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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 ISOLA® Growing Spine 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 ISOLA® Growing Spine System may be used with any cleared traditional ISOLA® Spine System 3/16 inch rod constructs.

The EXPEDIUM® Growing Spine 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.

The ISOLA and EXPEDIUM Growing Spine Systems consist of an assortment of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The ISOLA and EXPEDIUM Growing Spine Systems' components are manufactured from titanium alloy and stainless steel and are designed to interact with constructs consisting of rods ranging in diameter from 4.5 to 5.5mm, hooks, screws, offset connectors, and cross connectors. The ISOLA and EXPEDIUM Growing Spine Systems are intended for use only with ISOLA (3/16 inch rod diameter) and EXPEDIUM Spinal Systems (4.5 and 5.5mm rod diameter) fusion constructs for cleared pediatric use.

This document describes the ISOLA® and EXPEDIUM® Growing Spine Systems which are surgical devices, not AI/ML software. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies for AI/ML performance is not applicable to this submission.

The provided document, K141509, is a 510(k) premarket notification for medical devices. The relevant performance data for this type of device typically involves mechanical and material testing, not clinical studies in the context of AI/ML performance.

However, based on the information provided in the document, here's what can be extracted regarding the device's assessment:

1. Acceptance Criteria and Reported Device Performance:

The document broadly states that "Performance data per ASTM F 1717 (static and dynamic compression bending and static torsion) were submitted to characterize the subject ISOLA and EXPEDIUM Growing Spine Systems components addressed in this notification."

• Acceptance Criteria (Implied): The acceptance criteria are implicitly based on meeting the standards outlined in ASTM F 1717 for static and dynamic compression bending and static torsion for spinal implant constructs. These standards define the mechanical properties and performance expectations for such devices. Specific numerical thresholds or pass/fail criteria are not detailed in this summary but would have been part of the full submission to the FDA.
• Reported Device Performance: The summary concludes that "Both the Performance Testing and Substantial Equivalence Justification demonstrate that the proposed device is substantially equivalent to the predicate devices." This indicates that the device met the performance requirements of ASTM F 1717 and demonstrated performance comparable to its predicate devices.

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

• Test Set: Not applicable in the context of AI/ML. For mechanical testing, the "sample size" would refer to the number of device components or constructs subjected to testing. This information is not provided in this summary but would be detailed in the full test reports.
• Data Provenance: Not applicable in the context of AI/ML. Mechanical test data is typically generated in a lab setting, not from patient data, and is therefore not "retrospective or prospective" in the medical study sense.

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

• Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant for the mechanical testing of a surgical implant.

4. Adjudication Method for the Test Set:

• Not applicable.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. Type of Ground Truth Used:

• Not applicable for AI/ML. For mechanical performance, the "ground truth" is defined by the objective physical measurements and engineering specifications outlined in the ASTM F 1717 standard.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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The EXPEDIUM™ Spine 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.

The subject EXPEDIUM™ Spine System rods are designed to work in conjunction with the components of the following DePuy Spine spine systems: EXPEDIUM™ 6.35mm Spine System (Ti + SS), EXPEDIUM™ 5.5mm Spine System (Ti + SS), ISOLA® 4.75mm Spine System (Ti + SS), ISOLA® 6.35mm Spine System (Ti + SS), MONARCH™ 5.5mm Spine System (Ti), MONARCH™ 6.35mm Spine System (Ti), MOSS MIAMI™ 5.0mm Spine System (SS), MOSS MIAMITM 5.5mm Spine System (Ti), MOSS MIAMI™ 6.35mm Spine System (SS), VIPERTM 5.5mm Spine System (Ti). Manufactured from ASTM F 138 implant grade stainless steel and ASTM F 136 implant grade titanium alloy.

The provided document is a 510(k) summary for the EXPEDIUM™ Spine System, a medical device for spinal fixation. It describes the device, its intended use, materials, and a declaration of substantial equivalence to predicate devices, noting performance data per ASTM F 1717.

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically for diagnostic or AI-assisted devices.

The product is a physical orthotic system, not a diagnostic device or an AI/software product that would typically have acceptance criteria related to performance metrics like sensitivity, specificity, or reader improvement. The "performance data" mentioned refers to mechanical testing (ASTM F 1717) for the physical components of the spinal system, not clinical or diagnostic performance criteria.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance using the provided text, as this information is not present. The questions about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information are all pertinent to the evaluation of AI or diagnostic devices, which this product is not.

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The CPOD/LPOD is indicated for use in the thoracolumbar spine (i.c. T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (e.g. fracture).

The CPOD/LPOD is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. middle alle posterior upmar over and to be packed into the interior openings of the device prior to implantation.

The CPOD/LPOD is intended to be used with supplemental, internal spinal fixation The Cr OD/El OD is intended to or arm Thoracolumbar Fixation System (K983622) or the DePuy Acromed ISOLA System (K980485).

