(86 days)
The Aries® Lumbar Interbodies (Aries®-TS, Aries®-TC, Aries®-O, Aries®-A, and Aries®-L) are interbody fusion devices intended 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 L2 to S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Aries® Lumbar Interbodies are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Aries® Lumbar Interbodies are interbody fusion devices used to provide structural stability in skeletally mature patients. The implants were developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The system is comprised of interbodies of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients and multiple surgical approaches. Each interbody has an axial hole to allow grafting material to be placed inside of the interbody. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
This document describes Aries® Lumbar Interbodies, an intervertebral body fusion device, and its acceptance criteria for FDA clearance.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static & Dynamic Compression (per ASTM F2077) | Met recommended performance, equivalent to predicate devices. |
| Static & Dynamic Torsion (per ASTM F2077) | Met recommended performance, equivalent to predicate devices. |
| Static & Dynamic Compression-Shear (per ASTM F2077) | Met recommended performance, equivalent to predicate devices. |
| Subsidence (per ASTM F2267) | Met recommended performance, equivalent to predicate devices. |
| Pyrogenicity (LAL assay) | Meets recommended maximum endotoxin level of 20 EU per device. |
| Material (Ti-6Al-4V per ASTM F3001) | Device fabricated from the same material as predicate devices. |
| Design Features/Functions | Similar basic design features and functions as predicate devices. |
| Dimensions | Dimensionally similar to cited predicate devices. |
| Sterilization | Provided sterile, similar to predicate devices (sterile for single use only). |
| Intended Use | Similar intended uses as predicate devices. |
| Mechanical Safety and Performance | Equivalent performance to the cited predicate device under the same test conditions. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information on sample size for a test set or data provenance for any clinical studies. It explicitly states, "No clinical studies were performed." The testing conducted was non-clinical (mechanical and pyrogenicity).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as no clinical studies were performed, and thus no expert-established ground truth for a test set was required in this submission. The "ground truth" for the non-clinical tests was established through adherence to recognized ASTM standards.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical studies requiring human adjudication were performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical studies were performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is an intervertebral body fusion device, which is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was based on established industry standards and specifications (ASTM F2077, ASTM F2267, ASTM F3001, and pyrogenicity limits). The goal was to demonstrate equivalence to predicate devices, meaning the device performed within the acceptable parameters defined by these standards, similar to already cleared devices.
8. The Sample Size for the Training Set
This information is not applicable as there was no algorithm or AI component requiring a training set. The device is a physical medical implant.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there was no algorithm or AI component requiring a training set or its associated ground truth.
§ 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.