(145 days)
The MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
The MiRus™ Lumbar Interbody Fusion System consist of implants manufactured from VESTAKEEP®i4R PEEK per ASTM F2026 and instrumentation manufactured from stainless steel per ASTM F899. The Interbody Fusion Devices are offered in four configurations of various sizes to accommodate different patient anatomy and the surgical approaches listed: Posterior Lumbar Approach (PLIF), Transforaminal Lumbar Approach (TLIF), Lateral Lumbar Approach (LLIF), and Anterior Lumbar Approach (ALIF). The implants will be provided non-sterile and are intended for single use only.
The provided document is a 510(k) Summary for a medical device called the "MiRus™ Lumbar Interbody Fusion System." This document focuses on demonstrating the substantial equivalence of the new device to previously cleared predicate devices, primarily through comparison of indications for use, materials, technological characteristics, and particularly, mechanical performance.
It explicitly states: "The preclinical testing listed above that was performed on the MiRus™ Lumbar Interbody Fusion System...indicate that it is substantially equivalent to the predicate devices in mechanical performance."
Therefore, the acceptance criteria and the study that proves the device meets them are entirely based on mechanical testing, not on clinical performance or AI/human reader studies.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by the referenced ASTM standards, which outline specific mechanical tests and their requirements. The document does not provide a table with numerical criteria or directly compare the device's numerical performance against those criteria. Instead, it states the methodology used and the conclusion of acceptable performance.
| Acceptance Criteria (Measured Values/Tests specified by ASTM Standards) | Reported Device Performance (Compliance) |
|---|---|
| Static Compression (per ASTM F2077-17) | Performed, indicates substantial equivalence in mechanical performance. |
| Dynamic Compression (per ASTM F2077-17) | Performed, indicates substantial equivalence in mechanical performance. |
| Static Shear (per ASTM F2077-17) | Performed, indicates substantial equivalence in mechanical performance. |
| Dynamic Shear (per ASTM F2077-17) | Performed, indicates substantial equivalence in mechanical performance. |
| Subsidence Testing (per ASTM F2267-04) | Performed, indicates substantial equivalence in mechanical performance. |
| Expulsion of the device (per widely accepted methodology) | Evaluated, indicates substantial equivalence in mechanical performance. |
The crucial point is that the acceptance criterion is meeting the performance of the predicate device as demonstrated by these tests, rather than a specific numerical threshold explicitly listed in this document. The conclusion states "substantial equivalent" in mechanical performance, implying that the tested device performed comparably to the predicate under these standard tests.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the number of individual devices or test replicates used for each mechanical test. ASTM standards typically specify minimum sample sizes for such tests, but the exact numbers are not provided here.
- Data Provenance: The tests were "performed on the MiRus™ Lumbar Interbody Fusion System," implying prospective testing of the new device's physical properties. The data does not originate from a specific country or clinical cohort; it's from laboratory mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is established by the physical properties and performance metrics defined by the ASTM standards, measured using calibrated equipment and standard methodologies. There are no human experts "establishing ground truth" in the way they would for image-based diagnostics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus building among human readers/experts, typically in clinical studies or image review. Mechanical testing relies on objective measurements that do not require human adjudication in this sense.
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
This question is not applicable. The device is an intervertebral body fusion system (an implant), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI-related performance improvements are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is a physical implant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established mechanical testing standards (ASTM F2077-17, ASTM F2267-04) and "widely accepted methodology" for expulsion testing. The performance of the predicate devices under these same conditions serves as the baseline for demonstrating substantial equivalence.
8. The sample size for the training set
This question is not applicable. This document describes the testing of a physical medical device (an implant), not an AI model requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.