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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 EXPEDIUM and VIPER/VIPER2 Spine Systems are intended to provide immobilization and stabilization 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 EXPEDIUM and VIPER/VIPER2 Spine 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, 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 VIPER/VIPER2 System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion 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 for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct 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 and VIPER/VIPER2 PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from LI-SI in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated 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 subject EXPEDIUM® Spine System and VIPER®/VIPER®2 Systems are pedicle screw scoliosis systems for the treatment of pediatric patients consisting of a wide range of components in a variety of geometries and sizes.

The provided document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of diagnostic accuracy or algorithmic performance.

Instead, this is a 510(k) summary for the "EXPEDIUM® Spine System, VIPER® System, VIPER®2 System," which are pedicle screw spinal systems. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, an approval pathway primarily concerned with the safety and effectiveness of a new device compared to an existing one, rather than novel performance benchmarks.

Here's a breakdown of what the document does state regarding performance:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document does not define specific performance metrics or acceptance criteria for the device's function or a study comparing it to those criteria.

2. Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance for performance evaluation is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.

4. Adjudication method for the test set: Not applicable. No test set adjudication is described.

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 device is a surgical implant (pedicle screw system), not an AI-assisted diagnostic tool, so an MRMC study is irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic or AI device.

7. The type of ground truth used: Not applicable. No ground truth is mentioned.

8. The sample size for the training set: Not applicable. No training set is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set ground truth is mentioned.

Key statements from the document regarding performance:

• "No new testing was performed. Published clinical results and engineering analysis supported the expansion of indications." (Page 2, section "Performance Data")
• "The substantial equivalence justification demonstrates that the device is as effective, and performs as well as the predicate device." (Page 3, Conclusion)

In summary, this 510(k) submission relies on demonstrating substantial equivalence to predicate devices, drawing on existing clinical results and engineering analyses, rather than presenting a performance study with defined acceptance criteria for the device itself.

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The VIPER systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine.

The VIPER System 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); 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 percutaneous, posterior approach with MIS instrumentation, the VIPER Systems 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, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VIPER® System is a 5.5mm rod system offered in both stainless steels and titanium materials. The system consists of monoaxial screws. polyaxial screws. uni-planar screws, and extended tab implants. They are available in various geometries and sizes to accommodate patient anatomy.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The performance data relied on Finite Element Analysis (FEA), which is a computational simulation method, not a test on physical samples in the traditional sense requiring a "test set" sample size or data provenance from a specific geographical region (country of origin). It's a predictive engineering analysis.

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

This information is not applicable/not provided. FEA uses engineering principles and material properties as its "ground truth" for simulation, not expert human interpretation of test data in the way a clinical study would. The analysis is performed by engineering professionals.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As FEA is a computational analysis, there is no "adjudication method" in the sense of reconciling human expert opinions on a test set. The results are derived directly from the simulation model.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers interpreting medical images or data, which is not relevant to the engineering rationale and Finite Element Analysis performed for this device modification.

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

Yes, in essence, a "standalone" performance evaluation was done, though not a standalone algorithm in the typical AI sense. The Finite Element Analysis (FEA) is a computational method that stands alone in evaluating the mechanical performance based on engineering models, without human intervention in the execution of the mechanical test itself. The FEA itself is the "algorithm" that provides the performance data without a human-in-the-loop for the mechanical assessment.

7. The Type of Ground Truth Used

The ground truth used for the Finite Element Analysis (FEA) would be established engineering principles, material properties (e.g., strength, stiffness of ASTM F 138, F 139 stainless steel, and F 136 titanium alloy), and validated computational models (e.g., meshing, boundary conditions, load application matching physiological conditions). There is no expert consensus, pathology, or outcomes data used as ground truth for this type of mechanical equivalence study.

8. The Sample Size for the Training Set

This information is not applicable/not provided. FEA is a simulation method, not a machine learning algorithm that requires a "training set." The models are built based on design specifications and material properties.

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

This information is not applicable/not provided. As there is no training set in the machine learning sense, there's no ground truth established for it. The "ground truth" for the FEA itself (as explained in point 7) is based on established scientific and engineering principles.

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The VIPER Systems are intended to provide immobilization and stabilization 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 VIPER Systems metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion 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 VIPER Systems metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion 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, pseudarthrosis; and failed previous fusion in skeletally mature patients.

The VIPER PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from L1-S1 in skeletally mature patients.

The VIPER Systems are 5.5mm rod systems offered in both titanium and stainless steel materials. The systems consist of monoaxial screws, polyaxial screws, uni-planar screws, and extended tab implants. They are available in various geometries and sizes to accommodate patient anatomy. The VIPER Systems 8mm to 12mm diameter favored angle polyaxial screws are not intended to be used with the VIPER PEEK rods.

