(89 days)
The Stryker PROFESS™ system is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system tracks and displays the intraoperative location of navigated surgical instruments relative to a CT image. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Stryker PROFESS™ system is indicated for intranasal and sinus surgery in which the use of computer-assisted surgery is appropriate and for which a CT image of the patient in accordance with the imaging protocol is available. The Stryker PROFESS™ system supports the following surgical procedures:
• Endoscopic sinus surgery
• Intranasal procedures
The PROFESS™ System, consisting of a computer platform, software and sterile single-use accessories, is designed to enable image guided surgery in intranasal and sinus surgery. Specifically, the system tracks and displays to the surgeon the intraoperative location of navigated surgical instruments, for example suction tools, relative to a CT image. The PROFESS™ System is based on the use of live video images captured by the miniature video camera mounted on the PROFESS™ Navigated Surgical Instruments. The captured images can be processed by the PROFESS™ Software for localization and tracking of the PROFESS™ Navigated Surgical Instrument relative to the PROFESS™ Patient Tracker as long as the PROFESS™ Patient Tracker is partially visible in the video image.
The following are the PROFESS™ System components:
- PROFESS™ Software
- PROFESS™ Navigated Surgical Instruments:
- PROFESS™ Straight Suction
- PROFESS™ Curved 70°Suction
- PROFESS™ Curved 90° Suction
- PROFESS™ Frontal Sinus Seeker
- PROFESS™ Registration Stickers
- PROFESS™ Patient Tracker
- PROFESS™ Adaptor Cable
- Computer platform containing an SPC-3 Workstation and IO-Tablet, one of:
- Stryker ADAPT® Platform
- Stryker Nav3® Platform
- Stryker Nav3i™ Platform
The provided document describes the Stryker PROFESS™ System, a navigation surgical software module intended for intraoperative guidance in intranasal and sinus computer-assisted surgery. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
Accuracy | Verified accuracy of ± 2 mm within nasal cavities (according to ASTM F2554:2010 and in phantom and cadaver tests) |
Accelerated Ageing Testing | Verified functionality of all single-use, sterile components and packaging integrity after accelerated ageing |
Biocompatibility | Verified biocompatibility of all patient contact materials (according to ISO 10993-1:2009 and FDA draft guidance on the use of ISO 10993-1, April 23, 2013) |
Electrical Safety | Verified conformance to ANSI/AAMI ES 60601-1:2006-02 |
Electromagnetic Compatibility | Verified conformance to IEC 60601-1-2: 2007-03, CISPR 11 Group 1, Class A requirements, and compatibility with RFID devices (125 - 134 kHz) |
General Requirements and Performance | Verified all components against their design specifications |
Safety | Verified the effectiveness of all risk controls determined in the device risk analysis |
Shipping | Verified functionality of all components after simulated shipping conditions |
Software | Verification and validation according to IEC 62304:2006 and FDA guidance on general principles of software validation, June 9, 1997 |
Sterilization | Validated EO sterilization process for single-use, sterile components to a sterility assurance level (SAL) of 10-6 (according to ISO 11135-1:2007) and verified EO and ECH residuals within ISO 10993-7:2008 limits |
Product Validation | Validated product with users in cadaver labs; verified compatibility with conventional operative technique and other devices |
2. Sample size used for the test set and the data provenance
The document states "No clinical testing has been conducted." (Page 15). The non-clinical testing included "phantom and cadaver tests" for accuracy and "users in cadaver labs" for product validation. However, the exact sample sizes (number of phantoms or cadavers) and their provenance (e.g., country of origin, retrospective/prospective) are not specified for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "users in cadaver labs" for product validation, implying medical professionals, but it does not specify the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth in the non-clinical tests.
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 MRMC comparative effectiveness study was conducted. The document explicitly states, "No clinical testing has been conducted." The device is intended as an intraoperative guidance system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Accuracy" test (± 2 mm) was performed on "phantom and cadaver tests," which appears to be a standalone measurement of the system's ability to localize instruments relative to CT images. This can be considered a standalone performance assessment of the navigation component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the accuracy testing, the ground truth was likely established by precise physical measurements in phantom models and cadaver dissections or using highly accurate measurement systems to determine the true position of instruments relative to the CT images. For product validation, "users in cadaver labs" were involved, suggesting practical effectiveness and usability were assessed. However, specific details about "ground truth" other than physical models are not provided.
8. The sample size for the training set
The document does not mention any training set or details about machine learning model development. This submission is for a surgical navigation system, and the provided information focuses on engineering verification and validation, not on AI model training for diagnostic or predictive tasks.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), this information is not applicable or provided in the document.
§ 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).