(209 days)
The Neurostructures Cavetto® 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 Neurostructures Cavetto® Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous bone graft and placed via an open, anterior approach. The Neurostructures Cavetto® Cervical Cage System is intended to be used with supplemental fixation.
The Cavetto® 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® 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 document is a 510(k) premarket notification for a medical device called the Neurostructures Cavetto® Cervical Cage System. It's an intervertebral fusion device to be used in the cervical spine.
Here's the breakdown of the information you requested based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum strength values). Instead, it lists the types of performance tests conducted and concludes that the strength of the device is sufficient for its intended use and substantially equivalent to legally marketed predicate devices.
| Test Mode | Reported Device Performance and Acceptance Criteria (Implied) |
|---|---|
| Static axial compression | Strength sufficient for intended use and substantially equivalent to predicate devices. (ASTM F2077) |
| Static torsion | Strength sufficient for intended use and substantially equivalent to predicate devices. (ASTM F2077) |
| Dynamic axial compression | Strength sufficient for intended use and substantially equivalent to predicate devices. (ASTM F2077) |
| Dynamic torsion | Strength sufficient for intended use and substantially equivalent to predicate devices. (ASTM F2077) |
| Static subsidence | Strength sufficient for intended use and substantially equivalent to predicate devices. (ASTM F2267) |
| Static expulsion | Strength sufficient for intended use and substantially equivalent to predicate devices. (ASTM F04.25.02.02) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size (number of devices or tests performed) for each mechanical test. It mentions that the tests were "non-clinical testing," which typically means laboratory-based mechanical testing, not human or animal data. There is no information regarding country of origin or whether it's retrospective or prospective, as these are typically not relevant for mechanical device 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. The Neurostructures Cavetto® Cervical Cage System is a physical medical device, not an AI/software device that requires expert-established ground truth from medical images or clinical data. The "ground truth" for this device's performance is its mechanical properties as measured by standardized tests.
4. Adjudication method for the test set
This information is not applicable for mechanical testing of a physical device. Adjudication methods (like 2+1, 3+1) are typically used for medical image interpretation or clinical outcome assessment where subjective human judgment is involved.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive tools, not for a physical intervertebral cage. The document focuses on the mechanical performance of the implant itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical cervical cage, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for this device's performance is based on the results of standardized mechanical testing as described in ASTM F2077, ASTM F2267, and ASTM F04.25.02.02. The comparison is made against the performance of legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable. The device is a physical product, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as 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.