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The Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used for posterior non-cervical screw fixation in pediatric patients, the Rexious System, Statera™ Spinal Fixation System, and Statera-MTM System are indicated as an adjunct to fusion to treat: adolescent idiopathic scoliosis, progressive spinal deformities (i.e., scolosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis, spondylolisthesis, spondylolysis, pseudarthrosis, failed prior fusion, and fracture caused by tumor and/or trauma in pediatric patients. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

When used as an anterolateral thoracolumbar system, the Rexious Spinal Fixation System, Statera™ Spinal Fixation System, and Statera-M™ Spinal Fixation System are intended for anterolateral screw (with staples) fixation for the following indications: degenerative discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System are top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, set screws, connectors, hooks, washers, staples, and transverse (cross) linking mechanisms.

The Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

This document describes the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System, which are spinal fixation systems. However, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study for AI/software devices.

Instead, this is a 510(k) summary for a medical device (spinal hardware), which focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than fulfilling specific performance acceptance criteria through clinical trials or software validation studies. The "performance data" referred to is primarily mechanical testing of the physical implants, comparing them to the predicate device.

Therefore, many of the requested sections (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of device and submission.

Here's an analysis based on the provided text, while acknowledging its limitations for the requested AI/software-centric details:

1. Table of Acceptance Criteria and Reported Device Performance

For this spinal fixation system, "acceptance criteria" and "reported device performance" are primarily focused on mechanical integrity and equivalence to the predicate device, not on diagnostic accuracy or AI performance.

• Static compression bending
• Dynamic compression bending
• Static Torsion

These tests "demonstrate that the Statera™ Spinal System, and Statera-M™ Spinal System are substantially equivalent to the legally marketed predicate devices." |
| Design and Functionality Equivalence: The device design (components, principle of operation) is substantially equivalent to the predicate device. | The subject device has "the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device." "There are no technological differences between the Subject device and its predicate devices." |

Note: For the Rexious Spinal Fixation System (part of the submission), no performance testing was required because it is identical to a system already cleared under K222415.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not applicable in the context of clinical/AI test sets. For mechanical testing, the "sample size" would refer to the number of physical implants tested. This specific number is not provided in the document, but it would have followed the requirements of ASTM F1717 for mechanical samples.
• Data Provenance: The data is from non-clinical bench testing of physical device components, performed to demonstrate mechanical equivalence. Country of origin is not specified, but it's typically internal lab testing or third-party accredited labs. It is not prospective or retrospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable. This submission does not involve ground truth established by medical experts for diagnostic or AI performance. The "ground truth" for mechanical testing is adherence to engineering standards and comparison to the predicate device's mechanical properties.

4. Adjudication Method for the Test Set

• Not applicable. There is no adjudication method in the context of expert consensus or diagnostic disagreements, as this is bench testing of physical hardware.

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

• Not applicable. This is a hardware medical device, not an AI/software device intended to assist human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical spinal fixation system, not a standalone algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance Standards and Predicate Device Data: The "ground truth" for this device's performance demonstration is based on established ASTM mechanical testing standards (specifically ASTM F1717) and comparative data from the legally marketed predicate devices. The goal is to show that the subject device performs similarly to or better than the predicate device in these mechanical tests.

8. The Sample Size for the Training Set

• Not applicable. There is no training set as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no training set for this type of device.

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The CarboClear® Pedicle Screw System is intended to provide rigid immobilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/ or allogenic bone graft comprised of cancellous and/or corticocancellous bone graff.

The CarboClear® Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The CarboClear® implants include pedicle screws, rods and locking elements. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants include tantalum markers. The implants are supplied sterile, and are intended for single use.

The provided text describes the CarboClear® Pedicle Screw System, a medical device for spinal stabilization, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication as might be seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria and study methodology for proving device performance through such studies is not available in this document.

However, based on the provided text, here's what can be extracted regarding performance and substantiation:

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

The document does not explicitly state quantitative acceptance criteria for device performance in a table format. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. Instead, it refers to "Performance data" and "Clinical data."

• Performance Data (Mechanical Testing): The sample size for mechanical tests (e.g., number of screws, rods tested) is not provided. The data provenance is laboratory testing conducted according to ASTM standards. Country of origin not specified, but the applicant is based in Israel.
• Clinical Data: The sample size for clinical data (e.g., number of patients) is not provided. The provenance (country of origin, retrospective/prospective) is also not specified.

