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.

AI/ML Overview

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.

Summary

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APR 2 8 2014

510(K) SUMMARY

510(K) Number K132042

Applicant's Name:	X6D Ltd.195, Arch. Makariou IIINeocleous House3030 Limassol, CyprusTel: +357 25 110000Fax: +357 25 110010
Contact Person:	Neta LandmanDuet Medical Consulting Ltd.21 Hanafa StreetZur- Moshe 42810, ISRAELP.O.Box 536T +972 54 443 6180F +972 153 52 833 7207Email: neta.l@duet-medical.com
Date Prepared:	05 November 2013
Trade Name:	Amblyz™
Classification:	Classification Name: Shield, eye, ophthalmicMedical Specialty: OphthalmicProduct Code: HOYDevice Class: IRegulation Number: 886.4750Panel: Ophthalmic

Predicate Devices:

LCG (Liquid Crystal Glasses) System; cleared under K050856; Product Code . HOY; Regulation Number 886.4750

Intended Use / Indication for Use:

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

Technological Characteristics:

The Amblyz™ system uses operation principles equivalent to those of the legally marketed LCG System. The device utilizes a Liquid Crystal and electronics technology to create an electronic shutter module that enables the exercise of the amblyopic eye combining with rest periods of the sound eye. There is no control mechanism change

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and no change in energy type. All changes that do exist are presented in the comparison table presented below under 'substantial equivalence'.

Device Description:

1. Spectacle Frame

The Spectacle frame designed to hold both the liquid crystal lens and the refractive lens. The frame is made of biocompatible durable plastics.

2. Liquid Crystal Shutter (LCS)

The LCS lens, which functions as an electronic shutter is bundled in the glasses frame. Controlled by the microcontroller on the PCB, the designated LCS performs repetitive occlusion and transparent sessions during which the lens is fully transparent ("OFF" state) when no voltage is applied and turns opaque ("ON" state) when voltage is applied.

3. Earpieces

The ear pieces are the part of the spectacle frame that extends from the hinges and to the back end of the device

4. Nose Piece

Nosepiece increases the distance between the nose and the spectacle frame, The nosepiece is detachable from the spectacle frame and the user can choose if to use it or not.

1. Clip to Hold Refractive Lens
  A plastic clip that holds the optic lenses (if needed).

6. Micro-USB Connector

During normal operation the connector is used only to charge the glasses. X6D technicians also use this connector to upload firmware to the electronic control for tests and/or updates.

7. LED Indicator

The Amblyz™ is equipped with an orange LED. The LED should be OFF when in normal operation and ON when properly connected to the USB charger and charging. Once the battery is fully charged, the LED indicator will turn OFF, even if Amblyz™ glasses are still connected to the USB charger. A flashing LED light indicates that the battery is low and charging is needed.

8. ON/OFF Switch

A mechanical rotary switch used only to power ON the glasses, an action that is performed only once, by the optician who initially sets up the glasses.

9. Programming Button

The programming button is a simple push button, located next to the ON switch. Push button is used for setting the eye to be occluded. This operation is performed only once, by the optician who initially sets up the glasses.

10 Amblyz™ onboard Software

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An onboard software (referred to as "firmware") controls the Amblyz [ glasses An onboard sonware (referred to as "limitate") Sontere the Amblyz™ glasses unit, is to allow the initial setting, and then after continuously deliver the therapy sequence without any option for user tampering. Other "house holding" functions of the software are to alert on low battery state, support the "watch-dog" component that resets the glasses in case of error.

11 Amblyz™ Technician Software

Amblyz™ PC Maintenance (Technician) Software is intended to be used only by qualified X6D personnel for the purpose of reprogramming / upgrading the onboard Amblyz™ software.

Substantial Equivalence:

The table below presents the comparison between the Amblyz™ System and the legally marketed device - the LCG System.

