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When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.

The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).

The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

The provided text is a 510(k) summary for the Zavation IBF System, which is an intervertebral body fusion device. This document details the regulatory classification, device description, intended use, and a comparison to predicate devices, but it does not describe acceptance criteria for a study proving device performance in the context of an AI/ML medical device, nor does it present a study of that nature.

The "Performance Data" section specifically states: "Mechanical test results demonstrated that the Zavation IBF System is substantially equivalent to the predicate devices. Testing was performed in accordance with: ASTM F2077, Test Methods for Intervertebral Body Fusion Devices - Static Axial Compression, Dynamic Axial Compression, Static Torsion (for cervical), Dynamic Torsion (for cervical). Testing per ISO 10993 was completed to demonstrate biocompatibility."

This indicates bench testing for mechanical properties and biocompatibility, which are standard for physical implantable medical devices. It does not involve AI/ML performance metrics, studies with human readers, or ground truth established by experts in the way requested for an AI/ML device.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/ML device meets those criteria from this document. The document pertains to a physical medical device (intervertebral body fusion implant) and its regulatory clearance based on substantial equivalence to existing devices, primarily through mechanical and biocompatibility testing.

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The Z-LINK.pc System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-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. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Z-LINKPC System may be connected to the Zavation System using rod connectors and tapered rods.

The Z-LINKمc System is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consist of polyaxial screws, hooks, rods, cross-connectors, rod connectors, offsets and cap screws. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.

The provided text is a 510(k) summary for the Z-LINKpc System, a medical device for spinal fixation. It describes the device, its intended use, and states that performance data was collected. However, it does not contain specific acceptance criteria, detailed study results, or information about how ground truth was established, or the involvement of experts, or MRMC studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone (algorithm only) performance study 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

The document only states the following regarding performance data:

"Static axial compression bending and torsion, and dynamic axial compression bending test were performed according to ASTM F1717 on a worst-case construct. Axial and torsional grip test were performed according to ASTM F1798 on the connectors. The mechanical test results demonstrated the Z-LINKoc system performs as well as or better than the predicate devices."

This indicates that mechanical tests were performed to compare the device to predicate devices, but the specific numerical acceptance criteria, raw performance data, or details about the study design that would address your questions are not present in this document.

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The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:
Fracture (including dislocation and subluxation)
Tumor
Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Pseudoarthrosis
Spondylolysis
Spondylolisthesis
Scoliosis
Lordotic deformities of the spine
Spinal stenosis
Failed previous spine surgery

The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws. The plates attach to the lumbar and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi)

This is a 510(k) premarket notification for a spinal implant, not a medical device software. Therefore, the request for information on acceptance criteria and study proving device meets criteria is not applicable in the context of AI/ML software.

The document describes the Z-Span Plate System, a physical spinal fixation device.

Here's why the AI/ML specific questions are not relevant:

• No AI/ML Component: The submission focuses on mechanical testing, materials, and design of a physical implant. There is no mention of any software component, AI, or machine learning.
• Performance Data: The performance data presented refers to mechanical testing (static and dynamic axial compression bending testing and static torsion testing) conducted in accordance with ASTM F1717, comparing the device to a predicate device. This is standard for orthopedic implants, not software.
• Ground Truth, Training/Test Sets, Experts: These concepts are specific to evaluating diagnostic or predictive AI/ML algorithms, where the algorithm's output is compared against a "ground truth" established by experts or other definitive methods. They do not apply to the mechanical performance evaluation of a spinal plate.

Therefore, I cannot provide answers to the requested questions as they are designed for AI/ML medical devices, and this document pertains to a physical orthopedic implant.

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The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction in patients with 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) and/or tumor. The Z-Clamp ISP System is not intended for standalone use.

The Zavation Z-CLAMP ISP System is a spinous process plate which is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), multiple component system comprised of a variety of nonsterile, single use implantable components. The system consist of plates and lock screw. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.

This document is a 510(k) premarket notification for a medical device called the Z-Clamp ISP System. It is focused on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for diagnostic accuracy or efficacy through clinical studies. Therefore, much of the requested information regarding diagnostic device performance, expert review, and MRMC studies is not available in these documents.

Here's a breakdown of the available information and how it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are largely defined by its mechanical performance compared to the predicate device, as it's a spinal fixation orthosis. The document states that the device performs "as well as or better than the predicate devices" in several mechanical tests. Since the predicate device is already marketed, this implies that its established mechanical performance serves as the de facto acceptance criteria.

2. Sample Size for the Test Set and Data Provenance

This is not applicable to this type of submission. The performance assessment is based on mechanical testing of the device itself, not on a test set of patient data.

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

This is not applicable. Ground truth, in the context of device performance, would relate to its physical and mechanical properties, not diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable. The device's performance is determined through reproducible mechanical tests, not based on expert adjudication of a test set.

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

No MRMC study was done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess diagnostic performance. The Z-Clamp ISP System is a physical spinal implant.

