalence to human performance for these metrics, the table is structured as follows:
| Metric | Implied Acceptance: Match/Approach Average Human Scoring Agreement | Reported Device Performance (Average Automated Analysis Agreement) | Difference (Human - Automated) | Confidence Interval +/- (95.0%) |
|---|---|---|---|---|
| Sleep Staging | ~82.8% | 71.53% | 11.27% | 3.04% |
| Microarousal | ~88.8% | 80.15% | 8.65% | 3.98% |
| Apnea | ~98.7% | 97.28% | 1.42% | 1.32% |
| Hypopnea | ~96.4% | 95.44% | 0.96% | 2.55% |
| Desaturation | ~97.1% | 95.72% | 1.38% | 1.32% |
| Limb Movement | ~98.9% | 92.57% | 6.33% | 4.35% |
In the "Additional Sleep Staging Analysis," which seems to be a more detailed analysis, the total agreement for automated scoring against consensus human scoring is:
| Metric | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Total Agreement | Not explicitly stated | 70.35% |
| Kappa | Not explicitly stated | 0.58 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Automated Analysis): 8,053 recorded epochs, of which 7,606 were scored.
- Sample Size (Additional Sleep Staging Analysis): 20 sleep studies.
- Data Provenance: The studies were chosen at random from existing sleep studies of acceptable signal quality from accredited labs. For the automated analysis, studies were chosen at random from a sleep lab independent of Neurotronics. The document does not specify the country of origin, but given the FDA submission, it's likely US-based or compliant with US standards. The data is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Automated Analysis: Two expert scorers from different organizations. Each is a registered sleep clinician with at least 5 years' experience scoring sleep records.
- Additional Sleep Staging Analysis: Three independent scorers. Each is a registered sleep specialist with at least five years' experience in the field. Each had some prior experience using Polysmith to manually score studies.
4. Adjudication Method for the Test Set
- Automated Analysis: The document states "The human scoring was completed by two expert scorers." It then calculates "Average Human Scoring Agreement," implying an average of their individual scores or comparison. It doesn't explicitly describe an adjudication process for disagreements between the two human scorers to establish a single ground truth for direct comparison with the automated analysis. Instead, it compares the automated system's performance against this average human agreement, and also compares the two human scorers' agreement with each other.
- Additional Sleep Staging Analysis: This section explicitly used a majority method (2/3 majority-rule) to establish the "true sleep staging (consensus)." Epochs where there was no agreement among the human scorers were discarded (non-consensus).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a direct MRMC comparative effectiveness study "with AI vs without AI assistance" was not explicitly described in the context of improving human reader performance. The study focused on the standalone performance of the automated analysis system compared to human scoring. While humans scored the data, the goal was to assess the device's accuracy relative to human experts, not to measure the improvement in human performance aided by the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance analysis was conducted. The "Automated Analysis Agreement" and the "Results" section for "Additional Sleep Staging Analysis" directly report the performance of the algorithm itself against human expert assessments (either average or consensus). The scorers for the "Additional Sleep Staging Analysis" were explicitly provided with a version of Polysmith that "did not have any automated analysis capability," emphasizing that the human scoring served purely as ground truth.
7. The Type of Ground Truth Used
- Expert Consensus / Expert Scoring: For both analyses, the ground truth was established by human expert scorers. In the "Automated Analysis," it's based on two expert scorings. In the "Additional Sleep Staging Analysis," it's based on a 2/3 majority rule consensus of three expert scorers.
8. The Sample Size for the Training Set
- Not provided. The document states, "The studies used for this testing were not used to train the algorithm," but it does not specify the size or characteristics of the training set used for the algorithm's development.
9. How the Ground Truth for the Training Set Was Established
- Not provided. The document focuses solely on the ground truth for the test sets and explicitly states the test sets were not used for training. Information on how the training data's ground truth was established is absent.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2015
Neurotronics, Inc. David Pezet Quality Manager 3600 NW 43td Street, Suite F1 Gainesville, FL 32606
Re: K142774
Trade/Device Name: Polysmith Sleep System NTI6600 Regulatory Class: II Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Product Code: OLZ, OLV, DQA Dated: January 12, 2015 Received: January 13, 2015
Dear Mr. Pezet:
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. Isting 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-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.
