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510(k) Data Aggregation
(17 days)
The Irix-C Cervical Integrated Fusion System is a stand-alone cervical fusion device intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies).
Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device.
The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device designed to restore biomechanical height and act as an aid in fusion of the cervical spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The Irix-C implant will be manufactured in either a composite construction of titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580.
The intervertebral fusion device is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6AI4V) per ASTM F136.
The devices are available in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The single-use implants are provided clean and non-sterile. These devices are intended to be sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.
A series of manual surgical instruments, provided clean and non-sterile, intended to assist with the insertion and placement of the implants, is included in an instrument tray, which is used for instrument sterilization and storage.
The system does not contain software/firmware.
This document is a 510(k) premarket notification for a medical device called the "Irix-C Cervical Integrated Fusion System." It is a submission to the FDA seeking clearance to market the device.
Based on the provided text, the device is an intervertebral body fusion device intended for spinal fusion procedures. It is classified as a Class II device with product code OVE.
Crucially, this document states: "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use. Therefore, no additional testing was required or performed."
This means there is NO EVIDENCE OF A STUDY to prove the device meets acceptance criteria related to its performance for this particular 510(k) submission. Instead, the submission relies on the substantial equivalence principle, arguing that the device is equivalent to previously cleared predicate devices for its expanded indications for use.
Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as no such study is described in this document for the current submission.
However, I can extract the proposed Indications for Use (the acceptance criteria in terms of clinical application) for the device and clarify why no performance study was conducted.
1. A table of acceptance criteria and the reported device performance
As stated above, this 510(k) submission did not involve new performance testing. The "acceptance criteria" for this submission are essentially the expanded "Indications for Use," which are compared to predicate devices for substantial equivalence, rather than being demonstrated through new performance data.
| Acceptance Criteria (Expanded Indications for Use) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use: Stand-alone cervical fusion device for spinal fusion. | Substantially equivalent to predicate devices (K131951, K161280, and other reference devices). |
| Level: One level (C2 – T1 inclusive) | Substantially equivalent to predicate devices for cervical levels, with an expansion from C3-T1 to C2-T1 deemed non-unique based on other cleared devices. |
| Patient Population: Skeletally mature patients. | Substantially equivalent to predicate devices. |
| Condition: Treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). | Substantially equivalent to predicate devices. |
| Implantation Method: Open, anterior approach. | Substantially equivalent to predicate devices. |
| Graft Material: Packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. | This is the primary expansion of the indication from the previous clearance, which presumably only included autograft. The inclusion of allograft is deemed substantially equivalent based on predicate devices from Orthofix and other reference devices that already have this indication. |
| Pre-operative Treatment: Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device prior to treatment. | Substantially equivalent to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No new performance study (test set) was conducted for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No new performance study requiring expert ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance study requiring adjudication was conducted.
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 device is a physical implant, not an AI/software device. The submission explicitly states "The system does not contain software/firmware."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No new performance study requiring ground truth was conducted. The ground for substantial equivalence is based on comparisons of design, materials, and established indications for use of predicate devices.
8. The sample size for the training set
- Not applicable. No new performance study (training set) was conducted as there is no algorithm or AI component.
9. How the ground truth for the training set was established
- Not applicable. No new performance study (training set) was conducted.
Summary of the document's approach:
The manufacturer, X-Spine Systems, Inc., submitted a 510(k) for their Irix-C Cervical Integrated Fusion System. The core of this submission is substantial equivalence to existing predicate devices. They are seeking to expand the device's "Indications for Use" to include:
- The use of allograft (in addition to autograft) as bone graft material.
- An expanded anatomical region for use, specifically including level C2 (whereas the previous clearance was for C3-T1 inclusive).
The document explicitly states that no new performance data or testing was required or performed because "No substantial technological changes were made to the existing Irix-C System, nor were any new components added to the Irix-C System. The only change is the expanded Indications for Use."
They argue that the expanded indications are not "unique" and are already covered by other legally marketed devices, thus demonstrating substantial equivalence.
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