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)

This information is not applicable to the type of submission described. The document does not describe a study involving expert-established ground truth for a test set, as would be relevant for an AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. There is no mention of an adjudication method as it relates to expert review of a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a physical pedicle screw system, not an AI/ML-driven diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical performance, the "ground truth" is established by adherence to recognized ASTM standards and comparison to predicate device performance. For clinical performance, the "ground truth" would likely be patient outcomes, but the specific type of clinical ground truth (e.g., imaging follow-up, functional scores, fusion rates) is not detailed.

8. The sample size for the training set

This information is not applicable. The device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. The device is not an AI/ML model that requires a training set with established ground truth.

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The EXCELSIUS GPS™ 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 EXCELSIUS GPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (preoperative CT, intraoperative CT and fluoroscopy), using a dynamic reference base and positioning camera. The navigation and quidance 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, including the end effector of the robotic arm, on the patient images. This visualization can help guide the surgeon's planning and approach. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. The information of the plan coupled with the registration provides the necessary information to provide visual assistance to the surgeon during free hand navigation or during automatic robotic alignment of the end effector. During surgery, the system tracks the position of GPS compatible instruments, including the end effector of the robotic arm, in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. Standard non-navigated metallic instruments that fit through the quide tube at the selected trajectory may be used without navigation while the quide tube is stationary, for uses such as bone preparation (e.g. rongeurs, reamers etc.) or placing implants (e.g. rod inserters, locking cap drivers) that are not related to screw placement. Navigation can also be performed without guidance. System software is responsible for all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions. EXCELSIUS GPSTM surgical instruments are non-sterile, re-usable instruments that can be operated manually or with the use of the positioning system. EXCELSIUS GPS™ instruments consist of registration instruments, patient reference instruments, surgical instruments, and end effectors. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification probe, surveillance marker, surgical instrument arrays, intra-op CT reqistration fixture, fluoroscopy registration fixture, and dynamic reference base (DRB). 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 DRB. Surqical instruments are used to prepare the implant site or implant the device, and include awls, drills, drivers, taps, and probes, End effectors are wirelessly powered quide tubes that attach to the distal end of the robotic arm and provide a rigid structure for insertion of surgical instruments.

The provided document is a 510(k) summary for the EXCELSIUS GPS™ robotic positioning system. It describes the device, its intended use, and a comparison to predicate devices, along with various performance testing categories. However, it does not contain acceptance criteria or detailed results from a specific study proving the device directly meets acceptance criteria for accuracy or clinical outcomes.

Instead, the document broadly describes categories of performance testing that were conducted to ensure safety and efficacy, and confirms compliance with recognized standards.

Therefore, many of the requested details about specific acceptance criteria and a study proving them cannot be extracted from this document. I will provide what can be gleamed and note where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that "Verification and validation testing was conducted... to confirm that the device meets performance requirements," but it does not explicitly list what those performance requirements (acceptance criteria) were in terms of specific quantitative metrics (e.g., accuracy in mm, successful screw placement rate).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided document. The document mentions "Surgical simulations conducted on phantom models" and "Human cadaveric quantitative validation under clinically relevant scenarios" but does not give the number of cases, studies, or specific phantom/cadaver units used.
• Data Provenance: Not specified. It's likely these tests were conducted internally by Globus Medical or a contracted research organization, but no country of origin or whether it was retrospective/prospective is mentioned. Given the nature of cadaveric and phantom studies, they are typically prospective experimental designs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Not specified. The document does not describe a method for establishing or adjudicating ground truth in a clinical or expert review context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on how human readers improve with AI vs. without AI assistance is not described in this document. The EXCELSIUS GPS is a robotic positioning system for surgical guidance, not an AI-assisted diagnostic imaging device for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the performance testing described (e.g., "Non-clinical system, software, and instrument verification and validation," "Surgical simulations conducted on phantom models," "Human cadaveric quantitative validation") generally represents standalone performance of the device's accuracy and functionality. The system "determines the registration or mapping," "displays the relative position of a tracked instrument," and "provides visual assistance to the surgeon," implying the device's inherent capability to perform these functions. Specific metrics for this standalone performance (e.g., tracking accuracy, registration accuracy) are not detailed.

7. The Type of Ground Truth Used

• For the performance testing mentioned:
  • For "Surgical simulations on phantom models" and "Human cadaveric quantitative validation," the ground truth would likely be established by direct measurement using precision instruments (e.g., coordinate measuring machines, highly accurate imaging) to compare the device's reported position/trajectory against the actual physical position/trajectory.
  • For compliance assessments (electrical safety, EMC, biocompatibility, software V&V), the "ground truth" is adherence to the specified international standards and FDA guidance.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This document describes a surgical guidance system, not a machine learning model that would typically have a distinct "training set" in the common sense of AI/ML algorithm development. While software development (which is discussed) involves testing, there's no mention of a traditional machine learning training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not specified (refer to point 8).

