(368 days)
The STCC is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an anterior approach and used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
STCC is an implantable intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V) and is available in a variety of different sizes to suit the individual anatomic and clinical circumstances of each patient. Intended for placement via an anterior approach, the device has a trapezoidal cross section with a hollow interior designed to accommodate the placement of autologous bone graft.
The Cardinal Spine, LLC STCC is an intervertebral body fusion device. The acceptance criteria for this device are based on passing a series of biomechanical tests as outlined in relevant ASTM standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Passing Requirement) | Reported Device Performance |
|---|---|---|
| Static axial compression (ASTM F2077) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2077) | Met or exceeded biomechanical requirements |
| Dynamic axial compression (ASTM F2077) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2077) | Met or exceeded biomechanical requirements |
| Static torsion (ASTM F2077) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2077) | Met or exceeded biomechanical requirements |
| Dynamic torsion (ASTM F2077) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2077) | Met or exceeded biomechanical requirements |
| Static subsidence (ASTM F2267) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM F2267) | Met or exceeded biomechanical requirements |
| Static expulsion (ASTM Draft Standard F-04.25.02.02) | (Implicit: Meet or exceed biomechanical requirements for intended use as per ASTM Draft Standard F-04.25.02.02) | Met or exceeded biomechanical requirements |
Note: The provided text explicitly states that the device was "demonstrated to meet or exceed the biomechanical requirements of the intended use" for all listed tests. The specific quantitative acceptance criteria or thresholds for these tests are not detailed in the provided 510(k) summary, but are instead referenced to the respective ASTM standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size (number of devices) used for each biomechanical test.
- Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that these are laboratory biomechanical tests, it's implied that the testing was conducted under controlled laboratory conditions, likely in the US where the manufacturer and consultant are located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable for this device. The "ground truth" for the performance of this intervertebral body fusion device is established through an objective assessment against pre-defined biomechanical standards (ASTM protocols), rather than through expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
This is not applicable for this device. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (like medical images) where human expert consensus is required to establish ground truth. For biomechanical testing, the "adjudication" is inherent in whether the device meets the quantitative pass/fail criteria of the specified ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI/software devices where human readers are involved. The STCC is an implantable medical device, and its performance is evaluated through engineering and biomechanical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the STCC is a physical implantable device, not an algorithm or software. Its performance is inherently "standalone" in a biomechanical sense, meaning its physical properties are tested without human interaction for its functionality, but it is ultimately implanted with human surgical intervention and used in conjunction with human healthcare.
7. The Type of Ground Truth Used
The "ground truth" for the STCC's performance is established by biomechanical engineering standards and test protocols (specifically ASTM F2077, ASTM F2267, and ASTM Draft Standard F-04.25.02.02). The device's ability to withstand specified loads and forces, as defined by these standards, serves as the objective measure of its performance and suitability for its intended use.
8. The Sample Size for the Training Set
This is not applicable for this device. The STCC is a manufactured medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for this device as it does not involve AI or machine learning and thus does not have a "training set" or "ground truth for a 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.