(28 days)
The Zipprep Electrode is applied directly to the patient's skin to enable recording of physiological signals.
The Zipprep Electrode is a single patient use, disposable pre-gelled electrode that is applied directly to the patient's forehead to record electro-physiological signals.
The provided text describes a 510(k) premarket notification for the Zipprep Electrode, a cutaneous electrode used for recording physiological signals. This submission seeks to demonstrate substantial equivalence to a predicate device, focusing on minor design changes rather than clinical performance.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or therapeutic efficacy, is not applicable to this 510(k) submission.
Here's why and what information is relevant:
The device is an electrode, a Class II device. The 510(k) filing primarily addresses design changes (shape, material of snap stud, tape, and shelf life) from a previously cleared device. The focus is on demonstrating that these changes do not raise new questions of safety or effectiveness, not on proving clinical accuracy or diagnostic performance.
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria:
- Biocompatibility in accordance with ISO10993.
- Electrical testing as per ANSI-AAMI EC12:2000.
- Maintain same indications for use as predicate.
- Maintain same intended use as predicate.
- Maintain same fundamental scientific technology as predicate.
- Maintain same basic design (with minor modifications noted).
- Maintain biocompatibility.
- Achieve an 18-month shelf life.
- Reported Device Performance (as stated in the submission materials):
- Biocompatibility testing performed in accordance with ISO10993 was referenced to support the device.
- Electrical testing performed as per ANSI-AAMI EC12:2000 was referenced to support the device.
- The device has the "Same indications for use," "Same intended use," "Same fundamental scientific technology," "Incorporates the same basic design" (with noted minor differences), and is "Biocompatible."
- The device has an "18 month shelf life."
- The submission asserts that these modifications "do not raise new questions of safety or effectiveness."
- The FDA's decision of "substantial equivalence" indicates the device met their criteria for market clearance.
2. Sample size used for the test set and the data provenance:
- Not applicable for clinical performance. The document refers to "Biocompatibility testing" and "electrical testing." These are likely bench tests on a sample of the electrodes, not a clinical test set with human subjects for performance evaluation in the context of diagnostic accuracy. The specific sample sizes and provenance for these engineering tests are not provided in the summary.
3. 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. No ground truth in a clinical diagnostic sense was established for a "test set" in this submission. The tests referenced (biocompatibility, electrical) are standard engineering and safety tests, not clinical evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was conducted or referred to.
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 electrode, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards and Benchmarking: The "ground truth" here is defined by compliance with established international and national standards for medical devices (ISO10993 for biocompatibility and ANSI-AAMI EC12:2000 for electrical performance). The comparison to the predicate device also serves as a "ground truth" of sorts, as the predicate's performance is already accepted.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).