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The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• . trauma (i.e., fracture or dislocation); and/or
• . tumor.

The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The HA Minuteman G3-R MIS Fusion Plate may be implanted via a minimally invasive lateral approach (L1-S1).

The HA Minuteman G3-R MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates. The Plate components include several spikes on the face of each Plate for attachment to the spinous processes. The HA Minuteman G3-R device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3-R is made from Ti6Al4V and Ti6Al4V ELI and has a hydroxyapatite coating on a portion of the implant.

The provided text describes a medical device, the HA Minuteman G3-R MIS Fusion Plate, and its submission for 510(k) clearance to the FDA. The document focuses on establishing substantial equivalence to a predicate device through technological characteristics and performance data. However, it does not contain information typically found in a study demonstrating how a device meets specific acceptance criteria based on clinical or extensive human-in-the-loop performance. Instead, it describes mechanical and simulated deployment tests.

Here's an analysis of the provided text in relation to your request, highlighting what information is available and what is not:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics like those found in a clinical study. It lists several mechanical tests performed, and for these, it states a general conclusion:

Important Note: The document lacks specific quantitative acceptance criteria (e.g., "withstanding X N-m of torque without failure") and the exact quantitative results from these tests. The statement "functioned as intended and the results observed were as expected" is a qualitative summary, implying that the device met internal design specifications or standards comparable to the predicate.

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: The document does not specify sample sizes for the mechanical tests. For "Cadaveric Insertion Testing," it does not state how many cadavers were used. For "bacterial endotoxin testing," it mentions "all batches of sterile packed devices," which refers to manufacturing quality control rather than a specific test set for initial device validation.
• Data Provenance: Not mentioned. The tests appear to be conducted by the manufacturer, Spinal Simplicity. The context suggests these are internal validation tests for the 510(k) submission.

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)

This information is not provided. The listed tests are primarily mechanical and engineering assessments, not human interpretation tasks that would require "experts to establish ground truth" in the sense of clinical diagnosis or image labeling. The "Cadaveric Insertion Testing" would have involved medical professionals, but their specific qualifications and role in establishing "ground truth" (e.g., successful implantation, stability assessment) are not detailed.

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

Not applicable. The tests described are objective mechanical tests or simulated procedures, not subjective assessments requiring adjudication by multiple experts.

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. The HA Minuteman G3-R MIS Fusion Plate is a physical surgical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical tests, the "ground truth" would be the established engineering specifications, material properties, and expected mechanical responses determined through design and industry standards for spinal implants. For the "Cadaveric Insertion Testing," the "ground truth" would be the successful, unhindered placement of the device according to surgical protocol within the cadaveric anatomy. These are performance benchmarks rather than diagnostic "ground truths."

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary of what the document implies about meeting acceptance criteria:

The document states that the device "functioned as intended and the results observed were as expected" for all mechanical and simulated deployment tests. This general statement indicates that the device met the manufacturer's performance specifications, which would have been established based on industry standards, predicate device data, and risk analysis. The purpose of this 510(k) submission is to demonstrate substantial equivalence to an already marketed predicate device, not necessarily to set new, independently validated clinical acceptance criteria using large studies. The FDA's review confirms that these internal tests, along with the device's technological characteristics, are sufficient to support the claim of substantial equivalence and do not raise new questions of safety or effectiveness.

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