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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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