The Theken CPOD / LPOD VBR is comprised of Titanium rounded rectangular and rectangular frames with fenestrations and radii on all sides and toothed spikes which are used in combination with Titanium spacer components. The frames and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular frames engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.

The Theken CPOD / LPOD VBR System is designed to be constructed using two cage components in conjunction with an appropriate single spacer component. This combination of components creates an implantable construct. The use of a single cage as an implant has not been tested or approved.

The provided text describes a 510(k) premarket notification for a medical device called the "Theken Surgical CPOD / LPOD Vertebral Body Replacement System (CPOD / LPOD VBR)". This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with acceptance criteria and performance data in the typical sense of algorithm-based device evaluations.

Therefore, many of the requested categories for a study proving acceptance criteria (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context, as this is a regulatory submission for a physical medical implant, not an AI/algorithm-based diagnostic or screening tool.

However, I can extract information related to the device's characteristics and the basis for its approval.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported performance metrics like one would find for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is therefore implicitly "equivalent" to that of the predicate devices.

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

• Not Applicable. This is a 510(k) for a physical implant, not a study involving a "test set" of patient data for performance evaluation in the typical sense. Equivalence is established through comparison of design, materials, intended use, and mechanical testing on the device itself.

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

• Not Applicable. See point 2. The "ground truth" here relates to engineering principles, material science, and clinical practice for spinal implants. Regulatory bodies (FDA) and potentially design engineers at Theken Surgical/consultants would be the "experts" in this context, evaluating compliance with standards and equivalence.

4. Adjudication Method:

• Not Applicable. See point 2.

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

• No. This is not a diagnostic device or an AI assistant for human readers. Therefore, an MRMC study is not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's acceptability is based on:
  • Regulatory Standards: Compliance with FDA regulations (e.g., 21 CFR 878.3060 for Vertebral Body Replacement Devices).
  • Material Standards: Use of ASTM F-136 compliant Titanium Ti-6Al-4V (ELI).
  • Biomechanical Engineering Principles: The design's ability to restore biomechanical integrity.
  • Clinical Precedent: The established safety and effectiveness of the predicate devices.
  • Mechanical Testing: Though not detailed in the provided text, the document mentions "mechanical testing" as a basis for equivalence. This typically involves in-vitro biomechanical tests simulating physiological loads on the implant.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning model.

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

• Not Applicable. This is not an AI/machine learning model.

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The Monarch 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Monarch Spine System is 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 Monarch Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine 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 AcroMed 4.75mm, 5.5mm, and 6.35mm diameter rod systems.

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, ISOLA Modular Cross Connector (MCC) transverse connectors, J-hooks, washers, and nuts. The rod-based system consists of spinal rods, pedicle screws, polyaxial screws, caps, various slotted connectors, open and closed hooks, various rod-to-rod connections, ISOLA Modular Cross Connector (MCC) transverse connectors, and ISOLA EZ-X transverse connectors.

The Monarch Spine System is manufactured from implant grade titanium alloy that conforms to ASTM standard F-136.

This document is a 510(k) premarket notification for the Monarch Spine System. It focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria or a dedicated study report for performance. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance is not present in the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The document states that substantial equivalence is based on "equivalence in design, materials, manufacturing methods, intended use, and relative indications and contraindications" to predicate devices, but no specific performance criteria or their achievement are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no pre-market clinical or performance study beyond substantial equivalence comparison is described.

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, as no independent expert ground-truthing for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring 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 spinal fixation system, not an AI-driven diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Monarch Spine System is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth for performance evaluation is described.

8. The sample size for the training set: Not applicable. The device is a physical implant, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what is available in the document:

• Device Name: Monarch Spine System
• Intended Use: Immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions (degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion, severe spondylolisthesis (Grades 3 and 4) of L5-S1, degenerative disc disease, trauma, spinal stenosis, deformities).
• Basis for Clearance: Substantial equivalence to predicate devices (TiMX Low Back System, Moss Miami Spinal System, ISOLA System) based on equivalence in design, materials, manufacturing methods, intended use, and indications/contraindications.
• Material: Implant grade titanium alloy conforming to ASTM standard F-136.

The provided text is a 510(k) summary, which is a pre-market notification to the FDA. Its purpose is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than to present detailed de novo performance study results against specific acceptance criteria.

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The ISOBAR Spinal 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F136.

The provided text describes the ISOBAR Spinal System and its substantial equivalence to predicate devices, but it does not contain information related to software or AI-based device performance, acceptance criteria, or a study to prove acceptance criteria.

The device in question is a physical pedicle screw spinal system, and its performance data is limited to "static and fatigue compression testing... according to ASTM F1717-96." This is a standard for mechanical testing of metallic spinal implant constructs, not for evaluating algorithm performance or clinical accuracy.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/software device, as these aspects are not applicable to the presented documentation for the ISOBAR Spinal System.

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