(133 days)
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.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-1 for implant devices. | Devices are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. Evaluation based on product-specific tests and published literature showed high demonstrable biological safety. Instruments' materials also have a medical grade and fulfill ISO 10993 requirements. No concerns arose that would preclude clinical use. |
| Pyrogenicity / Endotoxin Testing | ≤ 20 EU/kit (according to USP General Chapter and EP Ch 2.6.14, as recommended in ISO 10993-11:2009). | Testing on worst-case subject implants successfully confirmed that the GoPLF! Posterior Lateral Fusion System meets the acceptance criteria of ≤ 20 EU/kit. |
| Mechanical Testing | Equivalence to predicate device (Medtronic CD HORIZON® Spinal System) as demonstrated by ASTM F1717-15. | Testing performed according to ASTM F1717-15, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." Concluded that the GoPLF! Pedicle Screw System is "geometrically and mechanically equivalent" to the predicate device. |
| Magnetic Resonance Safety Testing (MR Conditional) | Conformance to ASTM F2503-20 standard definitions. | Nonclinical testing demonstrated that the GetSet Surgical GoPLF! Posterior Lateral Fusion Device range is "MR Conditional" in accordance with the ASTM F2503-20 standard definitions. |
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.