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The TGDC - 01 PRA Tonometer is used to measure ocular pressure (IOP) in the diagnosis for use. The intended device is 0, 1101.

The TGDc-01 "PRA" is a portable tonometer that measures IOP through the eyelid in the sclera area. It has a measurement range of 5-60 mm Hg, a single measurement time of not more than 3 seconds, and uses 2 CR2032 batteries. It weighs not more than 79 g and has dimensions of 173.5 x 25.5 x 19.5 mm. It displays the IOP measurement on an LCD screen.

Here's a breakdown of the acceptance criteria and study information for the Tonometer TGDc-01 "PRA", based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a formal study with statistical targets for performance. Instead, it relies on a qualitative comparison to predicate devices and highlights the device's technological characteristics.

However, based on the narrative, the implicit acceptance criteria are that the TGDc-01 "PRA" performs equivalently to the predicate devices (Goldmann Tonometer and Canon T-2 Non-Contact Tonometer) in terms of IOP measurement, particularly demonstrating "high coincidence degree in the whole range."

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

The document does not explicitly state the sample size used for the comparison medical tests.
The data provenance is from Russia, as the manufacturer is the "Ryazan State Instrument-Making Enterprise" in Ryazan, Russia.
The study appears to be retrospective in the context of summarizing existing comparison medical tests, although the tests themselves would have been prospective.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The statement "We achieved the same results from all devices" suggests a direct comparison rather than a consensus-based adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done with human readers improving with AI vs. without AI assistance. The Tonometer TGDc-01 "PRA" is a medical device for measuring Intraocular Pressure (IOP), not an AI-powered diagnostic system requiring human reader interaction for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone measurement tool. The "comparison medical tests" inherently evaluate its standalone performance against other standalone tonometers. There is no "algorithm" in the modern AI sense that would have a separate standalone evaluation beyond the device's primary function. The device's output (IOP measurement) is a direct reading.

7. The Type of Ground Truth Used

The ground truth for the comparison medical tests was established by measurements from legally marketed predicate devices, specifically the Goldmann Tonometer and the Canon T-2 Non-Contact Tonometer. These devices are considered the established standard for IOP measurement. Since the document states "We achieved the same results from all devices," this implies the predicate device readings served as the reference.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a measurement instrument, not a learning algorithm that requires a training set.

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

As there is no mention of a training set, there is no ground truth establishment method described for one. The device's functionality is based on its physical measurement principles, not on learned patterns from a dataset.

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