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The VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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), pseudoarthrosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components, The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping, self drilling or rigid cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a rigid cervical screw.

The acceptance criteria for the VERTEBRON SSP™ Cervical Plate System are based on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing. The study demonstrating this involved performing tests in accordance with ASTM F1717.

Here's the detailed breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size used for the mechanical tests. The "test set" in this context refers to the physical samples of the VERTEBRON SSP™ Cervical Plate System with the added rigid cervical screw that underwent mechanical testing.

• Sample Size: Not specified. Standard practice for such tests involves a sufficient number of samples to ensure statistical validity and representativeness of the device's performance.
• Data Provenance: The data comes from prospective mechanical testing conducted on the modified VERTEBRON SSP™ Cervical Plate System to evaluate its performance against established standards and predicate devices. No specific country of origin for the data generation is mentioned, but it would have been conducted by or for VERTEBRON Inc. in the US, given the submission to the FDA.

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

This information is not applicable as the acceptance criteria and study in question are for a medical device (spinal implant) and pertain to mechanical performance rather than diagnostic accuracy or clinical outcomes requiring expert interpretation of data. The "ground truth" here is the pass/fail criteria defined by the ASTM F1717 standard for mechanical properties.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing according to a defined standard like ASTM F1717 involves objective measurements and predefined pass/fail thresholds. There is no need for expert adjudication in the way it would be applied to clinical image interpretation or diagnostic accuracy studies.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The VERTEBRON SSP™ Cervical Plate System is a physical implant, and its acceptance is based on mechanical performance, not diagnostic effectiveness.

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

This is not applicable. The device is a physical medical implant, not an algorithm or AI system. Its performance is evaluated intrinsically, not as an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this study is defined by the mechanical performance specifications and limits outlined in the ASTM F1717 standard. This standard dictates the testing methodology and acceptance criteria for spinal intervertebral body fixation devices. The device's performance (e.g., strength, fatigue resistance) is measured and compared against the predefined limits within this standard.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this submission. The device is a physical product, not a machine learning model.

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

This is not applicable. As there is no training set for a machine learning model, there is no ground truth established for it. The "ground truth" for the device's mechanical performance is defined by the established and validated ASTM F1717 standard.

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The VERTEBRON PSS™ Pedicle Screw System is intended for non-cervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The modified VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spine and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks and locking caps. This submission adds Curved Rods and Screw Spacers.

The information primarily concerns the regulatory approval of a medical device, specifically the VERTEBRON PSS Pedicle Screw System, based on substantial equivalence to predicate devices, rather than a study evaluating its performance against pre-defined acceptance criteria using AI or image analysis. Therefore, most of the requested fields are not applicable to the provided text.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not applicable. The document describes a medical device (pedicle screw system), not an AI/image analysis software that would have a test set of data. The testing mentioned (ASTM F1717) refers to mechanical testing of the physical device.
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable. This information would be relevant for establishing ground truth for an AI/image analysis device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method:

• Adjudication Method: Not applicable. This is typically used in studies where multiple experts interpret data to establish a ground truth, which is not described here.

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

• MRMC Study Done: No. The document describes a 510(k) submission for a physical medical device (Pedicle Screw System), not an AI/image interpretation device that would involve human readers.
• Effect Size of Human Readers' Improvement with AI: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study Done: Not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. For the mechanical testing (ASTM F1717), the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices. This is not the same as ground truth for an AI/image analysis system (e.g., pathology, expert consensus).

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is a physical implant, not an AI/machine learning model that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable.

Summary based on the provided text:

The provided 510(k) summary for the VERTEBRON PSS Pedicle Screw System describes a submission for a physical medical device, not an AI or image analysis software. The device's approval is based on demonstrating substantial equivalence to existing predicate devices (VERTEBRON PSS Pedicle Screw System K071376, K051716, K043152 & K033352) through mechanical testing in accordance with ASTM F1717.

