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When used as an intervertebral body fusion device, the Custom Spine PATHWAY ACIF is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should receive 6 weeks of non-operative treatment prior to treatment with the Custom Spine ACIF.

When used as a vertebral body replacement, the Custom Spine PATHWAY ACIF is intended for use in the thoracic and/or throcolumbar spine (TI-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e. partial or total vertebrectomy procedures) due to tumor or trauma (i.e. fracture). The PATHWAY ACIF, when used as a vertebral body replacement, can be packed with autograft.

For all indications, the device is intended to be used with supplemental fixation systems that have been cleared for use in cervical, thoracic, or lumbar spine (posterior pedicle screw systems, anterior plate systems, and anterior screw and rod systems).

The PATHWAY ACIF is a cervical interbody fusion active as identification markers for the (Polyetheretherketone). The device continues of the implant both intra-operatively and postoperatively.

The device is trapezoidal in nature and is provided in various heights ranging from 5 mm to 12 mm and a The device is trapezondan in hatale and is pro naiss a central cavity which is to be packed with width of 15 mm, and 13 mm in length This abouts of Indusis (0 Degree and 7 Degree and 7 Degree). The superior autograft. This device is provided in various degrees of lordos autograft. This device is provided in the resist implant migration/displacement.
and inferior surfaces have serrated teeth to help resist implant migration/displacement.

The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The product is provided clean and "non-sterile".

The provided text describes the "PATHWAY ACIF" intervertebral body fusion device and its regulatory clearance (510(k) K092904). However, it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance, nor any AI/ML components for which such a study would be relevant.

The "Performance Data" section explicitly states:

The PATHWAY ACIF device was tested in accordance with ASTM F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Websited by Jan ASTM F2077-03 "Test Method For Intervertebral Body Fusion Devices". The data are located in Section 19 of this submission, "Bench Testing". The data demonstrate that the device is capable of performing in accordance with its intended use.

This indicates bench testing (mechanical testing) was performed to demonstrate the device's physical performance, not a clinical study or an AI/ML performance study. Therefore, most of the requested information regarding AI/ML study design (sample sizes, ground truth, experts, MRMC, standalone performance) is not applicable or available in this document.

Here's a breakdown of the information that can be extracted, and where the requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only mentions "mechanical support" and "resistant to migration/displacement" as performance goals, and refers to industry standards for testing. Specific acceptance criteria values (e.g., maximum allowable subsidence, specific load magnitudes) and quantitative performance results are not provided in this summary.

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

• Not applicable for AI/ML performance study. The device underwent mechanical bench testing, not a clinical test set with data provenance in the context of AI/ML.

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

• Not applicable. Ground truth in the context of clinical images or data interpretation by experts is not relevant to mechanical bench testing of an intervertebral fusion device.

4. Adjudication method for the test set

• Not applicable. This applies to expert review of clinical data, not mechanical testing.

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 comparative effectiveness study was not done. This device is a physical implant, not an AI/ML diagnostic or assistive tool for human readers.

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

• No, a standalone AI/ML performance study was not done. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

• For mechanical performance: The "ground truth" for the device's performance relies on the established engineering standards and requirements outlined in ASTM F2267-04 and ASTM F2077-03, and the physical measurements obtained during bench testing. There is no biological or expert consensus 'ground truth' in the clinical sense for this type of testing as described.

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. This device is not an AI/ML algorithm, so there is no training set or associated ground truth establishment process.

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