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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.

Ask a specific question about this device

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.

Ask a specific question about this device