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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 Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

This document describes the Zavation Cervical Plate System, a medical device. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does not contain information typically found in a study for an AI/ML diagnostic device, such as acceptance criteria based on metrics like sensitivity/specificity, nor does it discuss ground truth establishment, expert adjudication, or reader studies.

Therefore, many of the requested categories related to AI/ML device studies are not applicable to this submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The submission refers to "a worst-case, cervical plate construct" being tested, implying a limited number of constructs rather than a large clinical test set.
• Data provenance: Mechanical testing was performed according to ASTM F1717. This is laboratory-based testing, not human data.

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

Not applicable. Ground truth for mechanical performance is established by standardized testing protocols (ASTM F1717) and engineering measurements, not by expert medical review.

4. Adjudication method for the test set

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a spinal implant device, not an AI/ML diagnostic device requiring a reader study.

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

Not applicable. This is a spinal implant device, not an AI/ML diagnostic device.

7. The type of ground truth used

"Ground truth" was established through standardized mechanical testing (ASTM F1717) on physical device constructs, measuring parameters like bending strength, torsion stability, and fatigue resistance.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML system that requires a training set. Development and validation rely on engineering design principles and physical testing.

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

Not applicable. See point 8.

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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, 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.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not mention a test set in the traditional sense of a clinical or observational study with human participants. The "test" here refers to the validation of a computational method.

• Sample size for the test set: Not applicable, as detailed above.
• Data provenance: Not applicable. The "study" is a finite element analysis, meaning it's a computational simulation rather than an empirical study gathering data from a specific population or geographic region.

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

There's no mention of experts establishing ground truth for a test set in this context.

• Ground truth in this study: The "ground truth" for the finite element analysis (FEA) is the established engineering principles and material properties used in the simulation, and its validation against testing performed per ASTM F2077. This is a technical standard rather than an expert consensus.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process mentioned.

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

Not applicable. This submission concerns an intervertebral body fusion device, not an AI-powered diagnostic or interpretive system that would involve human readers.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this engineering analysis is based on established engineering principles, material properties (PEEK Zeniva ZA-500, Tantalum alloy), and validation against a recognized industry standard (ASTM F2077). It is not an expert consensus, pathology, or outcomes data in the biological sense. The outcome of the FEA is whether the new configurations maintain mechanical integrity and don't create a "new worst-case device" compared to the predicates.

8. The Sample Size for the Training Set

Not applicable. This is an engineering analysis of a physical device, not a machine learning model requiring a training set.

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

Not applicable. As above, there is no training set in this context.

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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 describes a medical device, the Zavation IBF System, and its acceptance criteria as demonstrated through performance data. However, it does not describe a study involving an AI/algorithmic device or its performance against ground truth established by experts.

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 and ASTM F2267. Static and Dynamic axial compression, subsidence and expulsion tests were completed."

This indicates that the study performed was a mechanical test of the physical implant device, not a study evaluating an AI algorithm's diagnostic or predictive performance. Therefore, most of the requested information regarding AI device performance (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) cannot be extracted from this document because it is not relevant to the described studies.

Here's the information that can be extracted:

Acceptance Criteria and Device Performance (Mechanical Testing)

Explanation of Missing Information for AI/Algorithmic Devices:

1. Sample size used for the test set and the data provenance: Not applicable. The study was mechanical testing of a physical implant.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods.
3. Adjudication method for the test set: Not applicable.
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: Not applicable. This document is not about an AI device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For mechanical testing, the "ground truth" is defined by the physical properties and performance standards (like ASTM F2077 and F2267) which the device must meet or exceed, or demonstrate equivalence to predicate devices.
7. The sample size for the training set: Not applicable. (No AI training set.)
8. How the ground truth for the training set was established: Not applicable. (No AI training set.)

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The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

The provided text describes a 510(k) submission for the Zavation Cervical Plate System, a medical device. This type of submission is for establishing substantial equivalence to a predicate device, not for proving novel clinical effectiveness through extensive studies as one might see for a new drug or a highly innovative device.

Therefore, many of the typical acceptance criteria and study elements listed in the prompt (like sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific effect sizes) are not applicable to this type of regulatory submission for this device.

The study presented here is a mechanical performance study comparing the new device against a predicate device.

Here's a breakdown 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

• Sample Size: Not explicitly stated as human or animal subjects as this was a mechanical bench test. The "worst-case, cervical plate construct" was used for testing. The number of constructs tested for each mechanical test (static and dynamic) is not specified.
• Data Provenance: Not applicable in the context of human data. The tests were performed according to ASTM F1717, an established standard for spinal implant testing. These are laboratory-generated data.

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

• Not applicable. Ground truth in this context refers to the pass/fail criteria of the ASTM F1717 standard and comparison of mechanical output values against the predicate device's performance. No human experts were used to establish "ground truth" for the mechanical characteristics of the device in the way a radiologist reviews images.

4. Adjudication Method for the Test Set

• Not applicable. This was a mechanical study, not a clinical study requiring human adjudication of outcomes or diagnoses. The "adjudication" was based on objective measurements adhering to ASTM F1717 and comparison to predicate device data.

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

• No. This was a mechanical performance study, not a clinical study involving human readers or comparative effectiveness in a clinical setting.

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

• Not applicable. This device is a physical implant, not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on engineering standards (ASTM F1717) and the performance data of legally marketed predicate devices. The new device's mechanical performance in specific tests (static compression bending, torsion, and dynamic compression bending) was compared to that of the predicate devices. The aim was to demonstrate equivalent or superior performance.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of a mechanical performance study for a physical medical device. This term is relevant for machine learning or AI models.

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

• Not applicable. As there is no training set, there is no ground truth for it to be established.

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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 crosslinks. 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 text describes the Zavation Spinal System, a medical device. This document is a 510(k) summary submission to the FDA, which focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Therefore, the study described here is not a clinical study involving human patients or AI algorithms. It is a biomechanical performance study of a spinal implant system. As such, many of the requested fields related to clinical studies and AI are not applicable.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

• Note: The specific numerical acceptance criteria (e.g., maximum load, cycles to failure) are not provided in this summary. The comparison is made against the performance of the predicate devices.

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

• Sample Size: Not explicitly stated, but mechanical testing typically involves a sufficient number of constructs to ensure statistical validity for the specific tests performed (e.g., 5-6 samples per test arm). The text mentions "a worst-case construct," implying specific configurations were tested.
• Data Provenance: This is a retrospective comparison against existing data for the predicate devices. The tests were performed in a lab setting ("biomechanical test lab"). There is no mention of country of origin as it's a lab study.

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

• Not Applicable. This was a mechanical engineering study, not a clinical study involving expert interpretation of data. The "ground truth" is defined by the physical properties and performance metrics of the materials and constructs themselves, as measured by testing equipment.

4. Adjudication Method for the Test Set

• Not Applicable. As a mechanical performance study, there's no adjudication in the sense of clinical agreement or consensus. The results are quantitative measurements from standardized 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

• Not Applicable. This study is not about AI or human reader performance. It's a mechanical device performance study.

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

• Not Applicable. This study is not about an algorithm.

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

• The "ground truth" for this study is the measured mechanical performance of the device components and construct under various load conditions, compared against the known mechanical performance of the predicate devices according to established ASTM standards (F1717).

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this mechanical performance study. The study involves physical testing of the device.

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

• Not Applicable.

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