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The VS Tabletop Tonometer is a digital tonometer intended to measure intraocular pressure of the human eye.

The VS Tabletop Tonometer (VS TT) is a non-contact, table-top tonometer used to measure intraocular pressure of the eye. The tonometer is based on the previously cleared MiiS tonometer, the Horus Scope DPT 100 (K181260). The core technology element of the VS TT is the air puff module, which is equivalent to the air puff module used in the DPT 100 predicate device. The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same. The main technological difference between the VS TT and the predicate DPT 100 is that the VS TT features an auto-alignment system that automatically brings the air puff module within a positional range with respect to the patient's cornea such that the air puff module is able to perform the IOP measurement. The auto-alignment system of the subject device performs the same pre-positioning adjustments that are performed manually by clinical staff with the DPT 100. Hence, the consequence of these design modifications is that a clinical staff member is not required to perform an intermediary, non-critical step in measurement acquisition. The VS TT device is intended to be used by patients in doctor's office with the assistance from eye care professional. Patients are first trained on how to use the device. The VS TT measures IOP in the range of 7-55 mmHg. It contains a graphical user interface on a color LCD touchscreen display where the IOP results are displayed. The device is powered by a rechargeable lithium-ion battery. It can either be used alone (i.e. not plugged in) or connected to a power adapter.

The information provided describes the VS Tabletop Tonometer (VS TT) and its substantial equivalence to predicate devices, but it does not include a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy against a gold standard).

The text focuses on demonstrating that the VS TT is substantially equivalent to existing devices based on technological characteristics and general performance/safety testing, rather than presenting a clinical study with detailed acceptance criteria for diagnostic accuracy.

However, based on the provided text, here's what can be extracted and inferred regarding performance and its supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a quantitative diagnostic sense (e.g., a target sensitivity or specificity). Instead, it refers to performance specifications and the outcome of equivalence testing. The "reported device performance" primarily focuses on the device's measurement range, accuracy, and the auto-alignment feature.

2. Sample Size for Test Set and Data Provenance

The document does not specify a distinct "test set" sample size for diagnostic performance.

• Sample Size for Auto-Alignment Clinical Validation: Not explicitly stated, but it was a "clinical validation performed on the VS TT" to demonstrate the auto-alignment feature.
• Data Provenance: Not explicitly stated. The submitter is from Hsinchu, Taiwan, which might suggest data could originate from there, but this is not confirmed. The study appears to be prospective for the auto-alignment feature.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The document does not describe a study involving expert readers establishing ground truth for diagnostic performance of the tonometer. The device's "accuracy" is described as being "within 5 mmHg" and is likely assessed against a reference tonometer rather than expert interpretation of images or symptoms.

4. Adjudication Method

Not applicable, as no expert-based ground truth establishment is described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done or reported in this document. The focus is on the device's intrinsic measurement capabilities and the effectiveness of its auto-alignment feature, not on human-in-the-loop performance improvement with AI assistance.

6. Standalone Performance (Algorithm Only)

Yes, the performance discussed seems to be primarily standalone (algorithm only for IOP measurement and auto-alignment). The device performs the IOP measurement autonomously once aligned. The document states: "The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same." and "Obtaining the IOP measurement: Automatic. Once air puff module detects that the center of the eye is in the right position, pneumatic and applanation systems are automatically activated."

7. Type of Ground Truth Used

For IOP Measurement Accuracy: Not explicitly stated, but typically a reference tonometer (e.g., Goldmann Applanation Tonometer) would be used as the ground truth or reference standard for calibrating and validating non-contact tonometers to achieve "within 5 mmHg" accuracy.

For Auto-alignment Feature: The ground truth was likely determined by the successful physical alignment of the device to the human eye within the specified time, confirmed by observation or internal sensors.

8. Sample Size for the Training Set

Not applicable. The device's core IOP measurement algorithm is stated to be the same as the predicate DPT 100, implying it was previously developed and validated. The auto-alignment system is a new feature, but the document does not discuss a "training set" for it in the context of machine learning, rather its successful operation in clinical validation.

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

Not applicable, as no training set for a machine learning algorithm is discussed.

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