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When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff 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 (defined 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 intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one 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 Pedicle Screw System and Zavation Cervical Plate System.

The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The VariSync Spacer is an interbody fusion device in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (0) weeks of non-operative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.

When used as a cervical intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff 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 (defined 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 LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one 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 LABYRINTH implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

The Zavation ALIF System 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 S1. 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 Zavation ALIF System is to be filled with autogenous bone graft material.

The Zavation ALIF System spacer and plate assembly are an integrated for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

Hyperlordotic interbody devices (>20 degrees) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.

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) Superior Polymers Magnolia PEEK (ASTM F2026).

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. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.

The VariSync Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136. The Screws for use with the VariSync Plates are manufactured from titanium alloy, as specified in ASTM F136.

VariSync Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The VariSync Spacers are manufactured from Superior Polymers Magnolia PEEK, with tantalum markers, as specified in ASTM F2026 and F560. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.

The LABYRINTH implants offer 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) Superior Polymers Magnolia PEEK (ASTM F2026). The LABYRINTH 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 LABYRINTH device has a porous structure on the end plate and through the device. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided sterile.

The Zavation ALIF System includes a spacer, plate, screws, and anchors. The spacer component is assembled to an interbody plate and implanted anteriorly. The spacer components are available in a variety of materials, depths, widths, and heights. The plate component includes three or four holes for inserting bone screws or anchors. The plate component also includes a lock at each hole. The bone screws are available in a variety of diameters and lengths. The anchors are available in a variety of lengths. The interbody plate components are available in a variety of heights. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.

The provided text describes several medical devices: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, and Zavation ALIF System. The 510(k) summary indicates that this submission is for the addition of an ion beam assisted deposition (IBAD) Titanium coating to previously cleared PEEK devices. The acceptance criteria and the study to prove the device meets these criteria are focused on the coating properties rather than the overall device performance for fusion, as the underlying PEEK devices were previously cleared.

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

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

Note: The document states "The specifications of the titanium coating are identical to that of the primary predicate device cleared in (K201367)." This implies that the acceptance criteria for these tests would be met if the results are comparable to the predicate device's coating performance. However, specific numerical thresholds for acceptance are not provided in this document. The conclusion states that "substantial equivalence to the cited legally marketed predicate devices" was demonstrated and "any differences between the subject devices and predicate devices do not impact the safety and effectiveness."

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

The document does not specify the sample size used for the coating property tests (Tensile Bond Strength, Static Shear Strength, Shear Fatigue Strength, Tabor Abrasion Test). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).

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 section is not applicable. The study described focuses on bench performance testing of coating properties, not clinical or image-based evaluations requiring expert interpretation.

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

This section is not applicable. The study described focuses on bench performance testing of coating properties, not clinical or image-based evaluations 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 section is not applicable. The document describes a 510(k) submission for an interbody fusion device with a new coating, not an AI-powered diagnostic or assistive technology.

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

This section is not applicable. The document describes a medical device (interbody fusion system), not an algorithm or AI system.

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

For the coating properties tests, the "ground truth" would be the established performance standards or specifications defined by the ASTM standards (ASTM F1147, ASTM F1044, ASTM F1160, and ASTM F1978) and the performance of the predicate device's coating (from K201367).

8. The sample size for the training set

This section is not applicable. The document describes bench testing of a medical device coating, not a machine learning model that requires a training set.

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

This section is not applicable, as there is no training set for the described bench tests.

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The Z-LINKpc System implants are intended to provide immobilization and stabilization 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.

To achieve additional levels of fixation, the Z-LINKsc System may be connected to the Zavation Spinal System using rod connectors and tapered rods.

When used with the occipital plate, the Z-LINKpc System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic juction (occiput-T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.

The Z-LINKsc System is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537), 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, occipital plates, bone screws, and cap screws. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.

This document describes the Z-LINKpc System, a medical device, and its marketing authorization, not an AI/ML powered device. As such, the information requested regarding acceptance criteria and study proving the device meets those criteria (especially related to AI/ML specific aspects like training/test sets, ground truth establishment, expert adjudication, or MRMC studies) is not present in the provided text.

