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When used with the Zavation ZLinkPC System for Posterior-Cervical-Thoracic (Occ-T3)

The Zavation Connector System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of 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 radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

When used with the Zavation Spinal System for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Illium)

The Zavation Connector System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Illium) in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Connector System is designed to aid in revision surgeries and extensions of existing hardware constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile titanium implants including parallel rod to rod domino connectors, axial connectors with and without attachment rods, bypass connectors, lateral offsets, double tulips (angled and parallel), and Z rods. The implant options allow revisions and extension to be performed without removing existing hardware. The Zavation Connector System is designed to be used with the Zavation Z-Linkpc System for Posterior-Cervical-Thoracic (Occ-T3) and the Zavation Spinal System for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Illium).

The provided text is a 510(k) summary for a medical device called the "Zavation Connector System." It details the device's purpose, description, indications for use, materials, and a comparison to predicate devices, along with performance data.

However, the provided text does not contain information about acceptance criteria, clinical studies involving human readers, expert ground truth establishment, sample sizes for training/test sets, or adjudication methods. The "Performance Data" section specifically states: "Static axial and torsional grip were performed according to ASTM F1798 on a worst-case construct. The mechanical test results demonstrated substantial equivalency to the predicate device." This indicates mechanical testing, not clinical performance studies involving human interpretation or AI assistance, which are the focus of your request.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided document in the context of an AI/human reader performance study. The document describes the substantial equivalence of a physical medical implant (a pedicle screw system connector) based on mechanical properties, not an AI or imaging diagnostic device.

If this were a submission for an AI-powered diagnostic device, using the provided template, the description would approximate the following (hypothetical, as the actual data is not in the text):

Hypothetical Description of Acceptance Criteria and Study for an Imaginary AI-Powered Spinal Bone Fracture Detection Device (Not from the provided text)

Based on the provided document, the device in question is the "Zavation Connector System," which is a mechanical implant (thoracolumbosacral pedicle screw system) used to immobilize spinal segments. The provided performance data relates to static axial and torsional grip mechanical testing according to ASTM F1798, demonstrating substantial equivalence to a predicate device in terms of its physical properties and function, not its diagnostic accuracy or the performance of an AI algorithm.

Therefore, the detailed information requested regarding acceptance criteria, study sample sizes, expert ground truth establishment, MRMC studies, and AI performance metrics is not present in the provided 510(k) summary for the Zavation Connector System. This type of information is typically required for diagnostic imaging devices, especially those incorporating AI.

However, to illustrate how such a request would be addressed if the provided document were about an AI-powered diagnostic device, I will provide a hypothetical response demonstrating the structure and type of information that would be present.

Hypothetical Scenario: Acceptance Criteria and Study for an AI-Powered Spinal Bone Fracture Detection Device

Device Name (Hypothetical): SpinalFractureAI Assistant

Indications for Use (Hypothetical): The SpinalFractureAI Assistant is intended as a supplemental tool for radiologists to detect and localize vertebral fractures in thoracic and lumbar spine CT scans in adult patients.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: 500 unique CT scans (patients).
• Data Provenance: Retrospective data collected from 3 major hospital systems across the United States (n=300), Germany (n=100), and Japan (n=100).
• Data Type: De-identified thoracic and lumbar spine CT scans.

3. Number of Experts for Ground Truth and Qualifications:

• Number of Experts: 3 independent expert radiologists.
• Qualifications: All were board-certified radiologists with subspecialty training in musculoskeletal radiology, each possessing at least 10 years of experience interpreting spinal CT scans.

4. Adjudication Method for the Test Set:

• Adjudication Method: 2+1 Consensus. Initial reads by two independent expert radiologists. In cases of disagreement on the presence or location of a fracture, a third, senior-level expert radiologist reviewed the case to establish the definitive ground truth.

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

• Yes, an MRMC comparative effectiveness study was performed.
• Effect Size: Human readers (radiologists) demonstrated a 7.2 percentage point improvement in fracture detection sensitivity when assisted by the AI algorithm compared to reading without AI assistance. This was statistically significant (p

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Ascent POCT System: When intended to promote fusion of the cervical spine-cervico-thoracic junction (Occiput - T3), the Ascent POCT System is indicated for: · Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); - · Spondylolisthesis; - · Fracture/dislocation; - · Spinal Stenosis; - · Atlanto-axial fracture with instability; - · Occipito-cervical dislocation' - · Tumors' - · Revision of previous cervical spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (TI-T3). The hooks are intended to be placed from C1 to T3. The Songer Cables (titanum) System to be used with the Ascent POCT System allows for wire/cable attachment to the posterior cervical spine. The Ascent POCT System can also be linked to the Spinal Fixation System using the axial or parallel rod connector.