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The HAVEN™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The HAVEN™ Laminoplasty System is used to hold bone allograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.

The CANOPY® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY® Laminoplasty Fixation System is used to hold bone allograft or autograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.

The HAVEN™ Laminoplasty System consists of spinal fixation plates for use in Laminoplasty. These implants are composed of titanium or titanium alloy (per ASTM F67, F136, F1295, and F1472). HAVEN™ implants may be used with previously cleared CANOPY®, RELIEVE®, QUARTEX™, ELLIPSE®, PROTEX CT® screws and CANOPY® Spacer.

The CANOPY® Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY® implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

CANOPY® plates and screws are manufactured from titanium or titanium alloy, as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent PEEK as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.

This document describes the FDA's clearance of the HAVEN™ Laminoplasty System and CANOPY® Laminoplasty Fixation System. It is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria based on patient outcomes.

Therefore, the requested information about acceptance criteria and specific study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size) is largely not applicable in the context of this 510(k) submission.

Explanation:

• 510(k) Premarket Notification: This type of submission aims to demonstrate that a new device is "substantially equivalent" to a device already on the market (a predicate device). This often relies on comparing technical characteristics, materials, and mechanical or non-clinical performance, rather than clinical efficacy against pre-defined acceptance criteria for patient outcomes.
• Mechanical Testing vs. Clinical Studies: The performance data section explicitly states, "Compression, cantilever bending and expulsion testing performed on the HAVEN™ plates demonstrates substantial equivalence to the predicate devices. No additional testing for CANOPY® plates was performed." This indicates that the primary basis for clearance was a comparison of mechanical properties, not clinical performance against specific metrics.
• Absence of Clinical Study Details: The document does not mention any clinical studies, patient data, ground truth establishment by experts, or statistical analyses of human reader performance (MRMC) or standalone algorithm performance that would be typical for AI/ML device clearances requiring such details.

However, based on the provided document, I can extract the following relevant information regarding performance and its basis for substantial equivalence:

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

2. Sample size used for the test set and the data provenance:

• Not Applicable in the traditional sense for clinical data. The performance claims are based on mechanical testing of the devices themselves, not on a test set of patient data.
• Data Provenance: The mechanical testing was performed by the manufacturer, Globus Medical Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No expert-established ground truth for patient data is mentioned as part of this 510(k) clearance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. No adjudication method for expert review of patient data is mentioned.

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:

• Not Applicable. This is a physical medical device (spinal fixation system), not an AI/ML algorithm for image interpretation or diagnosis. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable for clinical ground truth. For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate device's established mechanical properties.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device relying on a training set of data.

9. How the ground truth for the training set was established:

• Not Applicable. As above, no training set for an algorithm is involved.

In summary: The provided document is a 510(k) clearance for a spinal implant system. The "study" referenced is mechanical performance testing to demonstrate substantial equivalence to predicate devices, not a clinical study involving patient data, expert review, or AI performance metrics.

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When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ -T3)
The Connector System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations: instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is 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.

When used with the Firebird System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium)
The Connector System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. spondylolisthesis,
3. trauma (i.e., fracture or dislocation),
4. spinal stenosis,
5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. tumor.
7. pseudoarthrosis, and
8. failed previous fusion
   When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.

The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g. Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, Spinal Fixation System, Centurion POCT System, Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.

The provided text is a 510(k) premarket notification for a medical device (Connector System). It describes the device's intended use, technological characteristics, and comparison to predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain the information required to answer your specific questions regarding acceptance criteria and performance study details typical for an AI/ML powered medical device.

The document details mechanical performance testing for the physical connector system (e.g., static compression bending, static torsion, dynamic compression bending) against industry standards like ASTM F1717 and F1798. It does not describe:

• Acceptance criteria for an AI/ML algorithm.
• Performance of an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets or training sets for AI.
• Data provenance, expert ground truth establishment, or adjudication methods for an AI study.
• Details of a multi-reader multi-case (MRMC) study or standalone AI performance.

Therefore, I cannot extract the information to fill out the table and answer the study-related questions as if this were an AI/ML device submission. This document pertains to a traditional orthopedic implant.

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