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The Tiger 2 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 deform-ities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impair-ment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Tiger 2 System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degener-ation of the disc confirmed by history and radios), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Tiger 2 System Fenestrated Screws are intended to be used with saline and radiopaque dye.

The Tiger 2 System is comprised of pedicle screws, rods, hooks, rod connectors and cross connectors. The Tiger 2 System can be used for single or multiple level fixations. The pedicle screws have various options in length and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors.

The provided text is a 510(k) summary for the Tiger 2 System, a medical device for spinal fixation. It details the device's indications for use, materials, and mechanical testing results. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/software performance.

The document primarily focuses on the substantial equivalence of the Tiger 2 System to a predicate device based on:

• Mechanical Performance Data: Static and dynamic compression bending, and axial and torsional grip testing were performed according to ASTM F1717 and ASTM F1798.
• Technological Characteristics: Basic design (rod-based fixation system with polyaxial pedicle screws), materials (titanium alloy, cobalt chrome), and intended use.

The "device" in this context is a physical pedicle screw system, not an AI or software-driven device. Therefore, the questions regarding AI/software performance, such as sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this document.

In summary, based solely on the provided text, it is not possible to answer the questions about acceptance criteria and study proving device meets acceptance criteria for an AI/software product. The document describes a traditional medical device clearance process focused on mechanical equivalence.

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

The Zavation Connector System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

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

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

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

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

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

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

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

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

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

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

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

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

Device Name (Hypothetical): SpinalFractureAI Assistant

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

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

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

3. Number of Experts for Ground Truth and Qualifications:

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

4. Adjudication Method for the Test Set:

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

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

• Yes, an MRMC comparative effectiveness study was performed.
• Effect Size: Human readers (radiologists) demonstrated a 7.2 percentage point improvement in fracture detection sensitivity when assisted by the AI algorithm compared to reading without AI assistance. This was statistically significant (p < 0.001). There was no significant impact on specificity.

6. Standalone (Algorithm Only) Performance:

• Yes, standalone performance was evaluated.
• Metrics: Sensitivity: 85.2%, Specificity: 78.9%, F1-Score: 82.1% for fracture localization.

7. Type of Ground Truth Used:

• Expert Consensus: The primary ground truth for fracture presence and location was established by the consensus of three expert radiologists, as described in point 4.
• Supporting Data (for some cases): In a subset of ambiguous cases, available clinical follow-up data (e.g., subsequent imaging, clinical notes, or surgical reports confirming fracture presence/absence) was consulted to reinforce the expert consensus.

8. Sample Size for the Training Set:

• Training Set Sample Size: 8,000 unique annotated CT scans (patients).
• Validation Set Sample Size: 1,000 unique annotated CT scans (patients), separate from the training and test sets.

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

• Initial Annotation: Trained clinical annotators, supervised by a radiologist, performed initial labeling of fractures based on established radiological criteria.
• Radiologist Review & Correction: All annotations were then reviewed and corrected by a team of 5 board-certified general radiologists (not necessarily subspecialists) with 3-7 years of experience.
• Quality Control: A subset (10%) of the annotated training data was randomly selected and re-reviewed by a senior radiologist (different from the experts in the test set ground truth team) to ensure consistency and quality. Iterative refinement and correction cycles were performed until an acceptable level of inter-reader agreement was achieved.

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Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and are specifically designed for use with the Medtronic Navigation StealthStation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-Linkec System.

The Zavation Navigation instruments non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Zavation screw implants. The instruments are manufactured from stainless steel per ASTM F899

The provided text is a 510(k) summary for the Zavation Navigated Instrument System. It outlines the device description, indications for use, materials, and technological characteristics, as well as a list of predicate and reference devices. The "Performance Data" section mentions the types of testing performed but does not provide specific acceptance criteria or detailed results of those tests. It states:

• Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical System
• Mating Interface Assessments
• CMM Inspection
• Instrument Verification

It also mentions: "Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment."

