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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 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 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 PSS Pedicle Screw System is intended for non pedicle 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 (2.0. , 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; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The device consists of a system of implantable rods, screw and hooks for the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the rod 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 does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the way typically found for AI/ML-based medical devices.

The document K033352 is a 510(k) summary for a non-AI/ML medical device, specifically a Spinal Rod System (Vertebron PSS Pedicle Screw System). This device is a traditional hardware implant for spinal fusion.

Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth establishment for AI, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and are not present in the provided submission.

Here's a breakdown of the information that is available based on the request:

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

• Acceptance Criteria: The submission states that the device was tested "in accordance with the requirements prescribed in ASTM F1717." ASTM F1717 is a standard specification for spinal implant constructs in a vertebrectomy model, which outlines mechanical testing protocols (e.g., static and dynamic compression bending, torsion). The specific quantitative acceptance criteria (e.g., maximum deflection, fatigue cycles survived, failure load) are not detailed in this summary.
• Reported Device Performance: "The device was found to perform comparably to other spinal rod systems." This is a qualitative statement of performance relative to predicate devices, but specific quantitative results against the ASTM F1717 criteria are not provided in this summary.

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

• Not applicable / Not provided. For a physical implant, testing involves mechanical samples of the device itself, not patient data in the typical sense of an AI/ML ground truth test set. The number of physical units tested is not specified.

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

• Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement instruments, not by medical experts interpreting data.

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

• Not applicable. This relates to human interpretation of data, which is not relevant for mechanical device testing.

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

• Not applicable. This study design is specifically for evaluating the impact of AI on human interpretation of medical images/data. This device is a physical implant.

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

• Not applicable. There is no algorithm; this is a physical medical device.

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

• The "ground truth" for this device would be its mechanical properties and performance as defined by the ASTM F1717 standard. This is based on engineering specifications and physical measurements, not clinical or pathology data.

8. The sample size for the training set

• Not applicable. There is no "training set" for physical mechanical testing.

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

• Not applicable.

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