Therefore, the concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" as defined by your request (referring to AI/image analysis performance metrics, ground truth, expert review, sample sizes for training/test sets, etc.) are not applicable to this document. The "study" mentioned is the mechanical testing to show substantial equivalence, not a clinical performance study with human readers or AI algorithms.

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The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems, such as the VERTEBRON PSS Pedicle Screw System.

The VERTEBRON Interbody Fusion System consists of various heights, angles and configurations (i.e., square, rectangular D-shaped, etc.). The device is use singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy.

The VERTEBRON Interbody Fusion System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM 2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.

The VERTEBRON Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F560) are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively.

The material used is PEEK ASTM F2026-07e1 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy (TI-6AI-4V) that conforms to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The VERTEBRON Interbody Fusion System is an intervertebral body fusion device. The acceptance criteria and the study performed for this device are described below, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided 510(k) summary does not contain information about a test set with human subject data for efficacy or safety comparisons. The studies mentioned are primarily bench testing for mechanical properties.

• Sample Size: Not applicable for human data. For mechanical testing, the sample size would be determined by the ASTM standards (e.g., number of devices tested). This specific detail is not provided.
• Data Provenance: Not applicable for human data. For mechanical testing, the data would be generated from laboratory tests.

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

Not applicable. The studies referenced are mechanical bench tests against established ASTM standards, not clinical studies requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a medical implant (interbody fusion system), not an AI or imaging diagnostic device where MRMC studies are typically performed.

6. Standalone Performance Study

Yes, a standalone study in the context of mechanical performance was conducted. The device's mechanical properties were evaluated in a standalone manner (i.e., the device itself, without human interaction influencing performance in the test) against the specified ASTM standards. This is a "standalone" evaluation of the device's physical and mechanical characteristics.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation of this device was based on widely accepted engineering and material standards (ASTM F2077-03 and ASTM F2267 for mechanical properties; ASTM F2026-07e1, ASTM F136, and ASTM F560 for material specifications). The device was evaluated against these predefined, objective standards for mechanical strength and material composition.

8. Sample Size for the Training Set

Not applicable. This device is an implanted medical device, not an AI or machine learning algorithm that requires a training set. The performance evaluation relies on engineering principles and bench testing.

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

Not applicable. As there is no AI/ML component, there is no training set or ground truth required to be established for one.

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The VERTEBRON PSSIM Pedicle Screw System is intended for noncervical, nonpedicte fixation for the following indications: degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicte fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VERTEBRON PSS Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 5.5, 6.5 & 7.5mm Cannulated MA Screws & Buttress Cap.

The VERTEBRON PSS Pedicle Screw System is a medical device and its acceptance is determined by demonstrating "substantial equivalence" to a predicate device already legally marketed. This is a common pathway for medical devices in the US through the 510(k) premarket notification process, rather than a typical "acceptance criteria" study for algorithm performance.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence, not typically on extensive clinical trials or independent algorithm performance studies as might be seen for AI/ML devices. Therefore, many of the requested categories (like number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) are not applicable in the context of this device and submission type.

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

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical trials. The "testing" refers to mechanical testing according to ASTM F1717. The number of samples for this mechanical test is not provided in this summary.
   • Data Provenance: Not applicable in the sense of clinical data origin. The testing is laboratory-based mechanical testing of the device components.

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

   • Not applicable. Ground truth in the context of clinical expert consensus is not relevant here. The ground truth for mechanical testing is established by engineering standards and measurements.

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

   • Not applicable. Adjudication methods are typically for clinical interpretations, not mechanical testing.

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

   • No, not done. This is a physical medical device (pedicle screw system), not an AI/ML-driven diagnostic or assistive tool.

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

   • No, not done. This is a physical medical device.

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

   • Mechanical standards and measurements. The "ground truth" for the device's performance is its ability to meet the specified mechanical properties and performance under the ASTM F1717 standard.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of AI/ML or a clinical trial.

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

   • Not applicable.