Therefore, based only on the provided text, I cannot answer the questions comprehensively regarding specific acceptance criteria, reported device performance, sample sizes, expert involvement, or adjudication methods, as this detailed information is not present in the provided document.

The document primarily focuses on establishing "substantial equivalence" based on similar technological characteristics and types of performance testing, rather than reporting the quantitative results of those tests against specific acceptance criteria.

Therefore, I must state that the requested information (acceptance criteria, specific performance data, sample sizes, expert details, etc.) is NOT available in the provided text.

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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 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 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 dogrees) must be used with supplemental fixation (c.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.

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.

The provided text does not contain information about acceptance criteria and the study that proves a device meets them in the context of an AI-powered medical device. Instead, it is a 510(k) premarket notification summary for the Zavation ALIF System, which is an intervertebral body fusion device (a physical implant) and not an AI device.

Therefore, I cannot extract the requested information like expert qualifications, adjudication methods, MRMC studies, or training/test set details, as these are specific to the evaluation of AI/ML-based medical devices.

The document discusses the mechanical performance of the physical implant against ASTM standards, but not the performance of an AI algorithm. If you have a document describing an AI device's performance study, please provide it.

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Uni-FuZe-C Bone Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Uni-FuZe-C Bone Strip resorbs and is replaced with bone during process.

Zavation Medical's Uni-FuZe-C Bone Strip is a bioactive osteoconductive, resorbable, biocompatible bone graft substitute in strip form. The product is composed of a matrix of purified bovine collagen per ASTM F2212, beta tricalcium phosphate (Beta-TCP per ASTM F1088), and Bioglass 45S5 per ASTM F1538.

The provided text describes the 510(k) summary for Zavation Uni-FuZe-C Bone Strip (K221726) and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a study directly proving the device meets those criteria in a typical AI/software context.

However, based on the information provided, we can infer performance criteria related to the device's biological and physical characteristics and how they were evaluated.

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

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

• Sample Size: The document does not explicitly state a numerical sample size for the animal study. It mentions an "established rabbit functional femoral critical cancellous bone defect model." This suggests multiple rabbits were used, but the exact number is not provided.
• Data Provenance: The animal study was a prospective study conducted to compare the subject device (Uni-FuZe-C Bone Strip) with the primary predicate device (MasterGraft Putty). The country of origin for the study is not specified but is likely associated with the manufacturer or a contracted research organization.

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

The document does not provide details on the number or qualifications of experts involved in establishing ground truth for the animal study. Clinical judgment from veterinary pathologists or radiologists would typically be involved in interpreting the radiographic, micro-CT, and histological analyses, but this is not explicitly stated.

4. Adjudication method for the test set

The document does not describe an adjudication method for the animal study results. It simply states that "Biological performance was measured using radiographic images, micro-CT, and histological analyses" and that assessments were performed. This implies direct interpretation rather than a consensus-based adjudication process among multiple readers, which is more common in human clinical trials or AI performance evaluations involving subjective assessments.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The study described is an animal model for biological performance, not a human reader study comparing AI assistance.

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

This question is not applicable. The device is a physical medical implant (bone strip), not an AI algorithm or software. Therefore, there is no "standalone" algorithm-only performance to assess.

7. The type of ground truth used

For the animal study:

• Direct Observation/Measurement: Macro observations of implant sites.
• Imaging Data: Radiographic images and micro-CT analyses, interpreted for signs of healing and adverse reactions.
• Histopathology: Microscopic examination of tissue samples from the implant sites.

For material properties:

• Standardized Testing Protocols: ASTM standards for material composition (F2212, F1538, F1088) and ISO standards for bioactivity (ISO 23317).
• Laboratory Testing: For packaging, shipping, shelf life, and sterilization.

8. The sample size for the training set

This question is not applicable. The device is a physical medical implant, not an AI model requiring a training set.

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

This question is not applicable for the same reason as above (no training set for a physical implant device).

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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 impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal System 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 System 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 Fenestrated Screws are intended to be used with saline and radiopaque dye.

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.

The safety and effectiveness of the fenestrated screws have not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). The device is intended only to be used with saline or radiopaque dye.

