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The SolarTec™ Source 270 System is intended for use:

1. To provide visible light for with various rigid or flexible endoscopes, other lighted tools, and surgical headlamps that contain fiber bundles or single fibers for illumination
2. In providing illumination for the purposes of allowing observation and manipulation of body cavities and tissues, hollow organs, and canals.
3. With applications that include, but are not limited to, headlights and/or externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhyno-laryngoscopy, urology, and vascular endoscopy as well as surgical headlights used in various open surgical procedures.

The Subject Device is designed with a safety interlock on the lamp replacement door. If the cover is opened, the power to the device will be interrupted. The Subject Device is cooled with a forced air fan to prevent the temperature of the unit from exceeding a safe level. If in the event that the fan malfunctions and/or fails to operate properly and the internal temperature of the device exceeds the engineered specifications, the device is designed with an internal thermal protection mechanism that automatically shuts off the power to the lamp. The Subject Device contains a user replaceable lamp fixture. The Subject Device has incorporated several safety features into the product design. These safety features include: a) The lamp is never operated beyond its specified power range, b) The lamp life is limited to approximately 1000 hours by analog circuitry. This limit is significantly below the safe rated life expectancy of the lamp (approximately 4000 hours) as stated by the lamp manufacturer, c) The enclosure has interlor structures (baffles), which will dampen the sound level and confine any debris which might result from the non-passive lamp failure. The Subject Device used with a Cogent Light single fiberoptic cable typically produces a uniform output image.

The provided document is a 510(k) Premarket Notification for the SolarTec™ Source 270. It primarily focuses on the safety and effectiveness of the device, rather than diagnostic performance metrics typically associated with AI/ML devices. Therefore, much of the requested information regarding sample sizes, expert evaluations, ground truth, and comparative effectiveness studies is not applicable to this type of device and submission.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a light source, not a diagnostic tool with performance metrics like sensitivity or specificity. The "acceptance criteria" presented are primarily safety standards and effectiveness claims related to light production and delivery.

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

This information is not applicable as this is a medical device for illumination, not a diagnostic AI/ML system requiring a test set of data. The submission focuses on engineering specifications and compliance with safety standards rather than performance on a clinical dataset.

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. The "ground truth" for this device would be its adherence to safety standards and its ability to produce light as described, not clinical diagnoses by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. No test set requiring adjudication of findings is described for this device.

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

This information is not applicable. This device is a light source, not an AI/ML diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

This information is not applicable. This is a physical device, not an algorithm.

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

The "ground truth" for this device's safety is its compliance with specified international and national safety standards (IEC601-1-2.1993, IEC601-2-18:1996, UL2601-1). For its effectiveness claims, the "ground truth" would be physical measurements of light output, spectral characteristics, and image uniformity, as demonstrated through engineering testing and design specifications. No clinical "ground truth" in the diagnostic sense (e.g., pathology) is relevant.

8. The sample size for the training set

This information is not applicable. This is a physical light source, not a machine learning model.

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

This information is not applicable.

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Both devices are intended for the same use, that of providing visible light for the illumination of surgical headlights and various rigid or flexible endoscopes that contain fiber bundles for illumination. Applications for both systems include, but are not limited to, externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhino-laryngoscopy, urology, and vascular endoscopy.

Both devices consist of a light source control box which houses a Xenon lamp, power supply, and connects to a proprietary fiberoptic cable. With a fiber bundle adapter, this illuminator can also be used with regular fiber bundle optic cables and headlamps.

It appears the provided text describes a 510(k) Premarket Notification for a medical device called the "Cogent Light XLS Illuminator System." However, the text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for an AI-powered diagnostic device.

The document focuses on:

• Safety: Discusses safety interlocks, cooling mechanisms, thermal protection, and measures to mitigate risks associated with lamp failure (e.g., specific power range, limited operating hours, baffles for sound/debris). These are safety design features, not performance metrics.
• Effectiveness: Describes the light spectral quality, the benefits of its single fiberoptic cable compared to traditional fiber bundles in terms of uniform illumination, and its equivalence to a predicate device. This section talks about the type of light produced and the method of delivery, which implicitly relates to effectiveness in illuminating surgical fields, but it doesn't quantify performance against specific criteria like sensitivity, specificity, accuracy, or human reader improvement, as would be expected for a diagnostic AI.
• Summary: States the device's intended use and design, emphasizing its substantial equivalence to a predicate device for providing visible light for illumination in various endoscopic procedures.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or MRMC studies because this information is not present in the provided 510(k) summary for the Cogent Light XLS Illuminator System. The device described is an illuminator, a tool for providing light during surgery, not a diagnostic or AI-powered system that would typically undergo such performance evaluations for regulatory submission.

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