(277 days)
The GALILEO™ Spine Alignment Monitoring System is intended to provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes.
The GALILEO™ Spine Alignment Monitoring System is indicated for patients undergoing orthopedic spine surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid spinal anatomical structure, such as a vertebral body, can be identified relative to the anatomy. The system aids the surgeon in controlling spinal sagittal alignment.
Example spine surgical procedures include:
- Spinal deformity correction
- Spinal fusion
The GALILEO™ Spine Alignment Monitoring System provides intra-operative real-time measurement of sagittal plane spine alignment parameters such as Lordosis and Kyphosis. The system consists of Orientation Sensing Modules (OSM) that are attached to vertebrae of interest with the patient in prone position. The OSM's are battery-powered devices containing inertial sensors that measure vertebral alignment changes and communicate the information wirelessly to a computer. The computer software calculates sagittal plane spinal alignment parameters in real-time based on the OSM measurements and displays the information on a touch screen tablet.
The provided text describes the GALILEO™ Spine Alignment Monitoring System, but it does not contain the specific details regarding acceptance criteria and the comprehensive study results that would be necessary to fully answer your request.
Here's an analysis of what information is available and what is missing:
Information Present:
- Device Name: GALILEO™ Spine Alignment Monitoring System
- Intended Use/Indications for Use: To provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes, during orthopedic spine surgery (e.g., spinal deformity correction, spinal fusion) to aid in controlling spinal sagittal alignment.
- Types of Performance Data Performed:
- Performance tests under simulated bench conditions to verify software algorithms and overall system accuracy for calibration, sagittal plane registration, vertebral registration, and sagittal plane spine alignment measurements.
- Simulated use testing (sawbones and cadaver) to verify and validate overall system performance and compare measurements with clinically accepted standardized radiographic measurements.
- Electrical, electromagnetic compatibility, and wireless telecommunication tests (IEC 60601-1-2, FCC 47 CFR part 15).
- Software tests for functionalities and features.
- Biocompatibility testing (using materials with established biocompatibility).
- Sterilization and packaging validation (ISO 14937, ISO 11607 for SAL of 10-9).
Missing Information (Crucial for your request):
- Specific Acceptance Criteria: While performance tests are mentioned, the actual numerical or qualitative acceptance criteria are not provided. For example, what was the acceptable margin of error for sagittal plane alignment measurements?
- Reported Device Performance (Quantitative): The document states that "The results demonstrated that the GALILEO™ Spine Alignment Monitoring System satisfied all user needs and intended use requirements," but it does not provide the actual measured performance values (e.g., accuracy, precision) from the tests.
- Sample Size for Test Set: The number of sawbones or cadaver specimens used for simulated use testing is not specified.
- Data Provenance (Country, Retrospective/Prospective): Not mentioned for any of the performance data.
- Number of Experts & Qualifications for Ground Truth: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: The document does not describe any study comparing human readers with and without AI assistance, nor does it mention an effect size.
- Standalone Performance Study: While "Performance tests were performed...to verify the implementation of the software algorithms and overall system accuracy," it's not explicitly stated as a standalone performance study with detailed results for the algorithm only.
- Type of Ground Truth Used: The text mentions comparing system measurements with "clinically accepted standardized radiographic measurements" for simulated use testing, which implies an external reference standard. However, the exact nature (e.g., expert consensus on radiographs, direct physical measurements) is not fully elaborated.
- Sample Size for Training Set: Not mentioned. The device is described as having "inertial sensors" and "computer software calculates sagittal plane spinal alignment parameters," suggesting an algorithm, but training data details are absent.
- How Ground Truth for Training Set Was Established: Not mentioned.
Based on the available information, here's what can be provided with the significant gaps highlighted:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Accuracy (Bench testing) | Not specified in document | "verified the implementation of the software algorithms and overall system accuracy" |
| Overall System Performance (Simulated use) | Not specified in document | "satisfied all user needs and intended use requirements" and "compare system measurements with clinically accepted standardized radiographic measurements" |
| Software Functionality | Not specified in document | "ensure that the required functionalities and features were implemented without the introduction of hazardous anomalies" |
| Electrical, EMC, Wireless | Compliance to IEC 60601-1-2 and FCC 47 CFR part 15 | "demonstrate compliance to IEC 60601-1-2, and FCC 47 CFR part 15" |
| Biocompatibility | Using materials with established biocompatibility | "achieved by using materials with established biocompatibility" |
| Sterilization & Packaging | Compliance with ISO 14937 and ISO 11607 to ensure a SAL of 10-9 | "performed for single-use components in compliance with ISO 14937 and ISO 11607 to ensure a SAL of 10-9 over the shelf life of the product." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document only mentions "simulated use testing involving sawbones and cadaver specimen." The number of sawbones or cadavers is not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Implicit: The ground truth for simulated use testing was compared to "clinically accepted standardized radiographic measurements," implying that these measurements would typically be interpreted or confirmed by radiology or orthopedic specialists, but the specific role and number of experts are not detailed.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No, the document does not describe a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance. The device is described as providing intra-operative measurements to a surgeon, not as an AI-assisted diagnostic tool for human readers in the traditional sense of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in part. The "Performance tests were performed under simulated bench test conditions to verify the implementation of the software algorithms and overall system accuracy covering all functional steps." These tests would likely assess the algorithm's performance in isolation from a human surgeon interacting with it, focusing on the accuracy of the measurements it produces. However, quantitative results of this standalone accuracy are not provided.
7. The type of ground truth used
- For the simulated use testing, the ground truth was "clinically accepted standardized radiographic measurements." This suggests that the device's output was compared against established radiographic parameters that are considered the standard.
8. The sample size for the training set
- Training Set Sample Size: Not specified. The document describes the device as containing "inertial sensors that measure vertebral alignment changes and communicate the information wirelessly to a computer. The computer software calculates sagittal plane spinal alignment parameters," implying an algorithm, but details about training data are absent.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not specified.
§ 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).