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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.

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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.

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HEDRON C® Spacers and HEDRON IC® Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

HEDRON C® Spacers and HEDRON IC® Spacers are intended to be used with supplemental fixation, such as an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When the HEDRON IC® Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC® Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-TI) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implants (≥20°) must be used with supplemental fixation in addition to the two screws.

HEDRON® Lumbar Spacers (HEDRON A™, HEDRON P®, HEDRON T™, and HEDRON RT™) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T -T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment. HEDRON® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

HEDRON IA® Integrated Lumbar Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. These devices are intended to be used with or without three screws and or anchors which accompany the implants. These devices are with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when

HEDRON® Cervical Spacers (HEDRON C® and HEDRON IC®) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRONIC® Spacer may be assembled to the COALITION AGX® Plate to create the HEDRON IC® Plate-Spacer, a standalone cervical interbody fusion device. HEDRON® Spacers are additively manufactured from titanium allov. as specified in ASTM F3001.

HEDRON® Lumbar Spacers are lumbar interbody fusion devices used to provide structural stability following discectomy. Each HEDRON® spacer has a different shape to accommodate various surgical approaches to the spine, including anterior, anterolateral, lateral, posterior or transforaminal approaches. All approaches are used in the lumbar spine; only anterolateral, or lateral approaches are used in the thoracic spine.

HEDRON® Integrated Lumbar Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability following discectomy. They are used with or without screws and/or anchors.

All HEDRON® Lumbar Spacers are additively manufactured from titanium powder. The mating screws and anchors are manufactured from titanium alloy and/or cobalt chrome alloy. Titanium screws and anchors are available with or without hydroxyapatite (HA) coating.

The SABLE® Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

SABLE® Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with ExcelsiusGPS® and may be used for a freehand navigated surgical procedure.

The provided text describes a 510(k) premarket notification for several spinal implant devices (HEDRON® Cervical Spacers, HEDRON® Lumbar Spacers, SABLE® Expandable Spacer, and ExcelsiusGPS® Instruments). However, it does not contain information about an AI/ML-based device.

Therefore, I cannot provide the detailed information requested regarding machine learning acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on the substantial equivalence of the new devices to existing predicate devices based on:

• Mechanical testing: Dynamic compression-shear testing was conducted in accordance with "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, and ASTM F2077.
• Technological Characteristics: The subject implants are stated to have the same technological characteristics as the predicate devices, including design, intended use, material composition, and range of sizes.
• Basis of Substantial Equivalence: The information provided within the premarket notification supports substantial equivalence of the subject spacers to the predicate devices with respect to technical characteristics, performance, and intended use.

In summary, the document addresses the regulatory requirements for hardware medical devices and does not involve AI/ML components or related performance studies.

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The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients. These devices are indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Schevermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition, the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fision by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® Stabilization System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The CREO® Stabilization System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation the CREO® Stabilization System rods may be connected to the REVERE Stabilization System (4.5mm, 5.5mm, or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® system package insert for instructions and indications of use.

In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

Globus Navigation Instruments are intended to be used during the preparation and placement of CREO® screws 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 MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

When used for posterior fixation in conjunction with FORTRESS-Plus™ bone cement, the CREO® Fenestrated Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CREO® Fenestrated with FORTRESS™ and FORTRESS-Plus™ bone cements are for use at spinal levels where the structural integrity of the spine is not severely compromised.

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 Medtronic 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 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 and interbody spacers, and intracranial devices such as biopsy needles, electrodes, and tubes.

CREO® ONE Robotic Screws are polyaxial screws with a tapered distal awl tip to allow penetration of the cortex of the pedicle, for ease of use with the ExcelsiusGPS® robot and Globus Navigated Instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. CREO® ONE screws may be used with ExcelsiusGPS® instruments and CREO® Navigation instruments.

CREO® ONE Robotic Screws are composed of titanium alloy with optional hydroxyapatite (HA) coating.

This document describes the FDA's clearance of the CREO® ONE Robotic Screws, along with CREO® Stabilization System and Navigation Instruments, and the ExcelsiusGPS® system. However, the provided text does not contain any information about specific acceptance criteria or the study that proves the device meets those criteria in the context of human-in-the-loop performance, AI assistance, or standalone algorithm performance.

