(88 days)
The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The FIREBIRD SI Fusion System (formally SambaScrew 3D SI Fusion System) is a temporary multiple component system consisting of non-sterile instruments, sterile 11mm and 12mm FIREBIRD SI Screws and non-sterile 9mm FIREBIRD SI Screws. The FIREBIRD SI Screws are manufactured from medical-grade titanium alloy (Ti-6AI-4V ELI) with lengths ranging from 25mm to 70mm.
The 11mm FIREBIRD SI Screw is a cannulated screw featuring multiple fenestrations along the shaft, with a tapered proximal end and dual-pitch threads. The 12mm FIREBIRD SI Scew is a cannulated screw featuring multiple fenestrations along the shaft, with a single pitch thread on the proximal and distal ends. The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The 9mm FIREBIRD SI Screw features multiple fenestrations along the shaft and maintains a single pitch thread along the proximal and distal ends of the screw.
The FIREBIRD SI Fusion System allows for packing of autograft and allograft materials.
This document is a 510(k) premarket notification for the Orthofix FIREBIRD SI Fusion System. It primarily addresses the addition of nano-scale descriptors to the device labeling and explicitly states that the device's technological characteristics, performance data, and other critical aspects remain unchanged since its prior clearance (K200696). Therefore, there is no new study or new acceptance criteria presented in this document for the FIREBIRD SI Fusion System itself.
The document refers to studies from a predicate device (K200052 – Orthofix Inc. – PTC Systems) to support the nano-surface descriptors. These studies focused on surface characterization and in vitro cellular studies to demonstrate increased proliferation and alkaline phosphatase activity in human stem cells with the PTC modified surface.
Since the core device is unchanged and no new performance studies for the FIREBIRD SI Fusion System are detailed in this 510(k) submission, a table of acceptance criteria and reported device performance directly from this document cannot be created for the FIREBIRD SI Fusion System in the way requested. Instead, I will summarize the information provided regarding the reliance on prior clearances and the nature of the supporting data for the nano-surface descriptors.
Summary regarding Acceptance Criteria and Study for FIREBIRD SI Fusion System (K201664):
This 510(k) submission (K201664) for the FIREBIRD SI Fusion System does not introduce new acceptance criteria for the device's overall function or new studies to demonstrate its performance. The submission's purpose is to add nano-scale descriptors to the labeling.
The document explicitly states:
- "The technological characteristics of the FIREBIRD SI Fusion System are unchanged since the prior clearance K200696."
- "The performance data of the FIREBIRD SI Fusion System are unchanged since the prior clearance K200696. No new mechanical testing was performed for the FIREBIRD SI Fusion System as there are no design changes to the device."
- "The previously cleared indications for use, intended use, design, specifications, contraindications, warnings or precautions remain the same as previously cleared under K200696."
Therefore, the acceptance criteria and supporting studies for the overall device performance would be found in the K200696 submission.
However, the submission does refer to data used to support the nano-surface descriptors, which were previously cleared under predicate K200052. The details on this specific aspect are provided below, but it's important to note these studies are not for the overall performance of the FIREBIRD SI Fusion System as a fusion device, but rather for a specific material characteristic.
1. Table of acceptance criteria and the reported device performance
As no new performance data or acceptance criteria are presented for the FIREBIRD SI Fusion System in this 510(k) submission (K201664), a direct table cannot be provided. The submission relies on prior clearances.
However, regarding the nano-surface descriptors, which is the focus of this particular 510(k) (K201664):
| Acceptance Criteria (Implied for Nano-surface Features based on referenced K200052) | Reported Device Performance (from referenced K200052) |
|---|---|
| Demonstrated biological activity (e.g., cell proliferation, osteogenic differentiation) for the modified surface. | Increased proliferation and alkaline phosphatase activity (an early osteogenic differentiation marker) in human stem cells. |
| Surface characterization confirms nanoscale dimensions and specific properties. | Supported by "surface characterization" (details not provided in this document, but inferred to confirm nanoscale features and porosity). |
Note: These are derived from the limited information provided in K201664, which heavily references prior 510(k)s (K200696 for the device itself and K200052 for the nano-surface technology). Full details would be in those respective submissions.
Supporting Information for the nano-surface descriptors (based on referenced K200052):
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in this document. It refers to "in vitro cellular studies using HMSCs and normal human osteoblasts (NHOst) cells." The number of cells, replicates, or experiments is not detailed.
- Data Provenance: In vitro cellular studies. Country of origin not specified, but typically lab-based studies for medical device material properties are conducted by the manufacturer or a contract research organization. Retrospective or prospective is not applicable as it's a lab study, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Experts: Not applicable for in vitro cellular studies. The "ground truth" for such studies would be the objective measurements of cellular activity (proliferation, enzyme activity) quantified by laboratory equipment and interpreted by scientific personnel.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable for in vitro cellular studies. Data would be analyzed statistically, and results would be based on predefined scientific protocols and statistical significance.
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:
- MRMC Study: No. This is an orthopedic implant for physical fixation and fusion, supported by mechanical and in vitro cellular studies. It is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is an implanted medical device, not a software algorithm.
7. The type of ground truth used:
- Ground Truth: For the in vitro cellular studies referenced (from K200052), the "ground truth" would be the quantified biological responses of human stem cells and osteoblasts (e.g., cell counts for proliferation, enzymatic assay readings for alkaline phosphatase activity).
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is an experimental study for material characterization and biological response, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.