(405 days)
The Electrode Arrays Cap is intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
The Electrode Array Cap comprises an electrode placement system for positioning electrodes. The density of electrodes will vary, but in general will conform to the 10-20 to 5-5 positioning system (Oostenveld & Praamstra, 2005). The electrode will be compatible with all standard AC/DC EEG amplifiers The Electrode Array Cap will consist of an elastic can, electrode holders, sintered Ag/AgCl electrodes, and shielded wires. The Electrode Array Cap will fit all head shapes and will be comfortable to wear. Shielded wires will terminate into a standardized connector designed. Separate shielded cables, tailored to each amplifier system, will mate with the standardized cap connector. Located in each connector will be a passive memory chip that will read out the serial number and other device information.
The provided text is a 510(k) summary for a medical device called "Electrode Array Cap." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing direct acceptance criteria and performance against those criteria in the way a novel algorithmic device would.
Therefore, the study described does not involve AI, human-in-the-loop performance, or complex ground truth establishment as it would for an algorithm. Instead, it relies on demonstrating that the new device has "the same technological characteristics" and "intended use" as already approved devices.
Here's an analysis based on the provided text, addressing your questions to the extent possible given the nature of the document:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence):
Since this is a 510(k) for a physical medical device (an electrode cap) demonstrating substantial equivalence, the "acceptance criteria" are primarily that the device is as safe and effective as its predicate devices, based on having similar technological characteristics and intended use. Performance is implicitly accepted if these similarities are established.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use: Intended for routine clinical settings where rapid placement of large numbers of EEG electrodes is desired. | Intended Use: "The Electrode Array Cap has the same intended use as the predicate device and is intended for routine clinical settings where rapid placement of large numbers of EEG electrodes is desired." |
| Technological Characteristics: Similar materials, design, and functionality to predicate devices (Electro-Cap K780045, Quik-Cap K000865). Compliance with relevant standards (AAMI EC53-1995, IEC 60601-1 subclause 56.3 (c)). | Technological Characteristics: "The Electrode Array Cap has the same technological characteristics as the predicate device." "The design of the Electrode Array Cap is in conformance with AAMI Standard Specifications for ECG Cables and Leadwires and Other Devices that use Patient Cables. EC53-1995, and the IEC Standard 60601-1 subclause 56.3, (c)." "The Electrode Array Cap, like the predicate device, consists of a stretchable elastic fabric cap, sintered Ag/AgCl electrodes, in electrode holders and shielded lead wires." Specific design features are described (perforations, PVC electrode holders, internal lead wires) that are presented as improvements or design choices consistent with safety and effectiveness. |
| Safety & Effectiveness: No new questions of safety or effectiveness are raised. | Implied by the declaration of substantial equivalence; no specific adverse events or issues are reported or discussed in this summary. |
| Compatibility: Compatible with standard AC/DC EEG amplifiers. | "The electrode will be compatible with all standard AC/DC EEG amplifiers." |
| Fit & Comfort: Fits all head shapes and comfortable to wear. | "The Electrode Array Cap will fit all head shapes and will be comfortable to wear." |
Study Details:
The provided document describes a "510(k) Summary," which is an executive summary of a submission to the FDA seeking clearance for a medical device based on substantial equivalence to a predicate device already on the market. It is not a clinical study report in the traditional sense, especially not for an AI/algorithmic device. Therefore, many of your questions related to algorithmic performance metrics (like sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.
Here's an attempt to address the questions based on the information available and the nature of a 510(k) for a physical, non-AI device:
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A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" for a 510(k) of this nature are that the device is substantially equivalent to legally marketed predicate devices in terms of intended use and technological characteristics, and that it does not raise new questions of safety or effectiveness.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. This document describes a physical medical device (an electrode cap) and demonstrates substantial equivalence. It does not refer to a "test set" of data in the context of an algorithm's performance evaluation. The "study" here is a comparison of the new device's specifications and intended use against those of predicate devices.
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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):
- Not applicable. There is no "ground truth" establishment in the context of an algorithmic test set for this device type and submission. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the predicate devices based on their prior clearance or pre-amendment status.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process as described for an algorithm is mentioned or required for this type of device submission.
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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 not an AI device, and no MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI sense. For this 510(k), the "ground truth" for the new device's safety and effectiveness is its direct comparison to legally marketed predicate devices whose safety and effectiveness are already established. The justification relies on the similarity of design, materials, and intended use to these pre-existing devices.
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The sample size for the training set:
- Not applicable. There is no "training set" for this physical device.
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How the ground truth for the training set was established:
- Not applicable. There is no "training set" or corresponding ground truth establishment for this physical device.
Summary for the Electrode Array Cap:
The Electrode Array Cap achieved FDA clearance (K071446) based on demonstrating substantial equivalence to two predicate devices:
The "study" presented in this 510(k) summary is a detailed comparison of the new device's intended use and technological characteristics with those of the predicate devices. The core argument for acceptance is that the Electrode Array Cap shares the same intended use (rapid placement of EEG electrodes in routine clinical settings) and similar technological features (elastic cap, sintered Ag/AgCl electrodes, shielded wires, compatibility with EEG amplifiers), while also conforming to relevant industry standards (AAMI EC53-1995, IEC 60601-1 subclause 56.3 (c)). The specific design choices, such as internal lead wires and PVC electrode holders, are presented as consistent with or minor variations from the predicate devices, not raising new questions of safety or effectiveness.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).