6. Standalone Performance Study (Algorithm Only)

No standalone performance study of an algorithm was done. This device is not an algorithm; it's a physical medical device. The "performance" refers to its mechanical integrity and function.

7. Type of Ground Truth Used

The "ground truth" for this device is established through standardized mechanical testing. The tests performed were:

• Static torsion test
• Static compression bending test
• Dynamic compression bending test
• Static foam pull-off test
• Static plate dissociation test

These tests are specifically designed to assess the physical properties and structural integrity of the spinal fixation system under various forces, using methods "according to a modified ASTM F1717." The results are quantitative measurements against established engineering and material science standards for similar devices.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a physical medical device like this spinal clamp. This term is relevant for machine learning algorithms.

9. How Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

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The Zavation Spinal System 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, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal 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 Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is 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 Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance as one would typically find for an AI/ML medical device.

Instead, this document describes the Zavation Spinal System, its intended use, materials, predicate devices, and the basis for its substantial equivalence to those predicate devices. The "Performance Data" section specifically states:

"Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. The mechanical test results demonstrated that the Zavation Spinal System performs as well as or better than the predicate devices."

This indicates a mechanical performance study for a spinal implant, which is a different type of evaluation from what is typically done for AI/ML devices regarding diagnostic accuracy or clinical effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance in the context of an AI/ML device from this document. The document primarily focuses on:

• Mechanical Safety/Performance: Comparing the mechanical strength of the Zavation Spinal System to predicate devices according to a specific ASTM standard (F1717). The acceptance criterion here is implicit: the device must perform "as well as or better than" the predicate devices in these mechanical tests.
• Substantial Equivalence: Arguing that the device is substantially equivalent to legally marketed predicate devices based on technological characteristics, performance, and intended use.

To answer your specific questions in the context of an AI/ML device, I would need a document detailing a clinical performance study or an AI algorithm validation study.

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The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:

• Fracture (including dislocation and subluxation)
• Tumor
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Pseudoarthrosis
• Spondylolysis
• Spondylolisthesis
• Scoliosis
• Lordotic deformities of the spine
• Spinal stenosis
• Failed previous spine surgery

The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws. The plates attach to the lumbar and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi)

The provided document describes a 510(k) premarket notification for a medical device called the "Z-Span Plate System." This document is a regulatory approval notice from the FDA, not a research study report with detailed acceptance criteria and performance data in the context of a clinical trial or AI model evaluation.

Therefore, many of the requested sections about acceptance criteria, study design, expert involvement, and ground truth are not applicable or cannot be extracted from this type of document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

Here's what can be extracted and what cannot:

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

Note: The specific quantitative acceptance criteria (e.g., minimum load, fatigue cycles) and the exact performance values are not provided in this summary. It only states that the device "performs as well as or better than" the predicate device based on ASTM F1717 standards.

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

This information is not provided in the document. The testing mentioned is mechanical testing, not a clinical study on human subjects with a "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The "ground truth" here refers to the performance of the device in mechanical tests, which is measured objectively, not adjudicated by experts in the context of clinical outcomes.

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

This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments, typically in clinical trials. Mechanical testing results are objective measurements.

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 information is not applicable. This device is a spinal implant, not an AI diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

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

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

The "ground truth" for the mechanical testing is the objective measurement of the device's physical properties and performance against established ASTM F1717 standards, and comparison to the predicate device's performance under those same standards.

8. The sample size for the training set

This information is not applicable/not provided. This is not a machine learning model, so there is no "training set."

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

This information is not applicable/not provided. There is no "training set" for this physical device.

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The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation Posterior LEIF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.

The Zavation Posterior LEIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.

The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) devices are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The implants are provided in a shape that accommodates a posterior or transforaminal approach to the lumbar spine. After insertion the implant can be expanded to a larger footprint. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These implants are to be filled with autogenous bone graft material. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

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

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of mechanical tests performed on the Zavation Posterior LEIF. The document states: "Mechanical test results demonstrated that the Zavation Posterior LEIF is substantially equivalent to the predicate devices." These tests were conducted in accordance with the listed ASTM standards.

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

The document does not specify a "test set" in terms of patient data. The evaluation relies on mechanical testing of the device itself. Therefore, the sample size refers to the number of devices or components tested. This information is not explicitly stated in the provided document (e.g., "n=X devices tested").

Data provenance for this type of mechanical testing is typically within a laboratory setting, not related to country of origin of patient data or retrospective/prospective studies.

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

This information is not applicable as the "test set" in this context refers to mechanical performance, not clinical data requiring expert review for ground truth. The acceptance criteria are based on established ASTM standards for mechanical performance.

4. Adjudication Method for the Test Set

This is not applicable as the "test set" refers to mechanical performance, not clinical data requiring adjudication.

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 is not applicable. The Zavation Posterior LEIF is a physical intervertebral body fusion device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable. The Zavation Posterior LEIF is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing is based on the established performance specifications and methodologies outlined in the ASTM standards. The goal is to demonstrate that the device performs mechanically in a manner substantially equivalent to predicate devices, as defined by these industry standards.

