(194 days)
The BL-5000 portable 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 BL-5000 portable slit lamp 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 BL-5000 portable slit lamp is composed of the following components: microscope unit, illumination unit, base unit 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.
The provided text describes a 510(k) premarket notification for the BL-5000 Portable Slit Lamp, a medical device. The document primarily focuses on establishing substantial equivalence to a predicate device (PSL Portable Slit Lamp, K061330) based on technological characteristics and non-clinical testing.
However, the document does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of diagnostic accuracy or clinical effectiveness. Instead, it relies on demonstrating that the device's technical specifications and safety comply with relevant international standards and are comparable to its predicate.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not available in the provided text, as these are typically associated with performance studies, especially those involving AI or diagnostic accuracy, which is not the focus of this 510(k) submission for a slit lamp.
Here's an attempt to answer the questions based only on the provided text, highlighting the missing information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of clinical performance thresholds. Instead, it relies on compliance with international standards and similarity to the predicate device's specifications.
| Characteristic / Standard | Acceptance/Conformance Criteria (Implicit) | Reported Device Performance (BL-5000) |
|---|---|---|
| Safety and Essential Performance | Compliance with IEC 60601-1:2006+A1:2012 | Met requirements |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2007 | Met requirements |
| General Ophthalmic Instrument Requirements | Compliance with ISO 15004-1:2006 | Met requirements |
| Light Hazard Protection | Compliance with ISO 15004-2:2007 (classified as non-hazardous) | Classified as Group 2 instrument (non-hazardous) |
| Slit-lamp Microscope Requirements | Compliance with ISO 10939:2007 | Complies with requirements |
| Total Magnifications | Similar to predicate (10X, 16X) | 10X, 16X |
| Diopter Adjustment | Similar to predicate (± 7D) | ± 5D |
| Filter | Similar to predicate (Green, cobalt blue, Color temperature conversion) | Green, cobalt blue, Color temperature conversion |
| Slit Rotation | Similar to predicate (± 30°C) | ± 30°C |
| Light Source | Similar to predicate (High luminance white LED) | High luminance white LED |
| Slit Width | Similar to predicate (0~11mm) | 0~12.5mm |
| Slit Length | Similar to predicate (0~11mm) | 0~12.5mm |
Study to prove device meets acceptance criteria:
The study proving the device meets the "acceptance criteria" (which are primarily regulatory and technical compliance, and comparability to the predicate) consisted of bench testing against the listed international standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2, ISO 10939). The results of these tests indicated that the product met the requirements of these standards. Additionally, a comparison table was used to demonstrate the technological equivalence of the BL-5000 Portable Slit Lamp to the predicate device (PSL Portable Slit Lamp, K061330).
Detailed breakdown for remaining items:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document describes bench testing of the device itself against technical standards, rather than testing on a dataset of clinical cases. There is no mention of a clinical "test set" in the context of diagnostic accuracy.
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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):
- Not applicable / Not provided. No clinical test set or ground truth determination by experts is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set or adjudication process is described.
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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. The device is a "portable slit lamp" for eye examination, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / No. The device is a physical diagnostic instrument and does not involve an algorithm for standalone performance evaluation in the context of this submission. The document explicitly states "All controls are manual. Neither the BL-5000 nor its predicate device has data collection, display systems, motors, or software."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. For the bench testing, the "ground truth" was compliance with the specified international standards. No clinical ground truth (like pathology or expert consensus on patient cases) was used.
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The sample size for the training set:
- Not applicable / Not provided. As this is not an AI/machine learning device, there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable / Not provided. No training set exists for this 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.