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The restor3d lumbar cages are intended to be used as an intervertebral body fusion device with bone graft for use in lumbar spine. They are indicated for use in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels from L2-S1. DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Implants are used to facilitate fusion in the lumbar spine using autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbar spine.

The restor3d TiDAL Lumbar Interbody Fusion System are additively manufactured Titanium Alloy (Ti-6AL-4V per ASTM F2924) implants, designed for use as a lumbar interbody fusion device. They are provided sterile-packed. The system is comprised of various sizes to accommodate individual patient anatomy as well as multiple designs to support several surgical techniques (PLIF, ALIF, OLIF, LLIF). Each approach includes several offerings that vary by footprint (width and depth/length), height, and lordotic angle. All sizes have a large central window(s) for packing autogenous bone graft and/or allogenic bone graft. The inferior and superior faces have endplate surface lattices as well as teeth to resist migration when placed in between the vertebral bodies.

This document is a 510(k) premarket notification for a medical device called the "restor3d TiDAL Lumbar Interbody Fusion System." It's essentially an application to the FDA to market a new device by demonstrating that it's "substantially equivalent" to an already legally marketed device (the predicate device).

The request asks about acceptance criteria and a study that proves the device meets those criteria, typically found in the context of AI/ML-driven medical devices or diagnostic tools. However, the provided text describes a spinal implant (a physical device for interbody fusion in the lumbar spine), not an AI/ML-driven diagnostic or assistive technology. As such, the concepts of "acceptance criteria" and a "study that proves the device meets acceptance criteria" for AI performance metrics (like accuracy, sensitivity, specificity, expert consensus, MRMC studies, etc.) are not applicable to this type of medical device as described in the provided document.

Instead, for a physical implant like the restor3d TiDAL Lumbar Interbody Fusion System, "acceptance criteria" are related to mechanical properties, biocompatibility, sterilization, and manufacturing quality. The "study that proves the device meets acceptance criteria" would involve performance testing (e.g., mechanical testing to prove strength and durability, sterilization validation, cleaning validation, and biocompatibility testing).

Let's break down what is provided and why the requested information isn't directly present in the context of an AI/ML device:

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

• Not applicable in the AI/ML sense. For this implant, "acceptance criteria" would relate to standards for its material properties, manufacturing tolerances, and mechanical performance (e.g., compression strength, fatigue life). The document states that performance testing was conducted:
  • Cleaning per ISO 17664-1, AAMI TIR30, and ASTM F565.
  • Sterilization per ISO 17665-1, ISO 17665-3, AAMI TIR 12, ISO 11737-1, ISO 11737-2, and ASTM F565.
  • Biocompatibility per ISO 10993-1.
• The reported device performance is implicitly that it met the requirements of these standards, allowing the FDA to determine substantial equivalence. The document doesn't provide specific numerical results from these tests (e.g., actual measured compression strength in Newtons) but rather states the standards followed.

2. Sample size used for the test set and the data provenance:

• Not applicable in the AI/ML sense. There isn't a "test set" of images or patient data for an algorithm. The testing involves physical prototypes of the implant. The sample size for mechanical testing (e.g., how many implants were tested) is not specified in this summary but would be detailed in the full submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This relates to clinical or image-based ground truth for AI. For an implant, ground truth is established through adherence to engineering standards and material science.

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

• Not applicable. This refers to consensus reading for AI ground truth.

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 is a type of clinical study for diagnostic devices (often AI-assisted). This document is for a physical implant.

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

• Not applicable. No algorithm is being assessed.

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

• For a physical implant, the "ground truth" for performance is defined by established international and national standards (e.g., ISO, ASTM, AAMI) for mechanical properties, material safety, and manufacturing quality. Meeting these standards serves as the "ground truth" for device safety and effectiveness.

8. The sample size for the training set:

• Not applicable. No AI algorithm is being trained.

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

• Not applicable. No AI algorithm is being trained.

Summary with respect to the provided document:

The provided document is a 510(k) summary for a physical medical implant (lumbar interbody fusion system), not a software or AI-driven device. Therefore, most of the questions, which are tailored to evaluating AI/ML medical devices, are not applicable.

The "acceptance criteria" for this device are the successful completion of various performance tests according to recognized standards as listed in Section G:

• Cleaning: ISO 17664-1, AAMI TIR30, ASTM F565
• Sterilization: ISO 17665-1, ISO 17665-3, AAMI TIR 12, ISO 11737-1, ISO 11737-2, ASTM F565
• Biocompatibility: ISO 10993-1

The "study that proves the device meets the acceptance criteria" is the performance testing described in Section G. The outcome of these tests is stated indirectly by the FDA's decision of "substantial equivalence" based on "comparison to the predicate device" and confirmation that the additional components (disc preparation instruments) do "not raise any additional questions of safety and effectiveness."

No details on sample sizes for these physical tests are provided in this summary, nor are specific numerical results, as these are typically part of a more extensive technical file submitted to the FDA rather than the public 510(k) summary.

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