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The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.

The LCG System comprises the following main components:
The Spectacles Unit (LCGU) comprised of the refractive optical lens, Liquid Crystal Module (LCM) and the electronic control that resides in the holding strap. The adjustable holding strap contains an electronic controller with an activation button (Tact Switch) and small rechargeable batteries that provide the electric power.
The Reporting and Compliance Box (RCB) is a bedside device that serves as a charger of the spectacle's batteries. In addition, it provides a means to monitor the compliance of the patient, while providing a feedback to the user, as it records the actual wear-time of the glasses, comparing it to the prescribed time.
Technician/Factory Setup Software (LCG Set) is software residing on a PC at the factory and is used for setting the LCGU performance parameters. During setup, the LCGU is connected to the PC via the RCB by means of RS232 link.

The LCG System's acceptance criteria and studies are summarized below, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Electromagnetic compatibility (compliance with IEC 60601-1-2)
• Hazard analysis and risk mitigation (compliance with EN 1441 and ISO 14971) | - Device underwent and passed Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards.
• Hazard analysis including risk level and solutions performed in compliance with EN 1441 (1997) and AAMI/ISO 14971-1, 2000 for the entire system and for the software. |
  | Effectiveness/Performance| - Ability to provide intermittent occlusions of the eye (equivalent to eye patching)
• Software performs as specified
• Physical integrity and function (in-vitro bench testing) | - The LCG System provides a means of occlusion for the eye, with the technique being the primary difference from traditional eye patching.
• Software verification and validation testing conducted.
• A set of in vitro (bench) performance testing was performed. |
  | Substantial Equivalence | Device does not raise any new safety and effectiveness issues compared to predicate devices (Eye Patches, Spectacle frame, Prescription spectacle lens, Sunglasses). | - "Tests results demonstrate the safe and effective performance of the LCG System according to its specifications."
• "Based on the safety and performance testing results, including software verification and validation process and the analysis of similarities and differences as compared to its predicate devices, OphthoCare Ltd. believes that the LCG System is substantially equivalent to its predicate devices, without raising new safety and/or effectiveness issues." |

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

The provided document does not specify a sample size for a clinical test set for evaluating the LCG System's performance for its intended use. The studies mentioned are primarily in vitro (bench) testing, electrical safety, electromagnetic compatibility, and software verification/validation. These tests do not typically involve patient-specific clinical data in the same way an efficacy study would. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable in this context.

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

Not applicable. The reported studies are primarily engineering and bench tests, not clinical performance studies requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence based on engineering tests and the established method of eye occlusion, rather than a direct comparison of human reader performance with and without AI assistance. The device is the therapeutic intervention (eye occlusion), not an AI diagnostic aid for human readers.

6. Standalone Performance Study:

A standalone performance evaluation was done in the sense that the LCG System itself underwent "a comprehensive testing program... to verify that the LCG System does not raise any new safety and effectiveness issues." This included:

• Electrical safety and electromagnetic compatibility testing
• Software verification and validation testing
• A set of in vitro (bench) performance testing
• Hazard analysis

These studies assessed the device's functionality and safety independently. However, this is not a "standalone performance" in the context of an algorithm's diagnostic accuracy, but rather the performance of the physical device and its software.

7. Type of Ground Truth Used:

For the engineering and safety tests, the "ground truth" would be established by:

• Engineering specifications and regulatory standards: For electrical safety, EMC, and software function.
• Physical measurements and observation: For in-vitro bench testing.
• Risk assessment methodologies: For hazard analysis.

There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for the verification of the LCG System, as it's not a diagnostic device. Its "performance" is its ability to occlude the eye, which is a functional rather than interpretive outcome.

8. Sample Size for the Training Set:

Not applicable. The LCG System is a hardware device with embedded software, not a machine learning or AI algorithm that requires a "training set" of data in the conventional sense. The "LCG Set" software is described as "residing on a PC at the factory and is used for setting the LCGU performance parameters," indicating it's for configuration, not for training a predictive model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML model described for this device.

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