Summary of the "Study"

The "study" referenced in the document is the mechanical testing of the device components according to ASTM F1717. This standard evaluates the static and fatigue properties of metallic spinal implant ensembles. By demonstrating that the new components (5.5, 6.5 & 7.5mm Cannulated MA Screws & Buttress Cap) meet the criteria specified by ASTM F1717, the manufacturer showed that these components are substantially equivalent in performance to their previously cleared predicate devices (K033352, K043152 & K051716).

The purpose of this submission (Special 510(k)) is to introduce minor modifications (additional screw sizes and a cap) to an already cleared device, and the method for demonstrating safety and effectiveness for such modifications is primarily through engineering and biocompatibility testing, proving that the changes do not raise new questions of safety and effectiveness and perform comparably to the predicate.

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The Modified VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical soins fue tempor patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic shudies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordnois, ar scoliosis), pseudoarthriosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.

The provided text describes a medical device submission for the VERTEBRON SSP™ Cervical Plate System. However, it does not include information about acceptance criteria for a study, nor does it detail a study proving the device meets specific performance metrics.

The document primarily focuses on establishing "substantial equivalence" of a modified device to a previously cleared predicate device. This is a regulatory pathway that relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed device, rather than requiring a new, independent performance study with specific acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be filled based on the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided. The document does not describe specific acceptance criteria (e.g., minimum tensile strength, fatigue life) or quantitate device performance against such criteria. It states that "Testing in accordance with ASTM F1717 was performed and demonstrated that the modified VERTEBRON SSP™ Cervical Plate System is substantially equivalent" to the predicate device. This implies that the device met the requirements of ASTM F1717, but the specific acceptance criteria of that standard and the numerical performance results are not reported.

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

• Cannot be provided clearly. The document only mentions "Testing in accordance with ASTM F1717 was performed." It does not specify the sample size used for this testing or the provenance of any data (e.g., country of origin, retrospective/prospective). ASTM F1717 is a standard test method for spinal implant constructs, which would involve laboratory testing of physical samples, not clinical patient data.

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

• Not applicable. This question pertains to studies involving expert review for establishing ground truth, typically in imaging or diagnostic device studies. The described submission is for a physical orthopedic implant and its substantial equivalence, not a diagnostic or AI-driven device. Ground truth, in this context, would relate to the physical properties measured in laboratory tests, not expert consensus on clinical findings.

4. Adjudication method for the test set:

• Not applicable. Similar to point 3, adjudication methods (like 2+1, 3+1) are relevant for studies where expert disagreement needs to be resolved, typically in clinical interpretation or diagnostic accuracy studies. This is not described for the physical testing of an implant.

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 submission is for an orthopedic implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance evaluation is mentioned or relevant.

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

• Not applicable. This submission is for an orthopedic implant, not an algorithm or AI-driven device.

7. The type of ground truth used:

• Cannot be explicitly stated with detail, but inferred. For the "Testing in accordance with ASTM F1717," the ground truth would be the physical measurements obtained from the mechanical tests (e.g., stiffness, strength, fatigue life) as defined by the ASTM standard. This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This submission is not about an AI/ML algorithm that requires a training set.

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

• Not applicable. This submission is not about an AI/ML algorithm that requires a training set.

In summary, the provided document details a 510(k) submission for a physical medical device (cervical plate system) seeking market clearance based on substantial equivalence to a predicate device, as demonstrated through testing in accordance with ASTM F1717. It does not contain the kind of performance data, acceptance criteria, or study design information typically associated with AI/ML device evaluations or detailed clinical performance studies, which your questions are geared towards.

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The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The Reduced Stature VERTEBRON SCP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The VERTEBRON SCP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.

The provided text describes a medical device, the VERTEBRON SCP™ Cervical Plate System, and its clearance process with the FDA. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, accuracy).

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a clinical study. The "study" mentioned refers to mechanical testing for equivalence, not a clinical performance study with human subjects, ground truth, or expert readers.

Therefore, most of the requested information cannot be extracted from this document, and the following answers reflect that absence.

