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The CROSSWAY™ Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, or harvesting autogenous bone.

The CROSSWAY™ Spinal Access System consists of instruments used for minimally invasive visualization and access to the anterior spine. The system includes various guides, sleeves, temporary fixation screws, drills, and general surgical instruments.

Here's an analysis of the provided text regarding the CROSSWAY™ Spinal Access System, focusing on acceptance criteria and study details.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through extensive clinical trials with specific acceptance criteria. The performance data presented is primarily related to design verification and material testing.

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

The provided document does not mention a traditional "test set" in the context of clinical performance or algorithm evaluation. The studies mentioned are primarily engineering and material testing.

• Design/Dimensional Analysis: The "sample size" would refer to the specific instruments and components of the CROSSWAY™ system that underwent review and analysis. The document does not specify this number.
• Bacterial Endotoxin Testing: The sample size would be the number of devices or material samples tested for endotoxin. This is not specified.
• Biocompatibility: The sample size would relate to the materials tested. This is not specified.

Data Provenance: Not applicable as there are no clinical test sets or patient data mentioned. The data provenance is from internal testing and material certification.

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

This information is not applicable as the provided document does not describe a study involving human expert evaluation of a test set (e.g., for image interpretation or diagnosis). The studies are engineering and materials-based.

4. Adjudication Method for the Test Set

This information is not applicable as there is no traditional "test set" requiring expert adjudication for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done or mentioned in this document. This submission is for a medical instrument system, not a diagnostic or AI-assisted interpretation device. Therefore, there's no mention of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done or mentioned. The CROSSWAY™ Spinal Access System is a set of physical surgical instruments, not an algorithm or AI system.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant here. For the studies mentioned:

• Design/Dimensional Analysis: The "ground truth" is adherence to engineering specifications and design tolerances.
• Bacterial Endotoxin Testing: The "ground truth" is compliance with the specified standard (ANSI/AAMI ST-72:2011) and its biological limits.
• Biocompatibility: The "ground truth" is that the materials either meet applicable standards or have been previously cleared for patient contact in other 510(k) devices.

8. Sample Size for the Training Set

This information is not applicable as the CROSSWAY™ Spinal Access System is a set of surgical instruments, not an AI or machine learning device that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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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 (CREO® 4.75 only). These devices are indicated as an adjunct to fusion for all of 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, 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 pedicle screw fixation in pediatric patients, the CREO® 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO® 4.75 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 in skeletally mature patients, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO® Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.

The CREO® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction 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.

This document is a 510(k) premarket notification for the CREO® Stabilization System. It details the device's indications for use, its description, and the basis for its substantial equivalence to previously cleared devices. The document highlights mechanical testing conducted to demonstrate this equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" with numerical targets and then list "reported device performance" against those targets in a table format. However, it does state that mechanical testing was conducted to demonstrate 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)

The document does not specify the sample size for the mechanical testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "mechanical testing (static and dynamic compression and static torsion) was conducted."

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 type of information is not applicable to this submission. The "ground truth" concept is typically relevant for studies evaluating diagnostic or AI-based devices where human expert consensus is used to label data. This document describes a medical device (spinal fixation system) cleared based on mechanical performance and substantial equivalence, not a diagnostic or AI device.

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

This information is not applicable for the same reasons as point 3. Adjudication methods are used in studies involving human interpretation or labeling of data, which is not the primary method for evaluating this type of medical device for 510(k) clearance.

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

This type of study is not applicable. An MRMC study evaluates the performance of human readers, typically in the context of diagnostic imaging, with and without AI assistance. This document pertains to a spinal fixation system and its mechanical and material properties, not an AI-based diagnostic tool.

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

This information is not applicable as this is not an AI algorithm. The device is a physical medical implant.

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

The "ground truth" in this context is the established performance standards and material properties defined by ASTM and FDA guidance documents for spinal systems. The device's performance is compared against these engineering and material specifications.

8. The sample size for the training set

This information is not applicable as this is not an AI algorithm that undergoes training.

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

This information is not applicable as this is not an AI algorithm that undergoes training.

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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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