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The RIGEL™ 3DR Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

The RIGEL™ 3DR (3D-printed Randomized-lattice) Anterior Cervical Interbody Fusion System consist of implants manufactured from Titanium 6AL-4V ELI per ASTM F3001-14 and instrumentation manufactured from stainless steel per ASTM F899. The Interbody Fusion Device is offered in various footprints, heights, and lordosis to accommodate different patient anatomy and the Anterior Cervical Surgical Approach. The implants will be provided sterile and are intended for single use only.

This document describes the RIGEL™ 3DR Anterior Cervical Interbody Fusion System, which is a medical device. The information provided is for regulatory clearance (510(k) submission) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of its clinical performance with acceptance criteria in the typical sense of algorithm evaluation.

Therefore, many of the requested elements for an AI/algorithm-based device study (like sample size for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training set details) are not applicable to this submission as it is for a physical medical implant.

However, I can extract information related to the device's mechanical performance data which serves as the "study" for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

For this physical interbody fusion system, the "acceptance criteria" are implied by the standards chosen for mechanical testing, and the "reported device performance" is that it successfully met these standards. The specific numerical acceptance criteria (e.g., minimum load before failure) are not explicitly stated in this summary, but the conclusion of the submitted study is that the device meets the relevant performance requirements for substantial equivalence.

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 used for the test set: Not explicitly stated in this summary (e.g., number of devices tested). For mechanical testing, this would typically involve a specific number of samples for each test type, determined by statistical considerations for materials testing.
• Data provenance: Not applicable in the context of clinical data. This is mechanical engineering test data, likely performed in a lab setting.

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 for mechanical testing is established by the physical testing itself and adherence to engineering standards. There are no "experts" in the human diagnostic sense establishing ground truth here.

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

• Not applicable. This is for mechanical testing, not a clinical trial requiring adjudication of patient outcomes or diagnoses.

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 is a physical medical implant, not an AI-assisted diagnostic device.

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

• Not applicable. This is a physical medical implant.

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

• The "ground truth" for this device's performance is its ability to withstand specified mechanical forces and conditions as defined by universally accepted ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. This is a form of engineering standard compliance and physical performance measurement.

8. The sample size for the training set

• Not applicable. This is a physical medical implant; there is no "training set" in the context of an algorithm.

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

• Not applicable. This is a physical medical implant; there is no "training set" in the context of an algorithm.

Summary of Conclusions from the Document regarding Performance:

The document states under "IX. PERFORMANCE DATA":
"The mechanical performance profile of the RIGEL™ 3DR Anterior Cervical Interbody Fusion System was assessed through static and fatigue construct testing in accordance with the following test methods:

• Static and dynamic compression testing (ASTM F2077-18)
• Static and dynamic compression shear testing (ASTM F2077-18)
• Static and dynamic torsion testing (ASTM F2077-18)
• Subsidence testing (ASTM F2267-04)
• Expulsion testing"

And under "X. CONCLUSIONS":
"Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems."

This indicates that all required mechanical tests were performed and the device successfully met the performance characteristics expected for substantial equivalence, as defined by the referenced ASTM standards and comparison to predicate devices.

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