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The ProXenon 350 Light Source is designed for use with fiber optic, headlight systems. It will accept fiber optic light guides for Wolf, Storz, Olympus and ACMI instrumentation. Accessory Headlight is a passive luminaire that is illuminated by fiber optic light and utilized to provide supplemental light for surgical and medical procedures.

The Welch Allyn ProXenon 350 Fiber Optic Surgical Illuminator is designed for use with fiber optic headlight systems. The ProXenon 350 Fiber Optic Surgical Illuminator uses a Welch Allyn high-intensity, narrow-beam, rugged xenon short arc lamp with a fixed internal reflector to produce a uniform profile beams. The Four Port Turret accepts Wolf, Storz, Olympus, and ACMI fiber optic cables. Each port is readily identified on the turret perimeter. The ProXenon 350 system consists of 3 major components; a 300W Xenon light source, a fiber optic bundle, a headlight consisting of a luminaire (contains optics to focus and direct the illumination) and a headband. The surgeon uses the headlight to provide auxiliary illumination when performing surgical procedures. The headlight is especially useful for illumination of deep body cavities since it provides shadow free illumination.

This Welch Allyn ProXenon 350 submission is for a surgical illuminator, which is a hardware device. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the way one would for a diagnostic or AI-driven medical device. Therefore, much of the requested information regarding "acceptance criteria and reported device performance" in terms of clinical metrics (like sensitivity, specificity, etc.), sample sizes for test sets, expert-established ground truth, and AI-specific study types (MRMC, standalone algorithm performance) is not applicable or present in this document.

However, I can extract the relevant information from the provided text based on the nature of this submission.

Here's an analysis of the provided text:

1. A table of acceptance criteria and the reported device performance

For a hardware device like a surgical illuminator, acceptance criteria and performance are typically related to engineering specifications, safety standards, and functional equivalence. These are usually established internally by the manufacturer and demonstrated through testing, rather than presented as clinical performance metrics in a 510(k) summary. The document states that the ProXenon 350 "uses a Welch Allyn high-intensity, narrow-beam, rugged xenon short arc lamp with a fixed internal reflector to produce a uniform profile beams." The performance goal is to provide "supplemental light for surgical and medical procedures" and "shadow free illumination" especially in deep body cavities. The acceptance criteria would likely be met through engineering tests ensuring brightness, beam uniformity, heat dissipation, and compatibility with various fiber optic cables. Since this is a 510(k) summary, these granular engineering details are not included.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided in the context of this 510(k) for a physical medical device. Performance testing for a surgical illuminator typically involves engineering and safety evaluations, not data-driven clinical studies with test sets in the typical sense of AI/diagnostic devices.

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)

This information is not applicable and not provided. Ground truth, in the context of expert review, is typically relevant for diagnostic devices that interpret images or other patient data. A surgical illuminator is a tool; its "performance" isn't assessed by expert interpretation of its output in a clinical ground truth setting.

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

This information is not applicable and not provided. Adjudication methods are used in studies involving subjective interpretation, often in clinical trials or diagnostic accuracy studies, which are not detailed in this 510(k) summary for a surgical illuminator.

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 and not provided. MRMC studies are specific to diagnostic performance, particularly for AI applications, and are entirely outside the scope of a 510(k) for a basic surgical illuminator. There is no AI involved in this device.

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

This information is not applicable and not provided. This device is a hardware illuminator; there is no algorithm or AI component to perform in "standalone" mode.

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

This information is not applicable and not provided. For a surgical illuminator, "ground truth" as a clinical reference standard is not a relevant concept for demonstrating its safety and effectiveness. Its function is direct illumination, not diagnosis or data interpretation.

8. The sample size for the training set

This information is not applicable and not provided. Training sets are used for machine learning models, which are not part of this device.

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

This information is not applicable and not provided. As above, ground truth for training data is not relevant to a hardware surgical illuminator.

Summary of the 510(k) information provided:

The provided document is a 510(k) Premarket Notification for the Welch Allyn ProXenon 350, a fiber optic surgical illuminator. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (the Isolux Fiber Optic Surgical Headlight System, K991572). This type of submission primarily focuses on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.

Key aspects highlighted in the submission regarding the device's characteristics and intended function:

• Intended Use: The ProXenon 350 Light Source is designed for use with fiber optic headlight systems to provide supplemental light for surgical and medical procedures, particularly useful for "shadow free illumination" in deep body cavities.
• Technological Characteristics: It uses a high-intensity, narrow-beam, rugged xenon short arc lamp with a fixed internal reflector for uniform illumination. It features a four-port turret compatible with Wolf, Storz, Olympus, and ACMI fiber optic cables.
• Predicate Device: Isolux Fiber Optic Surgical Headlight System (K991572).

Since this is a Class II device and a 510(k) submission for a non-AI hardware device, the documentation focuses on engineering specifications, safety, and functional equivalence rather than clinical performance data in the form of sensitivity/specificity or AI-specific study designs.

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