Search Results

Light Projector AUTO LP 5123 provides light for examination, diagnostic and therapeutic applications, in particular, in endoscopy.

The Xenon Light Source is classified as Cardiac Floating (CF) which permits its use for cardiac procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.

Light Projector AUTO LP 5123 uses a xenon arc lamp to provide illumination for an endoscope via a light guide which is connected to the projector's light port. The illumination level is automatically controlled by video.

The provided document is a 510(k) summary for the Auto LP 5123 Xenon Light Projector. It focuses on establishing substantial equivalence to a predicate device and safety through compliance with electrical standards. It does not contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/ML medical device.

Based on the document, I can provide the following, noting where information is explicitly not present for the type of device described:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This device is a xenon light projector, not an AI/ML device that processes data for diagnostic or prognostic purposes. The performance data refers to electrical safety and performance standards, not analysis of a data test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. See point 2.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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. This is not an AI/ML device. No MRMC study was conducted. The document explicitly states "No clinical tests performed."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This is a hardware device; there is no "algorithm only" performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. For this device, "ground truth" pertains to engineering standards and specifications (e.g., electrical parameters, light output, lifespan) rather than clinical outcomes or diagnostic classifications.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets acceptance criteria, as presented in this 510(k) summary, consists of independent laboratory testing against specified international electrical safety and performance standards.

• Standards Tested: IEC601-1 amendment 1 and 2, IEC601-1-1, and IEC601-2-18.
• Conclusion: The testing led to the conclusion that the device is "designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." This implies compliance with the standards, although specific test results are not detailed in this summary.
• Clinical Testing: The document explicitly states, "No clinical tests performed." This is common for predicate-based 510(k) submissions for devices like light sources, where safety and effectiveness are primarily demonstrated through compliance with recognized electrical and performance standards and comparison to a legally marketed predicate device.
• Substantial Equivalence: The main argument for market clearance is "substantial equivalence" to existing 510(k) devices (specifically K952696 from Richard Wolf M.I.C.), asserting that "The new technological characteristics have not diminished safety or effectiveness."

Ask a specific question about this device