(300 days)
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
| Test Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Operation time without charge | Over 48 hours (based on predicate comparison) | Over 48 hours |
| Charging time | Less than 2 hours (based on predicate comparison) | Less than 2 hours |
| Lens transparency | 40% (based on predicate comparison) | 40% |
| Contrast ratio | Over 400 (based on predicate comparison) | Over 400 |
| Electrical Characteristics Test | All tests passed successfully and meet acceptance criteria | All tests passed successfully and meet acceptance criteria |
| Lens Impact Resistance/Drop Ball | Lenses should not shatter into pieces when cracked | The lenses cracked but did not shatter into pieces and therefore comply with standard requirements |
| Destructive Test | Laminated films should hold glass pieces and no glass residues | The LC lens glass was cracked and the liquid crystal was spread across the glass. Nevertheless, the laminated films completely held the LCM glass pieces. No change in the overall package and no glass residues were found. Test was performed on four lenses, all resulting in same findings |
| Charge/Discharge Test | Sufficient operating time with the battery | Tests show, that glasses have more than enough operating time with the used battery. |
| Charging Time Test | All 10 test cases comply with acceptance criteria | All ten (10) test cases comply with the acceptance criteria |
| Climatic Testing | Samples sustain specified environmental testing without damage | The samples sustained the specified environmental testing, no damage was noted. |
| Unpacked Drop Test | All samples pass visual and operational checks after drop | All samples have passed all visual and operating/performance checks after the drop |
| Cosmetic Resistance | No visual change on tested samples after the test | No visual change on tested samples after the test was completed. |
| Sweat Resistance | No visual change on tested surfaces | No visual change observed on tested surfaces in all tested samples |
| Cleaning Resistance | No visual change on tested surfaces | No visual change observed on tested surfaces in all tested samples |
| Thermal Shock | All samples pass visual and operational checks after the test | All samples have passed all visual and operating/performance checks after the test |
| Fall Test - Master Packaging | Functional and cosmetic inspections pass successfully | Functional and cosmetic inspections have passed successfully. |
| Fall Test - Retail Packaging | All samples pass and meet acceptance criteria | All samples passed and meet acceptance criteria |
| Transportation Vibration Test | Units pass functionality check with no problems | After the completion of Transportation Vibration Test, units inside the carton box were subjected to functionality check. All test units passed the functionality check with no functionality and cosmetic problem. |
| Bump Test | Units pass functionality check with no problems | After the completion of Bump Test, units inside the carton box were subjected to functionality check. All test units passed the functionality check with no functionality and cosmetic problem. |
| Biocompatibility Testing (ISO 10993-5) | No in vitro cytotoxicity observed (implies) | Cytotoxicity testing was conducted on all components in direct contact with the patient (Spectacle Nosepiece, Front frame, Amblyz™ Insert left & right part of the handle), based on ISO 10993-5. (Results are not explicitly stated, but the conclusion implies compliance). |
| Electrical safety & EMC (IEC 60601-1, 60601-1-2) | Compliance with standard requirements | The Amblyz™ has found to comply with the requirements of these standards. (Certificate of Compliance attached to submission). |
| Software V&V | Software verifies and validates (implies) | Software verification and validation testing performed. (No specific results beyond "performed" are given, but the overall conclusion states acceptable safety and performance). |
| Hazard Analysis (ISO 14971:2012) | Hazard analysis performed with risk level and solutions (implies) | Hazard analysis including risk level and solutions performed in compliance with ISO 14971:2012 for the entire system and for the software. (No specific results beyond "performed" and "in compliance" are given). |
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.
§ 886.4750 Ophthalmic eye shield.
(a)
Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.(b)
Classification. Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.