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To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or microscope or video camera. The lightsource supplies light for the headlight or microscope or video camera.

Lightsource or illuminator I-100

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Lightsource Model or Illuminator I-100". It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

None of the requested details regarding acceptance criteria, device performance, study designs (sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information are present in the provided text.

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To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.

Lightsource or illuminator M-300

The provided text is a 510(k) clearance letter from the FDA for a device called "Cuda Products Corp. Model M300 (M-300) Lightsource". This document is a regulatory approval and does not contain information about acceptance criteria, study design, or performance metrics that would typically be found in a clinical study report.

Therefore, I cannot extract the information required in your request from this document. The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is approved for marketing. It specifies the product code, regulatory class, and indications for use, but no performance data.

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To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: Ilightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.

Lightsource or illuminator CERMAX300

This document is a 510(k) clearance letter from the FDA for a medical device called "Cermax300 Lightsource." It does not contain information about acceptance criteria or specific study details proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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To provide light for fiberoptic cables and provide a camera for procedure video capabilities. Provide light for instrumentation via fiberoptic cables For for use in. surgical fields or in office procedures. lightsource attaches to fiberoptic cable which is then attached to a video scope, the camera also attaches to the video scope (such as a video otoscope, or an intra oral dental scope).

Video Camera/Lightsource Combination Unit VCL-150

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a video camera/light source device (K980350 Video Camera/Lightsource Model VCL-150) and includes information about its substantial equivalence and indications for use. However, it does not detail:

• Acceptance criteria and reported device performance (in a table format).
• Sample size or data provenance for any test set.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Whether a multi-reader, multi-case (MRMC) study was done or its effect size.
• Whether a standalone algorithm-only performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than detailed performance study results against specific criteria.

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To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource actaches to fiberoptic cable which is then attached to an instrument or headlight.

Lightsource or Illuminator M2-250TR or 1-250

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "I-250 and M2-250TR Lightsources." This document indicates that the device has been cleared for marketing based on its substantial equivalence to previously marketed devices. However, this clearance letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval, not a scientific study report.

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Ask a specific question about this device