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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" (21CFR 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, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K142774
Device Name Polysmith Sleep System, Model NTI6600
Indications for Use (Describe)
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders.
The device is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional.
The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
The device or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system.
The device or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
The device or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
SUMMARY DATE:
February 18, 2015
510K SUBMITTER:
| Neurotronics, Inc. | Phone: | 352.372.9955 | |
|---|---|---|---|
| 3600 NW 43rd Street, Suite FLGainesville, FL, 32606 | Fax: | 815.550.2871 | |
| Primary Contact: | |||
| Name: | David Pezet | Title: | Quality Manager |
| Email: | quality@neurotronics.com | Phone: | 352.372.9955 Ext 355 |
| Establishment Registration Number:1063925 |
DEVICE TYPE (COMMON NAME):
Polysomnography Monitoring System
PROPRIETARY NAME OF THE DEVICE:
Polysmith Sleep System, Model NTI6600
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CLASSIFICATION:
Product Code:
| ProductCode | Device | RegulationDescription | RegulationNumber |
|---|---|---|---|
| OLZ | Automatic Event Detection SoftwareFor Polysomnograph WithElectroencephalograph | Electroencephalograph. | 882.1400 |
Subsequent Product Code:
| ProductCode | Device | RegulationDescription | RegulationNumber |
|---|---|---|---|
| OLV | Standard Polysomnograph WithElectroencephalograph | Electroencephalograph. | 882.1400 |
| DQA | Oximeter | Oximeter. | 870.2700 |
PREDICATE DEVICES
| Submitter/Holder | Device Name | Model | Product Codes | 510(K) |
|---|---|---|---|---|
| Neurotronics, Inc. | Polysmith SleepSystem | NTI5498 | OLZ, DQA, OLV | K062943 |
| Nihon Kohden Corp. | PSG-1100 SleepDiagnostic System | PSG-1100 | GWQ, OLV | K120888 |
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DESCRIPTION
The Polysmith Sleep System, Model NTI6600 is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The device consists of a compatible amplifier, head box, PC, patient sensors, and may include optional external devices, USB DC Box, and audio/video input devices.
Compatible amplifiers may use commercially available sensors and electrodes, an internal SpO2 module, and internal pressure transducers to collect, digitize, and send physiological signals to the host PC.
The Polysmith software may record from video, speaker and microphone equipment. The Polysmith software may also record auxiliary signals from compatible amplifiers or USB DC Box which allow for data inputs from compatible sources.
Polysmith records and displays the data for online or offline review. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders.
Image /page/5/Figure/5 description: This image is a block diagram of a patient monitoring system. The diagram shows the different components of the system, including patient sensors, an amplifier, a PC, and optional audio/video equipment. The patient sensors are connected to the amplifier, which is connected to the PC. The PC is also connected to the audio/video equipment and a USB DC box.
1 Polysmith Sleep System Basic Block Diagram
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INTENDED USE
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep disorders.
The device is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional.
The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
The device, or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system.
The device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
The device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.
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PREDICATE COMPARISON
Intended Use Comparison
The Polysmith Sleep System, Model NTI6600 improves upon the predicates' current capabilities access and review of on-line or previously recorded acquisitions. These improvements do not change the indications for use for the devices which it is an accessory. This device is intended to aid in diagnosis of sleep disorders, and other related disorders.
Technical Comparison
The Polysmith Sleep System. Model NTI6600 includes and improves upon the same feature set as found in the predicates. Therefore Neurotronics believes the Polysmith Sleep System, Model NTI6600 is substantially equivalent to the Polysmith Sleep System, Model NTI5498 (K062943), and PSG-1100 Sleep Diagnostic System (K120888).
