(235 days)
The Olympus Neuroendoscopes are intended for viewing the ventricles of the brain, for use in endoscopic assisted microsurgery for cerebral aneurysms, and shunt placement and for visualization of tumors, cysts and neurovascular compression syndromes.
The Olympus Neuroendoscope is a rigid endoscope indicated for intraventricular (and other intracranial CSF-containing cavities), subarachnoid and brain parenchymal environments.
The provided text is a 510(k) summary for the Olympus Neuroendoscopes. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the new device.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found within the provided document. This type of information is typically part of detailed validation studies that support the 510(k) submission, but is not usually included in the publicly available summary.
However, based on the information that is present, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance. Instead, it provides a comparison table of key physical specifications between the predicate device and several subject devices, implying that equivalent physical characteristics are a basis for substantial equivalence.
| Item | Predicate device, model A7594A | Subject device, S-1349/1 | Subject device, S-1349/2 | Subject device, S-1349/3 | Subject device, S-1349/4 |
|---|---|---|---|---|---|
| Telescope Diameter | Ø 4 mm | Ø 4 mm | Ø 2.7 mm | Ø 2.7 mm | Ø 2.7 mm |
| Telescope Total Length | 218.5 mm | 218.5 mm | 225.3 mm | 225.0 mm | 233 mm |
| Telescope Working Length | 158.1 mm | 158.1 mm | 158.1 mm | 157.7 mm | 156.7 mm |
| Lens Diameter | Ø 2.8 mm | Ø 2.8 mm | Ø 1.7 mm | Ø 1.7 mm | Ø 1.9 mm |
| Field of view | 95.8° | 95.8° | 70.8° | 68.4° | 85° |
| Direction of view | 0° | 0° | 0° | 30° | 70° |
| Best working distance | 10 mm | 10 mm | 10 mm | 10 mm | 10 mm |
| Magnification | 2.1 | 2.1 | 2.15 | 2.22 | 2.19 |
The implied "acceptance criterion" for these parameters is substantial equivalence to the predicate device, meaning the new devices' specifications are either identical or sufficiently similar not to raise new questions of safety or effectiveness. The table shows the performance (specifications) of the new devices in direct comparison to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For medical devices like endoscopes, "test set" might refer to the number of devices tested for mechanical, optical, and biocompatibility properties. The document is a regulatory submission, not a scientific study report detailing clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. It's unlikely that "experts" were used in this manner for the substantial equivalence demonstration of an endoscope's physical properties. If any clinical performance data were submitted (which is not detailed here), then expert assessment might be relevant, but it's not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically used in clinical studies where expert consensus is needed.
5. 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
No, a MRMC comparative effectiveness study was not done, as this device (Olympus Neuroendoscope) is an optical instrument for direct viewing, not an AI-assisted diagnostic tool for "human readers." Therefore, effect size related to AI assistance is irrelevant and not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is an endoscope, which is a tool used by a human surgeon; it is inherently "human-in-the-loop" and does not operate as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology for image classification or outcomes for predictive models) is not applicable in the context of this 510(k) submission for a rigid endoscope. The "truth" being established is that the device meets its stated physical specifications and is safe and effective when compared to an already legally marketed predicate device. This is typically verified through engineering testing and biocompatibility assessments, not through clinical "ground truth" data as understood for AI.
8. The sample size for the training set
This information is not provided and is not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no "training set" for this type of device.
§ 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).