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510(k) Data Aggregation
(286 days)
The device is intended for use for direct visualization, diagnosis and therapeutic application during intracranial procedures, such as
- cyst fenestration
- shunt placement
- intraventricular coagulation
- ventriculostomy of the 3rd ventricle when the aqueduct is obstructed
- coagulation of small intraventricular lesions
- biopsy of lesions which lead to the stricture of a ventricle
The instrument simultaneously permits visual control and utilization of a working, an irrigation, and an aspiration channel.
The Neuro-Endoscope can be used with or without a stereotactic frame. A special adapter is available to affix the endoscope.
The set consists of a sheath, obturators, telescope, forceps, scissors, electrodes, suction needle, and adapters.
Here is a summary of the acceptance criteria and study information for the Neurological Endoscope, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K970162) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria for a new device type. Therefore, explicit, quantifiable acceptance criteria in the typical sense (e.g., minimum sensitivity/specificity thresholds, precision limits) are not stated for clinical performance. Instead, the "acceptance criteria" are implied to be that the device performs safely and effectively for its intended use, comparable to its predicate devices.
The reported device performance is described through various safety and functional tests:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety: Electrical isolation of user from device. | Instruments and connection cables are designed with overlapping connections to ensure user is electrically isolated. |
| Material Integrity: Integrity and bonding of insulation material. | Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments. (No quantitative results provided, but the statement implies successful testing). |
| Thermal Safety: Minimizing thermal damage risks. | Testing was performed to verify thermal safety. "Thermal damage is unlikely to occur using the Richard Wolf Neuroendoscopy Set." (No quantitative results provided, but the statement implies successful testing). |
| Clinical Safety and Effectiveness: Operation for intended uses. | Clinical tests were performed by Eric Weber, MD, PhD, at the University of South Alabama under protocol # 92-105. The conclusion states: "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual." (Specific clinical performance metrics like success rates, complication rates, or direct comparisons to predicate devices are not provided in this summary document.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This information is not provided in the 510(k) summary. The document mentions "Clinical tests were performed," but does not explicitly state the number of patients, endoscopic procedures, or specific data points included in these clinical tests.
- Data Provenance: The clinical tests were performed in the USA at the University of South Alabama. The document does not explicitly state whether the study was retrospective or prospective, but clinical trials typically imply a prospective approach.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states that clinical tests were performed by "Eric Weber, MD, PhD." This identifies a single individual as the primary investigator. It does not mention a panel of experts or a specific number of individuals involved in establishing ground truth for the test set.
- Qualifications of Experts: Eric Weber, MD, PhD. His specific specialization (e.g., neurosurgeon, neurologist) is not explicitly stated, but his role in performing "clinical tests" for a neurological endoscope strongly implies relevant medical expertise in neurosurgery or a related field.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical tests or for establishing ground truth. With only one named clinical investigator, it's unlikely a formal multi-reader adjudication process was employed as part of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. The device is a medical instrument (endoscope), not an AI-powered diagnostic or assistive tool.
- Effect Size of AI: This question is not applicable as the device is not an Artificial Intelligence product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone (algorithm only) performance study was not done. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The type of ground truth used for the clinical tests is not explicitly detailed. However, for a surgical instrument like an endoscope, ground truth would likely be based on clinical observation, surgical findings, and potentially pathology of biopsied lesions, as assessed by the operating physician(s).
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument and does not employ a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this type of device.
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