(89 days)
LipiScan™ Dynamic Meibomian Imager is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.
The LipiScan™ Dynamic Meibomian Imager (DMI) (Model DMI-1000) is a bench-top ophthalmic camera used to image the meibomian glands. LipiScan™ contains a computer system, electronics, chin and forehead rest, camera and attached lens, illuminator, touchscreen display, handheld near-infrared (IR) lid everter and power supply. The chin and forehead rest and handheld near IR lid everter are the only components of the device that contact the patient's intact skin. LipiScan™ uses near infrared (NIR) illumination and an NIR-sensitive high-resolution camera to image the meibomian glands. The tissue between the meibomian glands and the surface of the eyelid is transparent to NIR light; the glands reflect NIR wavelengths, allowing them to be imaged. The images of the glands may be viewed on the computer screen display and in a printed report.
The provided text is a 510(k) Summary for the LipiScan™ Dynamic Meibomian Imager. It primarily focuses on demonstrating substantial equivalence to a predicate device (LipiView® II Ocular Surface Interferometer) rather than presenting a standalone study with specific acceptance criteria and detailed performance data against those criteria.
However, based on the information provided, I can infer the implied acceptance criteria, the general type of "study" conducted (performance testing to demonstrate substantial equivalence), and some details about the testing:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria and a direct performance table are not provided in the 510(k) summary, the acceptance criteria are implicitly defined by compliance with relevant standards and demonstrating substantial equivalence to the predicate device. The "reported device performance" is described in terms of meeting these standards and having equivalent functionality for its specific indications.
| Acceptance Criteria Category (Implied) | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | Demonstrated to be as safe and effective as the predicate device for imaging meibomian glands. Design differences do not raise new questions of safety and effectiveness. | "Design verification and validation and usability testing demonstrate that LipiScan™ DMI is as safe and effective as the predicate device for the intended use to image the Meibomian glands using near-infrared light." "Performance testing demonstrates that LipiScan™ DMI is substantially equivalent to the predicate device, and the design differences as compared to the predicate device do not raise new questions of safety and effectiveness." |
| Biocompatibility | Patient contact materials are biocompatible or identical to those of the cleared predicate device. | "The surface-contacting material composition and device manufacturing process are the same as those of the predicate LipiView® II device cleared in K152869; therefore, new biocompatibility testing is not needed." |
| Sterilization, Cleaning & Disinfection | Non-sterile device, proper disinfection methods for patient contact surfaces, and compatibility of materials with disinfectant. | "Patient contact surfaces are disinfected with 70-90% isopropyl alcohol prior to each patient use and prior to storage. The verification testing shows that the device patient contact materials are compatible with isopropyl alcohol disinfection." |
| Electrical Safety & EMC | Conformance to specified electrical safety and electromagnetic compatibility (EMC) standards. | Tested for conformance to: |
- ANSI AAMI ES60601-1 2005 /(R)2012 and A1:2012: C1:2009/(R)2012 and A2:2010/(R)
- IEC 60601-1-2 2007 |
| Light Hazard Protection | Conformance to specified light hazard protection standards, indicating no potential light hazard. | "LipiScan™ DMI meets Group 1 ophthalmic instruments as defined in the ISO 15004-2: 2007 and ANSI Z80.36:2016 standards for which no potential light hazard exists." (Note: Predicate meets Group 2, implying a higher hazard, but this difference for LipiScan is presented as a positive, not a deviation needing further evaluation). |
| Software | Software performance complies with specifications and requirements, and it is categorized as a Minor Level of Concern. | "Verification and Validation testing were completed to demonstrate that the device performance complies with specifications and requirements identified for the LipiScan™ DMI software." "As for the predicate device, LipiScan™ DMI software is categorized as a Minor Level of Concern." |
| Imaging Functionality | Able to capture, archive, manipulate, and store digital images of the meibomian glands using NIR illumination. (Implied by the "Indications for Use" and "Technological Characteristics" sections). | Demonstrated through "Performance testing" and the comparison to the predicate, stating it has "the same principle of operation as an ophthalmic camera to image the meibomian glands using a LED light source in the near-infrared spectrum." The software features for real-time display, image storage, and export also confirm this functionality. Additionally, "Methods are equivalent. Motorized stages are not needed to capture and focus an image using LipiScan™, as shown by performance testing." indicating functionality. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for any specific "test set" in the context of clinical performance or image analysis. The "performance testing" mentioned generally refers to design verification and validation, usability testing, and bench testing against standards.
The data provenance for any potential clinical images used in "performance testing" is also not specified. It is likely that such testing would involve capturing images from human subjects, but the details (e.g., country of origin, retrospective or prospective) are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention using experts to establish ground truth for a test set. This type of analysis (e.g., grading of meibomian gland images by experts) is not described in detail as part of the substantial equivalence claim.
4. Adjudication Method for the Test Set
Since the document does not describe the use of experts or a specific test set for diagnostic performance, an adjudication method is not mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned in the document. The filing focuses on demonstrating substantial equivalence of the device's functionality and safety characteristics to a predicate, not on improving human reader performance with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No standalone algorithm performance study is explicitly described. The device is an "ophthalmic imaging device intended for use by a physician... to capture, archive, manipulate and store digital images." While it uses software, the primary evaluation is of the device's ability to acquire and manage images, rather than an AI algorithm making diagnostic decisions or segmentations independently. The software evaluation is focused on compliance with specifications and requirements, not standalone diagnostic performance.
7. The Type of Ground Truth Used
Given the nature of the device (an imager) and the focus on substantial equivalence for technical characteristics and image acquisition, the "ground truth" implicitly refers to:
- Compliance with engineering and safety standards: The device passes tests against established standards for electrical safety, EMC, light hazard, and material flammability (e.g., ANSI, ISO, IEC, UL standards).
- Functional equivalence to the predicate: The LipiScan™'s ability to capture images of meibomian glands is considered equivalent to the predicate device's capability, which serves as the established gold standard for this function.
- Successful software verification and validation: The software performs according to its designed specifications.
8. The Sample Size for the Training Set
The document does not mention any training set size, as it does not describe the development or evaluation of a machine learning or AI algorithm that would typically require a training set for diagnostic or analytical tasks. The software development was largely based on existing software from the predicate device.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of an AI/ML algorithm, the method for establishing ground truth for a training set is not applicable/not provided.
§ 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.