(108 days)
The eCarbon-C is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The eCarbon-C is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one level or two contiguous levels from C2 - T1. The eCarbon-C is to be used with supplemental fixation. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
The eCarbon-P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, the eCarbon-P can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The eCarbon-P is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.
The eCarbon IBDs are a collection of interbody devices. The cervical implants (eCarbon-C) have basic keystone shape in a columnar form while the lumbar devices (eCarbon-P) are essentially rectangular. All have a central cavity for bone graft and are offered in a variety of height, length, width and lordotic angulation combinations are available to accommodate the anatomic requirements of individual patients.
The provided text is a 510(k) Summary for the eCarbon IBDs, which are intervertebral body fusion devices. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance reporting as one might find for novel AI/imaging devices.
Therefore, the document does not contain the detailed information requested for acceptance criteria, device performance, study types (MRMC, standalone), sample sizes, ground truth establishment, or expert qualifications in the context of an algorithm's performance.
Instead, the "Performance Data" section describes mechanical testing performed to demonstrate that the eCarbon IBDs are mechanically equivalent to their predicate devices.
Here's the information that can be extracted related to performance and testing:
1. Table of acceptance criteria and reported device performance:
The document does not specify quantitative acceptance criteria in terms of a pass/fail threshold. Instead, it states that the test results "demonstrated equivalent mechanical performance... compared to the cited predicate devices under the same test conditions." This implies that the performance of the eCarbon IBDs was expected to be comparable to or better than the predicate devices in the specific tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | Demonstrated equivalent mechanical performance compared to cited predicate devices under the same test conditions. |
| Worst-case eCarbon cervical implant: Tested for static and dynamic compression, and static and dynamic torsion according to ASTM F2077. | |
| Worst-case eCarbon lumbar implant: Tested for static and dynamic compression according to ASTM F2077. | |
| Both worst-case eCarbon implants: Evaluated for subsidence according to ASTM F2267 and expulsion testing. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but refers to "worst case eCarbon cervical implant" and "worst case eCarbon lumbar implant," implying a limited number of samples representing the most challenging configurations. These would be physical samples for mechanical testing, not data samples in the context of an AI study.
- Data Provenance: Not applicable in the context of clinical data provenance (e.g., country, retrospective/prospective). This refers to laboratory mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. "Ground truth" in this context would refer to established mechanical testing standards (ASTM F2077, ASTM F2267) which define how the performance is measured, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set:
Not applicable. Mechanical tests follow predefined protocols, and the results are quantitative measurements, not subjective interpretations requiring adjudication.
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 a medical device (intervertebral body fusion devices) for which mechanical performance, not AI-assisted image interpretation, is being evaluated.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is not an algorithm, but a physical implant.
7. The type of ground truth used:
The "ground truth" for mechanical testing is established by recognized industry standards (ASTM F2077, ASTM F2267) and the physical properties and behavior of the identical predicate devices.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI device.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" as this is not an AI 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.