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The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor system which it can attach to through the use of a Cam Joint. The Lite Wand II is designed to provide visible illumination of the surgical field or the patient through a Halogen light source only. It is intended to be used with ACMI, Storz, Wolf, or Olympus connector cables. The Lite Wand II is intended to be used by surgeons and medical care practitioners in a surgical setting.

Thompson Surgical Instruments, Inc. Lite Wand II is a fiber optic surgical light designed to provide visible illumination of the surgical field or the patient. The Lite Wand II consists of a Cam Joint fixture which attaches the device to a retractor system arm, a flexible "gooseneck" supported lighthead for easy positioning, and a fiber optic bundle. The Thompson surgical Lite Wand II is designed as a task light for surgical use.

The Lite Wand II is designed to be a replacement or substitute for headlamps and it uses the same technology currently used in other headlamps and light sources. These other devices have similar performance characteristics which have been previously cleared by the FDA.

The provided text is a 510(k) summary for the Lite Wand II, a surgical light. It describes the device, its intended use, and indicates that it has been found substantially equivalent to previously cleared devices. However, the document does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data as typically required for evaluating AI/ML-based medical devices.

Therefore, I cannot provide the detailed information requested in the prompt. The 510(k) summary for the Lite Wand II is focused on its substantial equivalence to predicate devices, which is generally established through a comparison of technological characteristics and intended use, rather than extensive performance studies with specific quantitative acceptance criteria like those needed for AI/ML devices.

Specifically, the following information is missing from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, or details about the effect size of AI assistance.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used for performance evaluation.
• Sample size for the training set.
• How ground truth for the training set was established.

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