	Amblyz™ System	LCG System (Predicate)
Indications	The Amblyz™ System is an electronicshutter module intended to provideocclusions of the eye in an intermittentfashion.(As the LCG)	The LCG (Liquid Crystal Glasses)System is an electronic shuttermodule intended to provideocclusions of the eye in anintermittent fashion.
TechnologicalCharacteristics	Computer derived, electrical and LiquidCrystal technology.	Computer derived, electrical andLiquid Crystal technology.
	A Liquid Crystal Module (LCM) lenscovers a spectacle unit lens, which isintermittently occluded when voltage isapplied.(As the LCG)	A Liquid Crystal Module (LCM)lens covers a spectacle unit lens,which is intermittently occludedwhen voltage is applied.
Materials	The Amblyz™ System's componentsthat come with direct contact with thepatient for a continuous duration of useare the Spectacle Frame (comprised offront frame, nose piece, ear handlesand clip).• The front frame is made of durableand biocompatible plastic PCMakrolon 2458.• The nose piece is made of TexinRXT50D• The Amblyz™ System's handlecomprises Elastosil Colour Paste PtYellow Ral 1021 and Elastosil R401/70All the above materials conform to	The LCG System's parts that comein direct contact with the patientand intended for a continuousduration of use are the SpectacleFrame and its Strap.• The Spectacle Frame is madeof a durable and biocompatibleplastic Grilamid TR 90.• The Strap is made ofbiocompatible Thermoplasticpolyurethanes (TPU)Carbothane®.
	Amblyz™ System	LCG System (Predicate)
	applicable biocompatibility and flammability requirements.
Mode of Action	• The patient is wearing the AMBLYZ™ (spectacle) Unit.• Intermittent occlusions are performed.• ON/OFF switch is used by technician only – in course of user operation the glasses are always ON	• The patient is wearing the LCG (spectacle) Unit.• Intermittent occlusions are performed.• ON/OFF switch is activated by a touch sensor on the glasses that is activated upon wearing the glasses
Set-Up	One time only "press button" set-up - done by healthcare professional	Set-up via dedicated PC software.
Charging	Mini-USB connection to computer or any other USB port or wall charger (not included in system)	Mini-USB connection to dedicated charging box
Compliance monitoring	None	Glasses mounted sensor monitors wear time
Occlusion Pattern	1) Occlusion is performed in an intermittent fashion, enabling rest periods2) Total occlusion time is approximately 50% of the time3) Occlusion pattern is fixed: 30 seconds and rest period is 30 seconds.	1) Occlusion is performed in an intermittent fashion, enabling rest period2) Total occlusion time is approximately 50% of the time:3) Occlusion pattern is quasi-random, with occlusion periods varying between 12 up to 35 seconds.
Indicators	(On glasses only) A flashing LED light indicates when battery is low.Constant LED light indicates charging.Shutter Lenses rapid flashing indicate correct connection to charger.	1. None on glasses2. The reporting box indicates actual and prescribed wear time and present smiley/sadly icons that indicate compliance.
Design	1. Frame dimensions: L129 x W129 x H40 mm2. Weight: 36,4 g3. The electronics and battery are housed within the frame4. Optic lenses on clip, can be detached for cleaning and/or replacement5. Viewing angle (pantoscopic angle) provides a 6 degrees	1. Frame dimensions: L120xW120xH34mm2. Weight: ~35gr3. The electronics and battery are housed in the spectacles strap.4. Optic lenses are coupled (glued) to device.5. Viewing angel zero (pantoscopic angel not
	Amblyz™ System	LCG System (Predicate)
	pantoscopic angle	applied)
Performance	1. Operation time without charge: over 48 hours2. Charging time: less than 2 hours3. Lens transparency: 40%4. Contrast ratio: Over 400	1. Operation time without charge: 20 hours2. Charging time: 8 hours3. Lens transparency: 40%4. Contrast ratio: 1:300

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ォ

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Safety and Performance Testing

A series of safety and performance testing were performed:

Electrical safety and electromagnetic compatibility testing according teg. IEC . 60601-1 (and amendments), and IEC 60601-1-2 standards. The Amblyz™ has found to comply with the requirements of these standards. Certificate of Compliance to these standards is attached to this submission.
Software verification and validation testing .
A set of in vitro (bench) performance testing: .

Test Description	Results
Lens Impact Resistance/Drop Ball Test	The lenses cracked but did not shatter into piecesand therefore comply with standard requirements
Destructive Test	The LC lens glass was cracked and the liquidcrystal was spread across the glass. Nevertheless,the laminated films completely held the LCM glasspieces. No change in the overall package and noglass residues were found. Test was performed onfour lenses, all resulting in same findings
Charge/Discharge Test	Tests show, that glasses have more than enoughoperating time with the used battery.
Charging Time Test	All ten (10) test cases comply with the acceptancecriteria
Climatic Testing	The samples sustained the specifiedenvironmental testing, no damage was noted.
Unpacked Drop Test	All samples have passed all visual andoperating/performance checks after the drop
Cosmetic Resistance	No visual change on tested samples after the testwas completed.
Sweat Resistance	No visual change observed on tested surfaces inall tested samples

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Test Description	Results
Cleaning Resistance	No visual change observed on tested surfaces inall tested samples
Thermal Shock	All samples have passed all visual andoperating/performance checks after the test
Electrical Characteristics Test	All tests passed successfully and meet acceptancecriteria.

Packaging Validation including the following tests: .

Test Description	Results
Fall Test - Master Packaging	Functional and cosmetic inspections have passedsuccessfully.
Fall Test - Retail Packaging	All samples passed and meet acceptance criteria
Transportation Vibration Test	After the completion of Transportation VibrationTest, units inside the carton box were subjected tofunctionality check. All test units passed thefunctionality check with no functionality andcosmetic problem.
Bump Test	After the completion of Bump Test, units inside thecarton box were subjected to functionality check.All test units passed the functionality check with nofunctionality and cosmetic problem.

Biocompatibility Testing

According to the Blue Book Memo, G95-1, Use of International Standard ISO-10993, and ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, the components of the Amblyz™ glasses are categorized as surface device with Intact skin permanent (>30days) contact. The parts that come in direct contact with the patient and intended for a continuous duration of use are the Spectacle Nosepiece, Front frame (Case left & right) prescription frame, and the Amblyz™ Insert left & right part of the handle. Cytotoxicity testing was conducted on all the above, based on the requirements of ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

Also, hazard analysis including risk level and solutions performed in compliance with ISO 14971:2012 for the entire system and for the software.

In conclusion, a series of in vitro, software, electrical safety, and biocompatibility test results demonstrate that the product has acceptable safety and performance characteristics.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized bird or a human figure with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2014

X6D Ltd. % Ms. Neta Landman Duct Medical Consulting Ltd. 21 Hanafa Street Zur- Moshe 42810, Israel P.O. Box 536

Re: K132042

Trade/Device Name: Amblyz™M Regulation Number: 21 CFR 886.4750 Regulation Name: Ophthalmic Eye Shield Regulatory Class: Class I Product Code: HOY Dated: March 21, 2014 Reccived: March 31, 2014

Dear Ms. Landman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Neta Landman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportalProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K132042

Device Name Amblyz

Indications for Use (Describe)

The Ambly2TM System is an electronic shutter module intended to provide occlusions of the eye in an internittent fashion.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

(Division Sign-Off)
Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number	K132042

Andrew Yang -S

2014.04.25

13:21:30 -04'00'

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FORM FDA 3881 (1/14)

Page 1 of 1

Regulation Number and Section

§ 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.