(18 days)
The G Surgical Marksman MIS System is intended to provide immobilization of the posterior noncervical spine (T1-S2/llium) in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities: degenerative disc disease (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, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The G Surgical Marksman MIS System can be used in an open approach or a percutaneous approach with MIS instrumentation.
The G Surgical Marksman MIS System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The devices are sold nonsterile.
The provided text describes a 510(k) premarket notification for the G Surgical Marksman MIS System. It details the device's indications for use, materials, and references mechanical testing. However, it does not provide specific acceptance criteria or the full study details in the format requested for an AI/software device.
The G Surgical Marksman MIS System is a medical device (a thoracolumbosacral pedicle screw system), not an AI/software device. The performance data mentioned refers to mechanical testing (ASTM F1717) to demonstrate structural integrity and durability, which is standard for orthopedic implants. It does not involve AI performance metrics like accuracy, sensitivity, or specificity, nor does it involve human readers or ground truth established by experts in the context of diagnostic or interpretive tasks.
Therefore, most of the requested information regarding AI/software device performance, such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI, is not applicable to this submission.
Here is the information that can be extracted or derived from the provided text, acknowledging the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary) |
|---|---|
| ASTM F1717 Mechanical Testing | Static and dynamic compression bending, and static torsion tests were performed on worst-case G Surgical Marksman MIS System constructs. (No specific numerical acceptance values or pass/fail results are provided in this summary, but the implication of clearance is that these tests met predefined standards.) |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated, as this refers to mechanical test constructs, not patient data or images for AI. The text mentions "worst-case G Surgical Marksman MIS System constructs."
- Data provenance: Not applicable in the context of patient data for AI. The "data" refers to the results of mechanical laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context would refer to material science and mechanical engineering standards, not expert medical opinion for diagnostic accuracy.
4. Adjudication method for the test set:
- Not applicable. Adjudication is relevant for expert disagreement in AI ground truth establishment. Mechanical testing follows standardized protocols.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
- Ground truth: Adherence to ASTM F1717 standards for mechanical safety and performance, as assessed through laboratory testing.
8. The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is a 510(k) clearance letter for a physical medical device (spinal implant components), not for an AI/software device. The performance data refers to mechanical testing for physical properties, not diagnostic accuracy or human-AI interaction. Therefore, many of the requested details are not relevant to this specific submission.
§ 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.