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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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KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The KOWA SL-17 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and a stand.

The document provided (K133755) describes the KOWA SL-17, a non-invasive ophthalmic device intended for eye examination of the anterior eye segment. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device (KOWA SL-15, K063640), rather than proving the device meets specific performance criteria for novel claims.

Therefore, the study described is a substantial equivalence comparison to a predicate device, not a performance study against acceptance criteria in the typical sense for a new clinical claim. The "acceptance criteria" here refer to conformance with various standards and safety requirements to demonstrate that the new device is as safe and effective as the predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are compliance with relevant safety and performance standards, and the "reported device performance" is the confirmation that the device met these standards. There are no specific clinical performance metrics (e.g., sensitivity, specificity) listed for the KOWA SL-17 itself, as its function is observation and illumination, and its equivalency is largely based on technical specifications and safety.

2. Sample Size Used for the Test Set and Data Provenance

This submission focuses on engineering and safety testing. There is no clinical "test set" or patient data mentioned for validating clinical performance in the provided document. The testing involved compliance with various international standards for medical devices (ISO, IEC, FDA guidance), which typically involve laboratory or bench testing rather than patient data.

• Sample Size for Test Set: Not applicable as no clinical test set is described.
• Data Provenance: Not applicable as no patient data (country of origin, retrospective/prospective) is described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This type of submission relies on engineering standards and comparisons, not on expert-established ground truth for clinical performance.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. The document does not describe an MRMC comparative effectiveness study. The submission is for substantial equivalence to a predicate device, focusing on technical and safety aspects, not on improving human reader performance with AI assistance.

• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

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

No. The KOWA SL-17 is a physical medical device (a slit lamp biomicroscope) used directly by a human operator, not an algorithm that performs standalone analysis.

7. The Type of Ground Truth Used

Not applicable as there is no mention of a ground truth for clinical performance. The "ground truth", in this context, would be the requirements of the standards (e.g., ISO, IEC) which were met by the device.

8. The Sample Size for the Training Set

Not applicable. The KOWA SL-17 is a physical optical device, not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable.

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