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The GetSet Surgical GoPLF! Posterior Lateral Fusion System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following: 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); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The GoPLF! Posterior Lateral Fusion System is for prescription use only and is to be used in an open, posterior approach, and can be used with autograft and/or allograft.

The GetSet Surgical GoPLF! Posterior Lateral Fusion System is offered sterile and consists of implants and instruments.

The GoPLF! Posterior Lateral Fusion System Implants consist of a variety of sizes of pedicle screws, and rods designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The pedicle screws are intended to be inserted bilaterally into the pedicles of each vertebral segment, connected with the rod, and intended for spinal fusion at the selected level. The system conforms to patient anatomy for placement in the thoracolumbar human spine and for iliosacral fixation.

The GoPLF! Posterior Lateral Fusion System is offered with GetSet GoPLF! general and system-specific instruments as accessories. The method of use of the instruments is provided in the Surgical Technique Guide.

This document is a 510(k) premarket notification for the GetSet Surgical GoPLF! Posterior Lateral Fusion System, a medical device. It does not describe an AI/ML powered device, nor does it detail acceptance criteria and a study proving a device meets those criteria in the way requested by the prompt.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, and MRMC studies is not applicable or available in this document.

However, I can extract information related to the device's performance testing and the conclusion of its substantial equivalence.

Here's a breakdown of the relevant information from the provided document:

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

Since this is a submission for a spinal implant system (not an AI/ML medical device), the "acceptance criteria" and "reported device performance" are primarily focused on the physical and biological properties of the implant, rather than diagnostic accuracy or predictive power.

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

This information is not applicable in the context of an AI/ML device testing. The "test set" here refers to physical components of the implant for engineering and biological safety evaluations.

• Sample Size: Not specified in terms of "test set" for data analysis, but physical samples of the implants were used for biocompatibility, pyrogenicity, mechanical, and MR safety testing.
• Data Provenance: Not applicable as it's not data-driven device. Testing was likely conducted in a controlled laboratory environment.

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 is not applicable as this is not an AI/ML device relying on human expert annotations for ground truth. The "ground truth" for this type of device is established by adherence to recognized national and international standards (e.g., ASTM, ISO, USP, EP) and established scientific/engineering principles. For example, "biological safety" is determined by established biocompatibility assays and "mechanical equivalence" by standardized mechanical tests rather than expert consensus on interpretive data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) to resolve disagreements. Here, the "test" outcomes are quantitative measurements or assessments against predefined physical/biological standards.

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

This is not applicable. An MRMC study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) use the AI. This submission is for a physical spinal implant.

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

This is not applicable. This device is a manual surgical implant system, not an algorithm.

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

The "ground truth" for this device's performance is based on established scientific and engineering standards and validated test methodologies.

• Biocompatibility: Adherence to ISO 10993-1.
• Pyrogenicity: Adherence to USP General Chapter and EP Ch 2.6.14.
• Mechanical Performance: Adherence to ASTM F1717-15.
• MR Safety: Adherence to ASTM F2503-20.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device, so there is no "training set."

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

This is not applicable. There is no training set for this type of medical device.

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