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The Spineology PEEK Bullet Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.

The Spineology PEEK Bullet Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Spineology PEEK Bullet Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.

The provided document describes a 510(k) summary for the Spineology PEEK Bullet Lumbar Interbody Fusion Device. It outlines the device's intended use, technological characteristics, and testing conducted, but it does not contain the specific information requested about acceptance criteria for a study proving the device meets those criteria.

The document states:

• Testing: "The Spineology PEEK Bullet Lumbar Interbody Fusion Device was tested in compliance with FDA's guidance document titled 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device'. Preclinical testing according to ASTM F2077, including static compression and static compression shear. This testing demonstrated improved performance characteristics to the identified predicate devices."

This indicates that the device underwent preclinical mechanical testing according to an ASTM standard, rather than a clinical study evaluating human readers or AI performance. The purpose of this testing was to show "improved performance characteristics" compared to predicate devices, focusing on physical properties like static compression and static compression shear.

Therefore, for the requested information:

1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not explicitly stated as numerical values in the document. The general criterion was "compliance with FDA's guidance document titled 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device'" and "preclinical testing according to ASTM F2077."
* Reported Device Performance: "demonstrated improved performance characteristics to the identified predicate devices" in terms of static compression and static compression shear. Specific quantitative results are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* This was preclinical mechanical testing of a physical device, not a clinical study with a test set of data. Thus, these concepts do not apply in the typical sense of AI/reader studies. The "sample size" would refer to the number of devices tested, which is not specified but would be dictated by ASTM F2077.

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 was mechanical testing, not a study requiring expert readers or ground truth establishment in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable. This was 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 MRMC study was conducted or mentioned. This document pertains to a physical interbody fusion device, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This document is about a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* Not applicable. Ground truth in this context would be the measured physical properties of the device as per ASTM standards.

8. The sample size for the training set:
* Not applicable. This was mechanical testing, not a machine learning study with a training set.

9. How the ground truth for the training set was established:
* Not applicable.

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