(86 days)
The KSEA Neuroendoscopes and Accessories are intended for use by qualified surgeons during endoscopic pituitary surgery.
The Neuroendoscope Set is intended for use by qualified surgeons in endoscopic pituitary surgery.
The Neuroendoscopes is intended for viewing the sella and pituitary gland in endoscopic pituitary surgery.
The Sheath is intended to be used to protect the Neuroendoscope and provides irrigation during the endoscopic procedures.
The KSEA Suction Tube is intended to remove blood, fluid, excised tissue, and debris from the operation site.
The KSEA Neuroendoscopes are straight shafted, rigid telescopes that utilize Hopkins rod lens. The accessory instruments include the irrigation sheaths, suction tubes, etc. The body contact materials are surgical grade stainless steel.
The provided text is a 510(k) summary for the KSEA Neuroendoscopes and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific performance criteria against acceptance thresholds. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-specific elements (like human-in-the-loop performance or expert consensus for ground truth) is not applicable or not present in the provided document.
Here’s a breakdown of the information that can be extracted or deduced from the text, and where gaps exist:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" for performance metrics as you've outlined (e.g., sensitivity, specificity) is not explicitly stated. This 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices, meaning its safety and effectiveness are considered to be on par with devices already legally marketed. The "performance" is implicitly considered acceptable because it's equivalent to existing devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | Substantially equivalent to predicate devices. The minor differences do not raise new issues of safety. |
| Effectiveness | Substantially equivalent to predicate devices. The minor differences have no effect on performance, function, or intended use. |
| Intended Use | Identical ("similar") to predicate devices: for use by qualified surgeons during endoscopic pituitary surgery. |
| Basic Design | Similar to predicate devices (straight shafted, rigid telescopes, Hopkins rod lens). |
| Dimensions | Similar to predicate devices. |
| Materials | Similar to predicate devices (surgical grade stainless steel). |
Study Information
The document describes a substantial equivalence determination process, not a clinical performance study with defined test sets, experts for ground truth, or adjudication methods in the way a diagnostic AI device might be.
- Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical performance study using a test set of data. The determination is based on a comparison to predicate devices and their established performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment in the context of a clinical study is not described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
- 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: Not applicable. This device is an endoscope, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a clinical performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
- The sample size for the training set: Not applicable. This device does not involve machine learning or a training set.
- How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.
In summary, the provided 510(k) pertains to a medical device (neuroendoscopes and accessories) where the regulatory pathway primarily involves demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than conducting new clinical performance studies with acceptance criteria, test sets, or AI-specific evaluations.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).