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510(k) Data Aggregation
(294 days)
SUZHOU KANGJIE MEDICAL INC
Portable Slit Lamp Microscope Model KJ5S is intended for use in the anterior and posterior segment of the eye.
The Portable Slit Lamp Microscope is a hand held converging stereomicroscope system powered by rechargeable batteries.
This document describes the FDA 510(k) clearance for the Portable Slit Lamp Microscope Model KJ5S by Suzhou Kangjie Medical Inc.
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 present a table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity). Instead, the performance evaluation for this device is based on non-clinical tests to ensure safety and functionality, and a comparison to a predicate device to demonstrate substantial equivalence.
The comparative table on pages 6-7 serves as the primary method to show the device's technical characteristics meet acceptable standards by demonstrating similarity to a legally marketed device.
| Characteristic / Acceptance Criterion (Implicitly, similarity to predicate) | Proposed Device (Model KJ5S) Performance | Predicate Device (K131711, YZ3 Portable Slit Lamp microscope) Performance | Difference / Assessment |
|---|---|---|---|
| Safety: | |||
| Flammability of materials near light source | NONE | NONE | Same |
| Max temp. of parts held by operator (Eyepiece, Grip, Slit width control ring) | 35°C | 35°C (Same) | Same |
| Max temp. of parts accessible to patient (Forehead rest) | 35°C | 35°C (Same) | Same |
| Functionality: | |||
| Maximal Illumination | ≥12000 Lx | ≥30000 Lx | Proposed device has lower maximal illumination, but still deemed acceptable in context. |
| Operating temperature | 10° to 35°C | 10° to 35°C | Same |
| Slit Width | 0 to 10mm continuously adjustable | 0 to 12mm continuously adjustable | Minor difference, within acceptable range. |
| Slit Length | 1mm, 3mm, 5mm, 10mm | 0.2mm, 1mm, 2mm, 12mm | Differences in specific lengths, but offers a range. |
| Illumination field diameter | 1mm, 3mm, 5mm, 10mm | 0.2mm, 1mm, 2mm, 12mm | Differences in specific diameters, but offers a range. |
| Radial movement of the slit light illumination | Horizontal ± 30° | Horizontal ± 30° | Same |
| Stereo angle | 13° | 13° | Same |
| Light sources | White LED Single Light Source | White LED Single Light Source | Same |
| Pupil-distance | 48 to 72mm | 50 to 75mm | Minor difference, within acceptable range. |
| Eyepiece | 10X, 16X | 10X, 16X | Same |
| Objective | 1X | 1X | Same |
| Total magnifications | 10X, 16X (Optional) | 10X, 16X (Optional) | Same |
| Filter | Heat-absorption, Cobalt blue, Red-free, Gray | Cobalt blue, Red-free, Color Temperature Compensation | Differences in filter types, but includes key diagnostic filters. |
| Illumination rotation angle | Horizontal ±30° | Horizontal ±30° | Same |
| Working distance | 80mm | 60mm | Different, but a functional parameter, not a direct safety/efficacy concern. |
| Power | 7.4V 680mAh Li Battery, Rechargeable | 7.4V 2200mA Li Battery, Rechargeable | Different battery capacity, impacts working time. |
| Working time | 5-6 hours | 2.5 hours | Longer working time for proposed device. |
| Net Weight | 750g | 900g | Lighter weight for proposed device. |
| Indications for Use | Same | Same | Same |
2. Sample Size Used for the Test Set and Data Provenance
- No clinical test set was used. The document explicitly states: "Discussion of Clinical Tests Performed: None".
- The "test set" for this device largely consists of its physical specifications and performance against recognized electrical, safety, and optical standards (IEC, ISO). The data provenance for these non-clinical tests is internal to the manufacturer's testing and compliance processes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Since no clinical studies were performed, there was no need for experts to establish ground truth for a clinical test set. The validation relies on engineering and safety standards.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or subjective interpretations requiring adjudication were involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. The document explicitly states: "Discussion of Clinical Tests Performed: None". Hence, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a hardware medical device (a slit lamp microscope), not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" is defined by the specifications and requirements outlined in the international standards (IEC, ISO) referenced (e.g., IEC 60601-1 for basic safety, ISO 10939 for slit-lamp microscope specific requirements). The device's performance characteristics (e.g., light intensity, dimensions, temperature) were measured and compared against these established engineering and safety benchmarks.
- For biocompatibility, the ground truth is established by the ISO 10993 series of standards.
8. The Sample Size for the Training Set
- Not applicable. Since this is not an AI/Machine Learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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