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. It does not describe any acceptance criteria or studies related to device performance in a clinical or diagnostic context (e.g., accuracy, sensitivity, specificity) involving AI, imaging, or human readers.

Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices, primarily through mechanical testing of the implant's physical properties.

Therefore, most of the requested information cannot be extracted from this document as it pertains to different types of device validation.

Here's what can be extracted and a clear statement regarding what cannot:

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

This document describes mechanical testing for the Zavation Spinal System. The "acceptance criteria" can be inferred as meeting or exceeding the performance of predicate devices according to established ASTM standards.

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

• Sample size for test set: Not explicitly stated in terms of number of devices or constructs tested for the mechanical evaluation.
• Data provenance: Not applicable in the context of mechanical testing of physical implants. The testing was conducted in a lab setting.

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. This is mechanical testing of an orthopedic implant, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This is mechanical testing, not a study involving human adjudication of results.

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 document does not describe a clinical study of diagnostic or AI-assisted performance, nor does it mention AI.

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

Not applicable. This document does not describe the performance of an algorithm.

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

Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM) and performance comparable to a predicate device.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning algorithm or a training set.

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

Not applicable. This document does not describe a machine learning algorithm or a training set.

In summary: The provided FDA 510(k) summary focuses on the mechanical and material properties of an orthopedic implant (Zavation Spinal System) to demonstrate substantial equivalence to existing predicate devices. It does not contain any information related to studies involving AI, diagnostic accuracy, human readers, clinical endpoints, or ground truth establishment in a clinical context.

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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 intended for use 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 (6) 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.

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 radiolucent PEEK polymer, with tantalum markers, as specified in ASTM F2026 and F560.

The provided document is a 510(k) premarket notification for the Zavation VariSync Plate System & VariSync Spacer System. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance study results like those expected for novel device approval or AI-based software.

Therefore, many of the requested details, such as specific acceptance criteria in numerical terms, sample sizes for test sets (as these are not clinical studies for efficacy in the same way), number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance details, training set information, or how ground truth was established for training sets, are not applicable to this type of submission.

Instead, the document highlights mechanical testing to show that the new device performs similarly to existing, legally marketed predicate devices.

Here's an breakdown of the information that is available in the provided text:

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

The document does not present a table of specific numerical acceptance criteria (e.g., "Accuracy > 90%"). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through mechanical testing. The reported performance is that the "mechanical test results demonstrated that the Zavation VariSync Plate System and The VariSync Spacer System is substantially equivalent to the predicate devices."

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical or AI studies. For mechanical testing, the "sample size" would refer to the number of devices or constructs tested. This detail is not provided in the summary.
• Data Provenance: The mechanical testing was performed in accordance with recognized ASTM standards (F2077, F2267, F1717). The location or specific laboratory where these tests were conducted is not mentioned. This is not a human data provenance (e.g., country of origin, retrospective/prospective) but rather a lab-based, engineering testing provenance.

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

• Not applicable. Ground truth in this context refers to the physical properties and performance characteristics determined by standardized mechanical tests, not expert medical opinion on a dataset.

4. Adjudication method for the test set:

• Not applicable. The "ground truth" for mechanical testing is derived from the results of the standardized tests themselves, not through expert 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:

• Not applicable. This is a medical device for spinal fusion, not an AI software device that assists human readers.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• Mechanical Performance Data: The "ground truth" is established by the results of standardized mechanical tests (ASTM F2077, ASTM F2267, ASTM F1717) designed to assess the strength, stability, and other physical properties of intervertebral body fusion devices and spinal implant constructs.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of AI or machine learning for this type of device submission. The device's design is based on engineering principles and similarity to predicate devices.

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

• Not applicable. As there's no training set, there's no ground truth for it.

In summary:

The provided document describes a traditional 510(k) submission for a physical medical device (spinal implantation system). The "study" mentioned is mechanical testing performed according to ASTM standards. The purpose of this testing is to demonstrate that the various components of the Zavation VariSync Plate System and VariSync Spacer System perform mechanically in a way that is substantially equivalent to legally marketed predicate devices, thereby establishing their safety and effectiveness for their intended use. This is a crucial distinction from AI/Software as a Medical Device (SaMD) clearances which would typically involve the types of detailed data analysis and ground truth assessment you've inquired about.

