(59 days)
The SLIT LAMP, HS-5000 is intended for use in eye examination of the anterior eye segment, from the cornea 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 eye segment.
A slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea 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 eye segment. These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific procedures (biomicroscopic examination of the eye). The instrument is consist of a microscope, a swivelling illumination system providing a slit image and a power supply. AC Power is converted to DC Power through the SMPS. DC Power is supplied to the Lamp providing the light. Light is converted to the slit image through the aperture, filter etc. The slit image is illuminate the eye. Observe the eye through the microscope.
The provided text describes a 510(k) premarket notification for a medical device called the "Slit Lamp HS-5000" by HUVITZ Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device, the "Slit lamp SL 990" by C.S.O.S.R.L.
However, the provided text does not describe a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML medical device would. Instead, it focuses on demonstrating safety and effectiveness for a traditional medical device (a slit lamp) through comparison with a predicate device and adherence to established safety and performance standards.
Therefore, many of the requested sections related to AI/ML device study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this submission.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission confirms the device's adherence to relevant safety and EMC standards as its "acceptance criteria" for demonstrating safety and effectiveness. The "reported device performance" is its successful testing against these standards. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy) provided as would be expected for an AI/ML device.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| Electrical, mechanical, and environmental safety | Performed by UL Korea, Ltd. according to Standard IEC 60601-1. |
| EMC testing | Performed by EMC Compliance Co., Ltd. according to Standard IEC 60601-1-2(2001). |
| Overall Conclusion of Safety and Effectiveness | All test results were satisfactory. Device is safe and effective and substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a traditional medical device submission based on engineering and safety standards, not a clinical performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth as understood in AI/ML is not relevant here. The "ground truth" for the device's functionality is its adherence to engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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:
- No. This is not an AI-powered device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-only device. It's a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the context of clinical "ground truth" for diagnostic performance. For the purpose of this submission, the "ground truth" for the device's safety and functionality is established by its compliance with recognized international safety and electromagnetic compatibility (EMC) standards (IEC 60601-1 and IEC 60601-1-2).
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable.
§ 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.