(129 days)
The RM Electrode® is a contact lens electrode intended to be applied on the cornea and to be used for the measurement and recording of electroretinography (ERG) signals, to support the diagnosis of retinal dysfunctions. It is indicated for use in patients aged 12 years and above undergoing diagnostic full-field electroretinogram (ERG) recording procedures.
The RM Electrode® is a single use, disposable device.
The RM Electrode® is a contact lens-type corneal electrode for use in electroretinography (ERG) procedures. Like other corneal electrodes classified under 21 CFR 886.1220 and cleared under product code HLZ, the RM Electrode is used for the measurement and recording of ERG signals, to support the diagnosis of retinal dysfunctions. It has four components, including (1) the contact lens (substrate), which supports the conductive element (electrode ring) and allows light from the stimulus source to enter the eye; (2) the electrode ring, which is the conductive element of the device; (3) the lead wire, which is connected to the electrode ring extension and terminates in an industry standard 1.5mm female "touchproof" connector that connects to a commercially available ERG recording system (not part of the subject device); and (4) heat shrink tubing which covers the electrode ring extension and junction with the lead wire. The device materials were demonstrated to be biocompatible.
The RM Electrode® is not a powered device. As with the predicate device (ERG Jet Electrode), it is a passive sensor for recording bioelectric signals from the surface of the eye and transmitting them to an ERG recording system. From an electrical perspective, the device is a single conductor that connects the eye surface to a data recorder.
The provided text describes the regulatory clearance of a medical device, the RM Electrode, and details the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device (ERG Jet Electrode). However, it does not contain information about an AI/algorithm-based device analysis or a multi-reader multi-case (MRMC) study. The acceptance criteria and performance data presented relate to the physical and electrical characteristics of the electrode itself, as well as its performance in recording electroretinography (ERG) signals, rather than the performance of an AI algorithm based on image analysis.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance Criteria for AI/Algorithm Performance: The document does not specify acceptance criteria for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).
- Reported Device Performance (for AI): No performance metrics for an AI algorithm are reported.
- Sample Size for Test Set (for AI): No test set sample size for an AI study is mentioned.
- Data Provenance (for AI): No information on origin or nature of data for AI.
- Number of Experts and Qualifications (for AI Ground Truth): Not applicable as there's no AI ground truth discussed.
- Adjudication Method (for AI Ground Truth): Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: The document does not mention an MRMC study.
- Standalone (algorithm only) Performance: No standalone AI performance is described.
- Type of Ground Truth (for AI): Not applicable.
- Sample Size for Training Set (for AI): No training set sample size for AI.
- How Ground Truth for Training Set was Established (for AI): Not applicable.
Instead, the document focuses on the performance of the physical electrode. Here's a summary of the acceptance criteria and studies that are present in the text, relating to the RM Electrode as a medical device:
1. Table of Acceptance Criteria and Reported Device Performance (Physical Electrode)
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity, sensitization, or ocular irritation (in animals or humans). Ocular irritation (bulbar redness, limbal redness, tarsal redness, corneal abrasion) to be equivalent to or less than predicate during extended wear. | Successfully completed testing for cytotoxicity, sensitization, and ocular irritation. |
| Lead Wire Integrity | Lead wire-electrode ring junction withstands a minimum failure load. | Subject device failure load was significantly higher (better) than predicate. All samples met prospectively defined acceptance criteria for minimum failure load. |
| Electrical Impedance | Electrical impedance at three frequencies within ERG signal passband to be equivalent to or less than predicate. | At all frequencies, the electrical impedance of the subject device was equivalent to, or less than (better) that of the predicate device. |
| Shelf Life | Maintenance of material hardness of eye contact portion; maintenance of electrical impedance at three frequencies within ERG signal passband; package integrity (seal strength, bubble leak) after accelerated aging. | Device properties (material hardness and electrical impedance) confirmed before and after accelerated aging. All samples met acceptance criteria demonstrating no significant changes. Integrity of sterile packaging confirmed through seal strength and bubble leak testing before and after accelerated aging. |
| Clinical Performance | Substantially equivalent (comparable) ERG signal quality (amplitudes, signal-to-noise ratios) to predicate device in full-field flash and 30 Hz flicker ERG protocols. No adverse events or complications. | Amplitudes (a-wave, b-wave, and flicker) and signal to noise ratios were substantially equivalent for both devices. No adverse events or complications related to the subject device reported in clinical performance study or ocular irritation study. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Clinical Performance Study: 15 subjects (sequentially wore both devices in the same eye).
- Human Ocular Irritation Study: 10 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). Both clinical studies appear to be prospective studies conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable in the context of "ground truth" for an AI algorithm.
- For the clinical studies, results were likely evaluated by ophthalmologists or trained medical professionals conducting the ERG procedures, but the specific number or qualifications of these "experts" used for data analysis/interpretation (beyond general "Ophthalmologists, optometrists, trained medical technicians and professionals and vision science researchers" listed as intended users) establishing a definitive "ground truth" for comparative effectiveness are not detailed. The comparison was based on quantitative ERG signal parameters.
4. Adjudication Method for the Test Set:
- Not applicable in the context of AI ground truth adjudication.
- For the clinical studies, comparison was based on quantitative measurements (amplitudes, signal-to-noise ratios, and objective measures of irritation). There's no mention of a reading or adjudication process beyond standard clinical data collection.
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:
- No, an MRMC comparative effectiveness study was not done. The device is a physical electrode, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm-only device. It is a physical medical electrode.
7. The Type of Ground Truth Used:
- For the clinical performance and ocular irritation studies, the "ground truth" was established by quantitative measurements of ERG signals (amplitudes, signal-to-noise ratios) and objective clinical observations of ocular irritation (bulbar redness, limbal redness, tarsal redness, corneal abrasion). This is based on direct physiological measurements and clinical assessment, not expert consensus on an interpretation task like in AI.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use a training set as it is not an AI/machine learning product.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
§ 886.1220 Corneal electrode.
(a)
Identification. A corneal electrode is an AC-powered device, usually part of a special contact lens, intended to be applied directly to the cornea to provide data showing the changes in electrical potential in the retina after electroretinography (stimulation by light).(b)
Classification. Class II.