Acceptance Criteria and Device Performance Study Information

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable (No test set for clinical performance is described).
• Data Provenance: Not applicable (No clinical data provenance is described). The study mentioned is mechanical testing.

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

• Not applicable (No experts for establishing ground truth are mentioned as this is not a study assessing diagnostic or clinical performance against ground truth).

4. Adjudication method for the test set

• Not applicable (No adjudication method is mentioned).

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

• No, an MRMC comparative effectiveness study was not done. The device is a cervical plate system, not an AI-powered diagnostic or assistive tool for human readers.

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

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

7. The type of ground truth used

• Not applicable. The document describes mechanical testing for substantial equivalence, not a study requiring clinical or diagnostic ground truth. The "ground truth" for the mechanical testing would be the physical properties and performance of the device under specific loads, as compared to established standards (ASTM F1717) and predicate devices.

8. The sample size for the training set

• Not applicable (No training set is mentioned as this device is not an AI/ML product).

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

• Not applicable (No training set or associated ground truth establishment is mentioned).

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The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 4.5mm Standard and MA Screws.

The provided text describes a Special 510(k) Summary for a medical device called the VERTEBRON PSS™ Pedicle Screw System, specifically for the addition of 4.5mm Standard and MA Screws. The document asserts the substantial equivalence of these new components to previously cleared devices.

Based on the provided information, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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 a "test set" in the context of clinical data or patient samples. The testing referred to is mechanical testing according to ASTM F1717. The sample size for this mechanical testing is not explicitly stated. The data provenance is not mentioned, as it is a laboratory-based mechanical test, not clinical data from a specific country or patient population.

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 to the provided document. The "ground truth" for the device's acceptance is established through the demonstration of substantial equivalence to predicate devices, which is primarily based on mechanical testing and material conformity, not expert evaluation of a clinical "test set."

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

This section is not applicable to the provided document for the same reasons as #3. There is no mention of a human-reviewed "test set" or adjudication process.

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 to the provided document. The device is a pedicle screw system, not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant in this context.

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

This section is not applicable to the provided document. The device is a mechanical medical implant, not an algorithm.

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

The "ground truth" for the acceptance of this device relies on demonstrated substantial equivalence to predicate devices. This is established through:

• Mechanical performance data (conformance to ASTM F1717).
• Material composition (conformance to ASTM F136).
• Design similarities to previously cleared devices.
• Intended use and indications being comparable to predicate devices.

8. The sample size for the training set

This section is not applicable to the provided document, as it concerns a mechanical medical device and not an AI/ML algorithm that requires a "training set."

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

This section is not applicable for the same reasons as #8.

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The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks and locking caps. This submission adds both adjustable and fixed cross connectors.

The provided text describes a 510(k) premarket notification for the VERTEBRON PSS™ Pedicle Screw System, specifically focusing on the addition of adjustable and fixed cross connectors. The submission primarily addresses substantial equivalence to predicate devices and describes the mechanical testing performed.

However, the provided text does not contain information related to a study proving the device meets acceptance criteria in terms of clinical performance, diagnostic accuracy, or human reader improvement, as typically seen in studies for AI/software as a medical device (SaMD). The acceptance criteria outlined are based on mechanical testing for substantial equivalence.

Therefore, I will extract the relevant information from the document regarding the acceptance criteria and the "study" (mechanical testing) that demonstrates equivalence. Many of the questions in your prompt are not applicable to this type of device submission (mechanical implant) and the information provided.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated in the provided text. Mechanical testing often involves a smaller number of physical samples compared to clinical trials or AI model evaluations.
• Data Provenance: The "study" was mechanical testing performed by VERTETEBRON Inc. It's not clinical data, so country of origin or retrospective/prospective does not apply in the typical sense.

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

• Not applicable. This was mechanical testing according to a standard (ASTM 1717), not an expert-driven ground truth establishment.

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

• Not applicable. Adjudication methods are relevant for expert-driven ground truth, not for standardized 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:

• No. This is a mechanical implant device, not an AI or diagnostic device that would involve human readers or AI assistance for interpretation.

