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The DePuy PULSE Thoracolumbar 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 DePuy PULSE Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and 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, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are pedicle screw systems intended to provide immobilization 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are also indicated for pedicle screw fixation for the 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 lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ISOLA, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are also a hook and sacral/iliac screw fixation system of the indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The ISOLA, VSP, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The ISOLA and MOSS MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MONARCH Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in posterior spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM, VIPER, VSP, ISOLA, MONARCH, MOSS MIAMI, and TiMX Spine Systems. Please refer to the labeling of the aforementioned spinal systems indications for use.

The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER 2 System, VIPER SAI, and VIPER PRIME 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 of the thoracic. Iumbar and sacral spine.

The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended for noncervical 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 (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 EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, VIPER PRIME is intended for noncervical pedicle fixation and 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); 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.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER 2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, and VIPER PRIME are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM Growing System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM Growing System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM Spine Systems. The EXPEDIUM Growing Spine System is not intended to be used with 4.0mm diameter screws.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with the CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Cross over and E-Z Link Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. The CrossOver and E-Z Link Cross Connectors are indicated as part of the ISOLA Spinal System.

The DePuy PULSE Thoracolumbar Screw System consists of a variety of rods, pedicle screws, connectors, setscrews and other connection components used to build a spinal construct. The DePuy PULSE Thoracolumbar Screw System is offered in titanium material in sizes ranging from 4.35mm to 12.0mm in shank diameter and 20mm to 130mm in length. Screw shanks with 7.0mm and smaller are assembled from the top of the outer head, while screws with 7.5mm and larger are assembled from the bottom using a flex ball. The implant components can be rigidly locked into a variety of configurations, with each construct being made for the individual case.

The EXPEDIUM, VIPER and VIPER PRIME screws with fenestrations are designed with a cortical fix screw shank that is fully cannulated with lateral fenestrations at the distal end and may be used in conjunction with, or without the CONFIDENCE High Viscosity Spinal Cement. The cannulation and fenestrations allow for the injection of bone cement through the screws into the vertebral body in patients with severe osteoporosis or pathological fractures due to osteoporosis and tumor in the thoracic, lumbar and sacral spine.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in constructs comprising spinal instrumentation components. It features an advanced top-loading design and unique snap-fit feature that simplify initial placement and tightening procedures which helps avoid impingement of surrounding anatomy. The EXPEDIUM SFX Cross Connector system incorporates a broad range of implant options in both and adjustable configurations for an optimal balance between dural clearance and implant profile.

The EXPEDIUM VERSE Spine System is designed to provide intraoperative polyaxial to monoaxial conversion. It facilitates easier rod capture and provides a powerful and precise reduction mechanism. EXPEDIUM VERSE is a reduced profile thoracolumbar implant for use for with wide range of patient statures. EXPEDIUM VERSE is a selfcontained, efficient, and intuitive instrument system that is compatible with EXPEDIUM 5.5 rods, hooks and mono screws to enhance versatility.

The ISOLA Spine System is a pedicle screw system 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. The ISOLA Spine System consists of connectors, open and closed iliac screws, iliac bolts, and angled closed iliac screws. These components have been designed to allow for rigid fixation of the sacral and pelvic regions of the spine.

The MONARCH Spine System is both a rod-based and plate-based system designed to interface with various spinal anatomies. The plate-based system consists of pedicle screws, spine plates, transverse connectors. J-hooks, washers, nuts and set screws. The rod-based system consists of spinal rods, pedicle screws, set screws, various slotted connectors, and transverse connectors.

The TiMX Low Back System is a construct that consists of pedicle and sacral screws, spine plates, nuts, washers, and transverse connectors. The TiMX Low Back System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of chronic instabilities and deformities of the thoracic, lumber, and sacral spine.

The MOSS MIAMI Spine System is a closure mechanism which secures the rod to the screw in one single, simple step. The unique square threads balance the forces vertically, creating a secure assembly. It consists of anatomic hooks, monoaxial screws, polyaxial screws and a dual closure mechanism.

The VIPER PRIME System is novel technique for percutaneous pedicle screw placement and posterior stabilization. This innovative technique eliminates the need for guidewires, Jamshidi needles and pedicle preparation instruments; utilizing a stylet that is fully controlled by the screwdriver. The VIPER PRIME System enables surgeons to target pedicles and insert the screw, without the need for instrument exchanges or reconfirmation of their trajectory.

The VIPER Sacral-Alar-Iliac Screw is an implant designed for sacropelvic fixation. The VIPER SAI Screw is optimized for Sacral-Alar-Iliac placement vis-à-vis a favored angle polyaxial head, smooth shank and robust drive feature. The in-line nature of this anchor allows not only stabilization but also correction of pelvic sagittal or coronal deformities.

The EXPEDIUM Spine System, VIPER System, and VIPER 2 System are metallic implants intended to provide immobilization and stabilization of spinal segments. They can be used for 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; or for posterior non-cervical pedicle screw fixation in pediatric patients as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM Spine System consist of longitudinal rods, monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers. The VIPER and VIPER 2 Systems consist of cannulated polyaxial screws, monoaxial screws, uni-planar screws, reduction screws, and rods used in a percutaneous approach.

The VSP Spine System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion. Levels of fixation are for the thoracic, lumbar and sacral spine. The VSP Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion us attained. Levels of fixation are from L3-S1.

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to previously cleared devices. Therefore, the information provided focuses on comparative data rather than a standalone clinical study with acceptance criteria in the same manner as a de novo or PMA submission might require.

