Search Results

The Pocket III is intended to be used in ophthalmology clinical applications for measurement of corneal thickness by ultrasonic means with pachymetry. This device should be operated by doctors or other appropriately-trained healthcare professionals and should be used in health institutions. The device is not intended for fetal use.

The Pocket III is a small hand-held device in pen-shaped design. Measurement results appear numerically on the LCD graphic display. The user can perform a basic cable transfer (USB-C) or activate Bluetooth to export data to a computer. The Pocket III is equipped with an integrated 30 MHz pachymetry probe. The ultrasonic transducer makes contact with, and transmits ultrasonic pulses through, the surface cornea. Echoes are returned from the anterior and posterior surfaces of the cornea.

Acceptance Criteria and Device Performance Study for Quantel Medical Pocket III

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Pachymetry measurements recorded with test blocks were verified for all available freeze acquisition measuring modes (Easy, Medium and Hard) from 208 um to 1042 um of theoretical value of test block."

• Sample Size for Test Set: Not explicitly stated as a number of individual measurements or "patients." The testing involved "test blocks" covering a range of corneal thickness values (208 µm to 1042 µm). The number of individual measurements taken on these blocks is not specified.
• Data Provenance: The data is from non-clinical testing using "test blocks." This indicates an in-vitro or simulated environment, not human subject data. Therefore, there is no country of origin or retrospective/prospective status as it is not derived from human patients.

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

• Number of Experts: Not applicable. The ground truth for the test set (the "theoretical value of test block") appears to be based on the known, calibrated values of the test blocks themselves, rather than expert interpretation of patient data.
• Qualifications of Experts: Not applicable, as expert consensus was not used to establish the ground truth for these test blocks.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As the ground truth was based on the known theoretical values of the test blocks, there was no need for expert adjudication. The device's measurements were directly compared to these known values.

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

• No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing focused on the device's technical specifications and accuracy against test blocks, not a comparison of human reader performance with and without AI assistance.

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

• Yes, in essence, a standalone performance evaluation was done for the device's core pachymetry function. The statement "Pachymetry measurements recorded with test blocks were verified... all results are acceptable and compliant with an accuracy of ±5μm" describes the device (algorithm and hardware) operating independently to produce a measurement, which was then compared to a known standard (the test block). While it's a physical device rather than purely an algorithm, the evaluation focuses on its direct output accuracy.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was based on the known, theoretical values of calibrated test blocks.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information regarding a training set. This is not a machine learning or AI device that typically requires a large training dataset for its primary function of ultrasonic pachymetry measurement. The device's operation relies on established physical principles of ultrasound.

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

• Not applicable. As no training set information is provided, the method for establishing its ground truth is also not mentioned.

Ask a specific question about this device