(202 days)
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD), DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft bone material and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
The Cervical Stand Alone device is a stand-alone spacer system designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.
The Cervical Stand Alone spacer is manufactured from PEEK and Titanium with Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior suffaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.
Here's an analysis of the provided text regarding the Cervical Stand Alone System, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance for Cervical Stand Alone System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM Standards) | Reported Device Performance (from Non-Clinical Tests) |
|---|---|
| Static Axial Compression (ASTM F2077-11) | Conducted |
| Dynamic Axial Compression (ASTM F2077-11) | Conducted |
| Static Torsion (ASTM F2077-11) | Conducted |
| Dynamic Torsion (ASTM F2077-11) | Conducted |
| Static Compression Shear (ASTM F2077-11) | Conducted |
| Dynamic Compression Shear (ASTM F2077-11) | Conducted |
| Subsidence (ASTM F2267-04) | Conducted |
| Expulsion (ASTM Draft Standard F-04.25.02.02) | Conducted |
Note: The provided document states that these tests were "conducted" in accordance with the specified ASTM standards. It does not provide specific numerical performance results or explicit pre-defined pass/fail criteria beyond the adherence to the standards. The basis of substantial equivalence is that the new device has "the same intended use, similar indications for use, the same technological characteristics and design, same materials and the same principles of operation as the predicate devices." Implied acceptance criteria are that the device's mechanical performance is equivalent to, or better than, the predicate devices when tested to these standards.
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document mentions "mechanical testing" but does not detail the number of units or repetitions used for each test.
- Data Provenance: Not applicable in the context of clinical data. This study is described as "Non-Clinical Test Conducted." Therefore, there is no country of origin for clinical data, nor is it retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This was a non-clinical, mechanical performance study. There was no "ground truth" derived from expert interpretation of images or patient outcomes. The "ground truth" for these tests would be the established scientific principles of mechanical engineering and the specifications of the ASTM standards themselves.
4. Adjudication Method for the Test Set
- Not applicable. As this was a non-clinical mechanical test, there was no need for expert adjudication. The results were likely compared against predefined limits or against the performance of predicate devices as per the ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document describes non-clinical mechanical testing, not a clinical MRMC study involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No. This device is a physical medical implant (intervertebral body fusion device), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
- The "ground truth" for this study was the mechanical performance specifications and methodologies outlined in the ASTM standards (ASTM F2077-11, ASTM F2267-04, and ASTM Draft Standard F-04.25.02.02). The device's performance was evaluated against the requirements, methods, and expected behaviors established by these engineering standards.
8. Sample Size for the Training Set
- Not applicable. Since this is a physical medical device undergoing mechanical testing, there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are informed by engineering principles and standards, but not by a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set. The "ground truth" for the design and manufacturing of such a device is rooted in:
- Biomechanical principles of the spine.
- Material science properties of PEEK and Titanium.
- Clinical experience with similar devices (as inferred by the predicate devices).
- Engineering design specifications aiming to meet the performance requirements of the relevant ASTM standards.
§ 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.