(90 days)
The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The IRIX-A™ System is intended to be used with autograft and/or allograft comprised of cancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system.
Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The IRIX-A™ implant is manufactured from both 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 device is 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. The spacers of the IRIX-A™ System are supplied clean and STERILE. The screws and accompanying instruments of the IRIX™-A System are provided clean and non-sterile.
The system does not contain software/firmware or electrical equipment.
The provided document is a 510(k) Pre-market Notification from the FDA for a medical device called the IRIX-A™ Lumbar Integrated Fusion System. This submission focuses on establishing substantial equivalence to existing predicate devices, rather than a clinical study evaluating the device's diagnostic performance against specific acceptance criteria for AI/software-based devices. Therefore, much of the requested information regarding acceptance criteria for device performance in a clinical context, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not applicable or not present in this type of regulatory document.
However, I can extract information related to the performance data provided within this 510(k) summary for non-clinical testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from testing standards) | Reported Device Performance |
|---|---|
| ASTM F2077: Static and dynamic compression testing (specific values not provided in this document) | Meets or exceeds the performance of the predicate device. |
| ASTM F2267: Subsidence (specific values not provided in this document) | Meets or exceeds the performance of the predicate device. |
| Expulsion as recommended by FDA (specific methodology/values not provided in this document) | Meets or exceeds the performance of the predicate device. |
Note: The document states the device "meets or exceeds the performance of the predicate device" for these tests, implying that the acceptance criteria are based on the performance of the predicate device as established through the same ASTM standards and FDA recommendations.
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable. This document describes non-clinical mechanical testing, not a clinical study involving a test set of data.
- Data provenance: Not applicable. The testing is described as "Nonclinical testing" and performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for clinical data is not relevant to this non-clinical mechanical testing.
4. Adjudication method for the test set:
- Not applicable.
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 is not an AI/software-based diagnostic device, nor a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device.
7. The type of ground truth used:
- For the non-clinical performance data: The "ground truth" or reference for performance is the established performance characteristics of the predicate device under the specified ASTM standards and FDA recommendations for static and dynamic compression, subsidence, and expulsion.
8. The sample size for the training set:
- Not applicable. This product does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
Summary based on the provided document:
The IRIX-A™ Lumbar Integrated Fusion System is a physical medical device (intervertebral body fusion device), not an AI/software-based diagnostic tool. The regulatory submission (510(k)) aims to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved through non-clinical performance testing (mechanical/physical tests) rather than clinical studies involving patient data and diagnostic performance metrics like sensitivity, specificity, or reader studies.
The performance data supplied focuses on:
- ASTM F2077: Static and dynamic compression testing
- ASTM F2267: Subsidence
- Expulsion testing as recommended by FDA
The conclusion is that the subject device "meets or exceeds the performance of the predicate device" for these tests, indicating that its mechanical integrity and function are comparable or superior, and it "does not introduce any new risks." The predicate device itself acts as the benchmark for establishing acceptable performance under these tests.
§ 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.