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510(k) Data Aggregation
(86 days)
The KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuroendoscope Sets are intended for use by qualified surgeons for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.
The Karl Storz GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuro-endoscope Sets are manually operated surgical devices. The body contact portions of the KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuro-endoscope Sets are composed of surgical grade stainless steel and medical grade silicone, which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided 510(k) summary and FDA clearance letter, it's important to note that this submission is for a medical device (neuroendoscopes), not a software or AI-based diagnostic device. Therefore, many of the typical acceptance criteria and study components associated with AI performance metrics (like sensitivity, specificity, F1-scores, or human reader improvement with AI assistance) are not applicable here.
The core of this 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices, rather than proving a specific diagnostic performance against quantifiable metrics.
Here's a breakdown of the requested information based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) for a physical surgical instrument, the "acceptance criteria" are not reported in terms of diagnostic performance metrics like those for AI software. Instead, they relate to safety, functionality, and equivalence to predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | The KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuroendoscope Sets are intended for use by qualified surgeons for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures. This matches the intended use of predicate devices as implied by substantial equivalence. |
| Device Description | Manually operated surgical devices. Body contact portions composed of surgical grade stainless steel and medical grade silicone. These materials have a long history of biocompatibility for human use. This description is consistent with common surgical instruments and predicate devices. |
| Biocompatibility | Materials (surgical grade stainless steel, medical grade silicone) are commonly used in medical devices and have a long history of biocompatibility for human use. While no specific test results are provided in this summary, the claim implies meeting established biocompatibility standards. |
| Substantial Equivalence | "The Karl Storz GAAB Neuroendoscope and CHAVANTES-Substantial Equivalence: ZAMORANO Neuro-endoscope Sets are substantially equivalent to the predicate devices since the basic features and intended uses are the same." This is the primary "acceptance criterion" for 510(k) submissions; the device is deemed safe and effective if it is substantially equivalent to a legally marketed predicate device. |
| Regulatory Class | Class II (Product Code: GWG - Neurological Endoscope) |
| Prescription Use | X (indicated by the checkbox on the Indications for Use page) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable to this 510(k) submission. No "test set" in the context of diagnostic data (images, signals, etc.) was used because this is a physical medical device. The submission relies on design specifications, material biocompatibility, and comparison to predicate devices, not clinical data from a "test set" in the AI sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no "test set" with ground truth in the context of diagnostic accuracy for this device. Ground truth for surgical instrument design generally relies on engineering standards, material science, and clinical surgical practice, not expert labeling of data.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication was used.
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
Not applicable. This is a physical neuroendoscope, not an AI diagnostic tool. No MRMC study was performed, and there is no AI component to improve human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For a physical device like a neuroendoscope, the "ground truth" for its safety and effectiveness is established through:
- Engineering design principles and specifications: Ensuring its physical construction, optical clarity (for viewing), and functional mechanics meet required standards.
- Material biocompatibility: Chemical and biological testing of materials to ensure they are safe for human contact, typically against ISO standards.
- Clinical experience with predicate devices: The "ground truth" that predicate devices are safe and effective in their intended use forms the basis for demonstrating substantial equivalence.
- Regulatory standards: Compliance with general controls and recognized standards for medical devices.
No "expert consensus," "pathology," or specific "outcomes data" in the typical AI diagnostic sense would be explicitly outlined in this type of 510(k) summary for a manually operated surgical instrument.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm and does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI algorithm and does not have a "training set" or corresponding ground truth establishment process.
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