(26 days)
The G Surgical Marksman System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of 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 consists of longitudinal members (rods), anchors (screws), connectors (crosslinks) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
The provided text is a 510(k) summary for the G Surgical Marksman System, which is a thoracolumbosacral pedicle screw system. This type of device is an implant used to stabilize the spine and is regulated as a Class II medical device.
Crucially, a 510(k) submission for this class of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and comparison of technological characteristics, rather than clinical efficacy studies on patient outcomes.
Therefore, most of the requested information regarding acceptance criteria, device performance from a study, sample sizes for test/training sets, expert consensus, and stand-alone performance for an AI/algorithm-based device is not applicable to this specific submission because it's for a mechanical implant, not an AI-driven diagnostic or therapeutic system.
Here's a breakdown of the information that is available and why other parts are not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Mechanical Testing) | Reported Device Performance |
|---|---|
| Static compression bending per ASTM F1717 | Marksman System performance demonstrated substantial equivalence to predicate devices. |
| Dynamic compression bending per ASTM F1717 | Marksman System performance demonstrated substantial equivalence to predicate devices. |
| Static torsion per ASTM F1717 | Marksman System performance demonstrated substantial equivalence to predicate devices. |
Explanation: The acceptance criteria for this type of device are primarily based on established mechanical testing standards (ASTM F1717) to ensure the implant's structural integrity and durability. The device is considered to meet the acceptance criteria if its mechanical performance is comparable to or better than predicate devices. The document explicitly states that the "mechanical test results demonstrate that G Surgical Marksman System performance is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The "test set" for this device refers to the physical specimens of the implant components that underwent mechanical testing, not a dataset of patient information. The document does not specify the number of samples tested for each mechanical test. Data provenance (country, retrospective/prospective) is not relevant for mechanical device testing.
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)
- Not Applicable. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic or AI-based devices. For a mechanical implant, the "ground truth" for performance is determined by adherence to engineering specifications and performance in standardized mechanical tests, not expert medical opinion on a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for clinical data and diagnostic accuracy. This is not relevant to the mechanical testing of an implant.
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
- No, not done. MRMC studies and the effect size of AI assistance are relevant for AI-powered diagnostic or interpretive tools, where human readers (e.g., radiologists) are involved. This device is a surgical implant and does not involve "human readers" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not applicable. The G Surgical Marksman System is a physical medical device (pedicle screw system), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Standards and Predicate Device Performance. The "ground truth" for this device's performance is established by its ability to meet specified mechanical properties (e.g., strength, durability) as defined by ASTM F1717 and by demonstrating equivalence to the performance of legally marketed predicate devices. There is no biological or diagnostic "ground truth" involved in this type of submission.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this device. This term refers to data used to train machine learning algorithms.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth for it to be established.
§ 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.