| Software TechnicalComparison | Polysmith SleepSystem,NTI6600Polysmith(NEW) | Polysmith SleepSystem,NTI5498Polysmith(K062943) | PSG-1100(K120888) | |
|---|---|---|---|---|
| Display electrical activity ofthe brain and otherphysiological signals on amonitor | Yes | Yes | Yes | |
| Device uses Windows on a32-bit or 64-bit computer | 32-bit & 64-bit | 32-bit | 32-bit & 64-bit | |
| Display waveforms inacquisition and review | Yes | Yes | Yes | |
| Maximum number ofwaveforms on screen | 32 | 32 | 32 | |
| Simultaneously viewwaveforms from multipleEEG/PSG instruments anddisplay values fromexternal instruments | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Variable waveform displayduration | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Change waveformparameters (pattern,montage, amplifierconditions, AV induction) | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| The device can record andmeasure vital signs(including ECG, EMG, | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Software TechnicalComparison | Polysmith SleepSystem,NTI6600Polysmith(NEW) | Polysmith SleepSystem,NTI5498Polysmith(K062943) | PSG-1100(K120888) | |
| Respiration, OcularMotility, SpO2, and CO2) | ||||
| Nihon Kohden AmplifiersCompatibility | Yes | Yes | Yes | |
| Lifelines Trackit SeriesAmplifiers Compatibility | Yes | Yes | Yes | |
| USB DC Box Compatibility | Yes | Yes | Yes | |
| Sleep Stage Analysis | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Arrhythmia Analysis | Off-line(integratedK012686) | Off-line(integratedK012686) | Off-line(integratedK012686) | |
| Respiratory Event Analysis | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| SpO2 Desaturation Analysis | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Limb Movement EventAnalysis | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Snore Event Analysis | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| FFT Analysis | Off-line | Off-line | Off-line | |
| Manual Event Scoring | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Manual Custom EventScoring | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Trend Plots | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Display patient video alongwith waveforms | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Record Patient Audio andVideo | Yes | Yes | Yes | |
| Integrated IntercomInterface | Yes(with PMU710) | No | No | |
| For use by medicalpersonnel in a medicalfacility, physician's office,laboratory, clinic, ornursing home | Yes | Yes | Yes | |
| Software TechnicalComparison | Polysmith SleepSystem,NTI6600Polysmith(NEW) | Polysmith SleepSystem,NTI5498Polysmith(K062943) | PSG-1100(K120888) | |
| Any patient populationincluding adults andchildren as determined bya trained professional | YesYesYes | |||
| Patient Database andScheduling | Yes | Yes | Yes | |
| Reporting and CustomReport Capabilities | Yes | Yes | Yes | |
| HL7 Interface Capabilities | Yes | Yes | Yes | |
| Remote Access Capabilities | On-line & Off-line | On-line & Off-line | On-line & Off-line | |
| Display Resolution | >=1600 x 1200 | >=1600 x 1200 | >=1600 x 1200 | |
| File Format | XDF (XML), EDF | XDF (XML),EDF | XDF (XML),EDF | |
| File Management | Yes | Yes | Yes | |
| Compatible Amplifiers forRecording | · NeurotronicsSphinxPMU710(NEW)Neurotronics●SphinxPMU700(K062943)NeurotronicsNomadPMU800(K092699)Nihon Kohden●PSG-1100(K120888)Nihon Kohden●EEG-1200aAmplifiers(K113117,K080546)Nihon KohdenWireless InputUnit, ModelWEE-1000a | Neurotronics●SphinxPMU700(K062943)Nihon Kohden●Wireless InputUnit, ModelWEE-1000aSeries(K033475)Nihon KohdenElectrodeJunction Box,Model JE-921a(K050833)Nihon Kohden●PSG InputBox, ModelJE-912ak(K022121)Nihon Kohden●Neurofax,Models EEG-1100a, EEG-9100a | NeurotronicsSphinxPMU700(K062943)Neurotronics●NomadPMU800(K092699)Nihon KohdenPSG-1100(K120888)Nihon KohdenEEG-1200aAmplifiers(K113117,K080546)Nihon Kohden●Wireless InputUnit. ModelWEE-1000aSeries(K033475)Nihon Kohden●ElectrodeJunction Box, | |
| Software TechnicalComparison | Polysmith SleepSystem,NTI6600Polysmith(NEW) | Polysmith SleepSystem,NTI5498Polysmith(K062943) | PSG-1100(K120888) | |
