(204 days)
The intended use for TWin Neurotrac-III is: To record the electroencephalogram (EEG) and the computed EEG trends over extended periods of time in order for trained health care professionals to observe changes over time. TWin Neurotrac-III does not provide any diagnostic conclusion about the patient's condition. TWin-Neurotrac-III is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.
TWin Neurotrac-III is used with Grass-Technologies TWin (#K012976) EEG Recording and Review systems for displaying and recording long term trends of EEG features during continuous EEG monitoring in the ICU, NICU, OR, EEGIPSG laboratories, and/or inpatient long-term seizure monitoring units. TWin Neurotrac-III can be used with EEG acquisition systems configured with any of Grass-Technologies' amplifiers, including AS40 (#K021807), AURA (#K033978), AURA-LTM64 (#K053606) and Beehive (#K884937) amplifiers. The number of EEG channels recorded is dependent on the amplifiers used, the number of electrodes applied to the patient. and the user selected EEG display montage. In addition to displaying and recording the EEG waveforms. TWin Neurotrac-III can also display and record trends of user selectable EEG features in the EEG over prolonged periods of time. The number and the EEG channels processed are selected by the user.
The provided text describes the TWin Neurotrac-III device and its 510(k) submission, K081551. However, it does not contain specific acceptance criteria, a detailed study protocol, or quantitative performance metrics as typically expected for a medical device. This device is an electroencephalograph (EEG) system accessory that displays and records EEG waveforms and trends. Its clearance is based on substantial equivalence to predicate devices, not on a new clinical efficacy study.
Therefore, many of the requested sections (e.g., acceptance criteria, detailed performance, sample sizes for test/training sets, ground truth establishment for AI, MRMC studies) cannot be directly addressed from the provided document. The document focuses on demonstrating functional equivalence through in-house and beta site testing.
Here's an attempt to answer based only on the information available in the provided text:
1. Table of acceptance criteria and the reported device performance
Since this is a 510(k) for substantial equivalence based on functional requirements rather than a novel diagnostic algorithm with quantitative performance metrics, there are no explicitly stated numerical acceptance criteria or performance metrics in terms of sensitivity, specificity, or similar. The "performance" is described in qualitative terms of meeting functional requirements and not adversely altering existing systems.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets design and performance functional requirements. | Met: "Testing has... shown that TWin Neurotrac-III meets design and performance functional requirements." "The testing carried out for the TWin Neurotrac-III indicates that it meets design and performance functional requirements." |
| Does not adversely alter the functionality of the TWin software. | Met: "Testing has also shown that TWin Neurotrac-III does not adversely alter the functionality of the TWin software." |
| Does not alter the functionality of the EEG amplifiers used. | Met: "Testing has also shown that TWin Neurotrac-III does not alter the functionality of the EEG amplifiers used." |
| Does not jeopardize the safety of the patient. | Met: "Testing has also shown that TWin Neurotrac-III... does not jeopardize the safety of the patient connected to the EEG amplifiers." |
| Does not jeopardize the safety of the operator. | Met: "Testing has also shown that TWin Neurotrac-III... does not jeopardize the safety of the operator." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "real EEG from previously recorded studies" for in-house testing and "Beta sites" for testing.
- Sample Size (Test Set): Not specified. The number of "previously recorded studies" or patients/cases at "Beta sites" is not provided.
- Data Provenance:
- In-house testing: "simulated signals, as well as real EEG from previously recorded studies". The origin of these "previously recorded studies" (country, institution) is not specified. It can be inferred as retrospective, as they are "previously recorded."
- Beta Site Testing: Performed "at Beta sites." The number or location of these sites, or the number of cases/patients involved, is not specified. The nature of this testing (retrospective/prospective) is also not specified, though "Beta site testing" often implies prospective usage by medical personnel in a real-world setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. The device records and displays EEG data; it "does not provide any diagnostic conclusion." The testing focused on functional requirements and safety. There is no mention of establishing ground truth for diagnostic accuracy, as the device itself is not making a diagnosis. The Beta site testing was supervised by "qualified medical personnel," but their specific number or qualifications are not given, nor was their role to establish a diagnostic ground truth for device performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. There was no diagnostic "ground truth" to adjudicate, as the device does not provide diagnostic conclusions. The testing was functional and safety-oriented.
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
N/A. No MRMC comparative effectiveness study was performed. The device is a tool for displaying and recording EEG, not an AI diagnostic aid designed to improve human reader performance for specific tasks. "No clinical testing was necessary to demonstrate substantial equivalence for this product."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. The TWin Neurotrac-III is intended for use by "medically trained and qualified personnel." It is an accessory to an EEG recording and review system. It is not a standalone diagnostic algorithm that operates without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. As the device does not provide diagnostic conclusions, no diagnostic ground truth (like expert consensus, pathology, or outcomes) was used to evaluate its performance. The "ground truth" for the testing performed was likely the expected functional output of the device (correct display of waveforms and trends, no adverse effects).
8. The sample size for the training set
N/A. This device is not described as employing machine learning or AI models that would require a distinct "training set." Its development and clearance relied on demonstrating functional performance and safety.
9. How the ground truth for the training set was established
N/A. No training set, as per point 8.
§ 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).