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510(k) Data Aggregation
(17 days)
Irix-C Cervical Integrated Fusion System
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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(48 days)
IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C3 - 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 radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. Patients should receive at least six (6) weeks of nonoperative treatment prior to treatment with a cervical intervertebral fusion device.
The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device 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 Irix-C implant is manufactured from both titanium alloy (Ti6Al4V) 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 device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes and screws are offered in multiple lengths to adjust for variations in patient anatomy.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Irix-C™ Cervical Integrated Fusion System:
Summary of Acceptance Criteria and Device Performance
The provided document describes the mechanical testing performed on the Irix-C Cervical Integrated Fusion System to demonstrate its substantial equivalence to predicate devices and its ability to safely and effectively perform its intended use. The acceptance criteria are implicitly defined by the standards and types of tests conducted, with the reported performance being "substantially equivalent" to predicate devices. Specific quantitative acceptance criteria or detailed numerical performance results beyond this qualitative statement are not provided in the excerpt.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| ASTM F2077: | - Static and Dynamic Compression: Withstand specified axial loads and cyclic loading without failure or excessive deformation, demonstrating structural integrity under physiological spinal forces. | Substantially equivalent to predicate device performance. Capable of safely and effectively performing in accordance with its intended use. |
| - Static and Dynamic Torsion: Withstand specified torsional loads and cyclic torsional loading without failure or excessive deformation, simulating rotational stresses in the spine. | ||
| ASTM F2267: | - Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression: Maintain construct height and integration with bone under static load, preventing subsidence into vertebrae. | Substantially equivalent to predicate device performance. Capable of safely and effectively performing in accordance with its intended use. |
| Expulsion Test | Resist dislodgement or migration from the surgical site under simulated physiological forces. | Tests performed and results indicate substantial equivalence. |
| Screw Back Out Test | Maintain secure screw fixation within the device and bone under simulated physiological forces, preventing screw migration. | Tests performed and results indicate substantial equivalence. |
| Dissociation Test | Maintain integrity of the integrated fixation mechanism (device and screws) under simulated physiological forces, preventing separation of components. | Tests performed and results indicate substantial equivalence. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not specify the exact number of devices tested for each mechanical test. However, it indicates that "The implant components were tested." This typically implies a statistically sufficient sample for medical device mechanical testing, often guided by standards like ASTM, but the precise number is not given.
- Data Provenance: The data is from mechanical testing performed by the manufacturer, X-spine Systems, Inc. This is prospective testing, where the devices are manufactured and then subjected to specific test protocols in a lab setting. The country of origin of the data is implicitly the USA, where X-spine Systems, Inc. is located.
3. Number of Experts and Qualifications for Ground Truth
- This section is not applicable to the provided document. The study described is a mechanical performance study of a medical device (spinal implant), not a study involving human interpretation of data where expert consensus for ground truth would be relevant. Ground truth in this context refers to the physical properties and performance of the device under mechanical load, measured directly by testing equipment.
4. Adjudication Method for the Test Set
- This section is not applicable to the provided document for the same reasons as above. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are making interpretations (e.g., medical image diagnosis) and disagreements need to be resolved to establish ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The provided text describes mechanical performance testing of a physical implant device, not a study evaluating human readers' performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. This type of study would be relevant for software or AI-driven devices. The Irix-C Cervical Integrated Fusion System is a physical medical implant.
7. Type of Ground Truth Used
- The ground truth used for this study is based on direct physical measurement and observation of the device's mechanical behavior when subjected to defined loads and conditions according to established ASTM standards (F2077, F2267) and specific proprietary tests (expulsion, screw back out, dissociation). The "ground truth" is that the device either passes or fails these pre-defined mechanical criteria, and its performance is quantifiable (e.g., load capacity, deformation, subsidence). The reported outcome is its "substantial equivalence" to predicate devices, implying its performance metrics fell within an acceptable range comparable to already approved devices.
8. Sample Size for the Training Set
- This section is not applicable to the provided document. The study described is mechanical testing of a physical device. There is no "training set" in the context of machine learning or AI that would be relevant here.
9. How the Ground Truth for the Training Set Was Established
- This section is not applicable to the provided document, as no training set was used.
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