(41 days)
The Master II Evoked Response System is intended for the recording and analysis of human physiological data necessary for the diagnosis of audiovestibular and hearing-related disorders.
Master II Evoked Response System is a Windows® based software application for use with the Navigator Pro hardware platform using Auditory Steady State Response Modality for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of audiovestibular and hearing related disorders.
This document is a 510(k) premarket notification for the Bio-logic Systems Master II Evoked Response System, not a study report. Therefore, it does not contain the detailed information needed to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance.
However, based on the provided text, I can extract what is available and identify what is missing:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of acceptance criteria or specific reported device performance metrics. The document focuses on establishing substantial equivalence to a predicate device rather than presenting quantitative performance data from a specific study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. A 510(k) summary primarily addresses the device's technical characteristics and intended use in comparison to a predicate device, rather than providing details of a clinical study's test set.
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)
This information is not available in the provided 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided 510(k) summary.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. The device described is an "Evoked Response System" which records and analyzes physiological data, implying an objective measurement system rather than an AI-assisted diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Master II Evoked Response System" is described as a "Windows® based software application for use with the Navigator Pro hardware platform using Auditory Steady State Response Modality for the recording and analysis of human physiological data." This description suggests that the system operates in a standalone capacity for data recording and analysis. However, specific standalone performance metrics or a detailed standalone study report are not provided in this 510(k) summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided 510(k) summary. For an auditory evoked response system, ground truth would typically relate to actual hearing thresholds/auditory system function, often established through behavioral pure-tone audiometry or other objective audiological assessments.
8. The sample size for the training set
This information is not available in the provided 510(k) summary. While the system uses "Auditory Steady State Response (ASSR) modality" which involves algorithms for analysis, details on a training set (which would be relevant for machine learning-based algorithms) are not provided.
9. How the ground truth for the training set was established
This information is not available in the provided 510(k) summary.
Summary of available information from the 510(k) document:
- Device Name: Bio-logic Systems Master II Evoked Response System
- Intended Use: Recording and analysis of human physiological data necessary for the diagnosis of audiovestibular and hearing-related disorders.
- Technological Characteristics: Windows® based application using Auditory Steady State Response (ASSR) modality. ASSR is used to predict frequency-specific behavioral hearing thresholds, particularly for patients who cannot provide a reliable behavioral response.
- Predicate Device: K021895 Master, a Modification to Bio-logic Evoked Potential.
- Regulatory Status: Cleared as substantially equivalent to the predicate device.
The provided document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed technical or clinical study report. Therefore, it lacks the specific performance data and study design details you've requested. Such information would typically be found in dedicated validation reports or scientific publications, which are not part of this 510(k) summary.
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Bio-logic Systems Special 510(k) Master II Evoked Response System
December 21, 2007
PREMARKET NOTIFICATION [510(K)] SUMMARY
FEB - 5 Wic
Trade Name:
Master II Evoked Response System
Common or Usual Name: Evoked Response Auditory Stimulator
Classification Name and Number: stimulator, auditory, evoked response 882.1900
Classification Name: stimulator, auditory, evoked response (per 21 CFR section 882.1900)
| Manufacturer's Name: | Bio-logic SystemsOne Bio-logic PlazaMundelein, IL 60060 |
|---|---|
| Corresponding Official: | Nicohl WildingDirector Quality Assurance and Regulatory AffairsOne Bio-logic PlazaMundelein, IL 60060 |
| Telephone Number:Fax Number: | 800-323-8326 ext. 267847-949-8615 |
| Predicate Device(s): | K021895 Master, a Modification to Bio-logic EvokedPotential |
| Device Description: | Master II Evoked Response System is a Windows® basedsoftware application for use with the Navigator Pro hardwareplatform using Auditory Steady State Response Modality forthe recording and analysis of human physiological data forthe purpose of neurological diagnosis and treatment ofaudiovestibular and hearing related disorders. |
| Intended Use: | The Master II Evoked Response System is intended for therecording and analysis of human physiological datanecessary for the diagnosis of audiovestibular and hearing-related disorders. |
| TechnologicalCharacteristics: | Master II is a Windows® based application using AuditorySteady State Response (ASSR) modality. ASSR is used topredict frequency-specific behavioral hearing thresholdsparticularly for patients who cannot provide a reliablebehavioral response. The ASSR technique uses acontinuous frequency and/or amplitude modulated tone asthe stimulus and can combine several stimuli together |
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December 21, 2007
Bio-logic Systems Special 510(k) Master II Evoked Response System
simultaneously to assess responses to various frequencies all at the same time. The evoked response recorded from scalp electrodes is reflective of the frequency of the modulation envelope of the stimulus.
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FEB - 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bio-logic Systems Corp. % Ms. Nicohl Wilding One Bio-logic Plaza Mundelein, IL 60060
Re: K073626 Trade/Device Name: Bio-Logic Master II Evoked Response System Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked response auditory stimulator Regulatory Class: Class II Product Code: GWJ Dated: January 21, 2008 Received: January 23, 2008
Dear Ms. Wilding:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Ms. Nicohl Wilding
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark W. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number:
Device Name: Master II Evoked Response System
indications for Use:
The Master II Evoked Response System is intended for the recording and analysis of human physiological data necessary for the diagnosis of audiovestibular and hearing-related disorders.
Prescription Use (per 21 CFR 801.109) and/or
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of C /Office of Device Evaluation (ODE)
(Division Sign-(Division of General, Restorative, Divisionological Devices
510(k)
:
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).