Search Results

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.

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.

Ask a specific question about this device

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.

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:

2. 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.

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):

   • Not applicable / Not provided. No clinical test set or ground truth determination by experts is described.

4. 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.

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. The device is a "portable slit lamp" for eye examination, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned.

6. 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."

7. 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.

8. 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."

9. How the ground truth for the training set was established:

   • Not applicable / Not provided. No training set exists for this device.

Ask a specific question about this device