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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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Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons.

Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are prescription spectacles that have been precision coated with varying hue and saturation filters similar to antireflection coatings and colored prescription sunglass coatings that are already included in the prescription spectacle lens classification. ChromaGen v30 Reading Aid & Color Discrimination Enhancement are available in varying hues and saturation levels duplicate of that available in the ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Soft Contact Lenses. The ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Spectacle Lens has been designed for binocular use, and when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading.

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lens coating/tinting process does not alter the optical and/or performance characteristics of the finished spectacle lens.

Here's an analysis of the provided text regarding the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lenses, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for the ChromaGen v3.0 Spectacle Lenses. Instead, the basis for clearance is substantial equivalence to previously cleared predicate devices (ChromaGen v3.0 Reading Aid Soft Contact Lenses (K012132) and ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses (K994320)).

The reported device performance, in this context, is that the ChromaGen v3.0 Spectacle Lenses achieve "Substantially Equivalent" efficacy to the predicate soft contact lenses.

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

• Test Set Sample Size: No new clinical studies were conducted for the ChromaGen v3.0 Spectacle Lenses directly. The submission relies on the efficacy established in the predicate contact lens studies (K994320 & K012132). Therefore, the sample size for a new test set for these spectacle lenses is 0.
• Data Provenance: Not specified within this document for the original predicate studies. However, the applicant is based in England. The 510(k) is submitted to the US FDA. We can infer the predicate studies (K994320 & K012132) were likely either performed in the UK or internationally, and were considered acceptable by the FDA for the previous contact lens clearances. This is a retrospective reliance on previously established data.

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

• Since no new studies were conducted, there were no new experts specifically used to establish ground truth for a new test set for these spectacle lenses. The ground truth for the predicate contact lens studies is not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set

• Not applicable, as no new test set was created or adjudicated for these spectacle lenses.

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

• No, an MRMC comparative effectiveness study was not done for the ChromaGen v3.0 Spectacle Lenses. The document explicitly states: "Clinical performance studies are not required for the spectacle version of the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement product line, as efficacy has been established in K994320 & K012132."
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable as this is not an AI device, and no MRMC study was performed.

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

• Not applicable. This device is a physical spectacle lens with colored filters and is not an algorithm or AI.

7. The Type of Ground Truth Used

• The ground truth for the efficacy of the predicate contact lenses (which this device relies upon) was established via "Clinical study" as stated repeatedly in the table. The specific type of clinical outcome or assessment used to establish efficacy (e.g., improved reading speed, improved scores on color vision tests, patient-reported outcomes) is not detailed in this 510(k) summary but would have been part of the K994320 and K012132 submissions.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It is a physical medical device.

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

• Not applicable. As stated above, this device does not utilize a training set.

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ColorMax Lenses are indicated for use as an optical aid for Deutan and Protan color vision deficiencies.

ColorMax Lenses are colored prescription spectacle lenses that are designed to aid color discrimination performance for those with Deutan and Protan color vision deficiencies. ColorMax Lenses are designed for binocular use. Use of this product may enhance the discrimination of certain colors and may reduce the discrimination of certain colors. This product is not a cure for color vision deficiencies or colorblindness.

Here's an analysis of the provided information regarding the acceptance criteria and study for the ColorMax Lens, structured as requested:

Acceptance Criteria and Study for ColorMax Lens (K984219)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "red-green color deficient subjects" in the plural, but provides no specific number.
• Data Provenance: Not explicitly stated. However, given the context of a US FDA submission, it is highly probable the data was collected in the United States. The study is described as "clinical performance studies," suggesting a prospective nature, although this is not explicitly confirmed.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The study relied on the Farnsworth Panel D-15 color vision test, which has established methods for interpreting results. It's therefore more about the standardized interpretation of a test result rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. The Farnsworth Panel D-15 test is a standard color vision test with objective scoring based on the arrangement of color caps by the subject. Ground truth is derived directly from the test's protocol, not from expert adjudication of subjective assessments.

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

• MRMC Study: No. This device is a physical optical aid, not an AI-powered diagnostic or assistive tool for human readers/analysts. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

• Standalone Performance: Not applicable. The ColorMax Lens is a passive optical device, not an algorithm. Its performance is evaluated through its direct effect on human visual perception when wearing the lenses, hence "human-in-the-loop" is its primary mode of operation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for effectiveness was established using the Farnsworth Panel D-15 color vision test. This test objectively measures a subject's ability to discriminate between specific colors, providing a quantifiable measure of color vision deficiency and the device's impact on it. The "ground truth" here is the objective performance on a standardized test designed to assess color discrimination.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a medical device submission, not a machine learning model. There is no concept of a "training set" in the context of the ColorMax Lens. The development of the lens itself would have involved optical engineering and material science, likely iterative design and testing, but not a data-driven training set in the AI sense.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" for this optical device.

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