(48 days)
The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: 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; pseudoarthrosis and failed previous fusion in skeletally mature patients.
The M.U.S.T. Combined Set Screws are intended to be used as part of the M.U.S.T. Pedicle Screw System (cleared under K12115, K132878, K141044, K141988, K153664, K162061, and K171170) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Pedicle Screw System includes: cannulated or non-cannulated poly-axial pedicle screws (K12115 and K132878), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K12115), straight and pre-bent rods (K121115 and K162061), cross connectors (K132878), hooks (K141044), enhanced screws and rods designed for percutaneous surgery (K141988 and K162061), cannulated or non-cannulated reduction screws (K153664), connectors (K162061 and K171170), and standard, enhanced, and reduction pedicle screws (K171170). The M.U.S.T. Combined Set Screws are manufactured from CoCrMo alloy (ISO 5832-12 and ASTM F1537-11) and are provided sterile and non-sterile screw is packaged individually as well as in packages of 2, 4, 6, and 8 screws. The non-sterile screw is packaged individually.
The provided text describes a 510(k) premarket notification for a medical device, the M.U.S.T. Combined Set Screws. It focuses on demonstrating substantial equivalence to a predicate device, not on validating an AI algorithm. Therefore, many of the requested items related to AI device performance, such as human reader improvement with AI, ground truth establishment for training and test sets, and multi-reader multi-case studies, are not applicable or cannot be extracted from this document.
However, I can extract information regarding the device's acceptance criteria, the study conducted, and other relevant details provided in the submission for the M.U.S.T. Combined Set Screws.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, it refers to performance studies conducted in accordance with specific ASTM standards. The acceptance criteria are implicitly that the device performs equivalently to the predicate device and meets the requirements of these standards. The reported device performance is that it met these standards and thus is "as safe and effective as the predicate devices."
| Acceptance Criteria Category | Reported Device Performance and Relevant Standard |
|---|---|
| Mechanical Strength (Dynamic Bending) | Met requirements of ASTM F1717-15 Standard Test Methods For Spinal Implant Constructs In A Vertebrectomy Model. |
| Mechanical Strength (Interconnection Mechanism) | Met requirements of ASTM F1798-13 Standard Guide For Evaluating The Static And Fatigue Properties Of Interconnection Mechanisms And Subassemblies Used In Spinal Arthrodesis Implants. |
| Biocompatibility/Safety (Pyrogenicity) | Pyrogenicity Testing (LAL Endotoxin Test) was conducted, implying it met relevant safety standards for non-pyrogenic materials. |
| Structural Integrity (Sawbones Testing) | Sawbones Testing was performed, implying it demonstrated structural integrity and appropriate interaction within a simulated bone environment. |
| Overall Equivalence | Based on performance data, "the M.U.S.T. Combined Set Screws are as safe and effective as the predicate devices." The minor design difference (interface) "does not raise any new questions of safety and effectiveness" due to the performance testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI algorithm, nor does it provide details on sample sizes for the mechanical and pyrogenicity tests beyond indicating that the tests were performed. The "data provenance" information (country of origin, retrospective/prospective) is not applicable to the device testing described. The materials for the device itself are CoCrMo. The manufacturing company, Medacta International SA, is located in Switzerland.
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 information is not applicable. The device is a physical medical implant (surgical screws), not an AI diagnostic or prognostic tool requiring expert-established ground truth from images or clinical data. The "ground truth" for this device would be its physical and mechanical properties, assessed through standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as there is no "test set" in the context of expert review for an AI algorithm. The device's performance was evaluated through laboratory testing against established engineering and material 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 information is not applicable. The M.U.S.T. Combined Set Screws are a physical orthopedic implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The "device" in question is a physical hardware component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established engineering standards and material properties, specifically through performance testing in accordance with:
- ASTM F1717-15 (for dynamic compression bending of spinal implant constructs)
- ASTM F1798-13 (for static and fatigue properties of interconnection mechanisms)
- Sawbones Testing (a simulated biomechanical environment)
- LAL Endotoxin Test (for pyrogenicity/safety of materials)
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI algorithm.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set."
§ 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.