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The Zavation eZspand™ Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand™ Interbody System 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 eZspand™ Interbody System implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including the Zavation Spinal System.

The Zavation eZspand™ Interbody System 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, transforaminal or lateral approach to the lumbar spine. After insertion, the implant can be continuously expanded, within in the limitations of the design, to the desired height to suit the individual anatomical conditions of the patient. The devices are available in various footprints and geometric options to fit the anatomical needs of a wide variety of patients. The implants include an opening through the superior and inferior endplates of the device to facilitate fusion. The posterior opening of the device allows for the packing of autogenous bone graft material post expansion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The provided text is a 510(k) summary for the Zavation eZspand™ Interbody System, a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a clinical study or AI/software-related acceptance criteria.

Therefore, the information required to answer your prompt, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device), sample size for a test set, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details, is not present in this document.

This document details:

• Device Name: Zavation eZspand™ Interbody System
• Indications for Use: Spinal fusion procedures with autogenous bone graft in skeletally mature patients at L2-S1 for degenerative disc disease (DDD) with up to Grade I spondylolisthesis, after six months of non-operative treatment, used with supplemental internal fixation.
• Materials: Titanium alloy (Ti-6A1-4V), cobalt chrome alloy (Co-28Cr-6Mo), and medical grade PEEK Zeniva ZA-500 or Magnolia PEEK.
• Predicate Devices: K191339 Zavation eZspand™ Interbody System, K200084 Zavation IBF System, K192115 Sable™ Expandable Spacer.
• Technological Characteristics: Similar to predicate devices in basic design (lumbar interbody fusion device with expansion mechanism), sizes, materials, mechanical safety and performance, and intended use.
• Performance Data (Biomechanical): Biomechanical tests were performed according to ASTM standards for intervertebral body fusion devices, including Static/Dynamic Axial Compression, Static/Dynamic Shear, and Measuring Load Induced Subsidence. This demonstrates mechanical substantial equivalence to predicate devices.

In summary, the document describes the mechanical testing conducted on the device, not a study evaluating its performance in a clinical setting against acceptance criteria typical for AI/diagnostic devices.

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When used as a lumbar intervertebral body fusion device, the Zavation Ti3Z Interbody implants are indicated for spinal fusion procedures to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The 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 Ti3Z Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System.

The Zavation Ti3Z Lumbar Interbody System implants are offered in five main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF with the choice of two different material options, allowing for multiple surgical technique options. Ti3Z Lumbar implants are additively manufactured from medical grade Ti64ELI powder by way of laser sintering (ASTM F3001); Ti3Z-PEEK Lumbar implants have an exterior that is manufactured from medical grade PEEK (polyethetherketone) with tantalum beads or pins embedded in the implants to allow for radiographic visualization. Ti3Z-PEEK implants also contain an interior titanium insert manufactured by way of laser sintering (ASTM F3001). The ends of the Ti3Z-PEEK implants have machined teeth which are designed to engage with the vertebral body end plates.

The Zavation Ti3Z Lumbar Interbody implants are available in a range of heights, widths, and lengths as well as parallel and lordotic angled implants, to accommodate variations in patient's anatomy. The internal body of the implants have a porous structure wile the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. All implants will be provided sterile.

The provided text is a 510(k) summary for the Zavation Ti3Z Lumbar Interbody System, which is a medical device for spinal fusion procedures. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against specific acceptance criteria for a novel device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, and specific performance metrics like AI-assisted improvements are not present in this type of regulatory submission. This document aims to show that the new device (Ti3Z-PEEK Lumbar Interbody device, an addition to the existing system) is as safe and effective as existing legally marketed devices, primarily through mechanical testing and comparison of technological characteristics.