The document discusses the substantial equivalence of the Z-LINKpc System to legally marketed predicate devices based on:

• Indications for Use: The intended purpose of the device (immobilization and stabilization of spinal segments as an adjunct to fusion for various instabilities).
• Technological Characteristics: Basic design (rod-based fixation system), materials (titanium alloy/cobalt chrome alloy), mechanical safety, and performance.
• Performance Data: Static compression bending and torsion, dynamic compression bending, and dynamic torsion tests performed according to ASTM F2706 on a worst-case construct.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance evaluation as the provided text does not contain that information. The "acceptance criteria" here are implicitly the demonstration of substantial equivalence to predicate devices through mechanical performance testing and similar indications for use and technological features.

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The Zavation Spinal System is a pedicle screw system intended to provide immobilization 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 imparment, fracture, 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 standard pedicle screws have various options in lengths and diameters as well as a sterile packaged Hydroxyapatite (HA) coated option. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

This submission describes a medical device, the Zavation Spinal System, which is a pedicle screw system. The provided text outlines the device's indications for use, materials, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain information about acceptance criteria or a study that typically proves a device meets acceptance criteria in the context of an AI/ML medical device.

In the context of the provided text, the "acceptance criteria" for this traditional medical device are primarily related to its mechanical performance and substantial equivalence to legally marketed predicate devices, not performance metrics for an AI/ML algorithm. The "study" refers to mechanical testing.

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

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

The following information is NOT available in the provided text as it pertains to AI/ML device studies, which this submission is not.

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

• Not applicable/Not provided. This is a traditional medical device, not an AI/ML device relying on a test set of data. The "test set" here refers to the physical devices tested mechanically.

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)

• Not applicable/Not provided. The "ground truth" for this device's performance is established through mechanical testing standards (ASTM F1717) and comparison to predicate device characteristics, not expert consensus on medical images or diagnoses.

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

• Not applicable/Not provided. This method is used for resolving discrepancies in expert labeling of data, which is not relevant to mechanical testing.

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/Not provided. This is specific to AI-assisted diagnostic devices.

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

• Not applicable/Not provided. This is specific to AI/ML device performance.

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

• For the mechanical testing, the "ground truth" is defined by the established ASTM F1717 standard for spinal implant mechanical performance. For substantial equivalence, the "ground truth" is the characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. This is a traditional medical device, not an AI/ML device requiring a training set.

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

• Not applicable/Not provided.

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When used as a cervical intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous 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 (defined 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 LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous 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 LABYRINTH implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

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

The LABYRINTH 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 LABYRINTH device includes a porous structure on the endplate and through the device. This submittal seeks clearance for LABYRINTH implants will be provided sterile.

This looks like an FDA 510(k) clearance letter for a medical device called LABYRINTH, an intervertebral body fusion device.

Crucially, this document does NOT describe the acceptance criteria or a study related to an AI/ML powered device. It describes the performance testing of a physical medical implant, specifically mechanical and biomechanical testing, to demonstrate its substantial equivalence to a predicate device.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device performance evaluation methods (e.g., sample sizes for test/training sets, expert consensus, MRMC studies, ground truth establishment, etc.). The document focuses on the mechanical and material properties of the LABYRINTH implant.

To answer your prompt, I would need a document detailing the performance study of an AI/ML-powered medical device.

If you can provide a document relevant to an AI/ML device, I would be happy to analyze it according to your requested criteria.

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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 thoracolumbar spine (T1-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 intended to provide immobilization as an adjunct to fusion in sketally 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 thoracic, lumbar, and sacral plates and screws. The plates attach to the thoracic, lumbar, and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi).

