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RetiCapture is a digital hand-held (portable) eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area.

RetiCapture is a hand-held digital ophthalmic camera that together with the optics modules used to capture digital images and video of fundus and surrounding area of the human eye. RetiCapture has an LED light source visible white light and infrared light. Light target LED's are used to eye position fixation during imaging. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.

The provided text is a 510(k) Summary for the RetiCapture ophthalmic camera. It outlines the device's technical characteristics and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop performance study.

The document focuses on:

• Device Description: A hand-held digital ophthalmic camera.
• Intended Use: To record digital photographs and video of the fundus of the human eye and surrounding area.
• Technical Characteristics: Comparison of specifications (FOV, Resolution, etc.) with a predicate device (MiiS Horus Scope DEC 100).
• Non-clinical tests: Performance according to various IEC and ISO standards related to safety, electromagnetic compatibility, photobiological safety, risk management, software validation, and ophthalmic instruments.

Therefore, I cannot provide the detailed information requested in the prompt based solely on the provided text. The requested information regarding acceptance criteria, study performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details for AI models is not present in the given document.

The document only states that "Extensive software testing and validation have been conducted to ensure that RetiCapture performs to acceptable level, repeatedly and reliably referring to consensus standard IEC 62304:2006 and ISO 14971:2012." This refers to software engineering practices and risk management, not a clinical performance study with defined acceptance criteria for image quality or diagnostic accuracy.

To fulfill your request, I would need a different document that details the clinical or performance validation studies, including specific acceptance criteria and the results of those studies.

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MiiS Horus+ Scope DEA 200 is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualization and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area.

MiiS Horus* Scope DEA 200 is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualize and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. It is a Li-ion battery-powered optical device. It brings more complete medical records about the static photos as well as the dynamic videos. MiiS Horus* Scope DEA 200 has an LED light source with visible white light. The device is designed with high-resolution lens and 5M pixels CMOS Sensor, faithful rendering color of the anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. The device can store pictures or videos in SD memory card, or via the USB transfer pictures or videos to a computer. In addition to rendering images in the 3.5-inch full color TFT-LCD, through the AV output, you can connect the device to the big screen (TV, LCD screen) showing the pictures or videos. Below includes a summary of the technical information used in the substantial equivalence comparison. It is more efficient and suitable for many different applications, such as electronic filing.

The provided document is a 510(k) Pre-market Notification from the FDA for a device named "MiiS Horus+ Scope DEA 200". This document focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, device performance, or human-in-the-loop studies as typically found in clinical validation reports for AI/CAD devices.

Therefore, the following information CANNOT be extracted from the document:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria (e.g., sensitivity, specificity, AUC targets) for detecting conditions, nor does it provide performance metrics against such criteria.
2. Sample size used for the test set and the data provenance: No information on a test set, its size, or origin is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document does not describe any expert-established ground truth or the qualifications of such experts.
4. Adjudication method for the test set: No test set means no 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: The document explicitly states, "No clinical studies were performed." This implies no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device described in the document is a digital hand-held slit lamp system, a hardware device for imaging and recording. It is not an AI algorithm, so a standalone algorithm performance study is not applicable.
7. The type of ground truth used: Not applicable as there's no mention of a test set or performance evaluation against any ground truth.
8. The sample size for the training set: The device is a hardware imaging system, not an AI model, so there is no concept of a "training set" in the context of this document.
9. How the ground truth for the training set was established: Not applicable.

What the document does describe is a technical comparison of the "MiiS Horus+ Scope DEA 200" with two predicate devices (KOWA SL-15 and MiiS Horus Scope DEC 100) to demonstrate "substantial equivalence" based on similar intended use, technological characteristics, and safety evaluations (e.g., EMC, electrical safety, and optical radiation hazard assessment according to ISO 15004-2:2007). The document concludes that "bench performance tests support the conclusion of substantial equivalence."

In summary, this document is a regulatory submission for a medical imaging device (a digital hand-held slit lamp) and not an AI/CAD algorithm. Therefore, it does not contain the information requested about acceptance criteria, device performance, or clinical validation studies typically associated with AI systems.

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