(90 days)
The Chongqing Sunkingdom Slit Lamp LS-1A, LS-1B are AC --- powered slit lamp Biomicroscopes 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 affects the structural properties of the anterior eye segment.
Sunkingdom slit lamp LS-1A, LS-1B are an AC-powered 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 affects the structural properties of the anterior eye segment. An AC-powered Slit lamp Bio-microscope 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. Components: The optical body, movement mechanism, illumination system, portable handle, power supply.
The given text is a 510(k) Pre-market Notification for the Sunkingdom Slit Lamp LS-1A, LS-1B. It details the device's technical characteristics and performance testing conducted to demonstrate substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance:
The document primarily relies on demonstrating compliance with relevant industry standards and showing that the proposed device's performance characteristics are comparable to or better than the predicate device. The acceptance criteria are implicitly defined by these standards and the comparison table.
| Acceptance Criteria (Implied by Standards and Predicate Comparison) | Reported Device Performance (Sunkingdom Slit Lamp LS-1A, LS-1B) |
|---|---|
| Biocompatibility: | |
| - No potential toxicity to L-929 cells (for patient contact materials) | Chinrest pat and Forehead band extract did not show potential toxicity to L-929 cells. |
| - No skin irritation (for patient contact materials) | Extract of applied sample Chinrest pat and Forehead band did not induce skin irritation in rabbitskin. |
| - No skin sensitization (for patient contact materials) | Chinrest pat and Forehead band extract showed no significant evidence of causing skin sensitization in the guinea pig. |
| Electrical Safety and Electromagnetic Compatibility (EMC): | |
| - Compliance with "ANSI AAMI IEC60601-1-2:2007/(R)2012" (EMC) | System complies with "ANSI AAMI IEC60601-1-2:2007/(R)2012". |
| - Compliance with "ANSI AAMIES60601-1:2005/(R)2012AndA1:2012" (Safety) | System complies with "ANSI AAMIES60601-1:2005/(R)2012AndA1:2012". |
| Performance Testing: | |
| - Compliance with "Standard ISO 10939: Ophthalmic instruments-Slit-Lamp microscopes" | System complies with Standard ISO 10939. |
| Light Hazard Protection: | |
| - Compliance with "ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection" | System complies with ISO 15004-2:2007. |
| - Classification for light hazard | Classified into Group 2 instruments. Exposure at maximum intensity will exceed safety guidelines after 83 seconds (caution indicated on label). |
| Operational Characteristics (Comparison to Predicate): | |
| - Flammability of materials near light source | None (Same as predicate) |
| - Maximum temperature of parts (operator/patient accessible) | Operator: Eyepiece, Grip, Slit width control ring all 35 °C. Patient: Forehead rest 35 °C. (Same as predicate) |
| - Brightness controls (Maximal Illumination) | ≥250000 Lux (Predicate: ≥30000 Lux. Proposed device is significantly different but justified by light hazard test.) |
| - Slit Width | 0.1mm, 0.2mm, 0.8mm, 1mm, 5mm, 12mm (Predicate: 0 to 12mm continuously adjustable. Differences deemed not significant.) |
| - Slit Length | 1mm, 5mm, 8mm, 12mm (Predicate: 0.2mm, 1mm, 2mm, 12mm. Differences deemed not significant.) |
| - Radial movement of slit light illumination relative to microscope axis | Horizontal ±60° (Predicate: Horizontal ±30°. Proposed device is better.) |
| - Stereo angle | 13° (Same as predicate) |
| - Light sources | LED (Same as predicate; deemed safe with IR/UV filter) |
| - Pupil-distance | 49-75mm (Predicate: 50-75mm. Differences deemed not significant.) |
| - Eyepiece | 12.5X (Predicate: 10X, 16X. Differences deemed not significant.) |
| - Objective | 1X (Same as predicate) |
| - Total magnifications | LS-1A: 10X; LS-1B: 10X, 16X (Predicate: 10X, 16X (Optional). Differences deemed not significant.) |
| - Filter | Neutral density, Red-free, Cobalt blue (Predicate: Cobalt blue, Red-free, Color Temperature Compensation. Differences deemed not significant.) |
| - Working distance | 100mm (10X), 80mm (16X) (Predicate: 60mm. Differences deemed not significant.) |
| - Power | 7.4V/680mAh, AA Battery (Predicate: 7.4V 2200mA Li Battery, Rechargeable. Differences deemed not significant as both conform to ISO 10939.) |
| - Working time | 4 hours (Predicate: 2.5 hours. Proposed device is better.) |
| - Net Weight | 890g (with battery) (Predicate: 900g. Differences deemed not significant.) |
Study Information:
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Sample size used for the test set and the data provenance:
- The document does not explicitly state a "test set" in the context of clinical data for performance evaluation. The performance data provided is primarily from bench testing and compliance with standardized tests (Biocompatibility, Electrical safety, EMC, Performance testing according to ISO 10939, Light Hazard Protection according to ISO 15004-2).
- For biocompatibility, the tests were conducted with specific samples (e.g., "Chinrest pat and Forehead band extract," "rabbitskin," "guinea pig," "L-929 cells").
- The data provenance is not specified beyond the tests being conducted on the "Sunkingdom Slit Lamp LS-1A, LS-1B" and under recognized FDA standards and Good Laboratory Practice (21 CFR 58). This suggests the tests were carried out by the manufacturer or a contracted lab. There's no indication of retrospective or prospective human clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the study did not involve human expert interpretation of clinical cases to establish ground truth. The "ground truth" for the performance claims were objective measurements and adherence to technical specifications and international standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no human adjudication of clinical cases was performed.
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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 MRMC comparative effectiveness study was done. This device is a traditional medical instrument (slit lamp biomicroscope), not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is a medical device for direct human use in eye examination, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The ground truth is established by objective measurements against engineering specifications and compliance with international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety/EMC, ISO 10939 for slit lamps, ISO 15004-2 for light hazard).
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The sample size for the training set:
- Not applicable. This device does not use an AI component requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. This device does not use an AI component or 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.