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This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Lumbar Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) implants which will be offered in four (4) configurations of various sizes to accommodate individual patient anatomy. The configurations are designed pursuant to a specific surgical approach, and consist of the following: 1) Anterior Lumbar Approach (ALIF); 2) Posterior Lumbar Approach (PLIF); 3) Lateral Lumbar Approach (LLIF) and 4) Transforaminal Posterior Lumbar Approach (TPLIF). The implants are single use and the system is provided non-sterile.

This document is a 510(k) Premarket Notification for a Lumbar Interbody Fusion System. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device submission. This document is for a traditional medical device (an implant) and the performance data described are related to mechanical testing, not a clinical study to evaluate diagnostic accuracy or human reader performance.

Therefore, many of your requested points are not applicable to the information provided in this document. I will fill in what I can and note where the information is not present.

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

Note: The document states that "The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to its predicate device(s)." This means the performance met the thresholds demonstrated by the predicate devices or relevant standards. Specific numerical acceptance values and actual measured performance data are not provided in this summary.

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 applicable. This document describes mechanical bench testing of an implant, not a clinical study with a "test set" of patient data. The "sample size" would refer to the number of devices tested, which is not specified but would be dictated by the ASTM standards.
• Data Provenance: Not applicable. The data comes from bench testing in a laboratory setting, not clinical data from patients.

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. This device is an implant, and its performance is evaluated based on engineering and mechanical standards, not expert interpretation of diagnostic images or clinical outcomes in the context of an AI/ML device.

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

• Not applicable. No expert adjudication method is mentioned as this is not an AI/ML device or a diagnostic study.

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 not an AI/ML medical device. No MRMC study was conducted.

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

• No. This is not an AI/ML medical device.

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

• Not applicable in the sense of clinical ground truth for an AI/ML device. The "ground truth" for this device's performance is defined by established engineering and mechanical testing standards (ASTM F2077-14 for mechanical properties, ASTM F2267-04 for subsidence, and a "widely accepted and validated methodology" for expulsion).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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The Interbody Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Interbody Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK) or titanium alloy. The devices are intended to be implanted either one device per level when used in the ALIF, Banana, or Lateral styles, and one or two devices per level when used in the PLIF/TLIF style.

Tantalum pins are embedded in the PEEK versions of the implants to help allow for radiographic visualization.

This document is a 510(k) premarket notification for an Interbody Cage and does not contain the specific type of detailed acceptance criteria and study results typically found in performance studies for AI/ML-driven medical devices. The device is a physical implant, not a software algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission.

However, I can extract the relevant "performance data" that addresses the device's equivalence to predicates, which serves as the "acceptance criteria" and "study" in the context of this 510(k) submission.

Here's a summary of the information that can be extracted, adapting the request to the nature of the provided document:

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

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

• The document mentions "worst-case size testing submitted as part of K113478" and "Additional testing (compression) per ASTMF F2077." However, it does not specify the sample size for these tests for the current submission or the original K113478.
• Data Provenance: The tests are likely prospective mechanical tests conducted on the manufactured devices/materials, rather than clinical data from human subjects. The country of origin of the data is not specified but is implicitly tied to the manufacturer/testing labs involved in the 510(k) process.

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 device submission. "Ground truth" in the sense of expert clinical annotation is not relevant here. Engineering standards and physical measurements are used.

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

• Not Applicable. Mechanical testing against industry standards (e.g., ASTM F2077) does not involve adjudication in this manner.

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 for a physical interbody fusion cage, not an AI-assisted diagnostic or therapeutic device.

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

• Not Applicable. This is for a physical interbody fusion cage.

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

• Based on engineering standards and physical properties: The "ground truth" for this device's performance evaluation lies in meeting established mechanical testing standards (e.g., ASTM F2077 for compression strength of intervertebral body fusion devices), material specifications (ASTM F2026, ASTM F560, ASTM F136), and demonstrating equivalence in design (geometry, footprint) to predicate devices. The goal is to show that the new variations (materials, sizes) do not introduce new safety or effectiveness concerns compared to already cleared devices.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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