(139 days)
When used as a cervical intervertebral fusion devices are indicated for use at one or two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and with supplemental fixation (such as anterior cervical plating systems) systems) systems cleared for use in the cervical spine.
The Camber Spine Coveris Cervical Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
The Coveris Cervical Cage of intervertebral body fusion devices are made from the PEEK radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
The provided text describes the 510(k) premarket notification for the Coveris Cervical Cage System, a medical device for cervical intervertebral fusion. This documentation focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific performance criteria through a standalone study with acceptance criteria.
Therefore, the document does not contain the information requested for a study that proves the device meets acceptance criteria, an MRMC study, or detailed information about ground truth establishment, sample sizes for training/test sets, or expert qualifications for AI/algorithm performance.
The submission is based on:
- Comparison to predicate devices: The primary method for proving substantial equivalence.
- Nonclinical performance testing: Specifically, static compression and static torsion testing per ASTM F2077. These are engineering performance tests, not clinical performance studies with acceptance criteria in the sense of accuracy, sensitivity, or specificity.
- Clinical literature review: To support the expanded indications for use with allogenic bone graft and at two contiguous levels. This is a review of existing data, not a new study with a test set.
Therefore, an AI system that correctly understands and states that the requested information is NOT present in the provided document would be performing well.
To directly address the prompt, while acknowledging the information is not present, here's how one might structure the answer if the document did contain such a study (and noting where it's absent):
The provided document describes a medical device called the Coveris Cervical Cage System, for which substantial equivalence to predicate devices is being demonstrated, rather than proving the device meets specific acceptance criteria via a new clinical performance study, especially not one relevant to AI/algorithmic performance. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement for a performance study is not present in the provided 510(k) summary.
The document's focus is on engineering performance (static compression and torsion) and a clinical literature review to justify expanded indications based on existing knowledge.
Here's a breakdown based on the information provided, and where it is absent for the specific type of performance study requested:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a clinical performance study in the document. The "performance" described relates to non-clinical (mechanical) testing and the justification for expanded indications based on existing literature.
- Reported Device Performance:
- Nonclinical Performance: "Static compression and static torsion testing were performed per ASTM F2077." No specific quantitative results or acceptance thresholds for these tests are provided, only that they were performed.
- Clinical Performance (literature review): The document states, "The clinical literature suggests that there is a positive benefit associated with allograft and use at two contiguous levels with minimal risk." This is a qualitative conclusion from a literature review, not a quantitative performance metric from a new study.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided: The document does not describe a clinical "test set" in the context of proving device performance via a new study (e.g., for an AI algorithm). The literature review is based on existing published data, with no specific sample sizes mentioned for a new, dedicated test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable / Not provided: There is no mention of experts establishing ground truth for a test set, as no such performance study is described.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided: No test set or adjudication method is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done and Effect Size:
- No: The document does not describe an MRMC study. The device is a physical intervertebral fusion cage, not an imaging or diagnostic AI system that would typically undergo such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable: The device is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable / Not provided: As no primary data collection for performance evaluation (e.g., for an AI/diagnostic device) is described, the concept of "ground truth" for a test set is not relevant here. The "ground truth" for the expanded indications relies on the conclusions drawn from existing clinical literature.
8. The Sample Size for the Training Set:
- Not applicable / Not provided: This concept is not relevant for the type of device and submission described.
9. How the Ground Truth for the Training Set was Established:
- Not applicable / Not provided: This concept is not relevant for the type of device and submission described.
§ 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.