(172 days)
The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific Stryker computer workstation, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system should be operated only by trained personnel such as surgeons and clinic staff. The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures: - Cranial biopsies - Puncture of abscesses - Craniotomies - Craniectomies - Resection of tumors and other lesions - Removal of foreign objects - Skull base procedures - Transnasal neurosurgical procedures - Transphenoidal pituitary surgery - Shunt placement, including pediatric shunt placement - Placement of electrodes for recording, stimulation and lesion generation - Endoscopic Sinus Surgery (ESS) - Intranasal procedures - Ear implant procedures - Craniofacial procedures - Skull reconstruction procedures - Orbital cavity reconstruction procedures.
The Stryker Navigation System - CranialMap Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified. The CranialMap Neuro Module is the Stryker Navigation System for cranial surgeries as described in the indications for use statement. The subject device is the Stryker Navigation Software - CranialMap Neuro which together with the Stryker Navigation Platform, Smart Instruments and Accessories forms the Stryker Navigation System - CranialMap Module. It is therefore regarded as a component of the Stryker Navigation System - CranialMap Neuro Module. The design modifications introduced with the Stryker Navigation Software CranialMap Neuro are intended to increase the user comfort, to enhance the look and feel of the software and to simplify and extend the provided functions using the latest system platform technology.
The provided text describes the CranialMap Neuro Module, a navigation surgical software, and its substantial equivalence to a predicate device. However, it does NOT contain the specific details required to answer all parts of your request, especially regarding acceptance criteria derived from a study proving device performance against those criteria.
Here's an breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
What's Available: The document states an "Accuracy Statement" for both the Predicate Device (iNtellect Cranial Software) and the Subject Device (CranialMap Neuro Software). This appears to be a key performance metric.
What's MISSING:
- A formal "acceptance criteria" table explicitly stating quantifiable thresholds the device must meet for various performance metrics.
- A "reported device performance" table that systematically presents the device's actual measured performance against these criteria.
- Other common performance metrics for navigation systems, such as registration accuracy (beyond just RMS display), latency, tracking stability, clinical accuracy in specific scenarios, etc.
| Acceptance Criteria (Inferred from Predicate Device Accuracy Statement) | Reported Device Performance (for CranialMap Neuro Software) |
|---|---|
| Mean accuracy of 2 mm for translation | Mean accuracy of 2 mm for translation |
| Mean accuracy of 2° for rotation | Mean accuracy of 2° for rotation |
Note: The document states that the accuracy statement is "Identical" for both predicate and subject devices. This implies that the CranialMap Neuro Software is expected to meet the same accuracy as the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
What's MISSING: The document explicitly states "No clinical testing has been conducted." (Section 8). It does not describe any specific "test set" in the context of clinical or performance data to validate the algorithm against real patient data. The non-clinical testing refers to "Validation activities, including human factors validation testing" and "system software validation acc, to IEC 62304," but these are general statements about software development processes, not specific studies with sample sizes or data provenance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
What's MISSING: Since no clinical testing or a formal test set is described, there's no information about experts used to establish ground truth.
4. Adjudication Method
What's MISSING: No information on adjudication methods, as no specific test set or expert review process is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
What's MISSING: No MRMC study is mentioned. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device based on technological characteristics and indications for use, without a comparative effectiveness study involving human readers with/without AI assistance.
6. Standalone (Algorithm Only) Performance
What's Available: The "Accuracy Statement" provided (mean accuracy of 2 mm for translation and 2° for rotation "Within the camera working space") refers to the system's accuracy, which would include the algorithm's contribution to tracking and spatial information computation. This is likely a standalone performance metric for the navigation system.
What's MISSING: Further details on how this "mean accuracy" was measured (e.g., phantom studies, specific methods used).
7. Type of Ground Truth Used
What's MISSING: For the accuracy statement, the document itself does not specify the ground truth mechanism (e.g., direct measurement with a CMM, high-precision phantom, etc.). Given it's a navigation system for surgical guidance, the ground truth for such accuracy measurements typically comes from high-precision physical measurements on phantoms or test setups.
8. Sample Size for the Training Set
What's MISSING: This device is a surgical navigation software module, not primarily an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for image analysis or diagnostics. The software's function is guidance based on predetermined anatomical structures and real-time tracking, not learning from a large dataset to make predictions or classifications. Therefore, the concept of a "training set" as typically understood in AI/ML is not applicable here.
9. How the Ground Truth for the Training Set Was Established
What's MISSING: As explained above, the concept of a training set and its ground truth is not applicable in the context of this traditional surgical navigation software.
Summary of the Study (as described in the document):
The "study" presented is primarily a substantial equivalence comparison between the CranialMap Neuro Software (subject device) and the iNtellect Cranial Software (predicate device). This is a regulatory pathway (510(k)) where the manufacturer demonstrates that a new device is as safe and effective as a legally marketed predicate device.
The "study" to meet acceptance criteria, in this context, involves:
- Non-clinical testing: This includes "Validation activities, including human factors validation testing" and "system software validation acc, to IEC 62304 'Medical device software - Software life cycle processes'." These are general statements about software development, quality assurance, and usability.
- Comparison of Technical Characteristics: A detailed table comparing aspects like indications for use, user interface, modes of operation, control mechanisms, operating principle, accuracy statement, registration accuracy, system components, etc. The claim of "Identical" for the accuracy statement (2mm translation, 2° rotation) is central to demonstrating equivalence in this critical performance aspect.
Conclusion:
The provided document details a regulatory submission for substantial equivalence. While it clarifies the intended performance (specifically the stated accuracy), it does not describe a conventional clinical or performance study with detailed acceptance criteria, test sets, expert ground truth, or MRMC studies that would typically be associated with AI/ML-driven diagnostic or prescriptive devices. The "proof" relies on demonstrating that the new device's technological characteristics, including its accuracy, are identical or equivalent to a previously cleared predicate device, along with general software validation activities.
§ 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).