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Optomed Smartscope M5 digital camera with Smartscope FA optics module is intended to capture fluorescein angiograms of the human eye.

Optomed Smartscope M5 camera with Smartscope FA optics module is designed for use in a medical environment. Captured images and video are used for documentation and consultation. Optomed Smartscope M5 camera has a memory card where captured images and recorded videos are saved. Optomed Smartscope M5 camera is used with interchangeable optics modules previously cleared Smartscope EY4 and Smartscope ES2 and subject device Smartscope FA. Optics modules are attached to the camera with bayonet connectors.

Optomed Smartscope FA optics module is designed for fundus fluorescein angiography imaging of the human eye. Optomed Smartscope FA optics module includes two light sources: Blue light and infrared light, optical component that reflects light to the optical path and lenses that guide light through the pupil to the back of the eye and back to the camera sensor. Optomed Smartscope FA optics module has nine internal fixation targets for the patient to fixate on during imaging. Optomed Smartscope FA optics module receives power from Optomed Smartscope M5 digital camera.

Optomed Smartscope M5 camera has a WLAN module inside and when WLAN is used, Optomed Smartscope M5 camera transfers captured images and recorded videos to the PC automatically immediately after imaging. Images and videos can also be transferred to PC from the memory card when the camera is placed on Charging Station and the USB cable is connected between Charging Station and the PC. The image data transfer method to PC is similar as with any other USB mass storage device.

Optomed Smartscope M5 camera has a rechargeable Ni-MH battery that is charged when the camera is placed on Charging Station, which is connected to the mains by power supply cable. Charging Station can also be used as an external battery charger for the spare battery included in sales case. When Optomed Smartscope M5 camera is not used, it may be stored on Charging Station. Storing the device on Optomed Smartscope M5 camera Charging Station is not harmful for the battery.

The provided text describes the regulatory clearance of the Optomed Smartscope M5 with Optomed Smartscope FA. It outlines numerous performance tests and standards met by the device to establish its substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with corresponding reported device performance in the format of a table, nor does it detail a study proving the device meets acceptance criteria in terms of diagnostic performance.

The information provided focuses on demonstrating safety, electromagnetic compatibility, optical safety, software validation, environmental testing, biocompatibility, optical performance (in relation to a standard), and usability. There is no mention of a clinical study assessing the device's diagnostic accuracy or effectiveness in capturing fluorescein angiograms against specific performance metrics (e.g., sensitivity, specificity for a particular pathology).

Therefore, based only on the provided text, the requested information regarding acceptance criteria and a study proving diagnostic performance cannot be fully extracted or answered.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document lists various standards that the device complies with, which can be considered "acceptance criteria" in a broad sense for safety and basic functionality. However, it does not present these in a comparative table with specific performance metrics as usually seen for diagnostic devices (e.g., sensitivity, specificity, image quality scores).

Missing Information: There are no acceptance criteria or reported device performance metrics related to the diagnostic capability of capturing fluorescein angiograms (e.g., image quality scores deemed acceptable for diagnosis, agreement with expert graders for specific features, etc.). The "Optical performance" entry refers to compliance to an instrument standard (ISO 10940:2009), not clinical performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing. The document does not describe any clinical study involving a test set of patient data to evaluate the device's performance in capturing fluorescein angiograms. The performance data section focuses on engineering and regulatory compliance testing rather than clinical validation on a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing. As no clinical test set is described, there's no mention of experts or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing. As no clinical test set is described, there's no mention of an adjudication method.

5. 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

Missing. The document does not describe an MRMC study. This device is an ophthalmic camera for capturing images, not an AI-assisted diagnostic tool for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing. This device is an imaging capture device. There is no mention of an embedded algorithm for standalone diagnostic performance being evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing. As no clinical study or test set is described, there's no mention of the type of ground truth used.

8. The sample size for the training set

The document does not describe any machine learning or AI component requiring a training set. The descriptions relate to the hardware and associated software fulfilling design requirements and safety standards.

9. How the ground truth for the training set was established

Missing. As no training set or AI component is described, this information is not applicable.

Summary regarding diagnostic performance study:

The provided text details the compliance of the Optomed Smartscope M5 with Optomed Smartscope FA to various safety, electrical, mechanical, biocompatibility, and optical performance standards (e.g., IEC, ISO, ANSI). This typically constitutes the "performance data" required for a 510(k) submission to demonstrate substantial equivalence, particularly for a device primarily focused on image capture over automated diagnosis.

However, the document does not contain information about a clinical study that evaluates the device's effectiveness in terms of diagnostic image quality, accuracy in detecting ocular pathologies from fluorescein angiograms, or any other performance metrics typically associated with studies proving a medical device meets specific diagnostic acceptance criteria based on patient data. The "optical performance" mentioned refers to compliance with ISO 10940:2009 (Ophthalmic instruments - Fundus cameras), which likely deals with technical specifications of the camera itself (e.g., resolution, field of view stability) rather than its diagnostic utility on actual patient cases.

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