Search Results

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 to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required 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.

ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required 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.

Subject ExcelsiusGPS® instruments consist of array sleeve adapters and surgical instruments, including drivers, drills, taps, and probes, that may be used manually or navigated with the use of ExcelsiusGPS® or ExcelsiusHub™. The surgical instruments are used to prepare the implant site or implant the device. Instruments are non-sterile and reusable.

The provided document is a 510(k) premarket notification for the ExcelsiusGPS® Instruments, specifically for additional instruments to be used with the existing ExcelsiusGPS® or ExcelsiusHub™ systems for navigating and/or guiding compatible surgical instruments for the placement of spinal and orthopedic bone screws.

There is no mention of an AI/ML component in this document. The device is a set of surgical instruments (array sleeve adapters, drivers, drills, taps, probes) that can be used manually or navigated with the existing ExcelsiusGPS® or ExcelsiusHub™ systems. Therefore, the questions related to AI/ML device performance, such as acceptance criteria for AI algorithms, test set sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

The "Performance Testing" section describes verification tests including "instrument integration and comparison to the predicate devices" to confirm the instruments meet performance requirements. However, specific acceptance criteria and the results of these tests are not detailed in this summary. Biocompatibility was also confirmed by using materials consistent with predicate devices.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and study details because the document does not indicate that the ExcelsiusGPS® Instruments or its associated systems utilize AI/ML technology subject to such evaluation.

Ask a specific question about this device

The QUARTEX® Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (CI-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating compatible surgical instruments in open or percutaneous provided that the required 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 and interbody spacers.

The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required 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 and interbody fusion devices.

QUARTEX® additional implants include monoaxial, polyaxial, and dual lead polyaxial screws manufactured from titanium alloy; MIS rods manufactured from titanium alloy, stainless steel, and/or cobalt chromium molybdenum; and, associated manual and navigated surgical instruments.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be used with ExcelsiusGPS® or ExcelsiusHub® and may be used for a navigated surgical procedure. No changes were made to the ExcelsiusGPS® or ExcelsiusHub® systems with the addition of the subject ExcelsiusGPS® instruments.

The provided text is a US FDA 510(k) K231850 clearance letter for the QUARTEX® Occipito-Cervico-Thoracic Spinal System and ExcelsiusGPS® Instruments. This document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving performance against acceptance criteria in the context of an AI/medical device standalone or comparative effectiveness study.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not available within the provided text.

The document mentions "Verification and validation testing were conducted to confirm implant placement accuracy with ExcelsiusGPS®" under the "Performance Data" section. However, it does not provide any specifics about these tests, methodologies, acceptance criteria, or the results of these tests.

In summary, the provided document does not contain the information needed to fill out the requested table or answer the detailed questions about the study proving the device meets acceptance criteria.

Ask a specific question about this device

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.

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