(364 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Elution Testing | Not explicitly stated (implied to meet MHW Japan requirements) | Passed the Elution test performed according to the requirements of the Ministry of Health and Welfare in Japan. |
| Rabbit Eye Irritation | Does not cause irritation to the eye | An eye irritation test performed by Juridical Foundation, Japan Food Research Laboratory indicates that the Tomey DTL Electrode does not cause irritation to the eye when used according to prescribed instructions. |
| Biocompatibility | No biocompatibility problems for short-term use | "Extensive use by many investigators, including Dawson, Prager and Lachapelle, has not revealed any biocompatibility problems with this type of an electrode. Eye Irritation studies performed by Tomey, also indicate that short term biocompatibility is not a problem for the Tomey DTL Electrode." |
| Safety and Compatibility | Compatible with commercially available ERG recording systems; unable to be mistakenly connected to a/c or d/c power source. | "The Tomey DTL Electrode, by means of adaptor cables, is compatible with commercially available ERG recording systems that employ protected electrode leads. The Tomey DTL Electrode is unable to be mistakenly connected to an a/c or d/c power source." |
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.
§ 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.