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When used as a cervical intervertebral fusion device, the HONOUR™ devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System).

When used as a lumbar intervertebral fusion device, the HONOUR™ devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine (e.g., the Inertia® Pedicle Screw System).

When used as a vertebral body replacement device, the HONOUR™ devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).

The HONOUR™ Spacer System is a collection of radiolucent cage devices. The basic shape of these implants is a structural column. The superior and inferior surfaces are open with serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

This is a 510(k) premarket notification for a medical device called the "HONOUR™ Spacer System," which is an intervertebral fusion device and vertebral body replacement device. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on rigorous clinical studies proving direct device performance against acceptance criteria in the way an AI/software device would.

Therefore, many of the typical elements of an AI/software device performance study (like specific acceptance criteria for diagnostic accuracy, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or not present in this document.

Instead, the performance data provided relates to mechanical testing of the physical implant and a comparison of its technological characteristics to predicate devices.

Here's the information extracted from the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of a clinical performance study with human data. The "test set" here refers to the physical devices subjected to mechanical testing. The document states "Mechanical testing of the worst case HONOUR spacer was performed." This implies a limited number of devices, possibly just one or a few, representing the most challenging configuration.
• Data Provenance: Not applicable for mechanical test data. The tests were performed in a lab setting according to ASTM standards.

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

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by conforming to defined ASTM standards and measurements, not by expert consensus on clinical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical test results are objective measurements from laboratory equipment, not subject to human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging algorithms where human readers' performance is evaluated with and without AI assistance. This submission is for a physical implant.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm with standalone performance to evaluate.

7. The Type of Ground Truth Used

• Ground Truth Type: For the mechanical testing, the "ground truth" is defined by the objective physical properties and performance characteristics as measured by standardized engineering tests (ASTM F2077 and ASTM F2267). The comparison is against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of Device Performance Study (as described in the 510(k) for this device):

The "study" described in the document is a mechanical performance study of the HONOUR™ Spacer System.

• Methodology: Mechanical testing was conducted on the "worst case HONOUR spacer" according to established ASTM standards:
  • ASTM F2077 (for static and dynamic compression, and static and dynamic torsion)
  • ASTM F2267 (for subsidence properties)
• Objective: To demonstrate that the HONOUR™ Spacer System devices perform "as well as or better than the predicate devices."
• Conclusion: The mechanical test results supported the claim that the device is "as safe and as effective as the predicates" based on its physical characteristics and performance under simulated load conditions. This is a key component for demonstrating substantial equivalence for physical implants.

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