(103 days)
The FF450 plus VISUPAC system is intended to capture, display, store, and manipulate images of eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
The FF450 plus VISUPAC system and the predicate devices use monocular ophthalmic cameras that function according to the same principles of operation and technological characteristics. Light from an external light source is used to generate images of the eye which are captured using the fundus camera, displayed on a monitor, stored on electronic media by a computer system, and manipulated by the user via the system software.
This 510(k) summary (K011877) for the Carl Zeiss Jena's FF450 plus VISUPAC System does not contain detailed acceptance criteria or a study demonstrating that the device meets such criteria.
The document primarily focuses on establishing "substantial equivalence" of the FF450 plus VISUPAC System to predicate devices (Topcon, Inc. IMAGEnet Digital Ophthalmic Imaging System and Tomey Corporation ImageScape Digital Retinal Imaging System). Substantial equivalence means that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested details about acceptance criteria, specific performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in this 510(k) submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance criteria" here are implicitly related to demonstrating "substantial equivalence" to predicate devices for its intended use (capturing, displaying, storing, and manipulating images to aid in diagnosing/monitoring eye diseases).
- Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution) are provided in the document. The document states that the device functions according to the "same principles of operation and technological characteristics" as the predicate devices, and that it permits the acquisition, manipulation, storage, and retrieval of images.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not mentioned. This document does not describe a clinical performance study with a test set.
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 mentioned. No test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not mentioned. No test set or adjudication method is described.
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 MRMC study was mentioned.
- This device is described as an "ophthalmic camera and image management system," not an AI-assisted diagnostic tool, so "human readers improve with AI" is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This device is an imaging and image management system, not an algorithm, so "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not mentioned. No ground truth is described.
8. The sample size for the training set
- Not mentioned. No training set is described as this is not an AI/ML device that undergoes a training process.
9. How the ground truth for the training set was established
- Not mentioned. Not applicable as no training set is described.
Summary based on the provided document:
The 510(k) submission for the FF450 plus VISUPAC System establishes substantial equivalence to existing predicate devices (Topcon IMAGEnet and Tomey ImageScape). The implicit "acceptance criteria" for this submission appear to be:
- Intended Use Equivalence: The device shares the same intended use as the predicate devices (capture, display, store, manipulate eye images to aid in diagnosing/monitoring diseases). (Met)
- Technological Characteristics Equivalence: The device operates on the same principles (monocular ophthalmic camera, light source for image generation) and has similar technological characteristics. Minor differences (e.g., user support, storage media) do not raise new safety or effectiveness concerns. (Met)
The document does not provide data from specific performance studies, clinical trials, or expert reviews for its own performance, but rather leverages the regulatory pathway of substantial equivalence to already marketed devices.
§ 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.