(137 days)
The KARL STORZ NAV 1 electromagnetic navigation system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures under visual control. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to radiological image data or digitized landmarks of the anatomy.
The NAV1 Electromagnetic is an intraoperative image guided localization system that links a navigated instrument tracked by an electromagnetical sensor to a virtual computer image space on a patient's preoperative diagnostic image data set (CT or MRI). The system is intended to be used as a positioning aid for navigation in ENT stereotactic surgery, including but not limited to the endoscopic surgery. The NAV1 Electromagnetic is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the radiological imaging-based model of the anatomy (CT or MRI). Surgical procedures include but are not limited to the following: maxillary antrostomies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, extensive sino-nasal polyposis, frontal sinusotomies, intranasal procedures, intranasal tumor resections, otologic surgery, and extracranial skull base diseases.
The provided text describes the Karl Storz NAV1 Electromagnetic Navigation System (K161555) and its performance characteristics. However, it does not include specific acceptance criteria with numerical thresholds, nor does it detail a study that explicitly proves the device meets such criteria in terms of diagnostic performance or clinical outcomes.
Instead, the document focuses on:
- System Verification and Validation: Ensuring the device functions as intended and does not introduce new safety or effectiveness concerns.
- Bench Testing: Evaluating accuracy, time accuracy, and user acceptance.
- Biocompatibility Testing: Ensuring patient-contacting components are safe.
- Electrical Safety and EMC Testing: Conforming to relevant electrical and electromagnetic compatibility standards.
- Software Verification and Validation: Following FDA guidance for software in medical devices.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not present in the provided document.
Here's a summary of what can be extracted or inferred from the text:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1, FDA Guidance) | Passed all tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity). "The biological-toxicological safety of the patient is not affected by the materials used in the tested items." |
| Electrical Safety (IEC 60601-1) | Complies with IEC 60601-1 standards. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2 standards. |
| Software Verification & Validation | Documentation provided as recommended by FDA guidance for "moderate" level of concern software. (Implies satisfactory performance, but no specifics given). |
| Bench Testing (Specific Criteria Not Quantified) | Evaluation of the accuracy of electromagnetically tracked instruments (before and after Reprocessing): Performed to ensure no new issues of safety or effectiveness. (No specific accuracy metric or threshold reported). |
| Evaluation of time accuracy of the ENT Navigation Software: Performed to ensure no new issues of safety or effectiveness. (No specific time accuracy metric or threshold reported). | |
| User acceptance testing: Performed to ensure no new issues of safety or effectiveness. (No specific user acceptance metrics reported). | |
| Cleaning and Sterilization Efficacy | Demonstrated "sterility assurance level of 10⁻⁶" for specific steam and V-PRO® sterilization cycles. |
| Manual cleaning effectiveness demonstrated with "sufficient recovery efficiency for residual protein and residual hemoglobin." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document refers to "system verification and validation testing," "bench testing," and "biocompatibility testing," but does not provide details on the number of units or cases tested for any of these.
- Data Provenance: Not specified. Given the nature of the device (surgical navigation system), the "bench testing" would likely involve laboratory setups, while biocompatibility testing would be conducted on materials. The document does not mention any clinical data or specific geographical origin for the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe studies that involve expert-established ground truth for diagnostic accuracy, as it is a navigation system and not a diagnostic device in the traditional sense. The testing focuses on system performance, safety, and functionality.
4. Adjudication method for the test set:
- Not applicable as there is no mention of expert-adjudicated performance studies in the provided text.
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. The device is a surgical navigation system, not an AI-assisted diagnostic tool for "human readers." No MRMC study is mentioned. The document states, "Animal and Clinical performance data are not required to demonstrate substantial equivalence for this type of device."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is a "standalone" system in operation (the algorithm provides the navigation aid without a separate "human-in-the-loop performance" study described here for its accuracy). The bench testing mentioned relates to the algorithm's performance (e.g., accuracy of tracked instruments, time accuracy of software). However, the document doesn't explicitly delineate "standalone" performance from integrated system performance.
7. The type of ground truth used:
- For biocompatibility: Laboratory standards and chemical/biological analysis results (e.g., cytotoxicity assays, irritation indices).
- For electrical safety and EMC: Compliance with international standards (IEC 60601-1, IEC 60601-1-2) implies validation against the requirements defined by these standards.
- For software verification and validation: Likely internal specifications, functional requirements, and error detection/prevention.
- For bench testing (accuracy): Likely comparison against known physical reference points or highly accurate measurement systems (e.g., a "true" position established by a more precise measurement device to verify the electromagnetically tracked instruments). No specific type of ground truth is explicitly stated beyond "verification and validation testing."
8. The sample size for the training set:
- Not applicable. The document describes a "traditional premarket notification submission" for a navigation system, not a machine learning or AI-based diagnostic tool that would typically involve a separate "training set" in the context of image analysis. The software validation is for system functionality, not for learning from data.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or machine learning components requiring ground truth establishment in this context.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).