(88 days)
CAVUX™ Cervical Cage-L SA System is indicated for standalone 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 patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device.
CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.
The Providence Medical Technology, Inc. CAVUX™ Cervical Cage-L SA System is supplied terminally sterilized and is single-use only. The subject device is manufactured from medical grade titanium and is available in various sizes. Subject device is a rectangular hollow box shape with space for allogenic and autogenous bone graft and teeth on the inferior and superior surfaces of the implant. Self-drilling and self-tapping screws are provided as part of the subject device.
The provided text is a 510(k) Summary for the CAVUX™ Cervical Cage-L SA System. This document outlines the device's description, indications for use, and a summary of performance data used to demonstrate substantial equivalence to predicate devices. However, this type of document is primarily focused on demonstrating the mechanical and structural integrity of an orthopedic implant for its intended "use case" based on industry standards, rather than evaluating an AI/ML powered device's performance in terms of diagnostic accuracy or clinical effectiveness.
Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission.
Here's the information that can be extracted or derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Mode) | Reported Device Performance |
|---|---|
| ASTM F2077-14 Static Axial Compression | "strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
| ASTM F2077-14 Static Torsion | "strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
| ASTM F2077-14 Static Shear | "strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
| ASTM F2077-14 Dynamic Axial Compression | "strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
| ASTM F2077-14 Dynamic Shear | "strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
| ASTM Draft F-04.25.02.02 Static Expulsion | "strength...is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The testing described is mechanical/non-clinical, implying material and component-level testing rather than a patient-based test set.
- Data Provenance: Not applicable in the context of patient data. The tests are laboratory-based mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context would refer to material properties or mechanical failure points, established through standardized testing procedures, not expert interpretation of patient data.
4. Adjudication method for the test set:
- Not applicable. Mechanical tests have objective pass/fail criteria based on physical measurements, not human 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:
- No. This is a submission for an orthopedic implant, not an AI/ML-powered diagnostic or assistive device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device would be established by the specifications and performance requirements defined by the ASTM standards for intervertebral body fusion devices, and the comparative performance data demonstrating substantial equivalence to predicate devices under those standards. This is a mechanical performance ground truth, not a clinical diagnostic ground truth.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for an implant.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.