The provided text outlines the 510(k) premarket notification for the DePuy Spine VIPER Systems, focusing on its substantial equivalence to predicate devices and performance data. It does not describe an AI medical device or a study involving acceptance criteria with sensitivity, specificity, or human reader performance. Instead, it describes a medical device (Pedicle Screw Spinal System) and its mechanical performance testing.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI, sample sizes for test sets or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided document.

The document describes Performance Data for the VIPER Systems, which are mechanical tests rather than clinical or AI performance evaluations:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified in the provided text. Mechanical testing typically involves a set number of samples per configuration (e.g., 5-10 samples per test condition) to satisfy statistical requirements for device qualification.
• Data provenance: The performance data was generated through "Performance data per ASTM F 1798" and submitted by DePuy Spine, Inc. This indicates laboratory testing of physical device components, not clinical data from patients or data from specific countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable. The "ground truth" for mechanical testing is based on the physical properties and performance of the device components as measured by test equipment, not on expert interpretation of results in the way clinical diagnostic accuracy studies require.

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

• This is not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, not for standard mechanical testing results.

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 is not applicable. This document describes a medical device (spinal pedicle screw system) and its mechanical performance, not an AI medical device.

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

• This is not applicable as the device is a physical pedicle screw system, not an algorithm.

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

• The "ground truth" for mechanical testing is based on objective, quantifiable measurements (e.g., load at failure, displacement, fatigue cycles) obtained from laboratory test equipment, adhering to ASTM F 1798 standards. There is no expert consensus, pathology, or outcomes data used to establish ground truth for this type of performance evaluation.

8. The sample size for the training set:

• This is not applicable as the document describes a physical medical device and its mechanical testing, not an AI model requiring a training set.

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

• This is not applicable.

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The EXPEDIUM and VIPER Systems are intended to provide immobilization and stabilization 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 EXPEDIUM and VIPER Systems 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems 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 proposed cortical fix polyaxial screws for EXPEDIUM and VIPER System are available in various geometries and sizes.

The provided 510(k) summary (K110216) describes the DePuy Spine EXPEDIUM® and VIPER® Systems. This device is a spinal fixation system, and the submission focuses on new cortical fix polyaxial screws for these systems.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "No clinical tests were performed." Therefore, there is no information regarding a test set sample size or data provenance from a human study. The testing performed was mechanical.

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

Not applicable, as no clinical tests were performed. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM F 1798-97) and the physical measurements against those standards. These would be assessed by engineers/technicians performing the tests.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical tests were performed involving human readers or interpretation.

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

No, an MRMC comparative effectiveness study was not done. The submission states, "No clinical tests were performed."

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

Not applicable, as this device is a physical medical implant (spinal fixation system), not a software algorithm.

7. The Type of Ground Truth Used:

For the mechanical tests performed, the "ground truth" is defined by the ASTM F 1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The device's performance was compared against the requirements and specifications outlined in this standard.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical implant, not a machine learning or AI algorithm, so there is no training set in the conventional sense. The "development" or "design" process for such a device involves engineering principles, material science, and manufacturing processes, rather than data-driven algorithm training.

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

Not applicable, as there is no training set for this type of device.

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The EXPEDIUM and VIPER Systems are intended to provide immobilization and stabilization 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 EXPEDIUM and VIPER Systems 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, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM and VIPER Spine System components consist of screws and are available in various geometries and sizes.

The provided document is a 510(k) Summary for the DePuy Spine EXPEDIUM® and VIPER® Systems, which are spinal fixation devices. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials and detailed acceptance criteria for an AI/algorithm.

Therefore, the specific information requested about acceptance criteria, study design for proving device performance against those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI/software-as-a-medical-device (SaMD) are not applicable to this submission.

Here's an explanation based on the provided document:

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

• Not Applicable. This submission is for mechanical spinal implants, not an AI/software device. The "performance" is assessed through a comparison to predicate devices and mechanical testing, not against specific diagnostic or treatment accuracy acceptance criteria as would be expected for a SaMD.

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

• Not Applicable. There is no "test set" in the context of an AI/software device. The performance was evaluated via non-clinical mechanical testing of the physical implants. The document does not specify the number of units tested, but mechanical tests typically involve a pre-determined number of samples to ensure statistical validity for the specific test (e.g., fatigue or static load).

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, in the context of AI/SaMD, refers to the verified correct output (e.g., diagnosis, measurement) for comparison with the algorithm's output. For mechanical implants, "ground truth" is typically defined by engineering specifications and material properties, verified through testing procedures against established standards (e.g., ASTM F1798). Experts involved would be engineers and material scientists.

