(406 days)
MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of eyeball.
MiiS Horus Scope DPT 100 is a Li-ion battery-powered device. The Li-ion battery is rechargeable. It is a digital portable tonometer used to measure intraocular pressure of eyeball.
The device uses a white LED for illumination and capture image. The device has been tested according to the ISO 15004-2 (first edition, 2/15/2007) and been classified as Group I device.
The device has a CMOS sensor. The sensor accomplishes a task of capturing light and converting it into electrical signals.
The device store images to a SD card and have connectivity towards PC. The device uses an USB 2.0 interface to transfer data or picture to PC when connected.
The operation method of the device is described step by step in the attachment A1 "User manual". There is a graphical user interface color TFT display and keypad that is used for making adjustments before and during measure intraocular pressure of eyeball. Its' measure rang is 7-55 mmHg.
The MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of the eyeball. The following information details its acceptance criteria and the study proving its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from ISO 8612:2009 and ANSI Z80.10-2014) | Reported Device Performance (MiiS DPT 100) |
|---|---|---|
| Operating Range | Not explicitly stated in the provided text as a numerical range, but implied to be sufficient for clinical use. Predicates have 0-60 mmHg. | 7-55 mmHg |
| Accuracy | Not explicitly quantified in the provided text, but implied to meet standards. | Met the acceptance criteria for accuracy with a manometer-controlled model. |
| Repeatability | Not explicitly quantified in the provided text, but implied to meet standards. | Met the acceptance criteria for repeatability with a manometer-controlled model. |
| Reproducibility | Not explicitly quantified in the provided text, but implied to meet standards. | Met the acceptance criteria for reproducibility with a manometer-controlled model. |
| Compliance with Ophthalmic Standards | Meets requirements of ISO 15004-2:2007 (for optical hazards, Group 1 classification). | Met all requirements of ISO 15004-2:2007, classified as Group 1 for optical hazards. |
| Biocompatibility | Meets ISO 10993-5:2009 and ISO 10993-10:2010 standards for contact materials. | Met ISO 10993-5:2009 and ISO 10993-10:2010 standards for the chin rest holder material. |
Note: The document primarily focuses on overall compliance with standards rather than specific numerical targets for all performance metrics. For "Accuracy," "Repeatability," and "Reproducibility," the text states "The units under test met the acceptance criteria," indicating successful conformance without providing the specific numerical criteria or results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Human Eye Clinical Performance Test: The document does not specify the exact number of human subjects or measurements used in the clinical performance test. It only states that "Data was collected" in comparison to the predicate device.
- Data Provenance: Not explicitly stated. The manufacturer is based in Taiwan (R.O.C.), but the country of origin for the clinical test data is not provided. The study appears to be prospective as it's a "Clinical Performance Test" conducted to evaluate the device against a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. Instead, it relies on a predicate device (Goldmann applanation tonometry (GAT) Keeler Digital Applanation Tonometer (D-KAT) (K133234)) as the comparative standard for the human eye clinical performance test.
4. Adjudication Method
Not applicable. The study compares the device's measurements directly to a predicate device, not against an adjudicated expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focused on the device's technical performance and its direct comparison to a predicate tonometer. There is no mention of human readers or AI assistance.
6. Standalone Performance
Yes, a standalone performance evaluation of the algorithm (or device in general, as it's a tonometer, not specifically an AI algorithm for image interpretation) was conducted. The "bench test" evaluated the operating range, accuracy, repeatability, and reproducibility with a manometer-controlled model. The "Clinical Performance Test" also assessed the device's standalone performance by comparing its measurements to a predicate device on human eyes.
7. Type of Ground Truth Used
- For bench testing: A manometer-controlled model was used as the ground truth for evaluating operating range, accuracy, repeatability, and reproducibility.
- For clinical performance testing: Measurements from a Goldmann applanation tonometry (GAT) Keeler Digital Applanation Tonometer (D-KAT) (K133234) served as the comparative standard (ground truth) for human eye measurements. Goldmann Applanation Tonometry (GAT) is widely considered the gold standard for intraocular pressure measurement.
8. Sample Size for the Training Set
Not applicable. The MiiS Horus Scope DPT 100 is presented as a tonometer device for direct measurement of intraocular pressure, not an AI-based system that requires a "training set" in the context of machine learning. The document does not mention any AI components or machine learning models that would necessitate a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI-based system.
§ 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.