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510(k) Data Aggregation
(113 days)
KEELER KAPTURE SOFTWARE
The Keeler Kapture Software Package is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps
The Keeler Kapture software is an ophthalmic imaging system. The Kapture software package is intended to run on a PC and will allow the user to capture images from a digital slit lamp or other camera for review and storage. Images can have basic adjustments (such as colour, brightness and contrast) and images can be visually compared.
The provided text describes the Keeler Kapture Software, an ophthalmic imaging system, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer all parts of your request. Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with quantitative metrics. Instead, it details a comparison of functional features between the Keeler Kapture Software and the predicate device, EyeCap Imaging System. The acceptance criterion implicitly seems to be functional equivalence to the predicate device.
| Kapture function/Feature | Acceptance Criterion (Presence in EyeCap) | Reported Device Performance (Kapture) |
|---|---|---|
| Administration | Yes | Yes (Implied: All tests passed) |
| Allow log-in as administrator or user | Yes | Yes (Implied: All tests passed) |
| Add and manage users and their scope | Yes | Yes (Implied: All tests passed) |
| Add cameras and manage cameras | Yes | Yes (Implied: All tests passed) |
| Assign cameras to workstations | Yes | Yes (Implied: All tests passed) |
| Manage user configurable options | Yes | Yes (Implied: All tests passed) |
| Manage user definable fields | Yes | Yes (Implied: All tests passed) |
| Manage data entry formats | Yes | Yes (Implied: All tests passed) |
| Manage system settings and file locations | Yes | Yes (Implied: All tests passed) |
| Manage the database | Yes | Yes (Implied: All tests passed) |
| Track changes to the database in an audit trail | Yes | Yes (Implied: All tests passed) |
| Show statistical information about the system | Yes | Yes (Implied: All tests passed) |
| Patient Database | Yes | Yes (Implied: All tests passed) |
| Allow addition, deletion and editing of patient data | Yes | Yes (Implied: All tests passed) |
| Information and images collected from each patient visit shall be stored separately | Yes | Yes (Implied: All tests passed) |
| Allow review of patient data and images | Yes | Yes (Implied: All tests passed) |
| Allow searching of the database | Yes | Yes (Implied: All tests passed) |
| Allow configuration of search reports | Yes | Yes (Implied: All tests passed) |
| Image Capture | Yes | Yes (Implied: All tests passed) |
| Image capture shall be available from within a patient episode | Yes | Yes (Implied: All tests passed) |
| It shall be possible to capture images from a camera | Yes | Yes (Implied: All tests passed) |
| It shall be possible to adjust the brightness of images captured from a camera | Yes | Yes (Implied: All tests passed) |
| It shall be possible to import an image from a file | Yes | Yes (Implied: All tests passed) |
| When an image is captured, an "X" is assigned to indicate that there is no left or right eye assignment | Yes | Yes (Implied: All tests passed) |
| It shall be possible to manually assign "L" or "R" to an image to indicate left or right eye | Yes | Yes (Implied: All tests passed) |
| Image Adjustment | Yes (Notes to image) | Yes (Implied: All tests passed) |
| It shall be possible to alter how images are printed | Yes | Yes (Implied: All tests passed) |
| It shall be possible to mosaic several images together | Yes | Yes (Implied: All tests passed) |
| It shall be possible to split image planes by colour | Yes | Yes (Implied: All tests passed) |
| It shall be possible to make annotations on the captured image | Yes | Yes (Implied: All tests passed) |
| It shall be possible to present images together for comparison | Yes | Yes (Implied: All tests passed) |
| Tools shall be provided to grade images | Yes | Yes (Implied: All tests passed) |
| An image brightness map, or histogram shall be provided | Yes | Yes (Implied: All tests passed) |
| It shall be possible to undo any image manipulation | Yes | Yes (Implied: All tests passed) |
| It shall be possible to apply a time and date to captured images | Yes | Yes (Implied: All tests passed) |
2. Sample size used for the test set and the data provenance
The document states, "A number of functional tests were carried out to verify the performance of the Keeler Kapture Software against the EyeCap Imaging System." It does not specify a numerical sample size for a test set in terms of patients or images. The data provenance is not mentioned. The study appears to be a functional verification against a predicate device, not a clinical study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The testing described focuses on functional equivalence to the predicate device, not on establishing a clinical ground truth with expert consensus.
4. Adjudication method for the test set
This information is not provided.
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 such study is mentioned in the provided text. The Keeler Kapture Software is described as an ophthalmic imaging system for capturing, storing, and managing images, not an AI-powered diagnostic tool for interpretation or assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of the Keeler Kapture Software as described. It is a software package for managing images, not an algorithm performing a diagnostic task independently. Its performance is evaluated based on its functionality matching a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the functional behavior and features of the predicate device, the Clement Clarke International Ltd EyeCap Imaging System. The Keeler Kapture Software was tested to ensure its functions matched those of the EyeCap.
8. The sample size for the training set
This information is not provided. The Keeler Kapture Software is not an AI/ML model that would typically have a "training set" in the sense of supervised learning. It's application software.
9. How the ground truth for the training set was established
This is not applicable, as it's not an AI/ML model requiring a training set with established ground truth from data. Its ground truth for development and testing was likely the functional specifications derived from the predicate device.
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