(339 days)
The MSFX Pedicle Screw System is 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Mikron Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods, and set screws. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construction to stabilize and promote spinal fusion and it functions to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136-11. Various sizes of these components are available.
Here's a breakdown of the acceptance criteria and study information for the Mikron Spinal Fixation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Standard Applied | Acceptance Criteria (Implied by equivalence) | Reported Device Performance |
|---|---|---|---|
| Determining Torsional Properties of Metallic Bone Screws | ASTM F 543 | Equivalent to or better than predicate devices (4S Spinal System K063708, Optima Spinal System K031585) in torsional properties. The specific quantitative criteria are not provided but are implied to be met through comparison to the predicate's performance. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Flexion-Extension Test of Subassembly | ASTM F 1798-97(2008) | Equivalent to or better than predicate devices in flexion-extension stability and fatigue resistance. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Axial Torque Gripping Capacity Test for Subassembly | ASTM F 1798-97(2008) | Equivalent to or better than predicate devices in axial torque gripping capacity. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Axial Gripping Capacity Test | ASTM F 1798-97(2008) | Equivalent to or better than predicate devices in axial gripping capacity. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Static Compression Test for Subassembly | ASTM F 1717-10 | Equivalent to or better than predicate devices in static compression strength. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Fatigue Test for Subassembly | ASTM F 1717-10 | Equivalent to or better than predicate devices in fatigue life under cyclic loading. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Static Torsion Test | ASTM F 1717-10 | Equivalent to or better than predicate devices in static torsional strength. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Single Cycle Bend Testing of Metallic Spinal Rods | ASTM F 2193 | Equivalent to or better than predicate devices in resistance to single-cycle bending. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
Explanation of Acceptance Criteria: The acceptance criteria for this medical device (Mikron Spinal Fixation System) are based on demonstrating substantial equivalence to existing legally marketed predicate devices (4S Spinal System K063708 and Optima Spinal System K031585). This means the device must perform "as well as or better than" the predicate devices in the described non-clinical mechanical tests. The specific quantitative values for acceptance are not explicitly stated but are determined by successful comparison to the predicate devices under the specified ASTM standards.
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical performance testing (mechanical tests), not a clinical study involving human patients or data from patient test sets. Therefore:
- Sample size used for the test set: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of physical device components tested for each test. This specific number is not provided in the document.
- Data provenance: Not applicable. The "data" are results from mechanical tests performed on the physical device components, not from patient populations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device's evaluation is based on non-clinical mechanical testing for substantial equivalence, not on interpretation of patient data by experts. Ground truth in this context would refer to objective mechanical properties rather than expert consensus on medical conditions.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of patient data requiring adjudication. The evaluation is based on direct comparison of mechanical test results against performance of predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study involves human readers interpreting cases (e.g., medical images) with and without AI assistance. This document describes a 510(k) submission for a spinal fixation system, relying on mechanical testing for substantial equivalence, not a study of AI-assisted human reading.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device (spinal fixation system), not an algorithm or AI. Standalone performance testing typically applies to software or AI devices.
7. The Type of Ground Truth Used
The "ground truth" used is the mechanical performance and material characteristics of the legally marketed predicate devices. The Mikron Spinal Fixation System's performance is compared directly against the established performance of the 4S Spinal System (K063708) and Optima Spinal System (K031585) in rigorous laboratory mechanical tests designed to ASTM standards.
8. The Sample Size for the Training Set
Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device 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.