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The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.

Device Description

The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in various sizes to accommodate individual patient anatomy. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with (4) bone screws provided and the accompanying anterior cover plate assembly. The implant spacer components are made from two materials: Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTM F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per ASTM F136.

AI/ML Overview

The provided text describes a medical device, the Choice Spine HARRIER-SA™ Lumbar Interbody System, and its FDA 510(k) clearance. This document is a premarket notification for a traditional medical device, not a software as a medical device (SaMD) or AI/ML device that would have performance criteria in terms of accuracy, sensitivity, or specificity. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic performance (as implied by questions about ground truth, expert adjudication, MRMC studies, etc.) is not applicable here.

Instead, the "acceptance criteria" and "study" for this type of device refer to its mechanical and material safety and performance, as demonstrated through non-clinical testing in comparison to predicate devices. The study proves the device meets these criteria by demonstrating substantial equivalence.

Here's an interpretation of the request based on the provided document:

Acceptance Criteria and Study for the Choice Spine HARRIER-SA™ Lumbar Interbody System

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance/Study Conclusion
Material Equivalence: Materials used are comparable to predicates and are biocompatible.	The implant spacer components are made from Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTM F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per ASTM F136. These materials are well-established for interbody fusion devices and are similar to predicate devices, ensuring biocompatibility.
Mechanical Performance (Static Compression): Device withstands static compressive forces as per ASTM F2077.	Non-clinical testing, including Static Compression per ASTM F2077, was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Mechanical Performance (Static Compression Shear): Device withstands static compression shear forces as per ASTM F2077.	Non-clinical testing, including Static Compression Shear per ASTM F2077, was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Mechanical Performance (Dynamic Compression): Device withstands dynamic compressive forces as per ASTM F2077.	Non-clinical testing, including Dynamic Compression per ASTM F2077, was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Mechanical Performance (Dynamic Compression Shear): Device withstands dynamic compression shear forces as per ASTM F2077.	Non-clinical testing, including Dynamic Compression Shear per ASTM F2077, was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Expulsion Resistance: Device effectively resists expulsion forces.	Non-clinical testing for Expulsion was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Subsidence Resistance: Device effectively resists subsidence as per ASTM F2267.	Non-clinical testing for Subsidence per ASTM F2267 was conducted. The conclusion states: "Mechanical testing was conducted to prove that the Choice Spine HARRIER-SA™ Lumbar Interbody System design is equivalent when compared to the predicate devices." Implies satisfactory performance.
Functional Equivalence: Device's principle of operation, indications for use, stabilization method, and anatomical location are substantially equivalent to legally marketed predicate devices.	The device is deemed "substantially equivalent" to predicate devices (Spine Smith Cynch Spinal System, NuVasive Lumbar Interbody Implants, Choice Spine TOMCAT™ Cervical Spinal System, and Choice Spine TiGer Shark™) in principle of operation, indications for use (L2-S1, DDD with Grade I spondylolisthesis), biocompatibility, manufacturing, stabilization method, sterilization method, anatomic location, and product code. Slight differences in screw number and bone graft type were addressed by mechanical testing to confirm equivalence.
Safety and Effectiveness: The device is as safe and effective as predicate devices when used for its intended purpose.	The overarching conclusion is that "After considering all similarities and differences to the predicate devices, the subject device has shown to be equivalent when compared to the predicate devices in safety, effectiveness, and performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the clearance is based on non-clinical (mechanical) testing and comparison to existing predicate devices, not on a clinical trial with a "test set" of patient data. The "test set" here would refer to the mechanical test specimens.

Sample Size: The document does not specify the exact number of samples used for each non-clinical test (e.g., how many constructs were tested for static compression). This information is typically detailed in the full test reports submitted to the FDA, but not usually summarized in the 510(k) summary.
Data Provenance: Not applicable. These are laboratory tests, not clinical data from patients.

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)

This is not applicable. "Ground truth" in this context would refer to the established standards and specifications for mechanical testing (e.g., ASTM standards F2077, F2267). The "experts" involved are those who designed and conducted the mechanical tests according to these standards, typically engineers and biomechanical scientists, not medical professionals establishing diagnostic ground truth.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish a consensus "ground truth" for diagnostic purposes. Mechanical testing relies on objective measurements against defined standards, not subjective expert adjudication.

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

This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices, especially AI-assisted ones, where human readers interpret medical images. This device is an intervertebral body fusion system, not a diagnostic imaging or AI tool.

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

This is not applicable. This question pertains to AI/ML software performance. The device is a physical implant.

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

The "ground truth" for this device's performance is established by validated mechanical testing standards (e.g., ASTM F2077 for intervertebral body fusion devices, ASTM F2267 for subsidence) and material specifications (e.g., ASTM F3001, ASTM F560, ASTM F136). The "truth" is whether the device meets or exceeds the biomechanical requirements and material properties as defined by these industry standards and the performance of predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a physical medical device undergoing mechanical testing for 510(k) clearance.

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

This is not applicable. As there is no training set, there is no ground truth to be established for it.

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