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The EVOL® ha – D Lateral Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. EVOL® ha - D Lateral Interbody Fusion System is indicated for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) 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. The EVOL® ha - D Lateral Interbody Fusion System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The EVOL® ha -D Lateral Interbody Fusion System is designed for use as a lumbar interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and depth), height, and lordotic angle. All sizes have two central windows for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The provided text is a 510(k) summary for a medical device called the EVOL® ha - D Lateral Interbody Fusion System. It describes the device, its intended use, and its comparison to predicate devices, including performance testing. However, it does not contain the specific information required to complete the detailed table about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study specifics (like MRMC studies, expert qualifications, or adjudication methods).

This document focuses on demonstrating substantial equivalence for regulatory approval, primarily through mechanical performance testing to established standards, rather than establishing clinical effectiveness or diagnostic accuracy.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria: The document states that "Testing was performed for the EVOL® ha – D Lateral Interbody Fusion System and demonstrated substantial equivalent performance to the identified predicate" and "In all, the biomechanical testing results demonstrate the EVOL® ha – D Lateral Interbody Fusion System is substantially equivalent to the predicate device." It also mentions testing in accordance with ASTM F2077 and ASTM F2267 standards (static & dynamic tests for compression and compression shear, subsidence, and expulsion tests).
  • However, the specific numerical acceptance criteria (e.g., "must withstand X N of compression for Y cycles") and the numerical reported device performance (e.g., "device withstood Z N for W cycles") are NOT provided in this summary. The summary only states that the device "demonstrated substantial equivalent performance" to the predicate.

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 for Test Set: Not specified. This refers to the number of physical devices or constructs tested, which is not detailed in this summary.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. This type of information is typically for clinical data, which is not the focus here.

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. This device is an interbody fusion system (an implant), not a diagnostic algorithm. The "ground truth" for mechanical testing is based on the physical properties and performance of the device under stress, compared against established standards and predicate devices, not expert human interpretation of medical images or diagnostic outcomes.

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

• Not Applicable. As above, this is for diagnostic algorithms assessing human interpretation, not mechanical device testing.

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:

• No. This is a mechanical orthopedic implant, not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.

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

• No. This is a mechanical orthopedic implant, not an algorithm.

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

• The "ground truth" for this type of submission is the mechanical performance standards (ASTM F2077, ASTM F2267) and the established performance of the predicate devices. The device is deemed "substantially equivalent" if it meets or exceeds these mechanical benchmarks.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, not an AI/ML model that requires a training set.

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

• Not Applicable. As above, this is for AI/ML models.

In summary, the provided document focuses on the mechanical equivalence for regulatory clearance of an orthopedic implant. It is not an evaluation of a diagnostic AI device, which would require the kinds of detailed clinical study information requested in your prompt.

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