(89 days)
The Stryker ENT Navigation System 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 a CT or MR based model of the anatomy.
Example procedures include, but are not limited to the following ENT procedures:
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Transphenoidal access procedures;
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Intranasal procedures;
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Sinus procedures, such as maxillary antrostomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies;
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ENT related anterior skull based procedures.
The Stryker ENT Navigation System is a computer-assisted image-guided surgery system. The system displays the position of navigated instruments on a model of the patient's anatomy based on preoperative images (CT or MRI) using electromagnetic tracking technology. The position of the instruments and the patient are localized within an electromagnetic field produced by a field generator. The navigation of instruments relative to the patient's anatomy is established via registration of the patient's anatomy to the preoperative images via anatomical landmarks, or surface matching. The position of navigated instruments is then displayed with respect to preoperative images.
The system comprises a computer platform, the software, patient trackers, pointers and suction tubes, instrument trackers, and a dedicated calibration body.
This submission is about the new version 3.6 of the Scopis software application, and the updated computer platform called Electromagnetic Navigation Unit with the new operating system version 3.6.A.
The provided text describes the Stryker ENT Navigation System and its associated software, but it does not include a study that proves the device meets specific acceptance criteria in the way described in the prompt's request.
Instead, the document states:
- "To ensure accuracy, subject devices are tested in accordance with ASTM F2554. The devices meet state-of-the-art acceptance criteria for point accuracy, precision, and distance accuracy."
- "Scopis software applications were subject to verification and validation testing in compliance with IEC 62304 and FDA guidances. All testing criteria were met."
This indicates that internal testing was conducted against existing standards and internal acceptance criteria, but the specific results of such a study are not detailed in the provided K221098 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices, not on presenting a detailed clinical or performance study with specific metrics as requested.
Therefore, many of the requested fields cannot be directly extracted from the provided text.
Here's what can be inferred or explicitly stated from the document, along with what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria Category | Specific Acceptance Criteria (as described in the document) | Reported Device Performance (as described in the document) |
|---|---|---|
| Accuracy | Adherence to ASTM F2554 standards for point accuracy, precision, and distance accuracy. | "The devices meet state-of-the-art acceptance criteria for point accuracy, precision, and distance accuracy." |
| Software | Compliance with IEC 62304 and FDA guidances for verification and validation testing. | "All testing criteria were met." |
| Electrical Safety & EMC | Compliance with ANSI/AAMI ES 60601-1 and IEC 60601-1-2. | "Applicable devices in scope were checked and certified for compliance." |
| Safety | Verification of risk controls in accordance with ISO 14971. | "Verification of risk controls...is in accordance with ISO 14971." |
| Security | Verification of operating system security with respect to NIST 800-53 and FDA Guidances; operating system updates. | "All testing criteria were met." |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated for accuracy testing. The document mentions "subject devices are tested," implying device-level testing rather than patient data.
- The "Performance Data" section discusses non-clinical testing. Clinical testing was "deemed unnecessary."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. No clinical study involving expert ground truth establishment is described or referenced. The testing mentioned is non-clinical.
4. Adjudication method for the test set:
- Not applicable/Not stated. No clinical study or expert review process is described.
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. The document explicitly states, "No clinical testing was deemed necessary for this Traditional 510(k) submission." This is not an AI-assisted diagnostic device for image interpretation by human readers. It's an image-guided surgery navigation system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, for the non-clinical performance aspects. The accuracy, software, electrical safety, safety, and security tests can be considered "standalone" evaluations of the device's functional and safety characteristics without human-in-the-loop performance in a clinical context. However, this isn't a traditional "algorithm only" performance evaluation as one might see for an AI diagnostic device. It's about the technical performance of the navigation system components.
7. The type of ground truth used:
- For the Accuracy testing (ASTM F2554), the ground truth would typically be established by highly accurate measurement systems and physical phantoms.
- For Software testing (IEC 62304), the "ground truth" would be the specified software requirements and expected behavior, validated through testing protocols.
- For Electrical Safety, EMC, Safety, and Security, the "ground truth" is adherence to the technical standards and regulations.
8. The sample size for the training set:
- Not applicable/Not stated. This device is a navigation system, not a machine learning model that requires a "training set" in the traditional sense for medical image analysis. Its "training" is in its engineering design and software development, not in learning from a large dataset.
9. How the ground truth for the training set was established:
- Not applicable/Not stated. As explained above, this isn't a machine learning model that involves a training set with established ground truth from data.
§ 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).