(279 days)
The Philips EasyGuide is a viewing and navigation tool for all cranial surgical processes such as
- Tumor resection: Meningioma, Glioma, Pituitary tumor, Skull base tumor, Metastasis
- Treatment of vascular malformations, aneurysms
- Transnasal approaches
The EasyGuide Standard Workstation with Spine option is intended for planning spine surgery and for localizing and navigating during spine surgery.
EasyGuide Spine is specially designed for spinal application areas such as:
- Stabilization techniques
- Tumor resection
The EasyGuide Spine option, which is the subject of this premarket notification, is an option for the EasyGuide Standard Workstation. The Spine option extends the functionality and application areas of the EasyGuide Standard Workstation to include pre-operative planning and intraoperative localizing and navigation during spinal surgical procedures.
The Spine option has the following features:
Hardware:
- Instrument Pointing
- Instrument Learner
- Instrument Switchbox
- Tracker
- Flexible camera pole
- Pedicle Awl
Software:
- 3D marker search
- Registration and tracking functions
- Planning and navigation functions
- Instrument learning
All instruments can be used in the surgical environments used in the sterile field can be autoclaved at 134° C. All other parts are easy to clean.
The provided document (K981480 for the Philips EasyGuide Spine option) is a 510(k) summary for a medical device and does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the traditional sense of a clinical or performance study with metrics like sensitivity, specificity, or accuracy.
Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices, and compliance with general safety and regulatory standards.
Therefore, for aspects of your request that pertain to performance metrics, sample sizes, expert adjudication, or MRMC studies, the information is not present in this document.
Below is a response based only on the information available in the provided text.
Acceptance Criteria and Device Performance (Based on provided document)
| Acceptance Criteria Category | Specific Criteria (as inferred from document) | Reported Device Performance (as inferred from document) |
|---|---|---|
| Safety Standards | Electrical safety standard UL-2601 | "This device complies with electrical safety standard UL-2601." |
| "The Philips EasyGuide Standard Workstation with Spine option is designed to comply with applicable requirements of Underwriters Laboratories Standard for Safety of Medical Electrical Equipment (UL-2601) and be classified by Underwriters Laboratories." | ||
| Electromagnetic compatibility standard IEC-601-1-2 | "This device complies with ... electromagnetic compatibility standard IEC-601-1-2." | |
| "Additionally, the Philips EasyGuide Standard Workstation with Spine option is designed to comply with international standard IEC-601-1-2 for electromagnetic compatibility." | ||
| Position digitizer laser compliance (21 CFR Part 1040.10) | "The position digitizer laser complies with Title 21 CFR Part 1040.10." | |
| Interoperability | ACR/NEMA DICOM Version 3 digital imaging communication standard | "This device complies with ... the ACR/NEMA DICOM Version 3 digital imaging communication standard." |
| "Additionally, the EasyGuide Standard Workstation with Spine option is in compliance with the ACR/NEMA Digital Imaging Communication (DICOM) standard." | ||
| Hazard Analysis | Device identified as "minor level of concern" as per "Reviewer's Guidance..." | "The results of a hazard analysis. combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the August 29, 1991 issue of the 'Reviewer's Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review'." |
| Substantial Equivalence | Equivalence to predicate devices | "The Philips EasyGuide Standard Workstation with the Spine option is considered substantially equivalent to the ISG Viewing Wand (K970865), the Picker ViewPoint (K970604), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276)." |
1. Sample sized used for the test set and the data provenance:
- Not explicitly stated in the document. The document discusses compliance with safety and interoperability standards and substantial equivalence, but it does not describe a performance study with a test set of data or data provenance (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not stated. As no specific performance study utilizing a test set with ground truth is described, this information is not present.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not stated. No test set requiring adjudication is described.
4. 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, an MRMC study was not described. The document focuses on the device itself for surgical guidance, not on diagnostic interpretation or human reader performance improvement with AI assistance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study with specific metrics was not described. The submission is for a surgical guidance system that is inherently human-in-the-loop. The "performance" assessment is based on compliance with standards and substantial equivalence, not quantitative standalone algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not stated. No specific performance study requiring ground truth is described. The "ground truth" implicitly referred to would be established regulatory standards and the functional capabilities of predicate devices for the substantial equivalence claim.
7. The sample size for the training set:
- Not applicable / Not stated. No machine learning or AI training set is mentioned or described in the context of this 510(k) submission.
8. How the ground truth for the training set was established:
- Not applicable / Not stated. As no training set is mentioned, this information is not available.
§ 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).