Search Results

Cold light sources are designed to supply light for endoscopic diagnostic and surgical procedures.

The power LED 175 is a high power medical cold light source used for endoscopic diagnostic and surgical procedures. The device can be controlled via buttons on the front panel or via SCB (STORZ Communication Bus). This device provides high light intensity at low power consumption with intelligent cooling concept for minimal noise emission. This device includes a cold light source power LED 175, power cord, and the 100 cm SCB connection cable. The light is transmitted through an optical cable and a scope to illuminate surgical sites during minimally invasive surgical procedures.

The provided text is a summary of a 510(k) premarket notification for a medical device, the KARL STORZ Power LED 175. It outlines the device description, intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not explicitly contain a formal "acceptance criteria" table with corresponding "reported device performance" data in the manner typically found in a detailed clinical or performance study report.

Instead, the document states that "performance testing to verify light output of Power LED 175 was done as per the Comparative Bench Testing attached in Enclosure # 6" and that "Design Verification Testing (DVT) demonstrates that the device functions as it is intended and its performance does not raise any new issues of safety and effectiveness." It also mentions software verification. These statements indicate that testing was performed to verify the device's functionality and safety, but the specifics of the acceptance criteria and the detailed results are not provided within this summary for public consumption. The "Comparative Bench Testing" enclosure would contain the detailed information.

Given the information available:

1. Table of acceptance criteria and the reported device performance:
   The document does not explicitly provide a table titled "acceptance criteria" and "reported device performance" with specific numerical values for metrics like light intensity, color temperature stability, etc. It broadly states that "Design Verification Testing (DVT) demonstrates that the device functions as it is intended and its performance does not raise any new issues of safety and effectiveness." The "Technological Characteristics" table compares the Power LED 175 to its predicate devices, showing:

   Parameter	Power LED 175 (Subject Device)	LED NOVA 100 (Predicate Device)	300 Watt Xenon (Predicate Device)
   Lamp Type	LED	LED	Xenon
   Color Temperature	6500 K	5600 K	6000 K

   The implication is that the Power LED 175's performance (e.g., light output, color temperature) is deemed acceptable if it is comparable to or better than the predicate devices and meets design specifications. However, the specific quantitative acceptance criteria and the exact measured performance values are not detailed in this summary.

2. Sample size used for the test set and the data provenance:
   The provided text does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "Comparative Bench Testing" and "Design Verification Testing (DVT)," which are typically internal engineering and validation tests rather than clinical studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable and not provided in the document. The testing described is technical "performance testing" and "design verification testing" of a light source, not a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set:
   This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies where multiple human readers assess cases, typically for diagnostic accuracy. The testing described focuses on the device's technical performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
   No MRMC study was done, and this information is not applicable. The device is a light source, not an AI-powered diagnostic tool, and the submission does not involve human-in-the-loop performance evaluation in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This information is not applicable. The device is a medical light source, not a standalone algorithm.

7. The type of ground truth used:
   For the "performance testing" and "design verification testing," the ground truth would be based on engineering specifications, established measurement standards, and comparison to the performance characteristics of the predicate devices. For example, light output would be measured against a specified lumen or candela output, and color temperature against a CCT (Correlated Color Temperature) value.

8. The sample size for the training set:
   This information is not applicable. There is no mention of a training set as the device is not an AI/machine learning system.

9. How the ground truth for the training set was established:
   This information is not applicable as there is no training set mentioned.

Ask a specific question about this device