(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.
§ 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).