Search Results

The HP-OCT™ instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of the posterior segment of the eye.

The Cylite Hyperparallel Optical Coherence Tomographer (HP-OCT) is an ophthalmic OCT system, intended to assist ophthalmic professionals in the diagnosis of ophthalmic conditions via non-contact imaging of the posterior segment. OCT imaging is accomplished in the HP-OCT instrument using a micro-lens array to separate the illumination from a super-luminescent diode (SLD) source into an array of parallel beamlets. The beamlet array is then projected simultaneously onto the eye. Each of the individual beamlets is equivalent to a single beam of an SD-OCT (Spectral Domain OCT) system. Each beamlet generates a spectral interferogram, equivalent to a single SD-OCT interferogram, which is processed to produce an individual A-scan. A set of 1008 parallel, SD-OCT type A-scans is thus acquired for each frame of the CMOS sensor, and multiple frames can be acquired to create dense volume images.

The HP-OCT instrument is supplied with an exchangeable lens which supports OCT imaging of the posterior segment.

The HP-OCT instrument is operated from the Cylite Focus softwarethat runs from a Windows 10 personal computer (PC) supplied by the user. The PC hosts the HP-OCT Capture and Focus Review software and connects to the HP-OCT instrument via a USB 3.0/3.1 cable. From the PC/software, the user employs the PC monitor, keyboard and mouse to interact with the HP-OCT instrument to perform instrument alignment, preview images, capture images, save or load image or patient data, review images, and manage patient data.

The Cylite HP-OCT is an ophthalmic OCT system intended for non-contact imaging and analysis of ocular structures, specifically for visualization of the posterior segment of the eye. Its substantial equivalence to the predicate device, the Carl Zeiss Meditec, Inc. Cirrus HD-OCT 5000 (K181534), was evaluated through both non-clinical and clinical performance testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative format for either the non-clinical or clinical performance. Instead, it describes the assessment of various performance aspects and concludes with a qualitative statement of "favorable clinical performance profile that supports a determination of substantial equivalence."

However, based on the comparative effectiveness study, we can infer the acceptance criterion was likely non-inferiority or comparability in the ability to identify anatomical structures and retinal abnormalities.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): A total of 83 eyes (43 normal eyes, 40 retinal diseased eyes) were enrolled in the clinical study.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. It mentions the study was conducted at three sites, implying prospective data collection for this specific study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Three independent graders were used.
• Qualifications of Experts: The specific qualifications (e.g., years of experience, subspecialty) of these graders are not provided in the document. They are identified as "image graders."

4. Adjudication Method for the Test Set

The document states that "For each image grader attempted to identify 9 anatomic structures and 11 abnormalities which were pre-defined and scored 1 (if identifiable) or 0 (if unidentifiable) for each structure/abnormality." It also mentions "inter-grader difference for HP-OCT for each structure and abnormity." However, it does not explicitly describe an adjudication method (like 2+1 or 3+1) to resolve discrepancies or establish a single ground truth from the three graders' individual assessments for either structures or abnormalities. It appears each grader's scores were compared directly between devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: Yes, a comparative effectiveness study involving multiple readers (three independent graders) and multiple cases (83 eyes) was performed, comparing the HP-OCT to the predicate device.
• Effect Size of Human Reader Improvement with AI: This information is not applicable as the HP-OCT is presented as an imaging device, not an AI-assisted diagnostic tool for human readers. The study compares the imaging performance of the device itself to a predicate, not the improvement of human readers using the device with AI versus without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: The document describes the device as a "non-contact ophthalmic imaging and analysis device" indicated for "visualization." The clinical study evaluated the device's ability to generate images that aid qualitative diagnosis by human graders. The results are based on human interpretation of the images produced by the device. Therefore, a standalone algorithm-only performance without human-in-the-loop is not explicitly described or indicated as the primary assessment. The device itself is not
  stated to perform automated diagnoses.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the clinical study was established by the identification and scoring of pre-defined anatomical structures and abnormalities by three independent expert graders based on the images generated by both the HP-OCT and the predicate device. This is a form of expert consensus/interpretation of imaging data. There is no mention of pathology, outcomes data, or other independent gold standards.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. The clinical study described is a performance validation study, not a study describing the development and training of an algorithm within the HP-OCT device itself. The HP-OCT is an imaging device, and while it uses software (Cylite Focus software), the provided information focuses on its image acquisition capabilities rather than an AI/ML component that would require a distinct training set for diagnostic purposes.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for an AI/ML diagnostic component, this information is not applicable.

Ask a specific question about this device