(84 days)
When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MN), The AMT Spinal™ System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine (1) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudoarthrosis).
The AMT Spinal™ Svstem is intended for skeletally mature patients (MNH): (1) having severe spondylolithesis (Grades 3 and 4) at the L5-S1 vertebral joint; (2) who are receiving fusion by autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
The AMT Spinal™ System is designed for use as a construct system and consists of set screws, hex nuts, hooks, rods, screws, and cross link assembly (cross link rod and connecting hook) which can be variously assembled to provide immobilization of the thoracic. lumbar, and lumbosacral spine. The system is composed of the following components: right hand set screw, left hand hex nut, pedicle screw, polyaxial screw, rod, cross link assembly (cross link rod and connecting hook). All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136).
The components under review are the Polvaxial screws. Polyaxial upper body head, and concave compression washer. The AMT Polyaxial Pedicle Screw serves as an additional option to the pedicle screw configurations currently offered in the AMT Spinal™ System (K002059). in a construct system. The AMT Polyaxial Pedicle Screw utilizes the same straight forward simple instruments and is identical to the pedicle screws currently offered in the AMT Spinal™ System in the all areas with the exception of the following:
The top loading polyaxial head allowing for greater positioning abilities.
- The rotating head (polyaxial) eliminates the need to bend rods for constructs up to the . three (3) vertebral levels.
- The rotating head (polyaxial) can be rotated allowing the surgeon greater versatility in ● positioning rod and screws to the anatomy.
- Allows anatomical screw placement and easy rod positioning. ●
- This allows the surgeon multi-angle pedicle screw insertion. .
- All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136). Materials:
Function: The system functions to assist in arthrodesis or fusion of the thoracic, lumbar and lumbosacral spine.
The provided document does not describe a study involving an AI/Machine Learning device or software. Instead, it's a 510(k) premarket notification for a spinal implant system: the Micron Precision Engineering AMT Spinal™ System, specifically the AMT Polyaxial Pedicle Screw.
Therefore, I cannot provide information about acceptance criteria or studies related to AI performance, as the document details:
- Mechanical testing of a physical medical device. The "study" mentioned is non-clinical performance testing for static and fatigue compression and static torsion of the pedicle screw, performed according to ASTM F1717-96.
- A "substantial equivalence" determination by the FDA, comparing the proposed device to legally marketed predicate devices. This process does not involve clinical trials with human subjects for this type of device, nor does it involve AI performance validation.
Here's what I can extract from the document regarding the device's performance and the basis for its clearance, as per the request, but adapted to the context of a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a physical medical device (spinal implant), the "acceptance criteria" are not reported as specific performance metrics against a predefined threshold like sensitivity, specificity, or AUC for an AI model. Instead, the acceptance criteria are generally met by demonstrating substantial equivalence to predicate devices and verifying mechanical performance through established standards.
| Parameter | Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Demonstrate that static and fatigue compression, and static torsion performance are similar to or exceed previously cleared spinal systems and meet the requirements of ASTM F1717-96. The FDA has no specific performance standards for pedicle screw systems, so adherence to this recognized standard is key. | "Static and fatigue compression and static torsion testing of the AMT Polyaxial Pedicle Screw were performed according to ASTM F1717-96. Data regarding the functional performance of the proposed AMT Polyaxial Pedicle Screw has been generated." |
| "Mechanical testing shows the biomechanical performance of the subject device to be similar to the performance of previously cleared spinal systems with similar indications." (Page 1) | ||
| Biocompatibility | Materials used must meet or exceed ASTM standards and have an extensive safe clinical history, being common to orthopedic products. | "The materials used meet or exceed ASTM standards, are common to orthopedic products today, and leave an extensive safe clinical history." (Page 3) |
| Pyrogenicity | Follow USP XXII, NF18 (1995 edition) guidelines, acknowledging that these requirements do not apply to orthopedic products. | "Neither the predicate nor the proposed devices are labeled as non-pyrogenic. Per USP XXII, NF18 (1995 edition). "These requirements do not apply to orthopedic products."" (Page 3) |
| Sterility | Devices are supplied non-sterile and intended for steam sterilization, consistent with predicate devices. | "Both the predicate and the proposed devices will be supplied as a non-sterile implant." |
| "Both the predicate and the proposed devices will be steam sterilized." (Page 3) | ||
| Design, Materials, Function, Intended Use | Demonstrates "substantial equivalence" to predicate devices, meaning no significant differences that would adversely affect use. Design, function, material, and intended use should be similar to legally marketed devices. The proposed device's unique features (e.g., polyaxial head) should not introduce new safety or effectiveness concerns. | No significant differences affecting use were found compared to predicate devices (Spine System Evolution Aesculap, Global Spinal Fixation System Forex, Global Spinal Fixation System U & I Corporation, Spiral Radius 90D - Surgical Dynamics, Trinity Polyaxial Screw Corin Spinal Systems, and the existing AMT Spinal™ System). The polyaxial head offers greater positioning versatility but is considered within the scope of similar intended uses and does not adversely affect safety/effectiveness. (Page 1, 3) |
The following points (2-9) are not applicable as this is not an AI/ML device study:
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the biomechanical samples tested in a lab, not a data set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering standards and physical measurements.
4. Adjudication method for the test set: Not applicable.
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 a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used: For mechanical testing, the "ground truth" is derived from established engineering principles, material properties, and the performance requirements of the ASTM F1717-96 standard. For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 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.