8. The Sample Size for the Training Set

This is not applicable. The Zavation Posterior LEIF is a physical device, and the evaluation relies on mechanical testing against pre-defined standards, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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The Zavation Z-Link Lumbar is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Z-Link Lumbar is to be filled with autogenous bone graft material.

The Zavation Z-Link Lumbar includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes four holes for inserting two bone screws in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.

The provided text describes a medical device, the "Zavation Z-Link Lumbar," and its 510(k) premarket notification. This document is a regulatory submission for a medical device and does not contain information about an AI/ML-based device. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device cannot be answered from this text.

The document discusses the substantial equivalence of a physical intervertebral body fusion device to predicate devices based on mechanical performance data.

Here's an analysis of what is available in the document, which pertains to the physical device rather than an AI/ML system:

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

The document states: "Mechanical test results demonstrated that the Zavation Z-Link Lumbar is substantially equivalent to the predicate devices." It also lists the ASTM standards used for testing:

• ASTM F2077, Test Methods for Intervertebral Body Fusion Devices
  • Static Axial Compression
  • Dynamic Axial Compression
  • Static Shear
  • Dynamic Shear
• ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
• ASTM Draft F04.25.02.02, Static Pushout Test Method for Intervertebral Body Fusion Devices.

However, the specific numerical acceptance criteria (e.g., minimum load, maximum displacement) and the exact reported performance values from these tests are not provided in this summary. The submission concludes that the device meets the criteria by stating "substantially equivalent to the 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)

This document pertains to mechanical testing of a physical device. "Test set" in the context of an AI/ML model's performance study does not apply here. For mechanical tests, the "sample size" would refer to the number of physical devices tested. This information is not provided in the document. Data provenance (country of origin, retrospective/prospective) is irrelevant for mechanical testing of a manufactured product.

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 question is not applicable. The "ground truth" for a physical device's mechanical performance is established through standardized engineering tests, not by expert interpretation of data.

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

This question is not applicable. Adjudication methods are relevant for subjective interpretations (e.g., medical image reading) in clinical studies, not for objective mechanical performance tests.

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 question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software.

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

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software.

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

The "ground truth" for this physical device is its mechanical performance as measured against established engineering standards (ASTM F2077, ASTM F2267, ASTM Draft F04.25.02.02).

8. The sample size for the training set

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software model that requires a training set.

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

This question is not applicable as the device is a physical intervertebral fusion device, not an AI/ML software model.

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The Zavation ZV plasty (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

The Zavation ZVplasty system is designed for use in vertebroplasty procedures for treatment of vertebral compression fractures in the lumbar or thoracic regions brought on by primary or secondary osteoporosis, cancer or trauma. The Zavation ZVplasty system consist of a variety of manual instruments which provide physicians with a means to access the vertebral body with a mechanical device in order to prepare a site for vertebroplasty. Once the site is prepared the Zavation ZVplasty system instruments are used to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine. The Zavation ZVplasty system instruments are to be used with the following previously FDA cleared items, balloon catheter, inflation syringe, vacuum syringe, stopcock, PMMA bone cement, cement mixing system.

The provided document is a 510(k) premarket notification letter and summary for the ZVplasty system. It explicitly states:

"No clinical tests were submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence because the technological performance characteristics of the subject system are the same as the predicates device."

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical data related to materials, luer lock connections, and sterilization.

Since there are no clinical trials or performance studies reported, I cannot provide the requested information for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone performance (i.e. algorithm only without human-in-the-loop 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

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The Z-Link Cervical is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Z-Link Cervical should be packed with autogenous bone graft and implanted with an anterior approach.

The Zavation Z-Link Cervical includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.

The provided document describes the Zavation Z-Link Cervical, an intervertebral body fusion device, and its acceptance criteria as demonstrated by mechanical testing. However, it does not include information about a study involving an AI algorithm or human readers. The acceptance criteria and the study proving it relate directly to the physical properties and performance of the medical device itself.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The document refers to "mechanical test results" but does not specify the number of devices or components tested. Data provenance is not applicable as this describes mechanical testing of a physical device, not analysis of human patient data.

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

This information is not applicable to the type of study described. The "ground truth" for this device's mechanical performance is established by standardized engineering tests (ASTM standards) rather than expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing according to established ASTM standards does not involve adjudication by experts in the same way clinical or imaging studies might. The results are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This document describes mechanical testing of a physical medical device, not a study involving human readers or AI.

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

No, a standalone algorithm study was not done. This document is about a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is based on the results of standardized mechanical engineering tests (ASTM F2077, ASTM F2267, ASTM Draft F04.25.02.02). The device's performance must meet the requirements of these standards to be considered "substantially equivalent" to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this document describes mechanical testing of a physical medical device, not an AI algorithm.

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

This information is not applicable. There is no "training set" or corresponding ground truth establishment described for an AI algorithm.

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