The "Performance Data" section is extremely brief and only states: "Verification and validation cadaveric testing was conducted, including planning and placement of CREO ONE screws, using the ExcelsiusGPS System and associated instruments to demonstrate that CREO ONE Robotic Screws meet performance and navigation accuracy requirements."

This summary indicates that performance and navigation accuracy requirements were met through cadaveric testing, but it does not provide details on:

• Specific acceptance criteria: What were the numerical thresholds for "performance" or "navigation accuracy"?
• Reported device performance values: What were the raw or statistical results from the cadaveric testing?
• Sample size: How many cadavers or screws were tested?
• Data provenance: Where did the cadavers come from? Was it a retrospective or prospective study?
• Experts for ground truth: Were experts involved in defining "ground truth" for navigation accuracy on cadavers? If so, how many and what were their qualifications?
• Adjudication method: How was accuracy adjudicated?
• MRMC comparative effectiveness study: No mention of human readers, AI assistance, or MRMC studies.
• Standalone algorithm performance: This is a physical device, not an AI algorithm, so this concept doesn't directly apply in the usual sense. The accuracy refers to the physical system's guidance.
• Type of ground truth: While it's cadaveric testing, the method of establishing the "true" anatomical position for comparison isn't detailed (e.g., micro-CT, physical measurement).
• Training set: This product is a medical device and navigation system, not an AI model requiring a separate "training set" in the context of machine learning. The term "training set" would not apply here.
• Ground truth for training set: Not applicable for this type of device.

Therefore, based solely on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance with the level of detail requested for an AI/algorithm-focused study. The document confirms that testing was done to demonstrate performance and navigation accuracy, but the specifics are not disclosed in this public summary.

The document is a 510(k) summary for a medical device (surgical instruments and a navigation system), not a software or AI product requiring the type of performance evaluation typically detailed in the prompt. The "performance data" here refers to the physical accuracy and functionality of the instruments and navigation system working together, likely tested in a lab or cadaveric setting against engineering specifications.

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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 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 and interbody spacers, and intracranial devices including biopsy needles, electrodes, and tubes.

The ExcelsiusGPS® Cranial Module includes hardware and software that enables real time surgical navigation using radiological patient images (MRI, CT, and fluoroscopy), using a dynamic reference base and positioning camera. The navigation system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument on the patient images. As an aid to visualization, the surgeon can plan trajectories for instrument placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments include non-sterile, re-usable instruments and sterile instruments that are operated manually or with the use of the positioning system.

The ExcelsiusGPS® Cranial Module is designed to assist with stereotactic procedures that include guidance to cranial targets for instrument navigation and device placement. Instruments consist of end effector instruments, registration instruments, navigated instruments, patient positioning instruments, and surgical instruments. End effector instruments include instruments to the Interchangeable Guide End Effector. Registration and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. Patient positioning instruments aid in patient fixation. Surgical instruments are used to access and prepare the local site and place devices, such as needles, electrodes, and tubes.

1. A table of acceptance criteria and the reported device performance

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The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients. These devices are indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Schevermann's Disease), tumor, stenosis. and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition. the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® Stabilization System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The CREO® Stabilization System is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (4.5mm, 5.5mm, or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE®, or ELLIPSE® system package insert for instructions and indications of use.

In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

Globus Navigation Instruments are intended to be used during the preparation and placement of CREO® screws 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 Medtronic 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 MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (OUARTEX®, 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 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.

CREO® Preferred Angle Screws are polyaxial screws with a preferred angle in one direction. They are composed of titanium alloy or cobalt chrome molybdenum alloy as specified in ASTM F136 and F1537, and are available with optional hydroxyapatite (HA) coating per ASTM F1185.

Navigation Instruments are nonsterile, reusable instruments that can be operated manually or under power using a power drill that are intended to be used with the Medtronic StealthStation® System.

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.

