(219 days)
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Epicage Interbody Fusion Device is a PEEK implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is designed with openings for bone growth and fusion. The rib allow for flexure of the device during insertion. The device is available in two lengths to accommodate various patients' anatomy. Each of these sizes is available in 4 heights ranging from 8mm to 14mm in 2mm increments.
The provided text describes pre-clinical performance testing for the Epicage Interbody Fusion Device, which is intended for interbody fusion procedures. This device is a PEEK implant designed to provide mechanical support to the lumbar spine during biologic fusion.
Here's an analysis of the acceptance criteria and study to prove the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The text indicates that the device's performance was evaluated against established ASTM standards and a recognized protocol for expulsion testing. The reported performance is a qualitative statement of meeting these standards and being "substantially equivalent" to predicate devices. Specific quantitative acceptance criteria or performance metrics are not explicitly provided in the extract.
| Acceptance Criteria (Implicit from testing standards) | Reported Device Performance |
|---|---|
| Compliance with ASTM F2077-03 for Static Axial Compression | Tested, indicated substantial equivalence to predicate devices and adequate for intended use. |
| Compliance with ASTM F2077-03 for Static Compression Shear | Tested, indicated substantial equivalence to predicate devices and adequate for intended use. |
| Compliance with ASTM F2077-03 for Static Torsion | Tested, indicated substantial equivalence to predicate devices and adequate for intended use. |
| Compliance with ASTM F2077-03 for Dynamic Axial Compression | Tested, indicated substantial equivalence to predicate devices and adequate for intended use. |
| Compliance with ASTM F2077-03 for Dynamic Torsion | Tested, indicated substantial equivalence to predicate devices and adequate for intended use. |
| Compliance with ASTM F2267-04 for Subsidence | Tested, indicated substantial equivalence to predicate devices and adequate for intended use. |
| Resistance to Expulsion (following recognized protocol) | Tested, indicated substantial equivalence to predicate devices and adequate for intended use. |
2. Sample Size and Data Provenance
The provided text focuses on pre-clinical bench testing. It does not describe a clinical study involving human patients. Therefore, there is no "test set" in the context of patient data nor data provenance from specific countries or retrospective/prospective collection methods. The "samples" would refer to the physical Epicage Interbody Fusion Device units used for mechanical testing. The specific number of devices tested for each type of performance test is not mentioned.
3. Number of Experts and Qualifications
This information is not applicable as the study described is pre-clinical bench testing of a mechanical device, not an evaluation requiring expert interpretation of medical images or patient outcomes.
4. Adjudication Method
This information is not applicable for the same reason as point 3. Bench testing results are typically based on objective measurements from laboratory equipment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text describes pre-clinical bench testing of a mechanical device. It does not involve human readers interpreting images or considering AI assistance.
6. Standalone Performance Study (Algorithm Only)
The device described is a physical medical implant (interbody fusion device), not a software algorithm. Therefore, "standalone" algorithm performance is not applicable. The performance testing focuses on the mechanical integrity and behavior of the implant itself.
7. Type of Ground Truth Used
The ground truth for the performance testing is based on the objective measurements obtained from standardized mechanical tests (ASTM standards and a recognized expulsion protocol). For example, the "ground truth" for static axial compression would be the force/displacement curves and failure points measured according to the ASTM F2077-03 standard. The study aims to demonstrate that the device's mechanical properties meet the expectations for its intended use and are comparable to predicate devices.
8. Sample Size for the Training Set
There is no "training set" in the context of an algorithm or machine learning model, as this is a physical medical device.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a physical medical device.
§ 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.