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510(k) Data Aggregation
(186 days)
The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort Microelectrode Array System is for temporary (
The NeuroPort Array connects to the NeuroPort System (510(k) K042626 and K060523). This combination of devices supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort System is not modified by this 510(k) submission. The NeuroPort Array has 100 electrode contacts on a silicon substrate of 4 mm by 4 mm. The NeuroPort Array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Array passes neural activity of the brain cortex to the NeuroPort System through the Patient Cable. The NeuroPort Array consists of high impedance electrodes. The NeuroPort Array impedance is in the range of 0.1 to 1.0 Meg ohms per electrode. The modification described within this 510(k) submission is summarized as providing a 1.5 mm length NeuroPort Array option in addition to the cleared to market 1,0 mm NeuroPort Array option. Along with the longer NeuroPort Array, the Inserter Wand applied to place the NeuroPort Array is modified to support a variation with the 0.5 mm additional insertion depth.
Here's an analysis of the provided text regarding the NeuroPort Microelectrode Array System, presented in the requested format.
It's important to note that this 510(k) submission is for a modification to an already cleared device (the 1.5mm NeuroPort Array option compared to the 1.0mm NeuroPort Array). As such, the "study" described is primarily focused on confirming that the modification does not alter the fundamental characteristics or safety/effectiveness of the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Confirmation of NeuroPort Array impedance characteristics. | Testing completed. No safety or effectiveness concerns remain. (Implicitly, impedance characteristics were confirmed to be acceptable, though specific values are not provided in this summary.) |
| Confirmation of Inserter Wand dimensional changes. | Testing completed. No safety or effectiveness concerns remain. (Implicitly, dimensional changes were confirmed to be acceptable for proper function.) |
| Overall Goal: Maintain safety and effectiveness of the modified device (1.5mm NeuroPort Array) compared to the predicate (1.0mm NeuroPort Array). | "The safety and effectiveness of the modified NeuroPort Array was demonstrated by testing in compliance with the Design Control process." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is engineering verification and validation of the physical and functional characteristics of the device modification. Therefore, the sample size would pertain to the number of devices or components tested, which is not detailed in this summary.
- Test Set Sample Size: Not explicitly stated as this was not a clinical study on patient data.
- Data Provenance: The document implies in-house testing by Cyberkinetics Neurotechnology Systems, Inc. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission does not involve a clinical study requiring ground truth established by medical experts. The "ground truth" for the engineering tests would be the design specifications and performance requirements for the device components (e.g., impedance range, dimensional tolerances). The experts would be the engineers and quality personnel involved in the design and testing processes, though their specific number and qualifications are not listed.
4. Adjudication Method for the Test Set
Not applicable. As this was primarily engineering verification/validation, an adjudication method for a "test set" of clinical cases is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the substantial equivalence of a device modification through engineering testing, not on clinical effectiveness in interpreting results by human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Not applicable. This device is a microelectrode array, not an AI algorithm. Its performance is evaluated through physical and electrical characteristics, rather than as a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on engineering specifications and performance standards. For example, the acceptable impedance range for electrodes, and the dimensional tolerances for the Inserter Wand.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" in manufacturing would refer to process parameters and quality control, not a data training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set (in the context of AI/machine learning) was used.
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