Centurion POCT System: The Centurion POCT 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 Centurion POCT 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. The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

Connector System: 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 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. 2. 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 and stabilization 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 scoliosis. Pediation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.

Spinal Fixation System (SFS): The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. The Spinal Fixation System (SFS), when used for pedicle screw fixation, is intended only for patients: - · Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; - · Who are receiving fusion using autogenous bone graft only; - · Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and - · Who are having the device removed after the development of a solid fusion mass. The Spinal Fixation System (SFS), when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: a) Degenerative spondylolistheses with objective evidence of neurologic impairment; b) Fracture; c) Dislocation; d) Scoliosis: e) Kyphosis; f) Spinal tumor; and g) Failed previous fusion (pseudarthrosis). The Spinal Fixation System (SFS), when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); b) Spondylolistheses; c) Spinal stenosis; d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis); e) Tumor: f) Pseudoarthrosis; g) Previous failed fusion; and h) Trauma (i.e., fracture or dislocation).

Firebird Spinal Fixation Systems: The Firebird Spinal Fixation Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion 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 fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level. The Firebird Spinal Fixation Systems components are used with certain components of the Spinal Fixation System (SFS), including rods, rod connectors and cross-connectors. When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Firebird Spinal Fixation Systems are intended to be used with autograft or allograft. The Phoenix MIS Fixation System when used with the Firebird Systems is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.

FIREBIRD SI Fusion System: The FIREBIRD System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including; · sacroiliac joint disruptions, · degenerative sacroiliitis, · to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Ascent POCT System - The Ascent POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The Ascent POCT System consists of an assortment of rods, set screws, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws and songer cables. When used in the occipito-cervico-thoracic spine. the Ascent POCT System may be used from the Occiput to T3.

Centurion POCT System - The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of titanium allov or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and cables (titanium).

Spinal Fixation System (SFS) - The Spinal Fixation System (SFS) is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws, and hooks to the non-cervical spine. The Spinal Fixation System consists of an assortment of screws, hooks, rods, spacers, staples, washers, dominos, lateral offsets, and cross-connectors. The Spinal Fixation System (SFS) titanium implants are not compatible with components or metal from any other manufacturer's system. The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. When used as a nonpedicle anterolateral fixation system it may be used from levels T1 to S1. When used with pedicle screw fixation, the Spinal Fixation System (SFS) will be used at L5-S1, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below). When used as a posterior non-pedicle fixation system it may be used from levels T 1 to S1. When used as a non-pedicle anterolateral screw fixation system to the non-cervical spine, the staple and washer may be used from levels T6-L5.

Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation, Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws)- The Firebird Spinal Fixation Systems include temporary, multiple component systems comprised of a variety of non-sterile and sterile single use components made of titanium alloy or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The systems consist of an assortment of rods, multi-axial and mono-axial pedicle screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and sterile packed HA coated bone screws. A subset of the systems' components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.

Connector System - 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.

FIREBIRD SI Fusion System - The FIREBIRD SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as both non-sterile and sterile, cannulated screws of various lengths and diameters with multiple fenestrations on their shafts. The FIREBIRD SI Screws are constructed from medical- grade titanium alloy (Ti-6Al-4V ELI). The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The FIREBIRD SI Screw allows for packing of autograft and allograft materials. FIREBIRD SI Fusion System consists of cannulated, fenestrated 9mm, 11mm, and 12mm diameter implants in lengths ranging from 25mm to 70mm. The 9mm diameter implant maintains a single pitch thread along the entire shaft of the 11mm diameter implant features a tapered proximal end and dual-pitch threads. The 12mm diameter implant maintains a single pitch thread form on the proximal and distal ends. The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.

The provided text is a 510(k) summary for several spinal fixation systems. This document outlines the devices' intended use, technological characteristics, and performance data related to MR Conditional labeling. It does not contain information about AI/ML algorithm acceptance criteria or studies proving device performance based on AI/ML.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document focuses on the mechanical and material safety of the spinal implants in an MRI environment, not on the performance of a diagnostic or assistive AI/ML algorithm.

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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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When intended for pedicle screw fixation from T1 -S1, the Sequoia® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondytolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scollosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity). degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

The Sequoia® Pedicle Screw System consisting of open style polyaxial screws, titanium rods (varying lengths) and connectors is intended to provide temporary stabilization following surgery to fuse the spine. The polyaxial screw design allows the surgeon to use a top-loading technique for dropping the spinal rod down to the fixation components into a u-shaped opening. SpeedLink II ™ Transverse Connectors are provided to increase rotational stiffness to the final construct.

The provided document does not describe a study that uses acceptance criteria in the typical sense for evaluating device performance in a clinical or diagnostic context. Instead, this is a 510(k) summary for a medical device (Zimmer Spine Sequoia® Pedicle Screw System) seeking regulatory clearance based on substantial equivalence to predicate devices. The "performance testing" described is primarily bench testing and evaluations to confirm the updated device's equivalence in design, materials, and mechanical properties to previously cleared devices.

