(147 days)
The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.
The Cavetto®-SA Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F560, and tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.
The provided document is a 510(k) premarket notification for the Cavetto®-SA Cervical Cage System, an intervertebral body fusion device. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold format for each test. Instead, it states that the "results of this non-clinical testing show that the strength of the Cavetto®-SA Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
This implies that the acceptance criterion for each test was to meet or exceed the performance of the legally marketed predicate devices. The specific performance values for the predicate devices are not provided in this summary.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Strength sufficient for intended use and substantially equivalent to legally marketed predicate devices for each test mode below. | Strength of the Cavetto®-SA Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. |
| Static axial compression per ASTM F2077 | (Results not numerically detailed, but stated to meet criterion) |
| Static compressive shear per ASTM F2077 | (Results not numerically detailed, but stated to meet criterion) |
| Static torsion per ASTM F2077 | (Results not numerically detailed, but stated to meet criterion) |
| Dynamic axial compression per ASTM F2077 | (Results not numerically detailed, but stated to meet criterion) |
| Dynamic compressive shear per ASTM F2077 | (Results not numerically detailed, but stated to meet criterion) |
| Dynamic torsion per ASTM F2077 | (Results not numerically detailed, but stated to meet criterion) |
| Static subsidence per ASTM F2267 | (Results not numerically detailed, but stated to meet criterion) |
| Expulsion per ASTM F-04.25.02.02 | (Results not numerically detailed, but stated to meet criterion) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the number of samples or units tested for each non-clinical performance test (e.g., how many cages were subjected to static axial compression).
- Data Provenance: The data is from non-clinical testing (mechanical testing), not human or animal studies. Therefore, concepts like country of origin for human data or retrospective/prospective don't apply in the same way. The testing was conducted to established ASTM standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This submission relies on non-clinical, mechanical performance data, not expert-derived ground truth based on interpreting medical images or clinical outcomes. The "ground truth" here is the physical measurement of the device's mechanical properties according to established engineering standards (ASTM).
4. Adjudication Method for the Test Set:
- Not applicable. As the data is purely mechanical testing against engineering standards, there's no "adjudication" in the sense of reconciling differing expert opinions. The tests are performed and measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No. This document describes a 510(k) submission based on non-clinical bench testing for a physical implantable device (a cervical cage). MRMC studies evaluate the performance of diagnostic algorithms or imaging techniques, often involving human readers. This type of study is not relevant to the evaluation of the Cavetto®-SA Cervical Cage System as presented here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a physical medical implant, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not a relevant concept for this submission.
7. The Type of Ground Truth Used:
- For the non-clinical performance tests, the "ground truth" is established by adherence to published ASTM standards and the expected mechanical properties for devices of this type for their intended use. The comparison is made to predicate devices which have already demonstrated safety and effectiveness through their regulatory clearance based on similar mechanical and material properties.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of this 510(k) submission. This is a physical medical device, not a machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, this question is not relevant.
In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical implant (intervertebral cage) through non-clinical mechanical testing, rather than evaluating the performance of a diagnostic algorithm or AI system. Therefore, many of the requested categories (expert ground truth, MRMC studies, training sets) are not applicable to this type of regulatory submission. The core of the "proof" is that the device's mechanical properties, tested against recognized ASTM standards, are sufficient for its intended use and comparable to already cleared predicate devices.
§ 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.