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The Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion 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 or two contiguous levels of the lumbar spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the lumbar spine (L2 to S1), and are intended to be used with autogenous bone graft and supplemental fixation systems that have been cleared by the FDA for use in the lumbar spine.

The proposed devices within the Coalesce™ Lumbar Interbody Fusion System are sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the lumbar spinal column in lumbar intervertebral body fusion procedures. Each device within the Coalesce™ System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more tantalum markers, depending on footprint, to enable visibility under x-ray in vivo.

The provided text describes a medical device, the Coalesce™ Lumbar Interbody Fusion System, and its clearance process with the FDA. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. The "testing" mentioned is primarily performance testing against engineering standards for intervertebral body fusion devices, not clinical studies with human participants or evaluation of algorithm performance in an AI context.

Therefore, I cannot provide the requested information. The text does not report:

1. A table of acceptance criteria and reported device performance related to diagnostic or evaluative metrics.
2. Sample sizes for test sets, data provenance, or details about training sets.
3. Number or qualifications of experts to establish ground truth.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used in a clinical or AI context.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Non-Clinical Testing" section (I) describes:

• Functional performance testing: static and dynamic compression, compression shear, subsidence, and expulsion.
• Standards referenced: (ASTM) F2077-14, (ASTM) F2267-04, and (ASTM) F1877-16.
• Conclusion: "Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices."

This indicates that the device met the requirements of these engineering standards, which likely have their own defined acceptance criteria (e.g., maximum deformation under load, minimum load to failure). However, these specific criteria and the detailed results showing compliance are not included in the summary.

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The Hedgehog Cervical Interbody Fusion Device 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. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

The proposed Hedgehog Cervical Interbody Fusion Device is a sterile, single use implant grade polyetheretherketone (PEEK) device, available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures.

The Hedgehog Cervical device is comprised of a single, continuous piece of PEEK Scoria™ formed into the final product shape. The Vertera device remains solid with a surface porous layer on the top surface of the implant body. This porous surface is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the cage assembly will have two marker bands, made from Tantalum, to enable visibility under xray.

The provided text describes a 510(k) premarket notification for the "Hedgehog Cervical Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the new device meets specific standalone performance criteria through extensive clinical trials for a novel technology. Therefore, the document does not contain information typically found in a study designed to prove a device meets acceptance criteria in the way an AI/ML device study would.

Specifically, the document states:

• "Non-clinical testing has demonstrated substantially equivalent performance to predicate devices."
• "Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices."

This means the "study" conducted for this device was a series of non-clinical tests (mechanical and material tests) to show that it performs similarly to an already approved device, not that it meets predefined performance metrics for a novel technology or that a clinical study was performed.

Therefore, many of the requested categories (like sample size for test set/training set, number of experts, adjudication methods, MRMC studies, or specific types of ground truth like pathology/outcomes data) are not applicable to this type of device submission and are not presented in the document.

However, based on the information provided, here's what can be extracted and inferred for the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to "non-clinical testing" and "functional performance testing" using ASTM standards. This implies laboratory testing of physical device samples, not a clinical test set of patient data.

• Sample size: Not specified. Standard practice for these ASTM tests involves a defined number of samples, but the exact count is not given in this summary.
• Data provenance: Laboratory-generated data from mechanical and material testing. Not applicable for retrospective/prospective patient data or country of origin in this context.

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

Not applicable. "Ground truth" in the context of this 510(k) for a physical implant device is established by the specifications and performance of the predicate device and the results of the non-clinical tests against established ASTM standards. No human experts were involved in establishing "ground truth" for a test set in the way they would be for diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to human interpretation of data, typically for clinical or diagnostic studies. The "test set" here refers to physical device samples undergoing engineering evaluation.

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

No. An MRMC study is a clinical study involving multiple human readers interpreting medical cases, often with and without AI assistance, to assess diagnostic performance. This device is a physical interbody fusion implant, not a diagnostic AI tool.

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

Yes, in a way that is applicable to a physical device. The "standalone" performance here relates to the device's intrinsic mechanical, material, and functional properties as assessed during non-clinical testing, without interaction with a human operator for diagnostic interpretation. The device's performance in these non-clinical tests is what was evaluated directly.

7. The Type of Ground Truth Used

For this physical medical device, the "ground truth" is intrinsically linked to:

• Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate device (Spinal Elements, Crystal® K133218).
• ASTM Standard Requirements: The acceptance criteria defined by the relevant ASTM standards for intervertebral body fusion devices (F2077-11, F2267-04, F1877-05). Adherence to these standards is an implicit "ground truth" for physical device performance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a physical interbody fusion implant device. This term applies to machine learning algorithms.

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

Not applicable, for the same reason as point 8.

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