Search Results

The PROTEX™ Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the PROTEX™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the PROTEX™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the PROTEX™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The PROTEX™ Stabilization System consists of a variety of shapes and sizes of rods, hooks, monoaxial screws, polyaxial screws, locking caps, tconnectors, staples, and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and tconnectors are intended for posterior use only. AccuRods are intended for posterior use with polyaxial and monoaxial screws only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.

The implants are composed of titanium alloy as specified in ASTM F136 and F1295.

The PROTEX™ Stabilization System is a medical device designed to provide immobilization and stabilization of spinal segments. The provided text indicates that the device's performance was evaluated through mechanical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes mechanical testing as the performance data.

• Sample Size for the Test Set: Not explicitly mentioned for the mechanical testing. ASTM F1717 specifies various tests (e.g., static and fatigue compression bending, static torsion, fatigue torsion, static cantilever bending). The sample size for each test would typically be defined within the ASTM standard or by the manufacturer based on statistical validity requirements, but this information is not provided in the summary.
• Data Provenance: Not explicitly stated. Mechanical testing is typically conducted in a laboratory setting, so it is prospective data focused on material and design performance. The country of origin for the testing itself is not mentioned, but the manufacturer is based in Phoenixville, PA, USA.

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

This type of information is not applicable to mechanical testing performed for device performance. Mechanical testing relies on established engineering standards (like ASTM F1717) and objective measurements, not expert human interpretation for "ground truth."

4. Adjudication Method for the Test Set

This is not applicable to the mechanical testing described. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective criteria, which is not the case for material property and structural integrity testing of a medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not conducted. The performance data presented focuses on mechanical testing of the device itself, not on human reader performance with or without AI assistance. This device is a surgical implant, not an AI-powered diagnostic or assistive tool.

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

No, a standalone algorithm performance study was not conducted. This device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for performance validation was adherence to established mechanical testing standards (ASTM F1717). This standard defines objective criteria for mechanical properties, strength, and fatigue life for spinal implant assemblies. The "ground truth" is whether the device can withstand the specified forces and cycles without failure, as defined by the standard.

8. The Sample Size for the Training Set

This information is not applicable. Mechanical testing for medical devices does not typically involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are validated through engineering principles and testing against established standards.

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

This is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The PROTEX™ Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the PROTEX™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the PROTEX ™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or fordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the PROTEX™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The PROTEX™ Stabilization System consists of a variety of shapes and sizes of rods, hooks, monoaxial screws, polyaxial screws, locking caps, tconnectors, staples, and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and tconnectors are intended for posterior use only. AccuRods are intended for posterior use with polyaxial and monoaxial screws only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.

The implants are composed of titanium alloy as specified in ASTM F136 and F1295.

The PROTEX(TM) Stabilization System is a spinal implant system. The provided text is a 510(k) summary for this device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the way a clinical trial for a novel AI device would.

Therefore, the requested information points regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, cannot be found in this 510(k) submission. This document is a regulatory filing for a medical device seeking market clearance based on substantial equivalence, not a clinical study report.

Here's why each point cannot be addressed with the provided text:

1. A table of acceptance criteria and the reported device performance: This type of information would be found in a clinical study report or a detailed design verification/validation report, neither of which is present in a 510(k) summary. The 510(k) focuses on a comparison to a predicate device.
2. Sample sized used for the test set and the data provenance: A 510(k) summary does not typically include details of clinical studies with test sets in the manner of an AI/diagnostic device. The "test set" for a spinal implant would usually involve mechanical testing and pre-clinical studies, not clinical data sets in the sense of AI. No sample sizes or data provenance are mentioned for any such 'test set'.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a spinal implant 510(k) submission. "Ground truth" in this context would typically refer to gold standard clinical outcomes or pathological findings in a clinical study, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of submission. Adjudication methods are relevant for clinical trials where expert consensus is needed to define an outcome.
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 type of study is completely unrelated to a spinal implant system. MRMC studies are designed for diagnostic imaging devices and AI algorithms that assist human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The PROTEX™ system is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): As noted, the concept of "ground truth" as typically discussed for AI or diagnostic devices does not apply here. For a spinal implant, success is measured by mechanical stability, biocompatibility, and clinical outcomes after surgery.
8. The sample size for the training set: Not applicable. There is no "training set" for a physical spinal implant device in the context of machine learning or AI.
9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) and does not contain the type of AI/diagnostic study information requested. It focuses on device description, indications for use, and comparison to predicate devices for substantial equivalence.

Ask a specific question about this device

The PROTEX™ Stabilization System, when used as a system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the PROTEX™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the PROTEX™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the PROTEX™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The PROTEX™ Stabilization System consists of a variety of shapes and sizes of rods, hooks, monoaxial screws, polyaxial screws, locking caps, tconnectors, staples, and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and tconnectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.

The implants are composed of titanium alloy as specified in ASTM F136 and F1295.

This 510(k) pertains to a spinal stabilization system, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are specific to the evaluation of AI/ML device performance, is not applicable to this document.

The "PERFORMANCE DATA" section of the 510(k) summary (Section {1}) states:

"Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', September 27, 2000 is presented."

This indicates that the device's performance was evaluated through mechanical testing to ensure its structural integrity and functional characteristics meet established standards for spinal implants. These types of devices do not involve AI/ML components for diagnostic or predictive purposes, and thus do not have "acceptance criteria" in the context of sensitivity, specificity, AUC, or reader studies that would typically be associated with AI/ML medical devices.

The "BASIS OF SUBSTANTIAL EQUIVALENCE" (Section {1}) further clarifies that:

"The PROTEX™ Stabilization System implants are similar to the predicate Synthes USS and Click'X (K992739, K022949, K031175) thoracolumbar stabilization systems with respect to technical characteristics and performance."

This suggests that the device's acceptance criteria primarily revolve around demonstrating mechanical equivalence and adherence to the same design and material specifications as the predicate devices, as evaluated through established biomechanical testing protocols.

Therefore, I cannot provide a table of acceptance criteria and device performance, sample sizes for test sets, details on expert establishment of ground truth, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set relevant to AI/ML devices.

Ask a specific question about this device