(89 days)
The Xcel 455 Slit Lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.
The Xcel 455 slit lamp is a general purpose examination instrument used in a wide range of eye care practices. Slit lamps are used for ophthalmic observation of the structures of the eye. By controlling the light source, nature of slit, and filters, physicians, optometrists, ophthalmologists and eye care technicians can observe various structures in the eye. The Xcel 455 can be used on any patient; there are no contraindications.
Ophthalmic slit lamp design has not changed in decades, and like most, including the predicate Xcel 255, the Xcel 455 slit lamp consists of two fundamental subsystems, the illumination source to illuminate the eye to be examined, and the microscope to enable the practitioner to view the structures of the eye under magnification.
The Xcel 455 uses a low voltage (6 Volt, 20 Watt) dimmable halogen lamp, and a selection of 4 color filters, or none, to illuminate the eye. The device uses a stereo microscope with 5 selections of magnification ranges, from 6.5x to 40x, to view the structure. There is a mount that allows other devices to attach in line with the optical path, such as a prism type contact tonometer.
Like the predicate Xcel 255 device, the Xcel 455 device uses a steel body and glass lenses. The scientific principle of all slit lamps is to project light onto a patient's eye, so that a doctor may view the eye and its structures through a microscope.
The document describes the Reichert Xcel 455 Slit Lamp, an AC-powered slit lamp biomicroscope intended for examining the anterior eye segment to aid in diagnosing diseases or trauma affecting its structural properties. The submission claims substantial equivalence to the Reichert Xcel 255 Slit Lamp (K063750).
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list acceptance criteria in a quantitative table with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it states that the device was evaluated against several international standards and "passed" them.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1:2007 (3rd edition) for electrical safety | Passed |
| IEC 60601-1-2 for EMC compliance | Passed at Class A radiated emissions limits |
| ISO 10993-1 for biocompatibility of forehead & chinrest materials | Passed |
| ISO 15004-1 for environmental tolerance of ophthalmic devices | Passed |
| ISO 15004-2 for photo-biological safety of light intensity limits | Passed |
| ISO 10939 (which includes ISO 15004-1, 15004-2, and IEC 60601-1) | Passed |
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The tests performed are engineering and safety standard compliance tests, not clinical performance studies involving a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no test set involving patient data requiring expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as there was no test set involving patient data.
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:
This information is not applicable. The device is a physical slit lamp, not an AI-powered diagnostic tool, and no MRMC study was mentioned. The determination of substantial equivalence was based on nonclinical performance data, and did not include clinical data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is an ophthalmic examination instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable as the studies conducted were engineering and safety compliance tests, not clinical performance studies. The "ground truth" for these tests would be the established specifications and requirements of the various IEC and ISO standards.
8. The sample size for the training set:
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.