| Series(K033475)• Nihon KohdenElectrodeJunction Box,Model JE-921a(K050833)• Nihon KohdenPSG Input Box,Model JE-912ak(K022121)• Nihon KohdenNeurofax,Models EEG-1100a, EEG-9100a(K011204,K992742)• LifelinesTrackit Seriesamplifiers(K010460) | (K011204,K992742)• LifelinesTrackit Seriesamplifiers(K010460) | Model JE-921a(K050833)• Nihon KohdenPSG InputBox, ModelJE-912ak(K022121)• Nihon KohdenNeurofax,Models EEG-1100a, EEG-9100a(K011204,K992742)• LifelinesTrackit Seriesamplifiers(K010460) | ||
| Amplifier TechnicalComparison | Polysmith SleepSystem, NTI6600Sphinx PMU710(NEW) | Polysmith SleepSystem, NTI5498Sphinx PMU700(K062943) | PSG-1100(K120888) | |
| Number of Channels | 23 | 33 | 42 | |
| Pulse Oximeter | Integrated NihonKohden OximeterModule | Integrated NoninOximeter Module | Integrated Nihon KohdenOximeter Module | |
| Input Impedance | >= 10 M Ohm | >= 10 M Ohm | 100 M ohm | |
| Calibration Check | Step square 50uV | Step square 50uV | Step square 50uV | |
| Impedance Check | Yes | Yes | Yes | |
| Common-Mode Rejection Ratio(CMRR) | >= 90 dB | >= 90 dB | >= 105 dB | |
| Noise Level | < 2 µV p-p(0.1 to 60 Hz) | < 2 uV p-p(0.53 to 60 Hz) | < 1.5 uV p-p(0.53 to 60Hz) | |
| Hardware Frequency Response | .072 Hz to 300 Hz | 0.1 Hz to 100 Hz | 0.08 to 300 Hz | |
| Software High-pass Filter | .072 HzDC Standard | .1 HzDC Standard | 0.08 to 53 HzDC Standard | |
| Software Low-pass Filter | 15 Hz to 300 Hz | 15 Hz to 100 Hz | 15 to 300 Hz | |
| AC Filter | 50 or 60 Hz | 50 or 60 Hz | 50 or 60 Hz | |
| Sensitivity | Off, 0.1 to 200uV/mm (20 steps)DC: Off, 10 to 200mV/mm (10 steps) | Off, 0.1 to 200uV/mm (20 steps)DC: Off, 10 to 200mV/mm (10 steps) | Off, 0.1 to 200 uV/mm (20steps)DC: Off, 10 to 200 mV/mm(10 steps) | |
| A-D Conversion | 16 bits | 16 bits | 16 bits | |
| Sampling | 1000 Hz | 1000 Hz | All Channels200, 250, 500,1000, 2000 Hz | |
| Power | Mains | USB | 100-240 V +/- 10%50 / 60 Hz42 VA (Main Unit only) | |
| PC Connection | Ethernet | USB | Ethernet | |
| Operating EnvironmentTemperature | 10 to 35 C | 0°C to +50°C | 10 to 35 degree Celsius | |
| Operating Environment Humidity | 0 to 93% non-condensing | 10% to 90% non-condensing | 30 to 80% Humidity | |
| Any patient population includingadults and children as determinedby a trained professional | Yes | Yes | Yes |
Software Technical Comparison
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Amplifier Technical Comparison
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Performance Data
Annlied Standards
| StandardsNumber | StandardsOrganization | Standards Title |
|---|---|---|
| 62304 | AAMI ANSI IEC | Medical device software - Software life cycle processes |
| 14971 | AAMI ANSI ISO | Medical devices - Applications of risk management tomedical devices |
| 62366 | AAMI ANSI IEC | Medical devices - Application of usability engineering tomedical devices |
| 60601-1 | AAMI ANSI IEC | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance |
| 60601-1-2 | AAMI ANSI IEC | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests (Edition 3) |
| 60601-2-26 | IEC | Medical electrical equipment - Part 2-26: Particularrequirements for the basic safety and essentialperformance of electroencephalographs |
Clinical Data Summary
Automated Analysis
Methodology
Our data included analysis of 8,053 recorded epochs, of which 7,606 were scored. These studies were chosen at random from existing sleep studies of acceptable signal quality from accredited labs.
The human scoring was completed by two expert scorers from different organizations. Each expert is a registered sleep clinician with at least 5 years' experience scoring sleep records.
The studies used for this testing were not used to train the algorithm. The experts were not affiliated with the development of the algorithm. Furthermore, these studies were chosen at random from a sleep lab independent of Neurotronics.
Scorers were instructed to make a copy of the ten test records to a separate folder before testing. This is to ensure the file settings do not change between test runs. Scorers were instructed to score the studies using the default Polysmith scoring settings using AASM scoring rules. Scorers were instructed to not change any file settings including the montage.
