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510(k) Data Aggregation
(15 days)
The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities 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 minimal invasive (MIS) instrumentation.
The ProMIS™ Fixation System consists of 3 main single use implanted parts:
- ProMIS™ Fusion Rods: a straight or bent rod of various lengths.
- Polyaxial Pedicle Screws: cannulated and non- cannulated screw bodies with self-tapping flutes and rounded or self-drilling tips, available in three diameters (5.5mm, 6.5mm, with length ranging from 25 to 60, in increments of 5mm.
- Setscrew.
All components are manufactured from Ti6Al4V per ASTM F136
Rods up to 100mm in length and the Pedicle Screws are provided sterile (gamma irradiated).
Rods exceeding 100mm are supplied non-sterile (steam/autoclave sterilization by the end user).
The provided text is a 510(k) summary for the Premia Spine Ltd.'s ProMIS™ Fixation System. It details a "Special 510(k) notice" for a modification to a previously cleared device (K150380).
Based on the information provided, this submission does not describe:
- Acceptance criteria for an AI/ML-driven device. The device is a "Thoracolumosacral Pedicle Screw System," which is a physical implant used in spinal surgery, not an AI/ML software device.
- A study proving device meets acceptance criteria related to AI/ML performance. The "Performance Data" section explicitly states, "The ProMIS™ Fixation System was subjected to static torsion and dynamic compression testing per ASTM F1717." This refers to mechanical testing of the physical implant, not a clinical study involving AI or human interpretation of images.
- Sample sizes for test sets, data provenance, expert numbers, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI/ML models. These concepts are entirely absent from the document as they are not relevant to the type of device being described.
Therefore, it is not possible to extract the requested information regarding AI/ML device acceptance criteria and study details from the provided text. The document focuses on demonstrating substantial equivalence for design modifications to a physical medical implant, primarily through mechanical performance testing.
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(27 days)
The ProMIS™ Fixation 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: 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 or curvatures (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 minimally invasive (MIS) instrumentation.
The ProMIS™ Fixation System consists of 3 main single use implanted parts:
- ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
- Polyaxial Pedicle screws.
- Setscrew.
All components are manufactured from Ti6Al4V per ASTM F136.
This document describes a 510(k) premarket notification for the Premia Spine Ltd.'s ProMIS™ Fixation System, which is a thoracolumbosacral pedicle screw system. The purpose of this 510(k) is to modify the sterilization method of certain rods, add new rod lengths, and introduce a modified set screw and new instrumentation. The document asserts substantial equivalence to a previously cleared device (K150380).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Description / Standard | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Sterilization validation for gamma irradiation to achieve a Sterility Assurance Level (SAL) of $10^{-6}$. | Validated according to ISO 11137-2:2013 by the method of substantiation of 25kGy as a sterilization dose for SAL $10^{-6}$ (VDmax25). This applies to pedicle and set screws, and fusion rods up to 100mm. Fusion rods longer than 100mm are provided non-sterile for steam sterilization by the user. |
| Pyrogenicity | Bacterial endotoxin testing (BET) to achieve an Endotoxin limit of to achieve the Endotoxin limit of ), and packaging integrity (ASTM D4169-16, AAMI/ISO 11607-1, ASTM F1980-07). |
- Engineering analysis and functional demonstration: For the mechanical performance of the modified set-screw and the overall system, demonstrating adherence to design specifications and non-deterioration of current worst-case scenarios.
8. Sample Size for the Training Set
Not applicable. There is no training set for an AI algorithm in this device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for an AI algorithm in this device submission.
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