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When used with or without the CONDUIT™ Lateral Switch Plate, the EIT Cellular Titanium® LLIF Cage is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features is 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 or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneve 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 with an intervertebral cage.

The CONDUIT™ Lateral Switch Plate ("Plate") is an optional device that connects to the EIT Cellular Titanium® LLIF Cage ("Cage") and adjacent vertebral body(s) to provide additional migration resistance and stability via DePuy Synthes AEGIS Screws ("Screws"). The subject device is not considered to be supplemental fixation. Both the Plate and Screws are manufactured from ASTM F136 titanium alloy (Ti-6A1-4V ELI). The Plate is supplied sterile in one- and two-hole configurations in a variety of sizes to attach to one or both adjacent vertebral bodies.

This document is a 510(k) premarket notification for a medical device called the CONDUIT™ Lateral Switch Plate. It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to legally marketed predicate devices.

Here's the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

Important Note: The provided document is a 510(k) summary for a mechanical orthopedic implant (CONDUIT™ Lateral Switch Plate) for spinal fusion, not an AI/software as a medical device (SaMD) or a device that typically involves human readers interpreting images, ground truth establishment through expert consensus (radiologists), or MRMC studies. Therefore, many of the requested points related to AI/imaging device validation (e.g., sample size for test/training set in an AI context, expert qualifications, adjudication methods, MRMC studies, effect size of human readers with/without AI, standalone AI performance) are not applicable to this type of device and its non-clinical testing methodology.

The acceptance criteria described here are for demonstrating substantial equivalence based on mechanical, material, and biological safety standards, not diagnostic accuracy or clinical effectiveness in the way an AI medical device would be evaluated.

Acceptance Criteria and Device Performance Study (Non-Clinical)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device, the "acceptance criteria" are based on meeting established industry standards for mechanical performance, biocompatibility, and MRI safety, demonstrating similar performance to predicate devices. The document does not provide specific numerical acceptance thresholds within the text itself, but rather states that tests were performed in accordance with the standards and that results demonstrate compliance or substantial equivalence.

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

• Sample Size: The document does not specify the exact number of test samples (e.g., number of plates tested) for each mechanical test. For devices cleared via 510(k), testing is typically performed on a sufficient number of samples (e.g., 3-6 or more) per configuration to demonstrate compliance with the chosen standard. These are non-clinical (
  in vitro) tests, not tests on patient data.
• Data Provenance: The data provenance is in-vitro laboratory testing. There is no patient-specific data or country of origin mentioned for the "test set" as this is not a study using clinical data. The tests are performed on the device prototypes themselves.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. For mechanical device testing for 510(k) clearance, "ground truth" is not established by medical experts like radiologists. Ground truth is defined by the objective measurements and pass/fail criteria of the ASTM/ISO standards for mechanical, material, and biological properties. The "experts" involved would be engineers and scientists performing and interpreting the laboratory tests according to the standards.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for "reading" studies involving human interpretation of medical images or data. For mechanical device testing, the results are quantitative measurements against predefined (standardized) physical acceptance criteria. There is no subjective interpretation requiring adjudication.

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

• No. This type of study is specifically for evaluating the effectiveness of a diagnostic or interpretive medical device, often AI-based, on reader performance using medical images. This device is a mechanical orthopedic implant, and such a study is not relevant to its clearance.

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

• Not Applicable. This is not an algorithm or AI-based device. "Standalone performance" here would refer to the mechanical device's performance in isolation, which is precisely what the listed mechanical and material tests (e.g., axial compression, shear, subsidence) evaluate.

7. The Type of Ground Truth Used

• Engineering Standards and Specifications: The "ground truth" for this device's performance is defined by adherence to specific, published, and internationally recognized engineering standards (ASTM and ISO). These standards specify test methods, fixtures, loading conditions, and acceptance criteria (implied or explicit) for the mechanical and biological properties of implantable devices. The "truth" is whether the device meets these pre-defined, objectively measurable criteria.

8. The Sample Size for the Training Set

• Not Applicable. "Training set" refers to data used to train an AI algorithm. This device is a mechanical implant; there is no AI algorithm being trained. The "design and development" process would involve iterative prototyping and testing, but not a "training set" in the machine learning sense.

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

• Not Applicable. As there is no AI algorithm and thus no "training set," this question is not relevant. The design and validation of this mechanical device rely on engineering principles, materials science, and testing against established performance standards.

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