Therefore, many of the typical questions regarding acceptance criteria for diagnostic devices, sample sizes for test sets, expert ground truth, and comparative effectiveness studies are not applicable in this context.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices in terms of design, materials, function, intended use, and performance characteristics. The "performance" here refers to mechanical and physical properties relevant to a spinal implant, rather than diagnostic accuracy or clinical outcomes.

Study Information (Based on 510(k) Premarket Notification)

Since this is a submission for substantial equivalence of a modified medical device, the categories requested often pertain to diagnostic or AI-driven devices. The "studies" described here are engineering and physical tests.

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

   • Test Set Sample Size: Not specified in terms of number of screws, rods, or connectors tested. The document generally states "components of the current Sequoia® Pedicle Screw System... were reviewed and tested."
   • Data Provenance: The testing was "Bench testing" (mechanical simulation) and "Cadaver lab testing." This suggests laboratory-controlled environments. No country of origin for test data is explicitly mentioned, but the submitting company is Zimmer Spine, Inc. in Minneapolis, MN, USA. The testing appears to be prospective for the modified device to demonstrate its equivalence.

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

   • Ground Truth Establishment: For mechanical bench testing, "ground truth" would be established by engineering standards (e.g., ASTM F1717 & F1798). These standards define the test methods and expected performance characteristics, not by experts in the typical clinical sense.
   • Expert Involvement: For "Cadaver lab testing... to evaluate human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants," it would imply surgeons or medical professionals were involved in using the system on cadavers. However, the number and qualifications of these experts are not specified. The purpose was to confirm "substantial equivalence of the changes compared to the identified predicate devices," not to establish a new clinical ground truth.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for reconciling disagreements among expert readers in diagnostic image interpretation or similar qualitative assessments. The tests described are objective, quantitative engineering tests (bench testing) and human factors evaluations.

4. 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 comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices. The device in question is a spinal implant for stabilization, not a diagnostic tool.

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

   • Not applicable. This question pertains to AI algorithms. The device is a physical pedicle screw system.

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

   • For the bench testing, the "ground truth" or reference for performance is established by engineering standards (ASTM F1717 & F1798). The device's performance is compared against these standards and against the performance of the predicate devices.
   • For biocompatibility, the ground truth is established by biocompatibility testing standards and regulatory requirements for medical device materials.
   • For human factors/cadaver lab testing, the "ground truth" is likely the practical usability and equivalence observed by the participating professionals when installing the device compared to the predicate.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this physical medical device. This term applies to machine learning models.

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

   • Not applicable. As there is no training set, this question is not relevant.

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The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM 5.5mm and 6.35mm Spine Systems.

The uses of the legally marketed EXPEDIUM 5.5mm and 6.35mm Spine System are as follows:

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available VSP Spine System.

The uses of the legally marketed VSP Spine System are as follows:

The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The VSP Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grade 3 and 4) at L5-S1, in skeletally mature patients, when autogeous bone graft is used, when affixed to the posterior lumbosacral spin, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available ISOLA 6.35mm Spine System.

The uses of the legally marketed ISOLA 6.35mm Spine System are as follows:

The ISOLA Spine Systems is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOLA Spine Systems is also indicated for pedicle screw fixation for the 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 lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ISOLA Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available MOSS Miami 6.35mm Spine System.

The uses of the legally marketed MOSS Miami 6.35mm Spine System are as follows:

When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami 6.35mm Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS Miami 6.35mm Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

The MOSS Miami 6.35mm Spine Systems is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1) and for whom the device system is intended to be removed after solid fusion is attained.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 5.5mm and 6.35mm spinal rods of the EXPEDIUM Spine System.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the VSP Spine System.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the ISOLA Spine System.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the MOSS Miami Spine System.

The provided text describes a Special 510(k) Submission for additions to the EXPEDIUM™ SFX Cross Connector System. This submission focuses on the mechanical performance and material compatibility of the device, rather than artificial intelligence or diagnostic algorithms. Therefore, many of the requested categories related to AI performance, expert consensus, and ground truth establishment are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The acceptance criterion for the EXPEDIUM™ SFX Cross Connector System is that its performance, when transversely connecting two rods, must be equivalent or superior to the predicate devices. Specifically, it must minimize torsional forces on the construct, thereby reducing micromotion and the probability of construct shifting after placement. This is assessed through Performance data per ASTM F 1717.

Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated as a numerical value within the provided text. The performance data is "per ASTM F 1717," which is a standard for in vitro mechanical testing of spinal implant constructs. The sample size would be determined by the requirements of this ASTM standard for various tests (e.g., static, fatigue, torsional).
• Data Provenance: The data is based on in vitro mechanical testing conducted according to ASTM F 1717. This is laboratory-based testing, not human-patient data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense.

