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510(k) Data Aggregation
(29 days)
The DSP Worldwide Snowden-Pencer Xenon Lightsource is intended for use as an accessory to fiberoptic endoscopes to provide illumination during endoscopic procedures.
The DSP Worldwide Snowden-Pencer Xenon Lightsource is a fiberoptic illuminator for use in endoscopic surgical procedures. The device includes a Power Switch/Circuit Breaker, Light Guide receptacle which accepts the fiber optic cables (designed to accept ACMI cables with Storz, Olympus, and Wolf adapters also available), Lamp Usage Clock which indicates elapsed bulb usage (in hours), Light Intensity Control which allows illumination to be adjusted (clockwise to increase intensity and counterclockwise to decrease intensity), Light Intensity Indicator which provides a graphic representation of the level of light intensity, a Lamp Door on the side of the unit to provide access for replacement of the lamp module, a Cooling Fan to cool the Xenon bulb and the power supply of the unit. Detailed specifications for the Lightsource were provided.
This 510(k) premarket notification for the DSP Worldwide Snowden-Pencer Xenon Lightsource does not contain information about acceptance criteria or a study proving the device meets specific performance acceptance criteria in the way this request is typically understood for AI/ML or diagnostic devices.
The document focuses on demonstrating substantial equivalence to a predicate device (Karl Storz Xenon Light Source) based on design, operational principles, and technological characteristics, rather than reporting on a clinical or performance study with quantified acceptance criteria and device performance results.
Therefore, many of the requested fields cannot be filled. I will explain why for each point.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| The device to be substantially equivalent to the predicate device in design characteristics, operational principles, and technological characteristics. | The document states, "The DSP Worldwide Snowden-Pencer Xenon Lightsource is substantially equivalent the Karl Storz Xenon Light Source and to other legally marketed xenon light sources in design characteristics, operational principles, and technological characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" for performance evaluation in the context of diagnostic accuracy or AI/ML. The assessment is based on a comparison of technical specifications and intended use against a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. There's no performance evaluation involving expert ground truth in this submission.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This document describes a medical device (a light source for endoscopy), not an AI/ML or diagnostic imaging device that would typically undergo such a study.
6. If a Standalone Performance Study was done
A standalone performance study in the context of diagnostic algorithms or AI performance was not conducted or reported. The 510(k) summary focuses on demonstrating equivalence through design and specifications.
7. The Type of Ground Truth Used
Not applicable. There is no ground truth concept as typically applied to AI/ML or diagnostic studies in this submission.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
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