(27 days)
The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.
The Icare HOME tonometer is a home-use handheld, battery operated device that measures the intraocular pressure (IOP) without the need for topical anaesthesia. It is for prescription use only and to be used under the supervision of a healthcare professional. The device is intended to be used by patients at home.
The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP.
The measurement sequence includes six measurements. The probe moves to the cornea and back during every measurement. The tonometer stores information on every complete measurement sequence of six measurements. The stored information includes the calculated final IOP, time and date of the measurement, identification of the eye (right or left) and the quality level of the measurement (i.e. the standard deviation of the six individual measurements).
The measurement data can be uploaded to Icare CLINIC for further analysis using either Icare EXPORT (desktop application) or Icare PATIENT (mobile application). Icare CLINIC is a browser-based software designed for managing patient information and the IOP measurement data.
The provided text does not contain detailed information about specific acceptance criteria related to a performance study for the Icare HOME tonometer, nor does it describe a study that explicitly proves the device meets such criteria in terms of clinical accuracy or diagnostic performance. Instead, this document is a 510(k) summary for a premarket notification, focusing on demonstrating substantial equivalence to a predicate device.
The document highlights:
- Changes: The modifications are primarily related to software (Icare LINK replaced with Icare CLINIC, Icare EXPORT, and Icare PATIENT) and connectivity (added Android support). There are also minor changes to user interface sounds and product appearance.
- Performance and Safety Data: The document states that the device has been tested according to relevant FDA recognized consensus standards for electrical safety, ophthalmic instruments, usability, software lifecycle processes, and photobiological safety.
- No Clinical Studies: Crucially, it explicitly states: "No clinical studies were performed to test this device modification." This means there is no new clinical data presented here to establish performance metrics (like accuracy, sensitivity, specificity, etc.) against a ground truth in a clinical setting for this specific modification. The substantial equivalence is based on the argument that the technological changes do not raise new issues of safety or effectiveness, and therefore, the performance is assumed to be equivalent to the predicate device.
Given this, I cannot extract the detailed information requested in the prompt (acceptance criteria, reported device performance, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, how training set ground truth was established) as this information is not present in the provided document for this specific 510(k) submission. The document focuses on demonstrating that the modified device is substantially equivalent to the predicate device without requiring new clinical performance data.
However, based on the general context of medical device regulatory submissions and the information provided, here's what can be inferred or stated regarding the lack of such information:
| Information Requested | Details from the Document |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not provided in this document. The document focuses on demonstrating substantial equivalence based on technical changes and compliance with general safety standards, not on new clinical performance metrics. The measurement range of the device is stated as 5-50 mmHg, but this is a characteristic, not a performance criterion against a ground truth. |
| 2. Sample size for the test set and data provenance | Not applicable/Not provided. No new clinical test set data is presented for this 510(k) submission, as it explicitly states, "No clinical studies were performed to test this device modification." The evaluation relies on the safety and effectiveness of the previously cleared predicate device and the assessment that the changes do not introduce new risks. |
| 3. Number of experts used to establish ground truth & qualifications | Not applicable/Not provided. As no new clinical studies were performed for this specific modification, there's no mention of experts establishing ground truth for a test set in this document. |
| 4. Adjudication method for the test set | Not applicable/Not provided. No new clinical studies were performed for this specific modification. |
| 5. MRMC comparative effectiveness study and effect size | Not applicable/Not provided. The document does not describe any MRMC studies or human-in-the-loop performance evaluations specifically for this device modification. The device is a tonometer, which directly measures IOP, and thus, comparative effectiveness with human readers (in the sense of image interpretation for AI) isn't directly relevant in the same way it would be for an AI-powered diagnostic imaging device. Its accuracy would typically be compared to a gold standard IOP measurement method. |
| 6. Standalone (algorithm only without human-in-the-loop) performance | Not explicitly detailed as a new study. While the tonometer itself operates standalone to measure IOP, the document does not present new standalone performance data (e.g., accuracy against a gold standard) for this modified device. The assertion of substantial equivalence implies that its standalone performance is considered equivalent to the predicate device, for which such data would have been provided in its original 510(k). |
| 7. Type of ground truth used | Not applicable/Not provided in this document for new studies. For IOP measurement devices, the ground truth for performance studies would typically be established by a well-calibrated reference tonometer (e.g., Goldmann Applanation Tonometer) or other validated methods, but this is referring to the original predicate device's clearance. |
| 8. Sample size for the training set | Not applicable. This device is hardware-based for IOP measurement and the modifications pertain to software for data management/connectivity and minor hardware appearance changes. There is no indication of a machine learning-based component that would require a "training set" in the traditional sense of AI algorithm development for classification or prediction from data within the scope of this 510(k) submission. Therefore, a training set is not pertinent to the changes described. |
| 9. How the ground truth for the training set was established | Not applicable. As there is no training set for a machine learning algorithm described in this 510(k) modification, this question is not relevant to the provided text. The device performs a direct physical measurement. The software changes concern data handling and connectivity, not interpretive AI. |
In summary, this 510(k) document is a "Special 510(k)" for a device modification, and the strategy is to demonstrate substantial equivalence to a predicate device without new clinical performance data, relying on the argument that the changes do not affect the fundamental safety and effectiveness of the IOP measurement.
§ 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.