(76 days)
The Nicolet Subdural Strip Electrodes can be temporarily placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.
Subdural Strip Electrodes are used by licensed medical professionals to support stimulation and recording of biopotentials from the surface of the brain or the subdural space above the surface of the brain. The electrodes connect to medical equipment in support of stimulation and recording. The electrodes are provided to the user sterile. The electrodes are single patient use, disposable devices. The electrodes are made from the same materials as the predicate devices. The electrode lead wires terminate in a safety connector, complying with the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898. These electrodes do not contain active electronics or software. The electrodes connect to the user's medical equipment.
This document describes a 510(k) premarket notification for a medical device, the Nicolet Subdural Strip Electrodes. Much of the typical information found in an AI/algorithm-based device study is not present because this is a hardware device, not a software algorithm. Therefore, many of the requested fields cannot be answered from the provided text.
Here is the information that can be extracted or deduced from the document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This is a hardware device submission, not a performance study for an AI/algorithm. The submission focuses on substantial equivalence to predicate devices rather than specific performance metrics against acceptance criteria.
2. Sample size used for the test set and the data provenance
Not applicable. No "test set" in the context of an algorithm's performance is mentioned as this is a hardware device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for an algorithm's test set.
4. Adjudication method for the test set
Not applicable. No test set adjudication detailed for an algorithm.
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 is a hardware device. No AI component or human reader study is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device. No algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For a hardware device being cleared via 510(k), the "ground truth" for clearance is typically demonstration of substantial equivalence to a legally marketed predicate device, often through material comparisons, manufacturing process reviews, and functional testing to ensure it meets its intended use safely and effectively, rather than a diagnostic ground truth like pathology for an AI.
8. The sample size for the training set
Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm is mentioned.
Summary of Device and 510(k) Submission:
The Nicolet Subdural Strip Electrodes are a hardware medical device intended for temporary placement on the surface of the brain or subdural space to support stimulating the brain or recording its electrical activity.
The 510(k) submission, K021144, asserts substantial equivalence to predicate devices (K970587, K923803, K850342 manufactured by Ad-Tech Medical Instrument Corp.). The basis for this claim is:
- Identical intended use: "The Nicolet Subdural Strip Electrodes can be temporally placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity."
- Similar technology: "The Subdural Strip Electrodes are made from the same materials as the predicate devices."
- Safety compliance: The electrode lead wires terminate in a safety connector, complying with the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898.
- Absence of active electronics or software: The device is passive and connects to existing medical equipment.
The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness. This clearance allows Nicolet Biomedical to market the device.
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).