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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. 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 (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 (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., TI-LS) 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 CONCORDE Bullet Spinal System contains cages featuring a bulleted nose to aid in insertion into the vertebral body. The CONCORDE Bullet Spinal System proposed additional cages are offered in carbon fiber reinforced polymer material. They are available in various geometries and sizes to accommodate patient anatomy.

Here's an analysis of the provided 510(k) summary regarding the CONCORDE Bullet Spinal System:

The document K110694 is a 510(k) summary for the CONCORDE Bullet Spinal System. This submission is for modifications to an existing device, specifically the inclusion of new cage heights and lengths.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This is achieved by showing that the modified device is as safe and effective as the predicates, and performs comparably.

The performance data submitted was for mechanical testing of the device.

• Static compression testing
• Dynamic compression testing
• Static torsion testing
• Dynamic torsion testing |
  | Safety and Effectiveness | Device is as safe and effective as the predicate device. | The submission concludes that "Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device." |

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

• Sample Size: Not explicitly stated. For mechanical testing per ASTM F 2077, the sample size would typically be a small number of physical devices tested to failure or under specified load conditions. The exact number of units tested is not provided in this summary.
• Data Provenance: The testing was conducted in a laboratory setting to characterize the physical and mechanical properties of the device components. The geographical origin of this testing is not specified, but it would typically be performed by the manufacturer or an accredited testing facility. This is prospective data collection in the sense of specifically designed tests, rather than retrospective analysis of patient data.

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

This type of submission for an intervertebral body device typically relies on engineering and material science expertise to establish performance criteria and interpret test results. It does not involve "experts" in the clinical sense (e.g., radiologists) for establishing ground truth of image interpretation. The "ground truth" here is the adherence to mechanical standards and material specifications.

4. Adjudication Method for the Test Set:

Not applicable in the context of mechanical performance testing. Mechanical tests have objective endpoints measured by equipment, not subjective reviewer adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical and material equivalence of a medical implant, not clinical diagnostic performance or interpretation by human readers.

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

Not applicable. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this submission is objective mechanical performance data from tests adhering to ASTM F 2077 standards, combined with detailed material specifications and design documentation. The "truth" is whether the device meets predefined engineering requirements and matches the characteristics of its predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical implant, and there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are informed by established engineering principles and prior device iterations, not a machine learning training dataset.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no corresponding method for establishing its ground truth. The design and validation of the device are based on engineering standards and scientific understanding of biomechanics.

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