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510(k) Data Aggregation
(86 days)
The SL OCT is an add on for a slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used for diagnostic purposes.
The SL-OCT enables non-destructive in-depth measurements of the structure and/or form of the anterior segment of the human eye. The visible structures are distinguished on the basis of their varying optical characteristics at the light wavelength used.
The information can be displayed, analysed and documented by the SL-OCT. To this end, a preinstalled software package - which may only be operated on this system - is supplied with the examination system.
This software records and displays the data and controls the measurement process. In addition. the software allows subsequent editing and saving of data to a database provides no permanent and secure archiving of OCT measurement data. For the documentation, the data are printed out and attached to the patient's medical record.
The images provided by the SL-OCT allow qualitative statements to be made about the dimensions and structures of the anterior segment and the dimensions of the identified structures to be quantified.
The SL-OCT is particularly suitable for non-contact in vivo imaging of the chamber angle and the anterior chamber.
This document is a 510(k) premarket notification for the SL-OCT (Slitlamp Optical Coherence Tomography) device. It describes the device's intended use and compares its technological characteristics to a predicate device, the Haag Streit AG Optical Low Coherence Pachymeter Pachy-01 SL, to demonstrate substantial equivalence.
This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way a modern AI/ML device would. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not applicable or explicitly stated in this type of regulatory document.
However, I can extract information related to the closest aspects of 'acceptance criteria' and 'study' as they appear in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device and meeting safety standards. The performance reported primarily involves comparisons of technical specifications.
| Acceptance Criteria (Implicit) | Reported Device Performance (SL-OCT) |
|---|---|
| Intended Use: Imaging and observation of the anterior segment of the eye for diagnostic purposes. | Intended Use: Imaging and observation of the anterior segment of the eye for diagnostic purposes. |
| Safety Standards: Compliance with relevant medical device safety and electromagnetic compatibility standards. | Tested according to IEC 60601-1 and IEC 60601-1-2, found to meet all requirements. Laser product of Class 1 according to 21 CFR Part 1040 Section 1040.10 and IEC 60825-1:1993+A2:2001. |
| Technological Characteristics: Similarities in key features to the predicate (Haag Streit AG Optical Low Coherence Pachymeter Pachy-01 SL). | - Corneal contact: No (same as predicate) |
| - Working distance cornea to objective: Ca. 50 mm (same as predicate) | |
| - Adjustment direction: Horizontal (same as predicate) | |
| - Working position: Horizontal (same as predicate) | |
| - Optical setup: Conventional microscope (same as predicate) | |
| - Type of scanning aperture: Point (same as predicate) | |
| - Lateral optical resolution: 20 μm - 100 µm (Predicate: ca. 10 microns) - Note: SL-OCT range is broader with lower resolution than predicate | |
| - Axial optical resolution capacity: |
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