(270 days)
The Slit Lamp SL-D701 is an AC-powered slittlamp biomicroscope 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.
The Slit Lamp SL-D701 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. The Slit Lamp SL-D701 is composed of the following components: microscope unit, illumination unit, base unit, chinrest, table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.
This document is a 510(k) Summary for the Topcon Slit Lamp SL-D701, a medical device. It provides information for substantial equivalence to previously cleared predicate devices. However, it does not include information about acceptance criteria and a study proving that the device meets those criteria, as typically seen in submissions for AI/ML-enabled devices.
The document states that the Topcon Slit Lamp SL-D701 is substantially equivalent to the predicate devices:
- Haag-Streit AG Slit Lamp BM 900, BQ 900, BP 900 (K100202)
- TOPCON CORPORATION Slit Lamp SL-2G (K110489)
The key takeaway is that this is a traditional medical device (Slit Lamp Biomicroscope), and the submission focuses on demonstrating substantial equivalence to existing devices based on similar intended use, technological characteristics, principles of operation, and compliance with recognized consensus standards. There is no mention of AI/ML, algorithms, or any associated acceptance criteria, test sets, or ground truth establishment studies typically required for such technologies.
Therefore, most of the requested information regarding acceptance criteria and a study proving an AI/ML device meets them is not applicable to this document.
Here's an attempt to answer the questions based on the provided document, highlighting where the information is not present or not applicable:
1. A table of acceptance criteria and the reported device performance
| Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Intended Use | Eye examination of the anterior eye segment to aid in diagnosis of diseases/trauma affecting structural properties. | "The Slit Lamp SL-D701 has the same intended use and indications for use... as the previously cleared predicates." |
| Technological Characteristics | AC-powered slit lamp biomicroscope, projects a thin, intense beam of light. Exposure parameters (slit image width, length, illumination field diameter, slit direction) within predicate specifications. LED light source. Magnification steps and eyepiece lens magnification. | "The Slit Lamp SL-D701 has similar technological characteristics to the predicate devices." |
| Slit image width: 0-14 mm (same as SL-2G). | ||
| Slit image length: 0-14 mm (same as SL-2G). | ||
| LED light source (similar to SL-2G, one of available sources for BM/BQ/BP 900). | ||
| Max brightness: 440,000 Lux (equivalent to Haag Streit slit lamps). | ||
| Same magnification steps (negligible difference between 6x and 6.3x) and eyepiece lens magnification as Haag-Streit. | ||
| Performance Standards Compliance | Compliance with specific international standards. | ISO 15004-1:2006: "The testing found that the product met the requirements." |
| ISO 15004-2:2007: "The testing found that the device is a Group 2 instrument which is non-hazardous." | ||
| ISO 10939:2007: "found that the SL-D701 complies with the requirements of the standard." | ||
| Predicate Device Equivalence | To be substantially equivalent to K100202 and K110489. | "The Topcon Slit Lamp SL-D701 is substantially equivalent to the predicate devices..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this 510(k) submission, as it describes a traditional hardware device (slit lamp) and not an AI/ML diagnostic algorithm that would require a test set of data samples. The performance data presented refers to bench testing against international standards for ophthalmic instruments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices, not for the physical performance testing of a slit lamp as described here. The "performance data" refers to compliance with engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used in studies involving human interpretation or AI/ML evaluations to resolve disagreements in ground truth or diagnostic outputs. This submission focuses on bench testing.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This type of study is typically conducted for AI/ML-assisted diagnostic devices to measure the impact of the AI on human reader performance, which is not relevant for this traditional slit lamp submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical slit lamp biomicroscope; there is no standalone algorithm to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The "ground truth" for this device's performance is its adherence to specified engineering and safety standards (e.g., light hazard protection, general requirements for ophthalmic instruments), as demonstrated through bench testing. There is no diagnostic "ground truth" in the context of disease detection or image interpretation for a software algorithm.
8. The sample size for the training set
This information is not applicable. There is no mention of a training set, as the device is a physical instrument, not an AI/ML algorithm that learns from data.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set mentioned or implied for this traditional medical device.
§ 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.