(288 days)
When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device cispine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. Additionally, the clspine implants are to be used with autogenous bone graft and supplemental fixation via an open, anterior approach.
When used as a lumbar intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device tispine implants are indicated for spinal fusion procedures in skeletally mature patients. Lumbar interbody fusion implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for treatment of lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The tlspine implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implanted via a transforaminal approach. These implants are to be used with autogenous bone graft and supplemental fixation.
Ackermann Intervertebral Body Fusion Device c|spine and t|spine is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from implant grade PEEK (polyetheretherketone, VESTAKEEP® i4 R bv Evonik).
The provided document is a 510(k) summary for a medical device called the "Ackermann Intervertebral Body Fusion Device." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results to establish acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested points regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, and expert ground truth establishment are not applicable to this document as it describes a physical implant device, not an AI or algorithmic diagnostic tool.
However, I can extract the relevant "performance data" which refers to mechanical testing as opposed to clinical or algorithmic performance.
Here's the information that can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document refers to adherence to ASTM standards for mechanical testing, which implies the acceptance criteria were defined by these standards. Specific numerical acceptance criteria or reported performance values (e.g., specific load resistance in Newtons) are not detailed in this summary. Instead, it states that the device was "tested in accordance with" specific ASTM standards.
| Acceptance Criteria (Implied by Standard) | Reported Device Performance (Summary) |
|---|---|
| Conformance to ASTM F2077 for static axial compression | Tested in accordance with ASTM F2077 |
| Conformance to ASTM F2077 for dynamic axial compression | Tested in accordance with ASTM F2077 |
| Conformance to ASTM F2077 for static torsion | Tested in accordance with ASTM F2077 |
| Conformance to ASTM F2077 for dynamic torsion | Tested in accordance with ASTM F2077 |
| Conformance to ASTM F2267 for load induced subsidence | Tested in accordance with ASTM F2267 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes mechanical testing of a physical device, not an AI/algorithmic device with a "test set" of patient data. The "test set" would refer to the number of physical devices or components tested. This detail is not provided. The manufacturer is Ackermann Instrumente GmbH, located in Rietheim-Weilheim, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of AI/algorithms, refers to expert-validated labels. For mechanical testing, the "ground truth" is adherence to ISO/ASTM standards and physical measurements, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/algorithm ground truth.
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. This is a physical medical device, not an AI algorithm. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a physical device's performance is objective measurement based on mechanical testing standards (ASTM F2077, ASTM F2267).
8. The sample size for the training set
Not applicable. This is not an AI/algorithmic device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this physical 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.