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510(k) Data Aggregation
(68 days)
Ophthalmic Devices
EQUIVALENT DEVICES:
This device is similar to a Color Vision Plate Illuminator (886.1160
Woburn, MA 01801
Re: K012298
Trade/Device Name: The Intuitive Colormeter Regulation Number: 21 CFR 886.1160
A Spectacle Lens Tint Color Selector is an AC powered device that is a variable-color illuminator intended to simulate vision through different colors of spectacle lens tints for the purpose of selecting preferred tint(s).
A spectacle Lens Tint Color Selector is an AC powered device that is a variable illumination box intended to simulate vision through different colors of spectacle lens tints for the purpose of selecting preferred tint(s). The device is a variable color illuminator and is intended as an aid in the selection of tinted spectacle coatings. It provides illumination that simulates visual perception through various colors of tinted spectacles. The Intuitive Colorimeter uses light produced by a fluorescent tube, and the light is passed through a filter drum composed of seven colored filters consist of the 7 positions. The light is then viewed through a window in the instrument. When the drum is moved or rotated, the light becomes colored. Neutral density filters can adjust the luminance. Thus there are four calibrated controls, one for hue (color), one for saturation (depth), and one for the neutral density filter, plus a control that permits white fluorescent light to be substituted, for the purpose of base line evaluation.
1. Acceptance Criteria and Reported Device Performance:
The provided document (K012298) is a 510(k) premarket notification for a medical device. It does not contain an "acceptance criteria" section or detailed "reported device performance" in the typical sense of a clinical study demonstrating specific efficacy metrics against predefined thresholds.
Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed device. The core "acceptance criteria" here is that the device is "substantially equivalent" to the predicate device in terms of intended use and technological characteristics, and that it does not raise new questions of safety or effectiveness.
Therefore, for this specific document, the table would be:
| Acceptance Criteria (Implicit) | Reported Device Performance (as claimed by applicant) |
|---|---|
| Substantially equivalent to a Color Vision Plate Illuminator (886.1160) | The Intuitive Colorimeter is similar to a Color Vision Plate Illuminator. It provides variable illumination to simulate vision through different colors of spectacle lens tints for selecting preferred tints. It uses a fluorescent tube, a filter drum with seven colored filters, and controls for hue, saturation, and neutral density, plus a white light option. This functionality aids in the selection of tinted spectacle coatings, which can be custom-made by Cerium Visual Technologies in England based on the Colorimeter's specifications. The device aims to provide "improved selection of tinted spectacle lenses with the use of CONTINUOUSLY variable light, rather than just the evaluation with a limited selection of tinted lenses." |
| Does not raise new questions of safety or effectiveness | The document implies this through its focus on similarity to a predicate device and its description of the device's operational principles, without presenting any novel or unproven mechanisms. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe any specific test set or clinical study conducted to evaluate the device's performance against predefined metrics. The submission relies on a comparison to a predicate device and a description of its features. There is no mention of a "test set" in the context of performance validation.
Therefore, this information is not applicable based on the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
As no specific test set or clinical study for performance evaluation is described, there is no mention of experts establishing ground truth.
Therefore, this information is not applicable based on the provided text.
4. Adjudication Method for the Test Set:
Since no test set or clinical study for performance evaluation is described, there is no adjudication method mentioned.
Therefore, this information is not applicable based on the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC comparative effectiveness study is mentioned in the document. The submission is focused on demonstrating substantial equivalence, not on comparing performance with or without AI assistance (as the device is not an AI-based system).
Therefore, this information is not applicable based on the provided text.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The device described, "The Intuitive Colorimeter," is not an algorithm or an AI-based device. It is a physical instrument used by human professionals (Optometrists and Ophthalmologists) to aid in selecting spectacle lens tints. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used:
As no specific study or test set is described to establish performance, there is no mention of a type of ground truth used. The device's "effectiveness" is linked to its ability to help subjects select "preferred tints" and its use by licensed professionals, but no objective ground truth for this selection process is presented in the context of a validation study.
Therefore, this information is not applicable based on the provided text.
8. The Sample Size for the Training Set:
The document does not describe any training set as it pertains to an AI/ML algorithm or a study with such a component.
Therefore, this information is not applicable based on the provided text.
9. How the Ground Truth for the Training Set Was Established:
Since no training set is mentioned, there is no information on how its ground truth was established.
Therefore, this information is not applicable based on the provided text.
In summary, the provided document is a 510(k) premarket notification that focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study with acceptance criteria, test sets, and performance metrics as typically expected for novel devices or AI/ML systems. The "acceptance criteria" were met by establishing that the device was substantially equivalent and did not raise new safety or effectiveness concerns, leading to its clearance by the FDA.
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