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The PATHWAY AVID intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have Grade I Spondylolisthesis at involved levels. The patients may have had a previous non-fusion spinal surgery at the involved level(s).

The device is intended to be used with supplemental fixation systems that have been cleared for the lumbosacral spine (i.e. posterior pedicle screws and rod systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device. The PATHWAY AVID Intervertebral body fusion device must be inserted from a transforaminal approach (TLIF).

The proposed modification subject device is to be provided to the users in one of two configurations: the predicate device containing PEEK Optima LT1with titanium hinges and linkages (Ti-6Al-4V, ASTM F136) or the proposed PEEK Optima LT1 with MP35N (Co-Cr-Ni-Mo Alloy, ASTM F562).

Here's an analysis of the provided text regarding the acceptance criteria and study for the PATHWAY AVID device, conforming to your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This document is a 510(k) summary for a modification to an existing device. The acceptance criteria and performance data are primarily focused on demonstrating substantial equivalence to the predicate device, rather than proving de novo clinical efficacy or specific accuracy metrics.

Here's a breakdown of the other requested information based on the provided text. Many of these points are not applicable or explicitly stated in a 510(k) summary for a device modification, which focuses on engineering and material equivalence:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated in terms of number of devices tested, but implied to be sufficient for mechanical and corrosion testing. Specific numbers of units are not provided.
• Data Provenance: Not specified. Standard practice for such tests is in a laboratory setting.
• Retrospective or Prospective: Not applicable for engineering bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The "ground truth" for these tests are objective measurements based on engineering standards (tensile strength, corrosion). No human experts are used to interpret the results in the same way as they would for medical images.

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

• Not applicable. This concept pertains to human interpretation/review, not objective engineering tests.

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. This is a medical device (intervertebral body fusion device), not an AI/software device. MRMC studies are not relevant here.

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

• No. This is a physical medical device, not an algorithm.

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

• Ground Truth: For mechanical testing, the ground truth is defined by the objective physical properties and performance under specific force/environmental conditions. For corrosion testing, the ground truth is determined by electrochemical measurements according to ASTM F 2129-08 standards.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device. The "training set" concept is not relevant.

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

• Not applicable. This is not an AI/machine learning device.

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The PATHWAY Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved level(s).

The device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rods systems and anterior screw and rod systems). The device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PATHWAY AVID device.

The PATHWAY AVID Intervertebral body fusion device must be inserted using a transforaminal approach.

The PATHWAY AVID Intervertebral Body Fusion Device is made from PEEK Optima. The device is made from multiple PEEK segments. The segments are serrated on the superior and inferior surfaces. The PEEK segments are attached with titanium pins and have a titanium linkage that attaches the segments. This pins and the linkage provide the means to form into its final articulated shape.

The titanium alloy pins serve as markers providing visual aid in determining the location of the implant both intra and postoperatively.

The articulated device foot print ranges from 8 mm through 14 mm in height, 20mm in width and 35 mm in length.

The implants are non-sterile and instruments are provided clean and non-sterile. These devices are to be sterilized by the user facility.

The provided text describes a medical device, the PATHWAY AVID Intervertebral Body Fusion Device, and its 510(k) summary for FDA clearance. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of AI/ML performance.

The "Performance Data" section states: "Performance data per ASTM 2077 and ASTM 2267 and compared to the predicate devices. In addition, cadaver testing demonstrated the PATHWAY AVID is substantially equivalent to its predicates, as it was shown that the device can be used as intended by the intended user population per its labeling following a standard training program."

This indicates physical performance testing and comparison to predicate devices, and cadaver testing for surgical use, but it does not involve any AI/ML components, acceptance criteria tables, or studies with a test set, ground truth experts, or training sets as requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance from the provided text.

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