Search Results

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)

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.

Ask a specific question about this device

The Tomey DTL Electrode is intended for use in the measurement and recording of ERG signals from the ocular surfaces of the eye. These measurements are only to be performed by licensed practitioners and trained technicians within a medical environment.

There are no differences with respect to the predicate devices for indications for use, or target population.

Tomey DTL Electrode consists of soft silver impregnated nylon fiber threads that are normally placed under the lower eye lid. The electrodes are constructed with 3 to 10 individual fibers between 5 and 20 microns in diameter. The fibers are stabilized at both ends with adhesive attachments. A thin wire is connected to an adaptor cable that permits the electrodes to be used with various ERG Recording systems including the Tomey PE-400/PS-400.

The provided text is a 510(k) summary for the Tomey DTL Electrode. It describes the device, its intended use, and substantial equivalence to predicate devices, along with non-clinical testing performed.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Elution Testing: Sample size for this specific test is not mentioned. The test was "performed according to the requirements of the Ministry of Health and Welfare in Japan," suggesting the data provenance is Japan. This would be considered retrospective in the context of the device's clearance application, as the testing was conducted prior to the submission.
• Rabbit Eye Irritation Testing: Sample size for this test is not mentioned. The test was performed by the "Juridical Foundation, Japan Food Research Laboratory," indicating data provenance is Japan. This is also retrospective.
• Biocompatibility (General): The text refers to "extensive use by many investigators." No specific sample size or formal prospective study is described. This relies on existing literature and collective experience, making it retrospective.
• Safety and Compatibility: This appears to be based on design verification and internal testing, not a formal test set with a specific sample size.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This document does not describe the use of experts to establish "ground truth" for a test set in the way this question typically implies (e.g., for diagnostic accuracy). The tests conducted are non-clinical, focusing on material properties and basic safety.

• For the eye irritation test, the "Juridical Foundation, Japan Food Research Laboratory" conducted the test, implying qualified personnel, but specific expert qualifications are not detailed.
• For biocompatibility, it refers to "many investigators, including Dawson, Prager and Lachapelle," but not in the context of establishing a ground truth for a specific test set for the Tomey device.

4. Adjudication Method for the Test Set

Not applicable. The tests described are not clinical diagnostic studies requiring an adjudication method (like 2+1 or 3+1). They are laboratory and material-based tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not mentioned. The device is an electrode for measuring ERG signals, and the testing focuses on its safety and compatibility, not its impact on human reader performance in interpreting ERG results.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical electrode, not an algorithm, so a standalone algorithm performance study is not applicable. The document focuses on the electrode's physical properties and biological reactions.

7. Type of Ground Truth Used

• Elution Testing: The "ground truth" is defined by the requirements and standards of the Ministry of Health and Welfare in Japan for elution.
• Rabbit Eye Irritation: The "ground truth" is typically defined by the observation of irritation in the rabbit eyes according to established toxicological protocols.
• Biocompatibility: The "ground truth" is derived from a lack of adverse biological reactions (irritation, toxicity) in established animal models and from extensive clinical experience with similar devices.
• Safety and Compatibility: The "ground truth" is based on engineering specifications and direct observation/testing of the device's physical connections and electrical isolation.

8. Sample Size for the Training Set

Not applicable. This document describes non-clinical testing for a medical device (electrode), not the development or training of an AI algorithm based on a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI algorithm is mentioned or relevant to the device described.

Ask a specific question about this device