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The EIT Cellular Titanium® Lumbar Cages - T/PLIF in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The EIT Cellular Titanium Lumbar Cages - T/PLIF are intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the lumbar spine (L2-S1). Multiple footprints, heights and lordotic angle cages are offered to accommodate varying patient anatomical and physiological requirements. The EIT Cellular Titanium Lumbar Cages - T/PLIF are made from Titanium-6Aluminum-4Vanadium ELI ASTM F3001 through an additive manufacturing process. The design contains solid structures and porous structures formed as a diamond mesh. The hollow geometry of the cages allows them to be packed with autogenous bone graft.

This FDA 510(k) K183447 document is for a medical device called the "EIT Cellular Titanium® Lumbar Cage - T/PLIF," which is an intervertebral body fusion device. The submission focuses on expanding the labeling of a previously cleared device (K172888) to include a transforaminal lumbar interbody fusion (TLIF) surgical approach and correcting a raw material specification.

Therefore, the document does NOT contain information regarding the acceptance criteria of AI/ML device performance or a study proving that the device meets such criteria because it is not an AI/ML device.

Here's a breakdown of what the document does provide:

1. Acceptance Criteria and Reported Device Performance: Not applicable to AI/ML device performance. The document describes the device's indications for use: for degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1, with autogenous bone graft and supplemental fixation. It can be used for patients with up to Grade I spondylolisthesis or retrolisthesis, and those who may have had previous non-fusion spinal surgery. Patients must be skeletally mature and have received 6 months of nonoperative treatment. The performance discussed relates to the device's ability to stabilize the spinal segment, restore intervertebral height, and facilitate interbody fusion.

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device.

4. Adjudication method: Not applicable as this is not an AI/ML device.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not an AI/ML device.

6. Standalone (algorithm only without human-in-the loop performance) study: Not applicable as this is not an AI/ML device.

7. Type of ground truth used: Not applicable as this is not an AI/ML device. The "ground truth" for this device would be its demonstrated safety and effectiveness through non-clinical performance testing (e.g., mechanical, biocompatibility) and clinical experience if applicable, compared to predicate devices. The document mentions performance testing summary but does not detail it, only stating that a "technical rationale comparing the current surgical technique with that proposed (a TLIF surgical approach) was supplied."

8. Sample size for the training set: Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

Key Information from the Document:

• Device Name: EIT Cellular Titanium® Lumbar Cage - T/PLIF
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Purpose of Submission: To expand the labeling of a previously cleared device (K172888) to include a transforaminal lumbar interbody fusion (TLIF) surgical approach and to correct a raw material specification reference (from ASTM F136 to ASTM F3001, but the actual material remains Titanium-6Aluminum-4Vanadium ELI).
• Predicate Devices:
  • Primary: Tritanium® PL Cage (K181014)
  • Additional: EIT Cellular Titanium Lumbar Cage - PLIF (K172888), EIT Cellular Titanium Lumbar Cage - PLIF (K170503)
• Conclusion: The device is substantially equivalent to previously cleared devices regarding indications for use, design, function, materials, and performance.

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