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

• Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions when establishing ground truth for AI/SaMD. This is not pertinent to the mechanical testing of spinal implants.

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. MRMC studies are designed to evaluate the impact of an AI algorithm on human reader performance (e.g., radiologists, pathologists). This device is a physical implant, not an AI system.

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

• Not Applicable. This concept applies to AI algorithms and not to physical medical devices like spinal implants.

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

• For mechanical testing: The "ground truth" (or reference standard) for the nonclinical tests would be the established scientific and engineering principles outlined in the cited ASTM standards (F1798). Performance is measured against physical properties and failure points defined by these standards, not against biological or clinical outcomes or expert consensus on images.

8. The sample size for the training set

• Not Applicable. There is no training set as this is not an AI/machine learning device.

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

• Not Applicable. Since there is no training set, this question is not relevant.

Summary of what the document does provide regarding device performance:

The document states that "No clinical tests were performed."
Instead, the device's performance and safety were established through "Nonclinical Test Summary:"

• Static Cantilever Beam in accordance with ASTM F1798
• Dynamic Cantilever Beam in accordance with ASTM F1798
• Axial Slip in accordance with ASTM F1798

These tests are designed to evaluate the mechanical properties and stability of the spinal implants and their interconnection mechanisms, ensuring they meet the requirements for their intended use and are comparable to predicate devices. The "acceptance criteria" here are implied to be the successful completion of these tests in accordance with the ASTM standards, demonstrating structural integrity and mechanical equivalence to the already cleared predicate devices. The specific results of these tests (e.g., actual load values, cycles to failure) are not detailed in this 510(k) summary but would have been submitted to the FDA in a more comprehensive report.

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The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoege, or of co-infection with both C. trachomatis and N. gonorrhoege. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper instrument.

The BD Viper System, when used with BD ProbeTec™ ET amplified nucleic acid assays, is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).

The BD ProbeTec ET CT/GC Amplified DNA Assays utilize homogeneous SDA technology as the amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of CT and GC DNA in clinical specimens.

The BD Viper System is comprised of a standalone lysing heater and a BD Viper Instrument. The BD Viper Instrument is comprised of five major subsystems: robotic pipetting arm, priming and warming heaters (two sets), liquid crystal display (LCD) monitor with touch screen, instrument software and two thermally controlled fluorescent readers.

The provided text describes the BD Viper™ System, a modification of existing devices (BD ProbeTec™ ET System and BD Viper™ Instrument) used for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) DNA. The 510(k) summary explains that the modifications did not introduce new issues of safety or effectiveness and that the system met acceptance criteria across various parameters.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Study Details for Device Performance Evaluation

The study described is a comparison of the modified BD Viper System to the predicate BD ProbeTec ET System or to expected results through spiked specimen studies. The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays were used for clinical performance evaluation.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify the exact sample size for the clinical test set. It mentions "clinical matrices" for the Analytical Limit of Detection and "Clinical Agreement" studies, but without specific numbers.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the text. The methods described are laboratory-based comparisons and spiked specimen studies, typical for molecular diagnostic device evaluations. There is no mention of "experts" establishing ground truth in the context of diagnostic interpretation.

3. Adjudication method for the test set:

   • This information is not applicable and therefore not provided, as the studies involve direct comparison of analytical detection capabilities and system performance with a predicate device or spiked samples, not human interpretation requiring adjudication.

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, an MRMC comparative effectiveness study was not conducted. This applies to diagnostic imaging devices where human interpretation is involved. The BD Viper System is an automated molecular diagnostic platform.

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

   • Yes, the studies described are inherently standalone performance evaluations. The device's analytical capabilities (e.g., limit of detection, precision, instrument contamination, clinical agreement with a predicate system) were assessed without human-in-the-loop performance measurement. The system is an automated diagnostic instrument.

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

   • For analytical performance (e.g., limit of detection, precision, instrument contamination), the ground truth was established by known concentrations of target DNA (spiked specimens) or known positive/negative controls.
   • For clinical agreement, the ground truth was essentially the results obtained from the legally marketed predicate device (BD ProbeTec ET System), as the study aimed to show equivalence.

7. The sample size for the training set:

   • This information is not applicable as the BD Viper System is a molecular diagnostic instrument, not an AI or machine learning model that requires a "training set" in the conventional sense. The "training" in this context refers to the development and optimization of the instrument's components and assays, rather than an algorithmic training phase with labeled data.

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

   • This information is not applicable for the reasons stated above. The system's design and optimization would rely on engineering principles, analytical chemistry, and molecular biology, validated through rigorous testing against known standards and the predicate device.

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