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The DePuy CONDUIT™ LLIF SQUID Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

EIT Cellular Titanium® LLIF Cage

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nanoscale features are 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 radiographic studies. 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. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The DePuy CONDUIT™ LLIF SQUID Inserter is designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instrument has been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instrument is provided non-sterile and made from commonly used orthopedic materials. There are no changes to the implants or to other instruments provided with the implants.

The provided document describes a medical device, the "DePuy CONDUIT™ LLIF SQUID Inserter," and its clearance process through the FDA 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel performance claims.

Therefore, many of the typical acceptance criteria and study components you'd expect for an AI/ML device (e.g., AUC, sensitivity, specificity, physician performance with/without AI, expert adjudication, ground truth establishment) are not applicable to this submission. This document describes a surgical instrument and its mechanical and functional performance, not an AI/ML diagnostic or therapeutic device.

Here's an analysis based on the information provided, explicitly stating where specific requested details are not relevant or available:

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

For this type of device (a surgical instrument), acceptance criteria are typically related to mechanical integrity, functionality, and compatibility, rather than clinical performance metrics like sensitivity or specificity.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The "bench tests" and "formative usability test" would have involved a sufficient number of device units and/or simulated use cases to demonstrate robust performance. However, these are not clinical "test sets" in the sense of patient data.
• Data Provenance: The tests are described as "non-clinical testing" and "bench tests," indicating in-house engineering and laboratory testing rather than patient data from a specific country or retrospective/prospective study.

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

• Not Applicable. This is a mechanical/functional device, not an AI/ML device requiring expert interpretation of medical images or data for ground truth. Ground truth for these tests would be established by engineering specifications and successful completion of physical actions (e.g., the inserter successfully grips the cage).

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

• Not Applicable. As no expert interpretation or diagnostic classification is involved, no adjudication method is relevant.

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

• No, an MRMC study was not done. This device is a surgical instrument, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical surgical instrument, not an algorithm.

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

• For surgical instruments, "ground truth" relates to successful mechanical function, adherence to material specifications, and safe interaction with other components (e.g., the implant cage) and the surgical environment. It is established by:
  • Engineering specifications and standards: The device must meet predefined mechanical strength, endurance, and dimensional tolerances.
  • Functional verification: The device must reliably perform its intended action (e.g., grasp, insert, release an implant).
  • Material conformity: Verification that materials meet specified ASTM standards.

8. The sample size for the training set

• Not Applicable. This is a manufactured physical device, not an AI/ML model that is 'trained' on data.

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

• Not Applicable. No training set for an AI/ML model is involved.

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