(48 days)
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.