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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.

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.

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.

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

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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The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The X-spine Calix® Lumbar Spinal Implant System is an intervertebral fusion device for use with bone graft, designed for surgical placement between adjacent vertebrae of the lumbar spine as an adjunct to fusion.

The X-spine Calix® Lumbar Spinal Implant System is a generally hollow box or oval shaped device manufactured from Invibio PEEK-Optima™ LT1 per ASTM F2026. The device contains an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without a medical grade commercially pure titanium (CP Ti) plasma coating (per ASTM F1580) on the superior and inferior surfaces of the device.

The hollow center of the implant allows the device to be packed with bone graft: autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft,

The single use implants are supplied in several width, height and lordosis options to accommodate variations in patient anatomy and differing pathologies. The devices contain radiographic markers made from tantalum per ASTM F560 to aid in final placement verification. Plasma coated implants are provided clean and sterile. Nonplasma coated implants and instruments are provided non-sterile. All implants are intended for single use only, and should not be reused under any circumstances.

The system does not contain software/firmware.

The provided text describes a 510(k) premarket notification for a medical device (Calix® Lumbar Spinal Implant System), which is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device. This type of submission primarily relies on non-clinical performance data (mechanical and material testing) to demonstrate that the new device performs as well as or better than the predicate, especially when modifications are made.

The document does not describe an AI/ML-driven device or diagnostic tool that would require a study involving human readers, ground truth establishment through expert consensus (radiologists), or MRMC/standalone performance metrics typical of AI models. Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

The acceptance criteria and proof of performance for this particular device (a spinal implant) are based on mechanical and material testing as per established ASTM standards and FDA recommendations for intervertebral body fusion devices.

Here's a breakdown of the relevant information from the provided text, addressing the points where applicable and noting when information is not present or relevant:

Acceptance Criteria and Device Performance (for a spinal implant)

The acceptance criteria for this medical device are primarily based on demonstrating mechanical equivalence and safety to predicate devices, adhering to recognized standards. The "performance" here refers to the physical and functional integrity of the implant, not diagnostic accuracy.

Table of Acceptance Criteria and Reported Device Performance

Detailed Information as per Request (with applicability notes):

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

   • See table above. The acceptance criteria are largely adherence to specified ASTM standards and demonstrating that the modifications (titanium coating, allograft use) do not negatively impact performance compared to the predicate.

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

   • N/A. For this type of device (spinal implant), "sample size" refers to the number of physical devices or material samples tested in a lab, not a population of patients or images. The document does not specify the exact number of implants tested for each mechanical test, which is common for 510(k) summaries where the methodology typically follows established engineering test standards.
   • Data Provenance: The data originates from the manufacturer's (X-spine Systems, Inc.) internal testing, conducted in their facilities or contracted labs. This is not clinical data, so terms like "retrospective" or "prospective" are not applicable.

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)

   • N/A. "Ground truth" in the context of this spinal implant device is established through physical mechanical testing and material characterization according to validated engineering standards (ASTM). It does not involve expert clinical assessment or image interpretation for establishing a "ground truth" diagnosis.

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

   • N/A. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-reader studies (e.g., in diagnostic imaging). This regulatory submission is for a physical implant, not a diagnostic AI 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

   • N/A. An MRMC study is designed to evaluate the performance of diagnostic devices, particularly AI-assisted ones, by comparing human reader performance with and without AI assistance. This submission is for an orthopedic implant and does not involve AI or human readers for diagnosis.

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

   • N/A. This refers to the standalone performance of an AI algorithm. The device is a physical implant, not an algorithm.

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

   • The "ground truth" for this device's performance is based on engineering standards and established physical properties. For example, the acceptable load-bearing capacity, expulsion resistance, and material characteristics determined by industry-standard mechanical testing are the "ground truth" for its functional performance.
   • For the Indications for Use, the "ground truth" for degenerative disc disease (DDD) is defined clinically: "back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies." This is a clinical definition for patient selection, not a ground truth for testing the device itself.

8. The sample size for the training set

   • N/A. There is no "training set" as this is not an AI/ML device.

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

   • N/A. No training set exists for this device.

Summary of Acceptance and Performance:

The Calix® Lumbar Spinal Implant System's acceptance and demonstrated performance hinge on its ability to meet or exceed the performance characteristics of its predicate device, the Calix® Lumbar Spinal Implant System (K131350), and other reference devices. The key elements of its "proof" are:

• Mechanical Testing: Demonstrating compliance with ASTM F2077 (for static/dynamic compression/shear) and ASTM F2267 (for subsidence) and FDA-recommended expulsion testing. The critical finding is that the new titanium plasma coating "does not present a new worst case, and does not impact the performance of the implants."
• Material Characterization: Showing the properties of the new CP Ti plasma coating via ASTM F1877.
• Indications for Use Expansion: Justifying that the addition of allograft use "does not impact the mechanical performance" and "does not introduce new risks," citing that allograft has been cleared for many other spinal implants.
• Substantial Equivalence: Ultimately, the study (mechanical and material testing) served to prove that the modified device is substantially equivalent to legally marketed predicate devices in terms of safety and effectiveness, despite the added coating and expanded graft options.

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