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510(k) Data Aggregation
(15 days)
TONOMETER DIATON
The Diaton Tonometer is intended to measure intraocular pressure (IOP). The device is intended for use as an aid in the diagnosis of glaucoma and for monitoring IOP.
Tonometer diaton. This new IOP measuring method through the eyelid in the sclera area, unique to our device, eliminates completely any effect on the mucous eye membrane.
Here's an analysis of the provided text regarding the Diaton Tonometer, focusing on acceptance criteria and the study that proves the device meets those criteria:
Diaton Tonometer Acceptance Criteria and Performance Study
The provided document describes the predicate device comparison and technological characteristics but does not explicitly define quantitative acceptance criteria for the Diaton Tonometer's performance in a standalone study. Instead, the "Conclusion" section states that the "results of the comparison medical tests of Tonometer diaton and Goldmann tonometer demonstrated their high coincidence degree in the whole range with the compared devices." This suggests that the acceptance criteria were based on demonstrating substantial equivalence to the predicate device (Goldmann Manual Tonometer) in terms of IOP measurement accuracy.
Given the information, we can infer the reported device performance and the implicit acceptance criteria based on its equivalence to the Goldmann Tonometer.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter/Criteria | Acceptance Criteria (Inferred from Substantial Equivalence to Goldmann Tonometer) | Reported Device Performance |
|---|---|---|
| IOP Measurement Accuracy | High coincidence with Goldmann Manual Tonometer across its measurement range. | "The results of the comparison medical tests of Tonometer diaton and Goldmann tonometer demonstrated their high coincidence degree in the whole range with the compared devices. We achieved the same results from all devices." (This implies a level of accuracy comparable to the Goldmann Tonometer, which is the gold standard). |
| Measurement Range | Comparable to or suitable for clinical needs (5-60 mmHg specified). | 5-60 mm Hg |
| Time of Single Measurement | Efficient for clinical use. | 3 seconds (not more) |
| Painless diagnostics | Yes | Achieved without anesthetics and antiseptics |
| Elimination of infection risk | Yes | Achieved |
| Independence from cornea's crookedness | Yes | Achieved |
| Evaluation of IOP in patients after corneal operations | Yes | Achieved |
| IOP measurement in children | Yes | Achieved |
| Monitoring of Glaucoma treatment | Yes | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size of patients or eyes used in the "comparison medical tests." It vaguely refers to "medical tests."
Data Provenance: The company is based in Ryazan, Russia (Ryazan State Instrument-Making Enterprise), so it's highly probable the study data originated from Russia. The document does not specify if the study was retrospective or prospective, but clinical comparison tests are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document refers to "comparison medical tests" where the Diaton Tonometer was compared to the Goldmann Tonometer. The Goldmann Tonometer is considered the clinical gold standard for IOP measurement. While it doesn't explicitly state "experts" establishing ground truth, the comparison implies that the Goldmann measurements served as the reference standard, which would typically be performed by trained ophthalmologists or technicians.
Qualifications of Experts: Not specified. However, for a Goldmann Tonometer, the measurements are performed by trained personnel, likely ophthalmologists, optometrists, or ophthalmic technicians.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set. It simply states that the results of the Diaton Tonometer were compared to those of the Goldmann Tonometer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not mentioned. The study described is a comparison study between the Diaton Tonometer and a predicate device (Goldmann Tonometer) for direct measurement. It does not evaluate how human readers improve with or without AI assistance, as the Diaton Tonometer itself is a measurement device, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the study described is essentially a standalone performance assessment of the Diaton Tonometer. It measures the device's ability to determine IOP independently and then compares those measurements to a predicate device. The device provides an objective reading on an LCD screen without requiring human interpretation other than reading the displayed value.
7. The Type of Ground Truth Used
The ground truth used was the measurement obtained from the Goldmann Manual Tonometer. The Goldmann Tonometer is widely considered the clinical gold standard for intraocular pressure measurement. Therefore, the ground truth is based on a clinical gold standard measurement.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" or "training data." As this is a medical device for direct measurement rather than an AI/machine learning algorithm requiring training, the concept of a training set is not applicable in the context described. The focus is on the performance of the device itself (hardware and its embedded algorithm, if any) against a known standard.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no mention of a "training set" in the context of this device. Therefore, how its ground truth was established is not applicable. The device's measurement mechanism and calibration would have been established during its development and manufacturing, but this is distinct from establishing ground truth for a dataset used to train an AI model.
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