(48 days)
The ImageScape is intended to be used to capture, store and manipulate digital images of the retina taken by fundus camera.
The ImageScape is intended to capture, store, and manipulate digital images of the retina taken by a fundus camera.
The ImageScape consists of: (1) a digital camera; (2) an imaging board; (3) a personal computer; (4) a monitor; and (5) Tomey's Windows-based image processing software. The ImageScape is used during ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp with a fundus camera. Images are transferred to the ImageScape's imaging board, located in the ImageScape's personal computer, and stored in the computer's Random Access memory ("RAM") and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to operate the icons.
The provided 510(k) summary for the Tomey Corporation's ImageScape Digital Retinal Image System (K971685) does not contain information related to specific acceptance criteria or a study proving the device meets such criteria in terms of clinical performance.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use: All devices (ImageScape, DFC, Imagenet, ORIMS) are intended to capture, store, and manipulate digital images of the retina taken by a fundus camera.
- Technological Characteristics: Similar components (e.g., Kodak MegaPlus digital camera), storage capabilities (Jaz drive, TIFF format), operating systems (Pentium chip, Windows/Macintosh), and input methods (keyboard, mouse).
- Software Functions: Similar functions for image acquisition, analysis, storage, and retrieval, including manipulation (zoom, invert, flip, rotate, brightness/contrast, sharpen) and enhancement (shadow, edge trace, blur).
- Operational Manner: Used by an ophthalmologist with a slit lamp and fundus camera, preparing the patient using standard ophthalmic procedures, and operating icon-driven interfaces.
- Software Verification and Validation: A statement that "Tomey has performed the software verification and validation. The verification and validation results demonstrate that the device meets the system and software specifications and requirements."
Therefore, many sections of your requested outline will be marked as "Not provided" or "Not applicable" based on the content of the K971685 submission. This is typical for 510(k) submissions demonstrating substantial equivalence for devices like this, where clinical performance studies are often not required if technological characteristics and intended use are similar to legally marketed predicate devices.
Here's the breakdown based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance: | Not provided. The submission focuses on substantial equivalence to predicate devices based on technological characteristics and intended use, not on specific clinical performance metrics for the ImageScape. |
| Software Verification & Validation: Device meets system and software specifications and requirements. | Met. "Tomey has performed the software verification and validation. The verification and validation results demonstrate that the device meets the system and software specifications and requirements." |
| Image Acquisition, Storage, Manipulation, Retrieval: Functions comparable to predicate devices. | Met. The ImageScape and predicate devices have "the same software functions: image acquisition, analysis, storage, and retrieval." |
| Image Quality: (Implied, derived from predicate equivalence) | Image transfer and processing does not use data compression, suggesting a focus on preserving image quality. No specific image quality metrics are provided. |
| Safety & Effectiveness: No new issues raised compared to predicate devices. | Met. "Minor differences do not raise any new issues of safety or effectiveness." and "This difference [operating system] does not raise any new issues of safety or effectiveness." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not provided. This type of information is typically part of a clinical performance study, which was not the primary basis for this 510(k) submission.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. Ground truth establishment for a clinical test set is not part of this substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/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
- Not applicable/Not provided. This device is a digital imaging system, not an AI-powered diagnostic aid that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. The device is described as being operated by an ophthalmologist.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The submission relies on demonstrating functional and technical equivalence to predicate devices, rather than a direct clinical performance study requiring a gold standard ground truth.
8. The sample size for the training set
- Not provided. Given that this is an imaging system and not a machine learning algorithm in the modern sense, a "training set" as concept might not directly apply. The device's software was developed and validated against specifications.
9. How the ground truth for the training set was established
- Not applicable/Not provided. The software verification and validation would have been against predetermined system and software specifications and requirements, as stated in the document. This is distinct from establishing a clinical "ground truth" for a diagnostic algorithm.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.