(126 days)
Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
The Nexy medical device is an automatic eye-fundus camera without the use of a mydriatic agent, designed to take color photos of the retinal fundus with a 45° field.
The device consists of two fundamental components: the eye-fundus camera and the tablet which represents the user interface where running a dedicated software application.
The instrument body includes: optical head, forehead and cheekbones rests and a base. The device is provided also with a front lens cap, a power cord and AC/DC adaptor.
Through the tablet, the user starts the automatic examination that provides as output the photo of the patient's retina saved in the internal database of the device in JPEG format.
The device can be used in a hospital environment, public and private health clinics and in public and private environments where eye or systemic diseases are screened.
The device must be used by medical personnel in some cases assisted by health professionals and/or optometry professionals. Users must be adequately trained in the use of the device and informed about the risks and side effects as well as being in possession of the qualifications required by law.
The provided document describes the Nexy device, an automatic eye-fundus camera, and its substantial equivalence to predicate devices, but does not contain specific acceptance criteria or a detailed study report proving the device meets acceptance criteria.
However, based on the information provided, we can infer some details related to performance testing and conformity.
Here's an analysis of the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists standards that the device complies with, implying that meeting these standards constitutes the acceptance criteria. The "reported device performance" is summarized as the device performing as intended and not raising new safety or effectiveness concerns.
| Acceptance Criteria (Inferred from Standards Compliance) | Reported Device Performance (Summary) |
|---|---|
| Ophthalmic Testing | |
| ISO 15004-1 | Complies |
| ISO 15004-2 | Complies |
| ISO 10940 (Fundus Cameras) | Complies |
| Software Verification and Validation | |
| AAMI/ANSI/IEC 62304 ("Moderate" level of concern) | Complies, performs as intended, no new safety/effectiveness concerns |
| Electrical Safety Testing | |
| IEC60601-1 | Complies |
| Electromagnetic Compatibility Testing | |
| IEC60601-1-2 | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench tests" and "Performance testing" but does not provide details about the sample size used for performance testing (test set) or the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing seems to be laboratory-based rather than involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document provided. The testing appears to be primarily technical compliance rather than clinical validation involving expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this document. The submission focuses on demonstrating substantial equivalence through technical specifications and compliance with standards, not on comparative clinical effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is an "automatic eye-fundus camera" designed for taking images. The testing described (ophthalmic testing, software verification, electrical safety, EMC) would classify as standalone performance testing of the device's ability to capture images and meet technical specifications. There is no mention of an AI algorithm within the device that would typically undergo a separate "standalone" performance evaluation in the context of diagnostic aid performance. The "automatic" aspect refers to alignment and autofocusing for image acquisition, not AI-driven image interpretation.
7. The Type of Ground Truth Used
For the type of testing described (compliance with standards like ISO 15004-1/2, ISO 10940, IEC 60601-1/1-2), the "ground truth" would be the technical specifications and requirements outlined in those standards. For example, for ISO 15004, the ground truth would be the specific image quality metrics, field of view, resolution, etc., defined by the standard. It's not clinical "ground truth" like expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable or not provided. The document does not describe the development or training of an AI algorithm that would require a training set. The device is a camera and its associated software for image acquisition.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided, as there is no mention of an AI algorithm training set.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.