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The CONCORDE Bullet Spinal System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach using autogenous bone. When used as interbody fusion devices, these implants are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE Bullet Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system 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. When used as a vertebral body replacement device, this system is intended for the use with DePuy Spine supplemental internal fixation products.

The CONCORDE Bullet Spinal System is a system of intervertebral body fusion devices consisting of cages and implantation instrumentation. The cages feature a bulleted nose to aid in implant insertion. The proposed cages will offer a titanium alternative at certain geometries to the primary predicate system, which is currently only available in polymer/carbon fiber composite. The cages are available in varying shape and size configurations to match patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The proposed cages will be implanted with the same instrumentation currently used in the system. The proposed cages will be offered sterile or non-sterile.

This document is a 510(k) premarket notification for a medical device called the CONCORDE Bullet Spinal System. It seeks to demonstrate substantial equivalence to previously cleared predicate devices. The "study" described herein is not a clinical study to assess patient outcomes or clinical effectiveness in the traditional sense, but rather an engineering and materials performance study to demonstrate the mechanical safety of a new material for an existing device.

Here's an analysis of the provided text in relation to your questions:

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

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

• Sample size for test set: Not explicitly stated as a "sample size" in the context of a clinical trial. The performance data refers to mechanical testing. The number of physical samples tested for dynamic axial compression and the specific models involved in the finite element analysis are not detailed.
• Data provenance: Not applicable in the context of patient data. The tests are engineering tests performed on the device itself.
• Retrospective or prospective: Not applicable. These are laboratory-based mechanical tests.

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 this context refers to engineering standards and specifications (ASTM F-2077) and comparisons to existing predicate device performance. This would be established by engineers and materials scientists, not medical experts like radiologists, as it's a mechanical device performance evaluation, not a diagnostic or treatment outcome evaluation.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for clinical assessments. This document describes mechanical testing of a physical device.

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

No. This is not an AI/software device. It is a physical intervertebral body fusion device.

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

No. This is not an algorithm/software.

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

The "ground truth" for demonstrating the device meets acceptance criteria is based on:

• Engineering Standards: Conformance to ASTM F136 for Ti-6A1-4V-Eli titanium alloy and mechanical testing per ASTM F-2077.
• Comparison to Predicate Devices: Demonstrating that the mechanical performance (dynamic axial compression, axial compressive strength) of the new titanium cages is equivalent to or better than the performance of the previously cleared polymer/carbon fiber composite predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary of the Study:

The "study" described is a materials and mechanical performance evaluation designed to demonstrate that a new material (titanium alloy) proposed for the CONCORDE Bullet Spinal System cages is substantially equivalent to the previously cleared polymer/carbon fiber composite material used in the predicate devices.

• Acceptance Criteria: Mechanical strength as characterized by dynamic axial compression testing per ASTM F-2077 and axial compressive strength confirmed by finite element analysis, with the benchmark being equivalence or superiority to the predicate device's performance.
• Methodology:
  • Dynamic axial compression testing: Physical samples of the proposed titanium implants were subjected to dynamic axial compression testing according to ASTM F-2077. The results "verified the mechanical strength."
  • Finite Element Analysis (FEA): FEA was used to confirm the axial compressive strength of the titanium material in comparison to the predicate's material.
• Justification for Limited Testing: The document explicitly states that "No other testing was required because the only modification that would affect performance compared to predicate and reference devices... is the material, which is used for the same indications in the predicate DEVEX System (K023835)." This indicates that since the design and intended use are similar, and the new material itself has been used in other cleared devices for similar applications, extensive re-testing beyond mechanical integrity was deemed unnecessary for substantial equivalence.

This is a typical approach for demonstrating substantial equivalence for minor material changes in a physical medical device under a 510(k) pathway, focusing on engineering safety and performance rather than clinical efficacy.

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The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLF (CONCORDE), TLIF (CONCORDE, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation.

The CONCORDE, COUGAR, DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal, column even in the absence of fusion fora prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation.

The BENGAL System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. BENGAL implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, DePuy Spine supplemental fixation should be used.

The BENGAL System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system 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. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation.

The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VBR Spinal Systems are also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal Systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The VBR Spinal System is intended for use with supplemental internal fixation.

The Concorde VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The Concorde VBR Spinal System 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. The Concorde VBR Spinal System is intended for use with supplemental internal fixation.

The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR, DEVEX, and LEOPARD Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (1-2-51). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF (CONCORDE, CONCORDE Bullet), TLIF (CONCORDE, CONCORDE Bullet, CONCORDE Curve, DEVEX, LEOPARD) or anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation products.

The CONCORDE, CONCORDE Bullet, CONCORDE Curve, COUGAR,DEVEX, and LEOPARD Systems are indicated for use in the thoracolumbar spine (i.e., T1-1-5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device these systems are intended for use with DePuy Spine supplemental internal fixation products.

The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., Tl to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The DePuy AcroMed VBR System is designed to restore the biomechanical integrity of thie anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DePuy AcroMed VBR System is intended for use with supplemental internal fixation.

The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine(i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. The system 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. When used as a vertebral body replacement device, this system is intended for use with DePuy Spine supplemental internal fixation. The COUGAR LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

The Devex Mesh System is indicated for use in the thoracolumbar spine (TI-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar · spine. The Devex Mesh System 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. The Devex Mesh System is intended for use with supplemental internal fixation.

The Stackable Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Stackable Cage System 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. The Stackable Cage System is intended for use with supplemental internal fixation.

The BENGAL® System is a carbon fiber reinforced polymer (CFRP) interbody fusion and VBR device. The cage distracts and maintains the intervertebral height, as well as providing restoration of cervical lordosis. The range of cages available is based on natural anatomical variation.