This document is a 510(k) premarket notification for a medical device called the Z-Span Plate System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the provided text does not contain information about acceptance criteria or a study proving that a software device meets acceptance criteria. Instead, it focuses on the Z-Span Plate System, which is an implantable orthopedic device for spinal fixation. The "Performance Data" section specifically mentions mechanical testing (static and dynamic axial compression bending testing and static torsion testing) according to ASTM F1717, which is relevant for the physical properties of surgical implants, not for the performance of a software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for a software device, its reported performance, sample sizes, ground truth establishment, or expert adjudication. The document pertains to a physical medical implant, not a software device.

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When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous 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 (defined 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 intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous 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 Pedicle Screw 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 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. This modification seeks clearance for the addition of PEEK devices coated with a plasma-spray Titanium coating. The Titanium coated implants will be provided non-sterile.

The provided text is a 510(k) summary for the Zavation IBF System, which is an intervertebral body fusion device.

Crucially, this document is a premarket notification for a medical device (an implant) and not for an AI/ML-based medical device. Therefore, the information requested in the prompt, such as acceptance criteria for AI model performance, sample sizes for test sets, ground truth establishment, MRMC studies, and training set details, is not applicable to this document.

The "Performance Data" section in the document refers to mechanical and material testing of the implant itself, specifically related to the addition of a titanium coating, and not to the performance of an AI algorithm.

To answer your request, if this were an AI device, here's what would be expected based on the prompt's structure:

Based on the provided document, it is not possible to answer the detailed questions regarding acceptance criteria for an AI/ML-based medical device, as this 510(k) pertains to a physical intervertebral body fusion implant, not an AI algorithm.

The "Performance Data" section in the document refers to the mechanical and material performance testing of the implant and its coating, not the performance of an AI algorithm.

If this document were for an AI/ML medical device, the information would typically include:

1. Table of Acceptance Criteria and Reported Device Performance:
This would typically list metrics like sensitivity, specificity, AUC, recall, precision, F1-score, etc., along with the pre-defined target values (acceptance criteria) and the actual achieved performance of the AI model. Since this is a physical device, these metrics are irrelevant.

2. Sample Size and Data Provenance:
For an AI device, this would detail the number of cases (e.g., images, patient records) in the test set, their country of origin, and whether the data was collected retrospectively or prospectively. The current document makes no mention of AI test data.

3. Number of Experts and Qualifications for Ground Truth:
For an AI device, this would specify how many experts (e.g., board-certified radiologists, pathologists) annotated the test data to establish the "ground truth" (the correct diagnosis or finding). It would also detail their experience level. This is not applicable to a physical implant.

4. Adjudication Method for the Test Set:
This would describe how disagreements among experts were resolved (e.g., 2+1 means two experts agree, or a third expert adjudicates if they disagree). This is for AI model validation, not implant testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
If performed for an AI device, this would assess if human performance (e.g., radiologists' accuracy) improved when assisted by the AI compared to working without it. The effect size would quantify this improvement. Not applicable here.

6. Standalone (Algorithm Only) Performance:
This would describe the performance of the AI algorithm operating independently without human intervention. Not applicable here.

7. Type of Ground Truth Used:
For an AI device, this would specify how the "truth" was determined for the test cases (e.g., consensus of multiple experts, pathological confirmation, long-term patient outcomes). For a physical implant, ground truth relates to mechanical properties validated by ASTM standards.

8. Sample Size for the Training Set:
For an AI device, this is the number of data points used to train the algorithm. This is not mentioned as no AI is involved.

9. How Ground Truth for the Training Set was Established:
For an AI device, this would explain the process for labeling the data used to train the model, often involving similar expert annotation or established medical records. This is not applicable to this physical device.

