(15 days)
The EYE-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected.
The Eye-deas EyesOPen tonometer is a precision electronic tonometer, which measures intraocular pressure (IOP). The body of the instrument is specially designed to fit comfortably in the user's hand, facilitating fast and accurate measurements.
The EyesOPen tonometer contains a solid-state force transducer and a CMOS image transducer that together produces electrical signals from which intraocular pressure is derived. When sufficient valid readings are obtained an IOP reading is displayed on a liquid crystal display.
Under each of the four digits are bars. The bars correspond to the goodness of fit to a linear regression of pressure against applanated diameter. The regression coefficient is 95% or better if the first bar is illuminated, 90%-95% if the second bar is illuminated, 80%-90% if the third bar is illuminated, or less than 80% if the fourth bar is illuminated.
The provided text does not contain a performance study with detailed acceptance criteria, sample sizes, or ground truth establishment for the EyesOPen Manual Tonometer that typically accompanies a medical device submission.
Instead, it states:
"Although not required to establish substantial equivalence, the EyesOPen tonometer was tested to establish baseline performance. The EyesOPen tonometer was tested on a simulated human eye. The EyesOPen tonometer performance was consistent with the performance of the predicate tonometer devices on this simulator."
This suggests that a formal clinical study with human subjects, defined acceptance criteria, and detailed statistical analysis, was not conducted or provided in this submission for proving the device meets specific performance criteria against a clinical ground truth. The submission focuses on demonstrating substantial equivalence to predicate devices (Perkins Tonometer and Tono-Pen 3) based on design features, intended use, and general performance consistency with a simulator.
Therefore, I cannot populate the requested tables and information based on the provided text, as the specific details of performance testing are largely absent.
What is present is a statement regarding performance testing against a simulator, indicating consistency with predicate devices, but no quantifiable acceptance criteria or detailed study results are provided.
Given this limitation, I can only provide the information that is mentioned or can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in document for clinical performance) | Reported Device Performance (as stated in document) |
|---|---|
| (Not explicitly defined beyond "consistency with predicate performance on simulator") | "The EyesOPen tonometer performance was consistent with the performance of the predicate tonometer devices on this simulator." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The testing was conducted "on a simulated human eye," implying a single or a limited number of simulated eyes were used.
- Data Provenance: Not applicable, as the testing was performed on a "simulated human eye" rather than human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for the "simulated human eye" would be inherent to the simulated eye's design, not established by human experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of human expert adjudication as the testing was done on a simulator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- Was an MRMC study done? No. The document only mentions testing on a simulated eye and does not describe any human reader study, with or without AI assistance.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed and this device is a standalone tonometer, not an AI assistance tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Was a standalone study done? Yes, the performance testing described is standalone, as it involves the device (EyesOPen tonometer) being tested on a "simulated human eye" without human intervention for interpretation or decision-making. The device itself performs the measurement and displays the result.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was based on the "simulated human eye" and its known or calibrated properties for intraocular pressure. The document states its performance was consistent with predicate devices on this simulator, suggesting the simulator itself provided the reference.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is described as having a "solid-state force transducer and a CMOS image transducer" to derive IOP using a "Goldmann" algorithm basis. There is no indication that the device utilizes machine learning requiring a training set.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable, as no training set is mentioned or implied for this device.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.