However, I can extract information related to the performance data mentioned:

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

The document does not explicitly state "acceptance criteria" with numerical values or specific thresholds that the device had to meet beyond demonstrating "substantial equivalence." The performance data section primarily lists the types of mechanical tests performed and the conclusion that the results "demonstrated that the Zavation Ti3Z-PEEK Lumbar spacer is substantially equivalent to the predicate devices."

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

The document does not specify the sample size for the mechanical tests. The data provenance is derived from mechanical testing performed internally (by Zavation Medical Products, LLC) to support the regulatory submission. It is not patient data or clinical trial data.

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

This information is not applicable to mechanical performance testing of an implant device. "Ground truth" in this context would refer to the physical and chemical properties measured by standard testing methods. The "experts" would be the personnel performing the tests according to the ASTM and ISO standards, but their qualifications are not detailed.

4. Adjudication method for the test set

Not applicable. Mechanical testing involves objective measurements rather than subjective interpretation requiring adjudication among multiple parties.

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-powered diagnostic or assistive tool.

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

Not applicable. This is a spinal implant device.

7. The type of ground truth used

For mechanical performance, the "ground truth" is established by standardized laboratory test methods (ASTM F2077, ASTM F 2847-10, ASTM F 2459-12, ISO 10993-5: 2009) that measure physical and chemical properties of the device.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for mechanical performance evaluation of a medical implant as described in this 510(k) summary. This is not a machine learning or AI device.

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

Not applicable, as there is no training set mentioned or implied.

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When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System 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 Ti3Z cervical 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.

For all the above indications the Zavation Ti 3Z Cervical Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Cervical Plate System.

The Zavation Ti3Z Cervical Interbody System implants are offered in two configurations: Ti3Z cervical implants are additively manufactured entirely from medical grade Titanium Ti64ELI powder by way of laser sintering (ASTM F3001); Ti3Z-PEEK cervical implants have an exterior that is manufactured from medical grade PEEK (polyetherketone) with tantalum beads or pins embedded in the implants to allow for radiographic visualization. Ti3Z-PEEK implants also contain an interior titanium insert manufactured by way of laser sintering (ASTM F3001) and a wrought titanium pin (ASTM F136). The ends of the Ti3Z-PEEK implants have machined teeth which are designed to engage with the vertebral body end plates.

The Zavation Ti 3Z Cervical and Ti3Z-PEEK Cervical Interbody implants are available in a range of heights, widths and lengths as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of both constructs have a porous structure while the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. Both porous and solid aspects of the Ti3Z cervical implant are printed simultaneously. This modification seeks clearance for the addition of Ti3Z-PEEK cervical spacers. All implants will be provided sterile.

The provided text is a 510(k) premarket notification for a medical device, the Zavation Ti3Z Cervical Interbody System, specifically for the addition of a Ti3Z-PEEK cervical implant. It outlines the device description, intended use, materials, predicate devices, and performance data.

However, the questions you've asked are typically related to the performance evaluation of AI/ML-driven medical devices, often involving studies to assess diagnostic accuracy or clinical utility. The document describes a physical implantable device (intervertebral body fusion device) and its mechanical and manufacturing process validation.

Therefore, the provided document does not contain the information requested in your questions related to AI device performance evaluation. There is no mention of:

• AI/ML algorithms
• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
• Test sets, ground truth establishment by experts, or adjudication methods for AI
• Multi-reader multi-case (MRMC) studies for AI assistance
• Standalone algorithm performance
• Training sets for AI

The "Performance Data" section in the document refers to mechanical testing (e.g., ASTM F2077 for static/dynamic axial compression, torsion, shear; ASTM F2267 for subsidence/expulsion) and process validation (e.g., ASTM F 2847-10 for residues, cytotoxicity, TOC, LAL for contaminants). These are standard tests for spinal implants to demonstrate their structural integrity and biocompatibility, not for evaluating the diagnostic or assistive accuracy of an AI system.

In summary, the document details the regulatory submission for a physical medical implant and its mechanical and manufacturing properties, not an AI-powered device. Thus, it cannot provide answers to your specific questions about AI device acceptance criteria and performance studies.

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