(66 days)
The Cavetto® MAXI Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Cavetto® MAXI Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Cavetto® MAXI Cervical Cage System is intended to be used with supplemental fixation.
The Cavetto® [MAX] Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® MAXI Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.
This 510(k) is submitted only for the purposes of changing the name of the Cavetto® Cervical Cage System (K172320) to the Cavetto® MAX) Cervical Cage System. The two devices are otherwise identical, and no changes whatsoever have been made to the Cavetto® Cervical Cage System (K172320).
The provided text describes a 510(k) premarket notification for the Cavetto® [MAX] Cervical Cage System. This submission is for changing the name of an already cleared device (Cavetto® Cervical Cage System, K172320). No changes were made to the device itself. Therefore, the information regarding acceptance criteria and performance data primarily refers to mechanical testing performed on the predicate device, which is identical to the subject device.
Here's an breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in numerical terms for the mechanical tests. Instead, it states that the performance data for the predicate device, also known as the Cavetto® Cervical Cage System (K172320), was leveraged. The conclusion drawn is that the strength of the Cavetto® [MAX] Cervical Cage System (which is identical to the predicate) is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
| Acceptance Criteria | Reported Device Performance (based on predicate device testing) |
|---|---|
| Sufficient strength for intended use and substantial equivalence to legally marketed predicate devices. | Testing included: |
- Static axial compression per ASTM F2077
- Static torsion per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic torsion per ASTM F2077
- Static subsidence per ASTM F2267
- Static expulsion
The results of this non-clinical testing show that the strength is sufficient for its intended use and substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the mechanical tests. It also does not provide information on the provenance of the data (e.g., country of origin, retrospective/prospective), as these are typical considerations for clinical studies, not mechanical bench testing.
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)
This question is not applicable. The study described is mechanical bench testing, not a clinical study involving human readers or expert consensus to establish ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are relevant for clinical studies where multiple experts interpret data. This submission focuses on mechanical performance testing.
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.
This question is not applicable. The device described is a cervical cage system, an implantable medical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
This question is not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" is defined by the physical properties and performance characteristics measured according to established ASTM standards. There is no expert consensus, pathology, or outcomes data used to establish ground truth for this type of evaluation.
8. The sample size for the training set
This question is not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This question is not applicable. There is no training set.
§ 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.