(115 days)
The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
The LipiView® Ocular Surface Interferometer is a bench-top imaging device containing a computer system and electronics, chin rest and forehead rest, camera and zoom lens, illuminator and a touch screen display. The LipiView® Interferometer operates on the principle of white light interferometry and provides an interferometry color assessment of the tear film by specular reflection. The computer system captures a video image file that is recorded over time since the interference pattern changes as the tear film is distributed across the cornea during blinking. The video image of the ocular surface may be viewed on the computer screen display and in a printed report.
The provided 510(k) summary for the LipiView® Ocular Surface Interferometer (K091935) does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in terms of clinical performance or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technological comparisons and compliance with relevant safety and manufacturing standards.
Here's an analysis based on the provided text, highlighting the absence of information where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not include a table of specific acceptance criteria related to a clinical performance study (e.g., sensitivity, specificity, accuracy for a particular clinical task) nor does it report such performance metrics. The "performance testing" mentioned refers to compliance with safety and manufacturing standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document for clinical performance or diagnostic accuracy. | Not specified in the provided document for clinical performance or diagnostic accuracy. |
| Electrical safety & electromagnetic compatibility standards | Conforms to requirements |
| Optical radiation safety standards | Conforms to requirements, exposure and level of illumination complies with ISO 15004-2 Group 1 instrument for safety |
| Slit lamp biomicroscope requirements | Conforms to requirements |
| Material flammability (materials near light source) | Complies with UL 94V-1 |
| Software validation | Developed and tested in compliance with FDA Guidance documents for software validation in medical devices |
| Risk management | Designed and will be manufactured in compliance with voluntary consensus standards for risk management |
| Quality management systems | Designed and will be manufactured in compliance with voluntary consensus standards for quality management systems |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study data is provided in the document from which to derive a sample size or data provenance. The submission focuses on device design and comparison to predicate devices, not a clinical performance evaluation.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Since no clinical performance study or test set data is provided, there is no mention of experts establishing ground truth for such a study.
4. Adjudication Method
Not applicable. Since no clinical performance study or test set data is provided, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on substantial equivalence based on technological characteristics and safety standards, rather than a clinical trial comparing device performance with and without AI assistance or against human readers.
6. Standalone Performance Study (Algorithm Only)
The device described is an "Ocular Surface Interferometer," an imaging device. While it contains computer software, the provided summary does not detail any standalone algorithmic performance (e.g., automated disease detection, quantification of a specific biological marker) that would necessitate a standalone performance study in the way modern AI/ML devices often do. Its intended use is to capture, archive, manipulate, and store digital images for visual monitoring and documentation by a physician.
7. Type of Ground Truth Used
Not applicable. As no clinical performance study is detailed, no specific ground truth (expert consensus, pathology, outcomes data) is discussed for such a study.
8. Sample Size for the Training Set
Not applicable. The document does not describe the development of an AI/ML algorithm that would require a training set in the conventional sense. The "software was developed and tested in compliance with FDA Guidance documents for software validation in medical devices," which refers to general software engineering principles, not necessarily AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no AI/ML algorithm requiring a training set is described, no ground truth establishment method for a training set is mentioned.
Conclusion based on the provided document:
The 510(k) submission for the LipiView® Ocular Surface Interferometer (K091935) relied primarily on demonstrating substantial equivalence to already cleared predicate devices by comparing their intended use, technological characteristics, and compliance with applicable safety and manufacturing standards. It does not present detailed clinical acceptance criteria or a study focused on clinical performance metrics like diagnostic accuracy, sensitivity, or specificity for a particular clinical condition. The "performance testing" cited pertains to engineering and safety standards, not clinical effectiveness.
§ 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.