The provided document is a 510(k) summary for the CREO® Stabilization System, Navigation Instruments, and ExcelsiusGPS®. It primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and mechanical testing. The document does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML-based medical devices.

Here's why and what can be extracted:

Why the requested information is not available in the provided text:

The request asks for details typically found in studies for AI/ML-based medical devices, such as:

• Acceptance Criteria/Reported Device Performance (Table): This would typically include metrics like sensitivity, specificity, AUC, or accuracy for a diagnostic/predictive AI. The document discusses mechanical testing criteria for spinal implants and instruments, not performance metrics for an AI system.
• Sample size and data provenance for test set: Relevant for AI algorithm performance evaluation.
• Number of experts and qualifications for ground truth: Essential for establishing ground truth in AI studies.
• Adjudication method: How disagreements among experts are resolved for ground truth.
• MRMC comparative effectiveness study: Measures the improvement in human reader performance with AI assistance.
• Standalone performance: Performance of the algorithm without human intervention.
• Type of ground truth: Pathology, expert consensus, outcomes data.
• Training set sample size and ground truth establishment: Details about the data used to train an AI algorithm.

The devices described (CREO® Stabilization System, various Navigation Instruments, and ExcelsiusGPS®) are spinal implants and surgical navigation systems, which are hardware devices. The text mentions "precisely locating anatomical structures" and "spatial positioning and orientation," which are functions of a navigation system, but it doesn't describe the use of an AI algorithm for diagnostic or predictive purposes that would necessitate the above detailed performance metrics. The navigation systems are designed for use with existing systems like Medtronic StealthStation® and ExcelsiusGPS® robotic arm.

What can be extracted or inferred:

While a table of acceptance criteria for an AI study cannot be created, here's what the document implies about how substantial equivalence was demonstrated:

Addressing the specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Mechanical testing (static and dynamic compression, static torsion) per ASTM F1717 and FDA Guidance for Spinal System 510(k)s. Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011.
   • Reported Device Performance: The document states that the testing was conducted "to demonstrate substantial equivalence" and that the "information provided within this premarket notification supports substantial equivalence to the predicate devices." Specific numerical performance data is not provided in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of submission which relies on mechanical testing rather than clinical data or AI algorithm performance data. The "test set" here refers to the physical devices and materials tested.

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 as understood in AI/ML is not established for mechanical testing of physical medical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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, an MRMC study was not done as this is not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI algorithm. The ExcelsiusGPS® is a navigation system that aids surgeons, but its function as described does not involve an AI algorithm that would have standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the mechanical testing would be the engineering specifications and established standards (ASTM F1717, ANSI/AAMI ST-72:2011).

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the provided FDA 510(k) document is for a traditional medical device (spinal implants and surgical navigation instruments) and not an AI/ML-based device. Therefore, the bulk of the questions asking about AI-specific validation metrics cannot be answered from this text.

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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 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.

The ExcelsiusGPS® Interbody Module includes hardware and software that enables real time surgical navigation using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. The navigation system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument, on the patient images. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments are non-sterile, re-usable instruments that are operated manually.

ExcelsiusGPS® Interbody Module instruments include registration instruments. patient reference instruments, and surgical instruments. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification adapters, surveillance marker, surgical instrument arrays, intra-op CT registration fixture, fluoroscopy registration fixture, and dynamic reference bases (DRB and DRB2). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRBs. Surgical instruments are used to prepare the implant site or implant the device, and include instrument handles, disc prep and trial instruments, interbody inserters, and a dilator holder. The Motion Lock End Effector attaches to the robotic arm and provides a rigid attachment connection for a surgical retractor or port.

The provided text is a Fragment and does not contain any information about acceptance criteria or specific studies that prove the device meets these criteria. It details the FDA clearance for the ExcelsiusGPS Spine 1.1 Interbody Module, its indications for use, technological characteristics, and general statements about performance testing. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies or effect sizes.
• Standalone (algorithm-only) performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The "Performance Testing" section states:

• "Surgical simulations conducted on phantom models Sawbone models and registration matrix were used to quantify accuracy in a controlled setting."
• "Human cadaveric quantitative validation under clinically relevant scenarios - Demonstrated system accuracy in navigating interbody fusion devices to the desired location on patient images."