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

This question is not applicable as the study is a mechanical performance study of a medical device, not an AI or diagnostic imaging study that requires expert review for ground truth establishment.

4. Adjudication Method for the Test Set

This question is not applicable as the study is a mechanical performance study. Adjudication methods like 2+1 or 3+1 refer to human expert consensus, which is not relevant here.

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

This question is not applicable. This submission concerns the mechanical properties of a spinal implant, not an AI-assisted diagnostic or treatment system.

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

This question is not applicable. This is a device related to mechanical stability in spinal instrumentation, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and material science standards, specifically ASTM F 1717, which dictates test methodologies and expected performance characteristics for spinal implant components. The "truth" is that the device must meet or exceed the mechanical performance characteristics of the predicate devices under standardized testing conditions.

8. The Sample Size for the Training Set

This question is not applicable as this is not an AI/machine learning study.

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

This question is not applicable as this is not an AI/machine learning study.

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The RyMed Technologies InVision-Plus™ Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.

The RyMed Technologies INVISION-PLUS™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y - Injection Port that contain a specialized two part valve made from medical grade Silicone material. The female luer housing, guide washer, and heparin lock are made from medical grade plastics. The valve provides excellent fluid Flow Rates, low Priming Volumes, and reseals after extended use.

The provided document is a 510(k) premarket notification for a medical device (RyMed Technologies INVISION-PLUS™ Injection Ports), not a study report for an AI/ML device. Therefore, the specific information requested in points 2-9 (related to AI/ML study design) is not applicable or cannot be extracted from this document.

However, I can extract and present the acceptance criteria for the device and its reported performance based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

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The RyMed Technologies SLAV™ Injection Port Systems are intended for single patient use in intravenous and blood administration.

The RyMed Technologies SLAV™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y-Injection Site Port that contain a specialized two piece valve made from a medical grade clear plastic and a medical grade Slicone material. This specialized valve completely eliminates the use of Needles forcing compliance with the new OSHA standards of safety avoiding accidental needle stick injuries, the valve also provides excellent fluid Flow Rates, requires very low Priming Volumes, and it eliminates "dead spaces" that could entrap blood. This valve has the ability to activate injection ports a minimum of 100 times without leaking or change in its performance.

Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document itself doesn't explicitly state "acceptance criteria" but rather "Performance Data" which implies these were the benchmarks the device needed to meet. The "Feature" table provides values (e.g., flow rate of 310-350 mls/min for SLAV™) which are even better than the pass/fail criteria listed in the performance summary. For instance, the stated flow rate of 310-350 mls/min comfortably exceeds the "≥ 150 cc / min." criterion.

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

• Sample Size for Test Set: Not explicitly stated. The document indicates tests were performed on the SLAV™ Injection Port, the BRAUN SafSite®, and the Medex Nu-Site™. However, the number of units of each device tested for these performance parameters (e.g., flow rate, priming volume, activations) is not provided.
• Data Provenance: Not explicitly stated. Given it's a pre-market notification (510k) within the US, it's reasonable to infer the data was generated in a testing environment likely within the US by or for RyMed Technologies, Inc. However, whether this was a retrospective analysis of existing data or prospectively gathered for this submission is not specified.

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

• This information is not applicable to this type of device and study. The "ground truth" for performance characteristics like flow rate, priming volume, and activation endurance is established by objective, measurable laboratory tests, not by expert consensus or interpretation.

4. Adjudication Method for the Test Set

• Not applicable. As the ground truth is based on objective laboratory measurements, there is no need for an adjudication method by human experts. The results are quantitative (e.g., flow rate in mls/min) or binary (pass/fail) based on predefined thresholds.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices where human readers (e.g., radiologists) are involved in interpreting outputs, and the AI's role is to assist or improve their performance. The SLAV™ Injection Port is a medical device with objective performance characteristics (e.g., flow rate, physical endurance), not an interpretive aid.

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

• Yes, a standalone performance assessment was effectively done. The performance data presented (Fluid Flow Rate, Ideal Priming Volume, 100 Activations) reflects the intrinsic performance of the device itself, independent of human interaction beyond operating the testing equipment. There is no AI algorithm involved in the function of this device, so the concept of "algorithm only" directly translates to the device's inherent performance.

7. The Type of Ground Truth Used

• Objective Laboratory Measurements against Predetermined Thresholds: The ground truth for the performance tests was established by objective, quantifiable laboratory measurements. For example, a flow rate was measured in mls/min and compared against a threshold (≥ 150 cc/min) to determine a "Pass" or "Fail." Similarly, priming volume was measured and compared to a threshold (

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