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The Expanding Innovations X-Pac Expandable LLIF Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. The X-Pac Expandable LLIF Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Expanding Innovations X-Pac Expandable LLIF Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy, and is designed to allow for intraoperative adjustment. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The Expanding Innovations X-Pac Expandable LLIF Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are reusable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.

The provided text is a 510(k) summary for the X-Pac Expandable LLIF Cage System, which is a medical device for intervertebral body fusion procedures. It does not describe an AI/ML powered device or an algorithm. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for training or test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

Here's a summary of the relevant performance data mentioned:

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

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

• Sample Size: Not specified. The testing described is mechanical, not involving patient data.
• Data Provenance: 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)

• Number of Experts: Not applicable. The ground truth is based on engineering standards and mechanical test results, not expert interpretation of diagnostic images or clinical data.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. The testing is mechanical and does not involve 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

• MRMC Study: No, this is not an AI/ML device.

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

• Standalone Performance: No, this is not an AI/ML device.

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

• Ground Truth Type: Mechanical integrity and performance according to ASTM F2077 standards for intervertebral body fusion devices.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Ground Truth Establishment for Training Set: Not applicable. This is not an AI/ML device.

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