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The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft to facilitate fusion.

The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / nonunion from previous unsuccessful fusion surgery. Patients should have undergone at least six months of nonoperative treatment.

The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family including the PLIF Caliber Lordotic, the TLIF Bullet, and the TLIF Camber consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy. The Southern TLIF family implants are offered with straight or curved profiles. The straight profiles include the PLIF Caliber Lordotic (a PLIF) implanted from the posterior approach and the TLIF Bullet (a T-PLIF or straight TLIF) implanted from the transforaminal approach. The curved version is the TLIF Camber (a curved TLIF) implanted from the transforaminal approach.

The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Southern TLIF family implants are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The curved TLIF designs include a titanium alloy hinge (Ti-6Al-4V per ASTM F136). The Southern TLIF family implants are provided sterile.

Here's a summary of the acceptance criteria and study information based on the provided FDA 510(k) summary, structured to answer your questions.

It's important to note that this document is an FDA 510(k) Summary for a medical device (intervertebral body fusion device), not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of your questions, particularly those related to AI/ML performance, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this type of medical device submission. The performance testing for these devices primarily focuses on mechanical and biological characteristics, not diagnostic accuracy.

Description of the Acceptance Criteria and Performance Study for Southern Transforaminal Lumbar Interbody Fusion (TLIF)

This 510(k) submission describes the Southern Transforaminal Lumbar Interbody Fusion (TLIF) device family. The acceptance criteria and performance study for this type of device are centered on demonstrating mechanical strength, durability, and biocompatibility, as opposed to diagnostic accuracy or AI performance. The study aims to prove that the device is substantially equivalent to legally marketed predicate devices.

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

For interbody fusion devices, acceptance criteria are generally based on meeting or exceeding the mechanical performance and safety standards demonstrated by legally marketed predicate devices, as well as relevant ASTM standards. The reported performance indicates that the device met these criteria.

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 Mechanical Testing: The specific number of devices tested for each mechanical test (axial compression, compression shear, subsidence) is not provided in this summary. It would typically follow the guidance within the respective ASTM standards (F2077, F2267).
• Data Provenance: The mechanical testing (non-clinical testing) would typically be conducted in a laboratory setting. The summary refers to the manufacturer's location as South Africa, but does not specify the testing location. This is not patient-derived data; it's device performance data.

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. For this type of mechanical device (interbody fusion device), "ground truth" is established through engineering and material science principles, laboratory testing against established standards, and comparison to predicate devices, not through expert clinical consensus on patient data.

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

Not applicable. Adjudication methods are typically associated with clinical studies, especially those involving expert review of patient data (e.g., imaging). Mechanical testing results are objective measurements from laboratory experiments.

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

Not applicable. This submission is for a physical implantable device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance is based on:

• Engineering Standards: Adherence to ASTM standards (F2077 for static/dynamic compression and shear, F2267 for subsidence) which define acceptable mechanical properties for spinal implants.
• Material Specifications: Use of materials (PEEK, Tantalum, Titanium Alloy) that meet established ASTM standards for biocompatibility and mechanical properties (e.g., ASTM F2026, F560, F136).
• Predicate Device Performance: Benchmarking against the known, safe, and effective mechanical performance of legally marketed predicate interbody fusion devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As the device does not involve a training set, the establishment of ground truth for such a set is irrelevant.

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