(154 days)
The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; 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; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with MIS instrumentation.
The ProMIS™ Fixation System consists of 3 main parts:
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- ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
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- Polyaxial Pedicle screws.
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- Setscrew.
All components are manufactured from Ti6Al4V per ASTM F136.
The provided text describes a medical device called the ProMIS™ Fixation System and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a study to meet specific acceptance criteria with performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested details about acceptance criteria and study design are not present in this document.
However, based on the Performance Data section, the acceptance criteria are implicit in the ASTM F1717 standard for spinal implant constructs. The device's performance is demonstrated by its compliance with this standard.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM F1717) | Reported Device Performance |
|---|---|
| Static Compression | Was subjected to testing. |
| Static Torsion | Was subjected to testing. |
| Dynamic Compression | Was subjected to testing. |
Note: The document states that the system was subjected to these tests, implying it met the criteria, but does not provide specific numerical performance results.
2. Sample size used for the test set and the data provenance
Not applicable. This document describes mechanical testing of a physical device, not an AI or diagnostic algorithm that would require a test set of data/images. The "data provenance" mentioned in your template (country of origin, retrospective/prospective) is relevant for clinical or AI studies, which this is not.
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 mechanical testing is established by the physical properties of the materials and the mechanical outcomes measured, not by expert consensus on data interpretation.
4. Adjudication method for the test set
Not applicable. Mechanical testing outcomes are typically objectively measured and do not require expert adjudication in the same way clinical data interpretation would.
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 medical device for spinal fixation, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance data in this context is the results of the mechanical tests performed according to ASTM F1717. These tests directly measure the physical performance and durability of the device under stress conditions, establishing whether it meets the engineering standards for spinal implants.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is physical device testing, not an AI/machine learning application.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of test.
Summary of the Study:
The "study" described in the document is a pre-clinical mechanical performance assessment. The ProMIS™ Fixation System was subjected to standard mechanical tests: static compression, static torsion, and dynamic compression, as specified by the ASTM F1717 standard. The purpose of these tests was to demonstrate the substantial equivalence of the ProMIS™ System to the predicate devices (THUNDERBOLT™ and LANCER™ Pedicle Screw Systems) in terms of mechanical properties and safety/effectiveness for its intended use. The document concludes that the performance data demonstrates substantial equivalence, indicating that the device met the mechanical acceptance criteria implied by the ASTM F1717 standard.
§ 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.