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The Amblyz™ System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.

The Amblyz™ device is an optical eyewear using a Liquid Crystal lens and electronics technology that acts as an intermittent shutter. The shutter incorporated in the optical lens performs an occlusion of the sound eye in an intermittent mode by changing the lens from a clear to an opaque state via electronic control. The system incorporates the following components: Spectacle Frame, Liquid Crystal Shutter (LCS), Earpieces, Nose Piece, Clip to Hold Refractive Lens, Micro-USB Connector, LED Indicator, ON/OFF Switch, Programming Button, Amblyz™ onboard Software, Amblyz™ Technician Software.

The Amblyz™ system is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion. The provided document details several performance tests for the Amblyz™ system, but it does not specify explicit acceptance criteria for each test in a quantitative manner. Instead, it describes the results of the tests, implying that these results meet unstated acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

The provided document describes a series of safety and performance tests conducted for the Amblyz™ device. These are primarily bench testing (in vitro) and engineering verification/validation activities, rather than a clinical study involving human patients to assess therapeutic efficacy. The intent of these tests is to demonstrate the physical, electrical, and material safety and performance of the device itself, and its compliance with relevant standards.

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

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

• Sample Size for Test Set:
  • Destructive Test: 4 lenses.
  • Charging Time Test: 10 test cases (presumably 10 devices or instances of testing).
  • Climatic Testing: "The samples" (specific number not given).
  • Unpacked Drop Test: "All samples" (specific number not given).
  • Cosmetic Resistance: "tested samples" (specific number not given).
  • Sweat Resistance: "all tested samples" (specific number not given).
  • Cleaning Resistance: "all tested samples" (specific number not given).
  • Thermal Shock: "All samples" (specific number not given).
  • Fall Test - Retail Packaging: "All samples" (specific number not given).
  • Transportation Vibration Test & Bump Test: "units inside the carton box" (specific number not given).
• Data Provenance: Not explicitly stated. These appear to be internal engineering and lab tests, so the "country of origin of the data" would likely be Cyprus (where the applicant is located) or the location of the testing laboratories. The tests are prospective in nature, as they were conducted to evaluate the device prior to submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable to the type of testing described. The tests are primarily for device performance, safety, and material properties, which are evaluated against engineering specifications and industry standards, not against "ground truth" established by clinical experts in the sense of diagnosis or treatment outcomes. The "ground truth" for these tests would be the physical properties, electrical outputs, or material integrity, as measured by standard laboratory equipment and procedures, and interpreted by qualified engineers/technicians in the testing facilities.

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

• This question is not applicable as the tests are for objective device performance and safety, not for subjective interpretation by multiple readers/experts. The evaluation relied on compliance with predetermined technical specifications and standards.

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:

• No, an MRMC comparative effectiveness study was NOT done. This device is an ophthalmic eye shield for amblyopia treatment, not an AI-powered diagnostic or assistive tool for human readers. The submission focuses on the safety and functional equivalence to a predicate device.

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

• Not applicable in the context of AI/algorithm performance. The "standalone" performance refers to the device's operational characteristics (e.g., battery life, lens transparency, shutter function) which are extensively tested and reported as per the table above. There is no AI algorithm being evaluated for performance on its own.

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

• For the physical and electrical performance tests, the "ground truth" is defined by engineering specifications, industry standards (e.g., IEC 60601-1, ISO 10993-5, ISO 14971), and objective physical measurements. For example, the "ground truth" for charging time is the measured time compared to the specified limit; for impact resistance, it's the observation of shattering vs. non-shattering.
• For biocompatibility, the ground truth is established by the results of in vitro cytotoxicity tests according to ISO 10993-5.

8. The sample size for the training set:

• Not applicable. This device is a hardware product with embedded firmware, not a machine learning or AI model that requires a "training set" in the conventional sense. The "Amblyz™ onboard Software (firmware)" is programmed, not trained.

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

• Not applicable. As there is no "training set" for an AI or machine learning model, this question does not apply. The firmware's correctness would be established through software verification and validation against its design specifications.

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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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