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The Altus Spine 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 Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle 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); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine 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); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Altus Spine 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 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.

This document describes a 510(k) premarket notification for the "Altus Spine Pedicle Screw System." It is a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices, not primarily a study proving a device meets specific acceptance criteria related to AI/software performance.

Therefore, many of the requested details, such as "acceptance criteria and reported device performance" in the context of an AI study, "sample sizes used for the test set and data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "ground truth for training set," are not applicable to this document.

This document focuses on the mechanical and material equivalence of a physical medical device (pedicle screws) to predicate devices, supported by bench testing.

Here's a breakdown of what is in the provided text, and why the requested information isn't present:

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

   • Acceptance Criteria (Implicit): For this mechanical device, the acceptance criteria are not explicitly stated in a quantitative table. Instead, the "acceptance" is demonstrating substantial equivalence to predicate devices through various tests.
   • Reported Device Performance: The document states that "Dynamic compression bend tests was performed in accordance with ASTM F1717-15. Flexion-extension, torsional grip, and axial grip was preformed in accordance with ASTM F1798-13. Bench tests demonstrated that the Altus Spine Pedicle Screw System is substantially equivalent to the predicate device."
   • Why a table isn't here: The specific numerical results of these bench tests are not provided in this summary document. The FDA 510(k) summary typically summarizes the conclusion of the tests (substantial equivalence) rather than raw data.

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

   • N/A. This is a mechanical device, and the "tests" refer to bench tests (e.g., mechanical load and fatigue testing), not clinical or AI data. There's no "test set" in the context of patient data.

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):

   • N/A. Ground truth from experts is relevant for diagnostic AI. Here, "ground truth" for a mechanical device would be its physical properties and mechanical performance under specified loads.

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

   • N/A. Adjudication is for resolving discrepancies in expert labeling/diagnosis, which is not applicable to mechanical bench 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:

   • N/A. This is a physical device, not an AI system that assists human readers.

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

   • N/A. Again, this is not an algorithm.

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

   • Implicit Ground Truth: For a physical device, mechanical properties, material composition (conforming to ASTM standards), and performance under specified load conditions (bench testing results) serve as the "ground truth" for demonstrating equivalence. This is not derived from expert consensus on medical images or pathology.

8. The sample size for the training set:

   • N/A. There is no "training set" for this type of device.

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

   • N/A. No training set exists.

In summary, the provided text pertains to a physical medical device (pedicle screws) and its regulatory clearance via a 510(k) submission, based on demonstrating substantial equivalence through bench testing. The questions asked are highly specific to the evaluation of AI/machine learning medical devices, which is not the subject of this document.

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The Altus Spine 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 Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle 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); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine 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); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Altus Spine Pedicle Screw System is a multiple component, posterior fusion spinal fixation system which consists of pedicle screws, cannulated pedicle screw, reduction screws, extended tab implants, cross-connectors, locking caps, hooks, and rods Altus Spine 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. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

This document is a 510(k) premarket notification for the Altus Spine Pedicle Screw System, outlining its substantial equivalence to previously marketed devices. However, it does not describe an AI/ML device or a study that evaluates its performance against specific acceptance criteria.

The document discusses a medical device (pedicle screw system), not an AI/ML system. Therefore, most of the requested information (AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable to this submission.

Here's an analysis based on the provided document, reinterpreting the request for a non-AI/ML medical device submission:

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

   • Acceptance Criteria (Implicit): Substantial equivalence to predicate devices, meaning the device's technological characteristics, materials, and intended use do not raise new questions of safety or effectiveness compared to legally marketed devices.
   • Reported Device Performance:
     • Materials: Titanium Alloy conforming to ASTM F136.
     • Design & Function: Multiple component, posterior fusion spinal fixation system consisting of pedicle screws, cannulated pedicle screws, reduction screws, extended tab implants, cross-connectors, locking caps, hooks, and rods. Attaches to the vertebral body using screws to stabilize the spinal operative site during fusion.
     • Indications for Use: Immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. Specifically for noncervical pedicle and nonpedicle fixation for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. Also, for a posterior percutaneous approach with MIS instrumentation for similar indications.

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. This is a 510(k) submission for a non-AI/ML implantable device, which typically relies on mechanical testing and comparison to predicate devices, not clinical data sets in the way an AI/ML algorithm would. The submission explicitly states: "There are no new worst case components to this system; therefore no new mechanical testing is warranted." The substantial equivalence is based on engineering design, materials, and similarity to previously cleared devices.

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. Ground truth for an AI/ML test set is not relevant here. The "ground truth" equivalent for this device is its adherence to material standards (ASTM F136) and its functional design principles, assessed by the manufacturer's engineers and reviewed by FDA engineers/scientists.

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

   • Not applicable. This concept pertains to AI/ML clinical study design, not the mechanical and design review of a pedicle screw system.

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 for AI/ML devices that assist human readers (e.g., radiologists). The Altus Spine Pedicle Screw System is a physical implant, not a diagnostic aid.

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

   • Not applicable. This refers to AI/ML algorithm performance.

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

   • For this device, the "ground truth" for demonstrating safety and effectiveness is implicitly established through:
     • Material Standards: Conformance to ASTM F136 (Titanium Alloy).
     • Mechanical Performance (Implicit): Assumed to be equivalent to predicate devices which have undergone mechanical testing. The document states "no new mechanical testing is warranted" because there are no new worst-case components.
     • Clinical Efficacy/Safety (Implicit): Demonstrated by the long-standing safe and effective use of the predicate devices for similar indications.

8. The sample size for the training set

   • Not applicable. This is for AI/ML algorithms.

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

   • Not applicable. This is for AI/ML algorithms.

In summary, this document is a regulatory submission demonstrating substantial equivalence for a conventional medical device (pedicle screw system), not an AI/ML device. Therefore, the requested information geared towards AI/ML performance evaluation is largely irrelevant to the content of this specific FDA 510(k) summary.

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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 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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