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The GetSet GoLIF! Lumbar Interbody Fusion (IBF) system is indicated for interbody fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with symptomatic Degenerative Disc Disease (DDD) at either one or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1. These DDD patients may also have up to Grade 1 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 implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These devices are intended to be used with supplemental posterior fixation, which has been cleared by the FDA for use in the lumbar spine.

The GoLIF! Lumbar Interbody Fusion System are sterile implantable cages and sterile instruments intended to be inserted into the intervertebral body space of the lumbosacral spine and intended for intervertebral body fusion. The GetSet GoLIF! implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. The implants are designed for a unilateral posterior transforaminal (TLIF) approach or posterior lumbar interbody fusion (PLIF) approach. It is specially designed for small incision (minimally invasive), resulting in a relatively atraumatic operation for the patient. Implants, used with supplemental fixation and bone graft, provide improved stability, height restoration and lordosis to optimize fusion. Based on anatomical reasons, implants will be offered in lengths of 22mm and 26mm, heights of 8-14mm in 1mm increments, and at a width of 10mm. The implant has a tapered tip to allow distraction upon insertion, and teeth on the superior and inferior surfaces help the implant to resist implant migration. The dome shape allows for 7-18 degree lordosis when placed at a TLIF Oblique or PLIF position whilst maintaining coronal alignment due to the neutral region in the mid-section of the implant when positioned in a lateral position. The openings allow for packing of bone graft. The GoLIF! Lumbar Interbody Fusion System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from Polyacrylamide (IXEF), Polybutylene terephthalate (PBT), and medical grade stainless steel.

The provided text is a 510(k) premarket notification letter and summary for the GoLIF! Lumbar Interbody Fusion System. It details the substantial equivalence determination for a medical device (an intervertebral body fusion device), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain information on:

1. Acceptance criteria for an AI/SaMD and reported device performance against those criteria.
2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/SaMD.
3. Training set sample size or how ground truth was established for a training set.

The document does mention performance testing, but this refers to mechanical testing (static and dynamic axial compression, compression shear, subsidence, and expulsion) conducted per ASTM standards and Limulus Amebocyte Lysate (LAL) testing to confirm endotoxin levels. These are standard tests for physical implants to ensure their mechanical integrity and biocompatibility, not for evaluating the performance of AI/software.

In summary, the information requested relates to the validation of an AI/SaMD, which is not the subject of this document. This submission is for a physical medical implant.

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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 <85> 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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