What the document does describe under "Performance Data" (relevant to the physical implant):

The performance data listed relates to biocompatibility and mechanical testing of the Zavation IBF System implants, particularly concerning the addition of a titanium coating. This includes:

• ASTM F2077, Test Methods for Intervertebral Body Fusion Devices:
  • Static Axial Compression
  • Dynamic Axial Compression
  • Static Torsion (cervical)
  • Dynamic Torsion (cervical)
• Coating properties evaluated using:
  • ASTM F1147 (Tensile Bond Strength)
  • ASTM F1044 (Shear Fatigue Strength)
  • ASTM F1160 (Static Shear Strength)
  • ASTM F1854 (Abrasion Test)
  • ASTM F1978 (Metallurgical Testing and Image Analysis)

The document states that "no additional testing was performed for the purpose of this submission" because the new titanium coating's specifications were identical to an already cleared predicate device (K150061 Lucent Ti-Bond®), and the original Zavation IBF System (K181246) had already undergone the listed ASTM tests. This implies that the acceptance criteria for this modification were met by demonstrating equivalence to previously cleared devices through adherence to established ASTM standards for intervertebral body fusion devices and their coatings.

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The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

The provided text describes a medical device, the Normandy VBR System, and its substantial equivalence determination by the FDA. However, it does not contain information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning an AI/algorithm's performance.

The document is a 510(k) premarket notification approval letter and summary for a spinal implant. It focuses on demonstrating that the Normandy VBR System is substantially equivalent to existing predicate devices based on design, intended use, material composition, function, and mechanical performance.

Therefore, I cannot fulfill your request for information regarding AI device acceptance criteria and a study proving an AI device meets them. The provided text does not describe an AI medical device or its performance evaluation in the context you've outlined.

Here's what the document does provide the closest to your request, but is entirely in the context of a physical medical device (spinal implant) and its mechanical testing, not AI:

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

Important Note: The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate devices through mechanical testing. The document doesn't provide specific quantitative thresholds for these tests but rather states that the "mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices."

The following points cannot be addressed as the provided text pertains to a physical spinal implant, not an AI/algorithmic device:

2. Sample size 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
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (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 System is intended to provide immobilization and stabilization of spinal segments in sketally mature patients as an adjunct to fusion in the tollowing acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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; tumor; pseudoarthrosis; and failed previous fusion.

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and rod 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 prelordosed (curved) configurations. The system has variable length cross connectors, offsets, and connectors.

This document is a 510(k) premarket notification for the Zavation Spinal System. It is primarily a regulatory submission for a medical device and therefore does not contain information about an AI/ML device, its acceptance criteria, or a study proving it meets them.

The document describes a spinal fixation system, which is a physical implant used in spinal surgery. The performance data section refers to "biomechanical testing including static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. Axial and torsional grip of rod connectors was tested according to ASTM F1798." These are standard mechanical engineering tests for implants to ensure their structural integrity and performance, not statistical or clinical studies for an AI/ML device.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

The provided text is a 510(k) premarket notification summary for a medical device called the "Normandy VBR System." This document describes the device's indications for use, its mechanical characteristics, and its substantial equivalence to predicate devices based on mechanical performance testing.

It is crucial to understand that this document does not describe a study involving an artificial intelligence (AI) device or a study involving human readers/interpreters of medical images. Therefore, I cannot provide information on acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details as requested in your prompt. These elements are typically associated with studies evaluating diagnostic or prognostic AI algorithms, not with physical implantable medical devices like the Normandy VBR System.

The "Performance Data" section explicitly states: "Mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices. Static and Dynamic Axial Compression, Static and Dynamic Torsion, Subsidence, and Expulsion (per internal protocol) testing was performed in accordance with ASTM F2077 and ASTM F2267."

This refers to physical, biomechanical testing of the device's structural integrity and function, not evaluation of a diagnostic algorithm's accuracy or interpretation by human readers.

Therefore, I must state that the requested information (points 1-9) about acceptance criteria and study proving device performance cannot be extracted from the provided text because the device and the associated testing are not related to an AI/diagnostic imaging 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 (defined 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 Pedicle Screw 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.

This document is an FDA 510(k) summary for the Zavation IBF System. It states that the submission is for the "Addition of sterile packaged implants and instruments", and that "Biomechanical testing was not repeated, as the basis for this submission is the addition of sterile packaged options for the predicate device." Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance tests. Instead, it relies on the substantial equivalence to a predicate device.

Given that, I cannot fulfill your request for the information outlined in your prompt as it is not present in the provided text.

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