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FIX-L PEEK PLIF and T-PLIF System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. FIX-L PEEK PLIF and T-PLIF System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

FIX-L PEEK PLIF and T-PLIF System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The device is available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The configurations are designed pursuant to a specific surgical approach and consist of the following: 1) Posterior Lumbar Approach (PLIF) and 2) Transforaminal Posterior Lumbar Approach (T-PLIF). FIX-L PEEK PLIF and T-PLIF System is made of PEEK VESTAKEEP i4R body (ASTM F2026) and tantalum markers (ASTM F560) for ease of visualization on radiographs. FIX-L PEEK PLIF and T-PLIF System is a non-sterile device, and it is required to be sterilized via autoclave method by the hospital prior to surgery.

The provided document is an FDA 510(k) clearance letter for an intervertebral body fusion device (FIX-L PEEK PLIF and T-PLIF System), which is a physical implant used in spinal surgery. This type of device is cleared based on non-clinical testing (bench tests) demonstrating substantial equivalence to a predicate device, not on clinical studies involving AI or human-in-the-loop performance.

Therefore, many of the questions related to AI device performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and stand-alone algorithm performance are not applicable to this specific medical device clearance. The document explicitly states: "No clinical studies were considered necessary and performed."

However, I can extract information relevant to the non-clinical acceptance criteria and the study that proves the device meets them based on the provided text.

Acceptance Criteria and Device Performance for FIX-L PEEK PLIF and T-PLIF System

This device is an intervertebral body fusion device (an implant). Acceptance criteria and performance are established through bench testing to demonstrate mechanical safety and substantial equivalence to a predicate device, not through clinical or AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

For non-clinical bench testing of an implantable device, the "test set" refers to the physical samples of the device undergoing mechanical testing. The document does not specify the exact number of device samples tested for each criterion (e.g., number of implants subjected to axial compression).

• Sample Size: Not explicitly stated (typically, a statistically representative number of physical samples are used for each bench test, as defined by the ASTM standards).
• Data Provenance: Not applicable in the context of clinical or image data. The "data" comes from controlled laboratory bench tests of the manufactured physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: For this type of device (physical implant), "ground truth" is established by adherence to recognized ASTM mechanical testing standards and comparison to a predicate device's established performance, not by expert human interpretation of data like in AI/imaging studies.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or AI performance evaluations involving subjective human interpretation. For mechanical bench testing, the results are quantitative and objective, measured against the specified ASTM standard thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: The document explicitly states: "No clinical studies were considered necessary and performed." MRMC studies are clinical studies typically used to evaluate the diagnostic performance of imaging systems or AI algorithms with human readers.

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

• No: This is a physical, implantable medical device, not an AI algorithm. Standalone performance studies are for AI systems.

7. The Type of Ground Truth Used

• Bench Test Standards and Predicate Device Equivalence: The "ground truth" for this device is based on its ability to meet the acceptance criteria outlined in recognized ASTM mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and to demonstrate mechanical characteristics that are substantially equivalent to a legally marketed predicate device (K190563 - 4CIS® PEEK PLIF Cage). The physical and material properties (e.g., PEEK VESTAKEEP i4R body, tantalum markers) also contribute to the basis for "truth" in terms of biocompatibility and radiolucency.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable: There is no "training set." The device design and manufacturing process are based on established engineering principles, material science, and the performance characteristics of the predicate device.

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