However, based on the provided text, we can infer some "acceptance criteria" related to magnetic resonance compatibility and how the study "proves" the device meets them.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are indirectly established by the selection of specific ASTM standards for magnetic resonance compatibility. The study "proves" the device meets these criteria by performing tests according to these standards and reporting that the "results demonstrated compatibility conditions." While the exact quantitative thresholds are not provided in this summary, the FDA's clearance implies that the performance met the requirements set by these recognized standards for MR safety.

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

• Sample Size for Test Set: Not specified. The document states that "non-clinical testing was conducted in alignment with the following standards." This usually means a set of representative devices or components are tested, but the specific number is not provided in this summary.
• Data Provenance: The nature of the tests (magnetic resonance compatibility) indicates laboratory testing of the devices themselves, rather than human subject data. Therefore, "country of origin of the data" and "retrospective or prospective" do not directly apply in the traditional sense of clinical studies. The tests were performed to demonstrate that the device materials and design are safe within an MR environment.

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

This submission is for device clearance based on non-clinical (laboratory) testing for MR compatibility. Therefore, there were no experts used to establish ground truth for a test set in the clinical sense. The "ground truth" is governed by the objective measurements defined by the ASTM standards for MR compatibility.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical laboratory testing, there is no adjudication method involving human interpretation or consensus. The data points are quantitative measurements against predefined ASTM standard limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on diagnostic performance with human readers, which is not the purpose of this submission. This submission is for the clearance of physical medical devices (spinal systems) and their magnetic resonance compatibility labeling.

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

No. A standalone algorithm-only performance study was not done. This submission concerns physical medical devices and their MR compatibility, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was defined by the specifications and limits within the cited ASTM standards (ASTM F2213, ASTM F2052, ASTM F2119, ASTM F2182) for magnetic resonance compatibility. These standards outline methodologies and acceptable thresholds for torque, displacement force, image artifacts, and heating.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission, as it relates to physical device testing for MR compatibility, not machine learning or AI algorithm development.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal re relevels in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and obginonic in sittlies or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spiral tumor, and failed previous fusion (pseudarthrosis).

The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patiently includion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended opine (Le to Gaeran) man reveal (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudoarthrosis; and failed previous fusion.

The ReForm Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

The ReForm Pedicle Screw System is a medical device, and the provided text is a 510(k) summary for its clearance. Medical devices, especially implants like pedicle screw systems, typically demonstrate performance through mechanical testing rather than clinical studies or AI algorithm evaluations. Therefore, many of the requested categories related to AI performance, expert consensus, and human reader studies are not applicable to this device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance limits (e.g., minimum load, cycles to failure) are not provided in this 510(k) summary, but the general outcome is stated as "equivalent to predicate device(s)". Equivalence implies that the ReForm Pedicle Screw System achieved performance comparable to, or better than, the predicate devices in these mechanical tests.

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

• Sample Size: Not explicitly stated. For mechanical tests, the "sample size" refers to the number of test specimens (e.g., screw constructs, rod-screw assemblies) subjected to testing. This information is typically found in the full test report, not usually in the 510(k) summary.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective clinical data, as this concerns mechanical testing of manufactured components. The data originates from non-clinical laboratory testing.

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

• Not applicable. This device is evaluated using objective mechanical engineering tests (ASTM F1717). There is no "ground truth" in the sense of expert medical diagnosis or interpretation required for these performance assessments. The performance is determined by physical measurements and engineering standards.

4. Adjudication Method for the Test Set

• Not applicable. As the performance is determined by objective mechanical testing against engineering standards, there is no need for an adjudication method by medical experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as this is a mechanical spinal fixation system, not an AI-driven diagnostic or assistive device for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This is a hardware medical device, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance. The "ground truth" for this device's performance is established by its ability to meet standardized mechanical test requirements (ASTM F1717) and demonstrate equivalence to the performance of previously cleared predicate devices.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. Its design and materials undergo engineering validation.

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

• Not applicable. As stated above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for its design and materials is established through engineering principles, material science, and compliance with relevant ASTM standards.

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The Range Spinal System is comprised of the DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the 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 lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (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.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The purpose of this submission is to add larger Mesa screws, transition rods, hooks, transverse connectors and rod connectors to the system.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the posterior thoracic and lumbar spine.

The provide 510(k) summary does not contain information typically associated with the acceptance criteria and study design for AI/ML devices, such as performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test/training data, expert qualifications, or details about standalone or MRMC studies.

Instead, this document describes a traditional medical device (Range Spinal System - spinal fixation system components) and its submission for 510(k) clearance based on substantial equivalence to predicate devices. The "performance data" referred to in the document relates to mechanical testing of the components, not clinical performance or AI/ML algorithm performance.

Therefore, I cannot fulfill the request as the provided text does not contain the required information for an AI/ML device.

However, I can extract the information that is present regarding the device's technical performance relative to acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a mechanical testing study comparing the modified components of the Range Spinal System to its predicate devices and original components.

Information on requested AI/ML specific aspects (Not applicable to this device type based on the provided text):

• Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical device components for mechanical testing. No patient data is mentioned for performance evaluation.
• 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 based on standardized tests and measurements, not expert consensus on clinical data.
• Adjudication method for the test set: Not applicable.
• 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 not an AI/ML device.
• If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For mechanical properties, the "ground truth" is derived from the physical properties of the materials and the results of the standardized ASTM F1717 tests.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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