Search Results
Found 1 results
510(k) Data Aggregation
(89 days)
The SI-LOK® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.
Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.
The SI-LOK® Sacroiliac Joint Fixation System (including SI-LOK® Select) consists of cannulated, fully or partially threaded screws that are available with or without slots and optional pre-assembled contouring washers. One, two or three screws may be placed in one sacroiliac joint, depending on the approach.
The screws and washers are manufactured from titanium alloy, as specified in ASTM F136 (Ti6Al4V) and F1295 (Ti6Al7Nb). SI-LOK® screws are available with or without hydroxyapatite (HA) coated, as specified in ASTM F1185.
SI-LOK® Sacroiliac Joint Fixation System include surgical instruments manufactured from stainless steel, as specified in ASTM F899.
SI-LOK® ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with the ExcelsiusGPS® robotic arm, or may be used for a freehand navigated surgical procedure.
SI-LOK® Navigation Instruments are nonsterile, reusable instruments that can be operated manually or under power using a power drill such as POWEREASE that are intended to be used with the Medtronic StealthStation® System.
This FDA 510(k) K183119 summary does not describe a study involving device performance metrics related to diagnostic accuracy, sensitivity, specificity, or reader studies utilizing AI. Instead, it focuses on the substantial equivalence of the "SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments" to previously cleared predicate devices based on mechanical, biocompatibility, and technological characteristics.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from the provided text. The device in question is a surgical fixation system and related navigation instruments, not an AI-powered diagnostic or assistive tool in the typical sense for which an MRMC study or standalone algorithm performance metrics would be assessed.
Here's a breakdown of what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of accuracy metrics for an AI system. Instead, the "acceptance criteria" are implied through the successful completion of specified mechanical and biocompatibility tests, demonstrating substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static Cantilever Bending | Performed in accordance with ASTM F2193 and ASTM F543 to demonstrate substantial equivalence to predicate devices. |
| Dynamic Cantilever Bending | Performed in accordance with ASTM F2193 and ASTM F543 to demonstrate substantial equivalence to predicate devices. |
| Screw Pull-Out | Performed in accordance with ASTM F543 to demonstrate substantial equivalence to predicate devices. |
| Biocompatibility: | |
| Material Biocompatibility | Demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices. |
| Bacterial Endotoxin Testing (BET) | Conducted in accordance with ANSI/AAMI ST-72:2011. |
| Accuracy (Navigation Instruments): | Accuracy testing performed on the predicate Navigation instruments is applicable for the subject instruments and has not been repeated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of human subjects or diagnostic cases, as this is primarily a mechanical and material performance evaluation for a surgical device. The "sample size" would refer to the number of devices or components tested in the mechanical evaluations, which is not detailed.
- Data Provenance: Not applicable in the context of diagnostic data. The provenance for the device materials and testing standards is US (ASTM, ANSI/AAMI).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth in the context of device performance in this submission refers to adherence to mechanical and material standards, not expert medical opinion on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication process involving expert readers 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 MRMC comparative effectiveness study was done or described. This submission is not for an AI-assisted diagnostic device. The ExcelsiusGPS® and Navigation Instruments are tools to assist surgeons in locating anatomical structures and positioning instruments, often used with imaging but not as a primary diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not a standalone algorithm. Its function is to aid a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's substantial equivalence is based on:
- Engineering standards (ASTM F2193, ASTM F543, ANSI/AAMI ST-72:2011) for mechanical and biocompatibility properties.
- Comparison of technological characteristics (design, intended use, material composition, function, range of sizes) to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
Ask a specific question about this device
Page 1 of 1