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When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Cloc -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 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 pedicle screw fixation is limited to a posterior aproach. 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, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.

The provided text describes a 510(k) premarket notification for a medical device called the "Connector System." This submission is for additions and modifications to an already cleared device (K172194). The document does not describe any acceptance criteria or studies related to AI/ML device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing for the physical components of the spinal fixation system.

Here's why the requested information about AI/ML acceptance criteria and studies cannot be extracted from this document:

• Device Type: The "Connector System" is a medical implant (spinal fixation system components like connectors and rods). It is a passive mechanical device and not an AI/ML-driven diagnostic or treatment planning tool.
• Performance Data Section: The "PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence" section explicitly states that mechanical testing was conducted. It lists specific physical components and the type of mechanical test (ASTM F1798 Axial Grip Testing) or justification (worst-case analysis, specification clarification). This confirms the evaluation of physical properties, not software performance.
• Lack of AI/ML Terminology: There is no mention of algorithms, machine learning, artificial intelligence, diagnostic accuracy, sensitivity, specificity, AUC, human readers, ground truth, training sets, test sets, or any other terms associated with AI/ML device evaluation.

Therefore, I cannot provide the requested information. The document details the regulatory submission for a traditional medical device, not an AI/ML device.

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1. 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 and stabilization 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 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 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.

2. When used with the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation

System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/llium) The Connector System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Illium), 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 tusion to treat adolescent idiopathic scoliosis. Pediatric pedicle 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, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.

This K172194 submission from Orthofix Inc. for their "Connector System" describes a modification to an already cleared device (K170647). As such, the submission focuses on demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the predicate device.

Given that this is a 510(k) summary for modifications to an already cleared spinal fixation system, the information typically requested for AI/software-as-a-medical-device (SaMD) studies (like multi-reader multi-case studies, ground truth establishment for AI models, training sets, etc.) is not applicable to this submission. This is a traditional K-submission for hardware modification, not a SaMD.

The "device" in this context is a system of physical connectors and rods used in spinal surgery, not a software algorithm. Therefore, the "acceptance criteria" and "study" are engineering performance standards and mechanical tests.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only lists the type of mechanical testing performed and a "justification" for one component. It does not provide specific quantitative acceptance criteria or detailed numerical results from the tests. This is common for 510(k) summaries where the full detailed test reports are submitted to the FDA but not typically included in the public summary.

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

• Sample Size: Not explicitly stated in the summary. Mechanical testing typically involves multiple samples for statistical validity, but the exact number is not provided.
• Data Provenance: Not applicable in the context of clinical data for a medical device. This refers to in-vitro mechanical robustness testing conducted in a lab environment to engineering standards.

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

• Not applicable. "Ground truth" in this context refers to engineering specifications and test standards (like ASTM F1798), not clinical expert reviews or labels for AI. The performance is assessed against established engineering criteria by qualified engineers in a testing lab.

4. Adjudication Method for the Test Set

• Not applicable. This is not a clinical study requiring adjudication of findings. Mechanical tests have pass/fail criteria based on load, displacement, and failure modes according to the specific ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

• No, an MRMC study was not done. This device is a physical implant (spinal fixation system) and not an AI or software product. Therefore, comparative effectiveness studies involving human readers and AI assistance are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. This is a hardware device, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Standards: The "ground truth" for the mechanical performance testing is the compliance with established mechanical engineering standards, specifically ASTM F1798 for static axial grip testing, and general biomechanical performance expectations for spinal fixation devices.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI models, therefore there is no training set.

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

• Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.

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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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