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510(k) Data Aggregation
(280 days)
The Trackit T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications and due to its small size, can be used in ambulatory applications. In this situation, the EEG electrodes are fitted to the patient by a trained clinician prior to the patient being sent home. No subsequent intervention is required by the patient. Upon completion of the recording, the data which is stored on a memory card is reviewed by a clinician using review and analysis software on a PC. It is a compact USB amplifier which provides 32 channels with internal expansion option) with built-in calibration and electrode impedance measurement. Also provided is a Nonin pulse oximeter interface, a Patient Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN WiFi). There are two variants of the Trackit T4 EEG Amplifier: - Trackit T4-32 providing 24 referential + 8 poly channels. . - . Trackit T4-68 providing 64 referential + 4 poly channels (using internal expansion board). Plug-on Patient Connection Units (PCUs) provide 32 channel touchproof inputs (model T4-PCU 24+8) or 68 channels (model T4-PCU 64+4). The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply. In addition it can be battery powered in ambulatory applications. This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
This document describes the Lifelines Trackit T4 EEG Amplifier, which is substantially equivalent to the predicate device, Lifelines R-40 EEG Amplifier (K151600). The information provided is primarily focused on pre-clinical performance testing and safety, not on a study proving a device meets specific acceptance criteria based on diagnostic accuracy or clinical outcomes.
Here's an analysis of the provided text in the context of your request:
1. Table of acceptance criteria and the reported device performance:
The document primarily shows that the new device (T4) performs similarly to its predicate (R-40) in various technical tests. The "acceptance criteria" are implied by the "Test specification" and the "Conclusion" indicating "Same test as predicate" or noting the specific values the predicate device achieved.
| Test | Test Method | T4 subject device (Reported Performance) | R-40 predicate device | Acceptance Criteria (Implied) |
|---|---|---|---|---|
| Insulation resistance | Measure resistance between TF1 'Aux. B' socket and USB plug metalwork. | > 200 MΩ (3.1) | > 200 MΩ (3.1) | > 200 MΩ |
| Dielectric strength | Increase voltage to 1500Vrms over 10s and hold for 1 min. | No flash-over/breakdown (3.2) | No flash-over/breakdown (3.2) | No signs of flash-over or breakdown |
| Mains on Applied Parts | Measure leakage current. | ≤ 5000uA AC (3.6) | ≤ 5000uA AC (3.6) | ≤ 5000uA AC |
| Patient leakage | Measure leakage current. | ≤ 100uA AC and ≤ 10uA DC (3.8) | ≤ 100uA AC and ≤ 10uA DC (3.8) | ≤ 100uA AC and ≤ 10uA DC |
| Calibration | Check for 8mVpp ±0.4 square wave signals on all channels at 1Hz frequency. | 8mVpp ±0.4 square wave (4.4) | 8mVpp ±0.4 square wave (4.4) | 8mVpp ±0.4 square wave signals on all channels at 1Hz frequency |
| Short circuit noise | Check short circuit noise for all channels. | < 1.5uVpp (4.8) | < 1.5uVpp (4.7) | < 1.5uVpp |
| HF response | Check HF response to 80 Hz. | (4.10) | (4.9) | Response to 80 Hz maintained (implied "Same test as predicate") |
| DC response | Check for a +300mV step and a -300mV step. | (4.11) | (4.10) | +300mV step and -300mV step detected (implied "Same test as predicate") |
| Impedance check | Check all channels indicate an impedance of 3000Ω ±500. | 3000Ω ±500 (4.16) | 3000Ω ±500 (4.15) | 3000Ω ±500 |
2. Sample size used for the test set and the data provenance:
The document describes "pre-clinical performance testing" using the device itself and comparing it to the predicate device. It does not refer to a "test set" of patient data or clinical samples. The tests were performed on the device hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This was hardware performance testing, not a clinical study involving experts establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As above, this was not a clinical study requiring adjudication of expert opinions.
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:
Not applicable. This device is an EEG amplifier, not an AI-powered diagnostic tool, and no MRMC study was conducted or mentioned. The document explicitly states: "Clinical testing was not performed with this device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an EEG amplifier; it does not operate as a standalone algorithm in the way a diagnostic AI would. The performance described is of the hardware itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests was defined by engineering specifications and direct measurements against those specifications, comparing the subject device's performance to that of the predicate device, or standard electrical and safety parameters.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device that requires a training set with established ground truth.
Summary of the Study:
The study described is a series of pre-clinical bench tests (hardware performance tests) conducted to demonstrate that the Lifelines Trackit T4 EEG Amplifier achieved similar technical performance and safety characteristics to its predicate device, the Lifelines R-40 EEG Amplifier. The "acceptance criteria" were based on the predicate device's established performance and relevant international safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-26, IEC 60601-1-2, etc.).
The document concludes that the T4 EEG Amplifier "meets the functional claims and intended use as described in the product labeling" and that its "safety and effectiveness are substantially equivalent to the predicate device." This determination of substantial equivalence relies on technical data rather than clinical performance data with patient populations.
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