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The Endius Spine Endoscope is indicated for aiding in the search and removal of nucleus material and for visualization of lumbar herniated discs. It is intended to be used percutaneously in the lumbar spine. The endoscope is also indicated for visualizing the tissues of the brain and for use in the knee, shoulder, wrist, and the temporomandibular joint (TMJ).

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The provided document is an FDA 510(k) clearance letter for the Endius Spine Endoscope (K982819). It indicates that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test or training sets.
• Data provenance.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Information about multi-reader multi-case (MRMC) studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for training was established.

The letter focuses on regulatory clearance based on substantial equivalence and lists the intended indications for use. To find the information requested, one would need to consult the original 510(k) submission (K982819) from Endius, which would contain the performance testing and data supporting the substantial equivalence claim.

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