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

• Not applicable. This is a mechanical implant device.

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

• The "ground truth" here is compliance with the ASTM 1717 standard for mechanical testing, demonstrating substantial equivalence to predicate devices. It is not a clinical ground truth.

8. The sample size for the training set:

• Not applicable. This is a mechanical implant device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. This is a mechanical implant device.

Summary of the Study (Mechanical Testing):

The study referenced is "Testing in accordance with ASTM 1717". This standard applies to the "Standard Test Method for Spinal Implant Constructs in a Corpectomy Model." The purpose of this testing was to demonstrate that the modified VERTEBRON PSS™ Pedicle Screw System (with cross connectors) is substantially equivalent in its mechanical performance to the previously cleared VERTEBRON PSS™ Pedicle Screw System (without cross connectors) and other predicate devices (Optima Spinal Fixation System; U&I America).

The acceptance criteria implicitly revolve around meeting the performance benchmarks or being within acceptable tolerance levels as compared to the predicate devices when tested under the ASTM 1717 protocol. The "reported device performance" is that it did demonstrate substantial equivalence.

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The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The material used is medical grade titanium material that conforms to ASTM F136.

This is not an AI/ML device. It is a medical device for spinal fixation, not an AI diagnostic or prognostic tool. The provided text is a 510(k) summary and approval letter for a cervical plate system, not a study evaluating AI performance. Therefore, I cannot extract the requested information as it does not exist in the provided document.

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The Vertebron SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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), pseudoarthriosis, and/or failed previous fusions. The SCP Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

The device consists of a system of implantable metal plates and screws intended the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

The provided text is a 510(k) summary for the Vertebron SCP™ Cervical Plate System. It details the device's description, indications for use, and a general statement about testing. However, it does not contain the specific information required to answer all parts of your request regarding detailed acceptance criteria, sample sizes, ground truth establishment, or expert involvement in a study proving the device meets acceptance criteria.

The 510(k) summary states that the device was tested in accordance with ASTM F1717 and "found to perform comparably to other cervical plate systems." This indicates a reliance on a recognized standard for performance, but the detailed results or specific acceptance criteria are not provided in this document.

Here's what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified, but generally, device performance testing for 510(k) submissions relies on laboratory or bench testing, not clinical data from patients in a specific country. This would be a prospective test against a standard.

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

• This type of information (expert review for ground truth) is typically relevant for studies involving qualitative assessments, such as image analysis for diagnostic devices. For a mechanical implant like a cervical plate, the "ground truth" is typically defined by engineering standards and measurable physical properties. Therefore, this information is not applicable to the type of testing described (ASTM F1717).

4. Adjudication Method for the Test Set

• Not applicable for the reported mechanical testing against a standard.

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

• No. This type of study is relevant for diagnostic devices where human readers interpret data. The Vertebron SCP™ Cervical Plate System is a physical implant, and its performance is evaluated against mechanical and material standards, not through human reader interpretation of images/cases.

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

• Not applicable. This concept pertains to AI/software performance. The device is a mechanical implant.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the performance of this device would be the requirements and specifications outlined in the ASTM F1717 standard for spinal plating systems. The device's performance characteristics (e.g., strength, fatigue resistance, biocompatibility) are measured against these standardized benchmarks.

8. The Sample Size for the Training Set

• Not applicable. The concept of "training set" is relevant for machine learning algorithms. For a medical device like a cervical plate, there is no "training set" in this context. Performance is established through laboratory physical testing.

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

• Not applicable, as there is no "training set."

Summary of what the document does tell us about the study:

• Study Type: Bench testing.
• Standard Used: ASTM F1717.
• Outcome: The device was "found to perform comparably to other cervical plate systems" (predicate devices).
• Purpose: To demonstrate substantial equivalence to legally marketed predicate devices.

The provided document is a 510(k) summary, which is deliberately concise and focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed technical report of all testing. Detailed test reports would be part of the full 510(k) submission but are not typically included in the publicly available summary.

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