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Results
Consistent with the AASM Inter-Scorer Reliability program, the percentage of agreement is calculated by True Positives (Agreements) divided by the total number of epochs compared. The overall results are as follows.
| Average HumanScoringAgreement | AverageAutomatedAnalysisAgreement | Confidence Interval +/-(95.0%) | |
|---|---|---|---|
| Sleep Staging | 82.8% | 71.53% | 3.04% |
| Microarousal | 88.8% | 80.15% | 3.98% |
| Apnea | 98.7% | 97.28% | 1.32% |
| Hypopnea | 96.4% | 95.44% | 2.55% |
| Desaturation | 97.1% | 95.72% | 1.32% |
| Limb Movement | 98.9% | 92.57% | 4.35% |
| Gender | BMI | Age | AHI | ||||
|---|---|---|---|---|---|---|---|
| Male | 10 | Min | 22.50 | Min | 16.0 | Min | 19.3 |
| Female | 0 | Max | 42.60 | Max | 74.3 | Max | 69.8 |
| Total | 10 | Avg | 31.81 | Avg | 52.3 | Avg | 41.0 |
Additional Sleep Staging Analysis
Methodology
Additionally, twenty sleep studies were procured from at least three different sources. Each study was manually scored by three independent scorers. Each scorer was a registered sleep specialist with at least five years' experience in the field. Each scorer has had some prior experience using Polysmith to manually score studies. The manual scoring was compared against the automated scoring to determine the accuracy of the analysis algorithm.
Each scorer was given a collection of files that contain the 20 studies along with a copy of Polysmith. This copy of Polysmith had the capability to score but did not have any automated analysis capability. Each scorer was instructed to manually score each study for sleep stage, arousal, desaturation, and airflow events including apnea, and hypopnea, and to only use the copy of Polysmith provided. The studies were scored blind to all other scorers including the Polysmith automated scoring. Scorers were instructed to only follow AASM guidelines for scoring all events. All files were configured with a minimal montage. Scorers were instructed to, as much as possible, use this montage without alteration.
Scorers were instructed that some files are split-night studies. For these studies. scorers were instructed to use the CPAP Flow channel for scoring Hypopnea and Flow Limitation after CPAP start.
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Once the files were manually scored, they were returned to Neurotronics for evaluation. Each file was then scored by the automated analysis and compared to the three human scorers.
Each of the three scorer files were compared against each other to determine the true sleep staging (consensus). These results use the majority method of comparison (2/3 majority-rule). Epochs for which there was no agreement among the human scorers were discarded (nonconsensus).
Results
The results from this collection of studies are as follows,
| - | W | N1 | N2 | N3 | R | Totals | Positive | Negative |
|---|---|---|---|---|---|---|---|---|
| W | 2907 | 859 | 279 | 44 | 202 | 4291 | 67.75% | 92.12% |
| N1 | 378 | 745 | 777 | 24 | 117 | 2041 | 36.50% | 92.62% |
| N2 | 336 | 367 | 6606 | 895 | 90 | 8294 | 79.65% | 90.39% |
| N3 | 4 | 6 | 51 | 757 | 1 | 819 | 92.43% | 99.65% |
| R | 136 | 305 | 333 | 2 | 1335 | 2111 | 63.24% | 95.58% |
| Totals | 3761 | 2282 | 8046 | 1722 | 1745 | 17556 | - |
| Total Agreement | k Lower Bound | kappa | k Upper Bound |
|---|---|---|---|
| 70.35% | 0.57 | 0.58 | 0.59 |
| TotalEpochs | Total ConsensusEpochs | Total Non-ConsensusEpochs |
|---|---|---|
| 18657 | 17556 | 1101 |
| Gender | BMI | Age | |||
|---|---|---|---|---|---|
| Male | 14 | Min | 23.30 | Min | 16.0 |
| Female | 6 | Max | 56.00 | Max | 74.3 |
| Total | 20 | Avg | 34.66 | Avg | 52.3 |
CONCLUSION
Based on the results of the Intended Use Comparison, the Technical Comparison, and Testing Data, it is believed that the Polysmith Sleep System, Model NT16600 presents no new questions of safety and effectiveness, and is substantially equivalent to the features provided by the identified predicates.
§ 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).