However, no specific data, acceptance criteria, or methodological details like sample sizes, ground truth establishment, or expert involvement are reported for these tests in the provided document.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the studies proving the device meets them based on the provided text.

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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 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.

The High Speed Drill Instruments consist of an array, array sleeves, a drill guard, and drill bits. These instruments are provided non-sterile, except for the drill bits which are provided sterile or non-sterile. These instruments are intended to be used with ExcelsiusGPS® and are manufactured from stainless steel, per ASTM F899, and PEEK.

The provided text summarizes a 510(k) submission for the "ExcelsiusGPS High Speed Drill Instruments" for use with the ExcelsiusGPS system. However, the document does not contain explicit acceptance criteria and corresponding performance data as typically presented in a clinical study report. Instead, it states that "Verification and Validation testing and comparison to the predicate demonstrate that the ExcelsiusGPS® High Speed Drill Instruments can be used in accordance with its indications."

Therefore, based on the provided text, I cannot produce the requested table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed clinical performance metrics from a specific study.

Information that is available from the text:

• Device Name: ExcelsiusGPS® High Speed Drill Instruments
• Intended 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 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.
• Basis of Substantial Equivalence: Technological characteristics (design, intended use, material composition, function, and range of sizes) are the same as predicate instruments. Performance testing (Verification and Validation) was conducted to demonstrate the instruments can be used in accordance with their indications. Bacterial endotoxin testing (BET) was conducted, and biocompatibility was demonstrated by using standard materials or materials from 510(k) cleared devices.
• Regulatory Clearance Document: K190653

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The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients. These devices are indicated as an adjunct to fusion for the following indications: degenerative disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition, the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pediatic patients, the CREO® Stabilization System implants are indicated as an adjunct to freat adolescent idiopathic scoliosis. The CREO® Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (4.5mm, 5.5mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® system package insett for instructions and indications of use.

In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.

Globus Navigation Instruments are intended to be used during the preparation and placement of CREO® serews 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 Medtronic 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 MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

When used for posterior fixation in conjunction with FORTRESS-Plus™ bone cement, the CREO® Fenestrated Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CREO® Fenestrated with FORTRESS™ and FORTRESS-Plus™ bone cements are for use at spinal levels where the structural integrity of the spine is not severely compromised.

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 MR 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 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.

The CREO® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, fenestrated screws, locking caps, t-connectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition.

CREO® implants are composed of titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537 and F138. Rods are also available in commercially pure titanium, as specified in ASTM F67. Screws are also available with hydroxyapatite (HA) coating per ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromiummolybdenum alloy implants.

CREO® Stabilization System include surgical instruments manufactured from stainless steel, as specified in ASTM F899.

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.

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.

The provided document for K182375 is an FDA 510(k) clearance letter and summary for a medical device called the CREO® Stabilization System, Navigation Instruments, and ExcelsiusGPS®. However, the document primarily focuses on bench testing (mechanical testing and bacterial endotoxin testing) to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's diagnostic performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not available in the provided text because a clinical study of that nature was not described for this submission.

The document states:

• "Mechanical testing (static and dynamic compression and static torsion) was conducted in accordance with ASTM F1717 and the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s,' May 3, 2004 to demonstrate substantial equivalence of the subject CREO implants to the predicate devices."
• "Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."
• "Subject CREO® implants, Navigation instruments, and ExcelsiusGPS® instruments have the same technological characteristics as the predicate devices including design, intended use, material composition, and range of sizes."
• "Subject CREO® implants and instruments are similar to the predicate device with respect to technological characteristics, performance, design, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices."

This indicates that the clearance was based on demonstrating the physical and mechanical equivalence of the new device to existing cleared devices, and on demonstrating biocompatibility (via bacterial endotoxin testing), not on a clinical performance study with predefined acceptance criteria for diagnostic output.

Therefore, I cannot populate the table or answer the specific questions about clinical study design parameters, as this information is not present in the provided 510(k) summary.

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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.

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