(38 days)
Lumbar System Indications: The Aurora Spine Interbody Fusion System devices are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications: The Aurora Spine Interbody Fusion System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
The Aurora Spine Interbody Fusion System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights and lordotic configurations with an open architecture to accept packing of autograft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.
The Aurora Spine Interbody Fusion System is a medical device, and its acceptance criteria are based on mechanical testing to demonstrate substantial equivalence to a predicate device. There is no clinical study involving human patients or AI reported in this document.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Description | Acceptance Criteria (Standard) | Reported Device Performance (as stated) |
|---|---|---|
| Static Compression | ASTM F2077 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Dynamic Compression | ASTM F2077 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Torsion | ASTM F2077 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Compression-Shear | ASTM F2077 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Subsidence Testing | ASTM F2267 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Expulsion Testing | (Not specified) | "All data indicates the device is substantial equivalence to the predicate systems" |
| Static Shear (Coating) | ASTM F1044 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Static Tension (Coating) | ASTM F1147 | "All data indicates the device is substantial equivalence to the predicate systems" |
| Abrasion (Coating) | ASTM F1978 | "All data indicates the device is substantial equivalence to the predicate systems" |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The document describes non-clinical mechanical testing, not a test set of patient data.
- Data Provenance: Not applicable. The data is from mechanical testing performed on the device components, not from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device's acceptance is based on mechanical engineering standards, not expert clinical interpretation of data.
4. Adjudication method for the test set:
- Not applicable. As described, no human adjudication was involved in the mechanical testing for substantial equivalence.
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:
- No MRMC comparative effectiveness study was done. This document explicitly states, "Clinical data and conclusions were not needed for this device." There is no mention of AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (interbody fusion system), not an algorithm or AI.
7. The type of ground truth used:
- The "ground truth" for this device's acceptance is adherence to established ASTM (American Society for Testing and Materials) standards for mechanical properties and the demonstration of substantial equivalence to a legally marketed predicate device (Tyber Medical Interbody System, K130573) based on these mechanical tests.
8. The sample size for the training set:
- Not applicable. There is no training set mentioned or required for this type of device submission, as it involves mechanical testing and not machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no corresponding ground truth establishment process.
§ 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.