The Bengal® Stackable System is a radiolucent, multilevel corpectomy solution that provides a system approach to restoring natural lordosis. The BENGAL® Stackable Cage System offers versatility in footprint options (3 are available), height options (18 to 66 mm increments), and lordotic angle options. The stackable cages (LRG and XLG) are held together by a titanium locking screw and nut. The titanium locking screw is used for all stackable constructs.

The CONCORDE Bullet implants. manufactured from Carbon Fiber Reinforced Polymer (CFRP), are interbody cages designed with a bulleted nose for ease of insertion into the interbody space. The CONCORDE Bullet offers optimized area for bone graft and tantalum markers.

The CONCORDE® Inline Lumbar Interbody System completes the offering within the CONCORDE® family of products with an implant designed to facilitate ease of posterior insertion and improve resistance to migration. The CONCORDE Inline is designed with a bulleted nose for ease of insertion into the interbody space and are manufactured from Carbon Fiber Reinforced Polymer (CFRP).

The COUGAR® System is an Anterior Spinal Implant System manufactured of Carbon Fiber Reinforced Polymer (CFRP). COUGAR® is available in three footprints - Small, Medium and Large and varying heights from 10-20mm. incorporates an anatomic design with 5, 10, 15, and 20 degrees of lordosis. The cages offer tantalum marker beads for radiographic location and orientation of the implant.

The COUGAR® LS Lateral Cage System consists of the PEEK/carbon fiber composite cages (CFRP).Cages are available in parallel or lordotic configurations and are available in various sizes to match patient anatomy. The cage structure is radiolucent with tantalum x-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft. The implants may be utilized in either an open or a minimally invasive surgical approach. The implants areplaced using a lateral surgical approach.

The DEVEX® System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The DEVEX® System is also indicated for treating fractures of the thoracic and lumbar spine. The DEVEX® System 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.

The LEOPARD® System is made of carbon fiber reinforced polymer (CFRP) material that has a modulus of elasticity approximating that of cortical bone. The LEOPARD® System meets the structural requirements of anterior column support while optimizing the fusion environment through an open, load-sharing design.

The OCELOT® Stackable Cage System provides anterior column support for single or multi-level corpectomies or total vertebrectomies from T1 to 15. The system consists of one or more PEEK™ Carbon Fiber Polymer cages that are stacked to a desired height, accommodating various patient needs. The PEEK™ Carbon Fiber Reinforced Polymer material emulates the biomechanical properties of human cortical bone, optimizing the likelihood of a sound arthrodesis.

This document describes a 510(k) premarket notification for several spinal intervertebral body fixation orthoses and intervertebral body fusion devices. The core of the submission is the addition of a sterile configuration to previously cleared non-sterile implants.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Performance data is not provided in this submission."
Therefore, there are no specific quantified acceptance criteria or reported device performance metrics in this document. The submission relies on demonstrating substantial equivalence to predicate devices.

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

No performance data is provided, so there is no test set or related sample size. The submission's core argument is that the sterile versions of the devices are identical in design, materials, indications, and technology to their non-sterile predicate devices, with the only change being the terminal sterilization via gamma radiation.

Data Provenance: Not applicable as no new performance data was generated for this submission. The devices themselves are spinal implants and would typically be used in patients.

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

Not applicable. As no new performance data was generated, there was no "test set" requiring expert ground truth establishment in the context of this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication was used.

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

No MRMC study was done. This type of study is typically used for diagnostic or screening devices to assess human reader performance with and without AI assistance. This submission is for spinal implants where the primary comparison relies on material and design equivalence, and the addition of sterilization, rather than interpretive performance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance):

No standalone performance study was done. This concept is generally relevant for AI/software algorithms. This submission is for physical medical devices (spinal implants), not an algorithm.

7. Type of Ground Truth Used:

Not applicable. As no new performance data needing ground truth was generated, there's no ground truth specified in the context of this submission. The "truth" being established here is that the new sterile devices are substantially equivalent to the previously cleared non-sterile devices, primarily based on manufacturing changes (sterilization) and material properties remaining unchanged.

8. Sample Size for the Training Set:

Not applicable. This submission does not involve a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set.

Summary of the Study and "Proof" for this Specific Submission (K140759):

The "study" in this context is a substantial equivalence determination by the FDA, not a clinical or performance study in the traditional sense.

• Acceptance Criteria/Core Argument: The primary acceptance criterion for this 510(k) (K140759) is that the modified devices (sterile versions) are as safe, as effective, and perform as well as their predicate devices (non-sterile versions). This is achieved by demonstrating that the only change is the addition of terminal sterilization via gamma radiation, and that the design, materials, indications for use, and technology remain identical.

• Proof: The submitter "proves" this by:

  • Identifying specific predicate devices for each product line (BENGAL System, OCELOT Stackable Cage System, etc.), all of which were previously cleared by the FDA for similar indications.
  • Stating explicitly that "The subject devices are identical to the predicate devices... except that the subject devices will be terminally sterilized via gamma radiation. The design, materials, indications, and technology remain identical to the predicate systems."
  • Confirming that "The materials of the subject implants remain unchanged from that of the previously cleared implants."
  • Not providing new performance data because the change (sterilization) is considered not to alter the fundamental performance characteristics, relying instead on the established safety and effectiveness of the equivalent, non-sterile predicate devices.

In essence, the submission relies on the established regulatory history and scientific understanding that gamma sterilization, when appropriately validated, does not fundamentally alter the mechanical performance or biological safety of these types of materials/devices in a way that requires new extensive performance testing beyond demonstrating material compatibility and sterility. The FDA's clearance letter confirms their agreement with this assessment by stating that the device is "substantially equivalent."

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