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The Altus Spine Monaco Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The Altus Spine Monaco Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); turnor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine Monaco Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins 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); turnor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Altus Spine Monaco Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine Monaco 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 with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136 and cobalt chrome meeting the requirements of ASTM F1537. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

The provided text is a 510(k) premarket notification for a medical device, the Altus Spine Monaco Pedicle Screw System. It describes the device's purpose, indications for use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices.

However, the document does not contain information about:

• Acceptance criteria for an AI/ML-based device performance study.
• Any study involving a test set, expert readers, ground truth establishment, or human-in-the-loop performance with AI assistance.
• Sample sizes for training sets or provenance of data for AI models.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.

The provided text focuses on the mechanical and material properties of the pedicle screw system, demonstrating its substantial equivalence to previously cleared devices through bench testing (in accordance with ASTM F1717-21 for Dynamic Compression Bend, Static Compression Bend, and Static Torsion tests). This is typical for orthopedic implant submissions concerning physical integrity and function.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies demonstrating a device meets those criteria for an AI/ML-based medical device from this document. The information requested (points 1-9) pertains to the evaluation of AI/ML software as a medical device (SaMD) or as part of a medical device, which is not what this document describes.

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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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