(52 days)
Optomed Aurora Camera is a medical digital camera that is used with dedicated optics modules intended to capture images and video of the fundus of the eye and surface of the eye.
Optomed Aurora Camera with Optomed Aurora Retinal Module is intended to capture digital images and video of the fundus of the human eye.
Optomed Aurora Camera with Optomed Aurora Anterior Module is intended to capture digital images and video of the surface of the human eye and surrounding areas.
Optomed Aurora device set for ophthalmic imaging consists of Optomed Aurora Camera, Optomed Aurora Retinal Module and Optomed Aurora Anterior Module with following accessories Optomed Aurora Charging Station, USB cable, power supply, eye cups (2 pcs), batteries (2 pcs), USB flash drive and cleaning cloth.
Optomed Aurora Camera is designed for use in a medical environment. Captured images and video are used for documentation. Optomed Aurora Camera has a memory card where captured images and recorded videos are saved. Optomed Aurora Camera is used with interchangeable optics modules Optomed Aurora Retinal Module and Optomed Aurora Anterior Module. Optics modules are attached to the camera with bayonet connectors.
Optomed Aurora Retinal Module is designed for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Optomed Aurora Retinal Module has nine internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The material of the eye cup is Momentive LIM 6030AB.
Optomed Aurora Anterior Module has two light sources for imaging eye surface and surrounding areas: white and cobalt blue light enables capturing of fluorescent images. There are four focus windows to focus the image. The material of the eye cup is Momentive Silopren LSR 4040.
Optomed Aurora Camera has a WLAN module inside and when WLAN is used, Optomed Aurora Camera transfers captured images and recorded videos to the PC automatically after imaging. Images and videos can also be transferred to PC from the memory card when the camera is placed on Optomed Aurora Charging Station and the USB cable is connected between Optomed Aurora Charging Station and the PC. The image data transfer method to PC is similar as with any other USB mass storage device.
Optomed Aurora Camera has a rechargeable Li-ion battery that is charged when the camera is placed on Optomed Aurora Charging Station, which is connected to the mains by power supply cable. Optomed Aurora Charging Station can also be used as an external battery charger for the spare battery included in sales case. When Optomed Aurora Camera is not used, it may be stored on Optomed Aurora Charging Station. Storing the device on Optomed Aurora Charging Station is not harmful for the battery.
The provided text describes a 510(k) premarket notification for the Optomed Aurora Camera with Optomed Aurora Retinal Module and Optomed Aurora Anterior Module. It focuses on demonstrating substantial equivalence to a predicate device (Optomed Smartscope M5 with Smartscope EY4 and ES2 optics modules) through various performance tests, rather than providing a detailed study that establishes specific acceptance criteria and then proves the device meets those criteria for general effectiveness.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" related to diagnostic performance (e.g., accuracy, sensitivity, specificity) is not explicitly present in the provided document. The document focuses on demonstrating that the new device is as safe and effective as the predicate based on engineering and safety standards, as well as functional similarities.
However, I can extract information regarding general acceptance criteria for safety, performance, and functionality, as well as the studies/tests conducted to meet these.
Here's a breakdown of what can be extracted and what cannot:
Information that can be extracted:
- Table of Acceptance Criteria and Reported Device Performance (interpreted from the document's structure): The document doesn't present a formal table with acceptance criteria versus reported performance in the way a diagnostic study would. Instead, it lists standards followed and states that the device "fulfills the requirements" or "complies with the standards."
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Electrical safety (IEC 60601-1:2012) | Fulfills the requirements of IEC 60601-1:2012 (safety). |
| Electromagnetic compatibility (EMC) (IEC 60601-1-2:2014) | Fulfills the requirements of IEC 60601-1-2:2014 (EMC). |
| Optical safety (IEC 62471:2006 for LEDs) | Optomed Aurora Retinal Module and Optomed Aurora Anterior Module are classified as "Exempt Group" (NO RISK) LED products. |
| Optical safety (ISO 15004-2:2007 for ophthalmic instruments) | Optomed Aurora Retinal Module and Optomed Aurora Anterior Module are classified as Group 2 ophthalmic instruments. |
| Software Verification and Validation (IEC 62304:2006+A1:2015) | Software level of concern is moderate. Software V&V conducted to ensure fulfillment of system requirements and functional specifications. Complies with IEC 62304:2006+A1:2015. |
| Environmental testing (ISO 15004-1:2006, IEC 60601-1, IEC 60068-2) | Tested to verify mechanical stress and ambient conditions for use and storage. Also tested for high temperature, low temperature, shock, vibration, and bump for transportation. Fulfills the requirements of these standards. |
| Biocompatibility (ISO 10993-5:2009 for eye cup materials) | In vitro cytotoxicity tests performed using ISO 10993-5:2009 for Momentive LIM 6030AB (Retinal Module eye cup) and Momentive Silopren LSR 4040 (Anterior Module eye cup). Biocompatibility is at a suitable level. |
| Optical performance (ISO 10940:2009 for Fundus cameras) | Aurora Camera with Aurora Retinal Module fulfills the requirements of ISO 10940:2009 Ophthalmic instruments - Fundus cameras. |
| Usability/Human Factors (IEC 60601-1-6:2010+A1:2013 and IEC 62366-1:2015) | Designed and evaluated following usability engineering principles. Usage evaluated to be suitable for intended use and complies with IEC 60601-1-6:2010+A1:2013 and IEC 62366-1:2015. |
| Substantial Equivalence (Overall) | Based on provided performance data and comparison, the device "is as safe, as effective and performs as well as or better than the predicate device. Optomed Aurora is substantially equivalent to the predicate device." |
Information that cannot be extracted from the document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable to the types of engineering and safety tests performed. No patient image data test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not established as no diagnostic performance study is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe an AI/CADe/CADx device or a clinical comparative effectiveness study involving human readers and AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device. It's an ophthalmic camera.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there is no diagnostic performance study. The "ground truth" for the engineering/safety performance criteria are the standards themselves (e.g., meeting the electrical safety parameters of IEC 60601-1).
- The sample size for the training set: Not applicable, as there is no AI/machine learning component described that would require a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.