(59 days)
The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.
The Cervical Stand-Alone System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. Cervical Stand-Alone devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. The cages are made from medical grade polyetheretherketone (PEEK) per ASTM F2026 with tantalum per ASTM F560 pins, from titanium alloy Ti-6A1-4V ELI per ASTM F136, or from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6A1-4V ELI per ASTM F136. These devices are offered non-sterile.
The provided FDA 510(k) summary is for a medical device called the "Cervical Stand-Alone System," which is an anterior cervical interbody fusion system. This documentation primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than presenting a clinical study with detailed acceptance criteria for an AI/software device.
Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance for an algorithm) are not applicable to this type of device and submission. This is a physical implant, not an AI or software-based medical device.
However, I can extract the relevant "acceptance criteria" (which in this context refers to the performance standards the physical device must meet) and the "study" that proves it.
Here's the information based on the provided text, with clarifications where the questions are not relevant to this type of device:
Device Name: Cervical Stand-Alone System
Device Type: Intervertebral Body Fusion Device (physical implant)
1. Table of Acceptance Criteria and Reported Device Performance
Note: The FDA 510(k) summary does not explicitly state numerical "acceptance criteria" values prior to presenting the results. Instead, it states that the device was tested per specific ASTM standards. The "reported device performance" is summarized as the device being "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices" based on these tests. The specific numerical results are not provided in this summary document.
| Acceptance Criteria (Implicitly, meeting ASTM F2077 and F2267 standards and demonstrating substantial equivalence to predicates) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static axial compression (per ASTM F2077) | Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices. |
| Dynamic axial compression (per ASTM F2077) | Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices. |
| Static compression shear (per ASTM F2077) | Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices. |
| Dynamic compression shear (per ASTM F2077) | Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices. |
| Static torsion (per ASTM F2077) | Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices. |
| Dynamic torsion (per ASTM F2077) | Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices. |
| Subsidence (per ASTM F2267) | Performed and deemed sufficient for intended use. Substantially equivalent to predicate devices. |
| Overall Conclusion: | The Cervical Stand-Alone System is substantially equivalent to the predicate device based on overall technology characteristics and mechanical performance data. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. This would refer to the number of physical devices or test specimens used in the mechanical tests. For mechanical testing of implants, sample sizes are typically small, determined by statistical requirements for engineering studies.
- Data Provenance: The data is from non-clinical mechanical testing conducted on the device itself. It is not patient data, nor is there a concept of "country of origin" as it relates to clinical data. The tests were performed to ASTM (American Society for Testing and Materials) standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device subject to mechanical engineering tests, not a diagnostic or AI device requiring expert ground truth for interpretation of clinical conditions. The "ground truth" for these tests would be the physical properties and failure points measured by specialized testing equipment.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in clinical studies or for establishing ground truth in diagnostic AI performance evaluation. This document describes mechanical device testing.
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
Not applicable. This is a physical medical implant, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question pertains to AI algorithms. The Cervical Stand-Alone System is a manufactured physical implant.
7. The type of ground truth used
The "ground truth" for this device's performance is established by engineering measurements against specified ASTM (American Society for Testing and Materials) standards. This involves measuring force, displacement, and cycles to failure under various loading conditions. It is not expert consensus, pathology, or outcomes data related to patient diagnosis or treatment efficacy, but rather the physical and mechanical integrity of the implant.
8. The sample size for the training set
Not applicable. This refers to training data for an algorithm. This device is a physical product, not an algorithm.
9. How the ground truth for the training set was established
Not applicable. This refers to establishing ground truth for algorithmic training data.
§ 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.