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The Aurora LED series surgical light is intended to provide local illumination at the surgical site on the patient's body at Hospitals, Clinics, VA's, Freestanding Surgical centers, Ambulatory/Care Centers and Doctor's offices.

The SKYTRON Aurora series surgical light fixture is intended to be used by medical personnel for the purpose of illuminating surgical sites.

The Aurora LED series surgical light is suitable for all types of surgical procedures. The Aurora series surgical light is intended to provide local surgical site illumination throughout the patient's body providing a high-intensity, shadow-free "cold" pattern of light. The lights consist of several modules containing LEDs (light emitting diodes) and optical color corrective reflectors. Each light head features independent focus capability allowing the user to adjust the illumination parameters. The light intensity is adjustable between 10% - 100% and a color temperature of 4000K - 4500K creating the infinite capability to adapt to different situations. LEDs offer low heat radiation and increased illumination and are energy saving.

The provided text is a 510(k) Summary for a medical device (Aurora LED Series Surgical Light). It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (STELLAR Series Surgical Light, K002463) based on its intended use and a primary difference in the light source (LED vs. traditional incandescent bulbs), highlighting the LED's longer lifetime and energy efficiency as improvements.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document is a regulatory submission for premarket notification, where the primary goal is to show the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance study results against specific criteria.

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The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC).

A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology and general surgery.

Stellar Series Surgical Lights with Hermes

The provided document is a 510(k) premarket notification letter from the FDA for a surgical lamp device (Skytron Stellar Series Surgical Lights with Hermes). This type of document is a regulatory approval and does not contain the detailed technical study information outlined in your request.

The letter confirms substantial equivalence to a predicate device, allowing the manufacturer to market the product. However, it does not include:

1. A table of acceptance criteria and reported device performance: This document does not detail specific performance metrics or acceptance criteria for the surgical lights.
2. Sample size for the test set or data provenance: There is no mention of a test set, sample sizes, or where data originated.
3. Number/qualifications of experts for ground truth: Ground truth determination is not discussed as there's no mention of a study involving expert assessment.
4. Adjudication method: Not applicable as no expert-based ground truth is discussed.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This is not pertinent to a surgical lamp and is not mentioned. AI assistance is also not relevant to this device.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device (surgical light), not an algorithm.
7. Type of ground truth used: Not applicable as there's no data analysis discussed in this letter.
8. Sample size for the training set: Not applicable as no algorithm training is discussed.
9. How ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence of a physical medical device. It does not contain the detailed study design, performance data, or AI-related metrics that your request is asking for.

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The Millennium Gold Series Surgical light is intended to be used by medical personnel for the purpose of illuminating surgical sites.

Not Found

This document is a 510(k) clearance letter from the FDA for the Millennium Gold Series Surgical Light. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. It is a regulatory clearance, not a scientific study report.

Therefore, I cannot provide the requested information based on this input.

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