(131 days)
The Cervical Spine Truss System – Stand Alone (CSTS-SA) Interbody Fusion Device is a standalone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment with the devices.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.
The provided text is a 510(k) summary from the FDA for a medical device called the Cervical Spinal Truss System-Stand Alone (CSTS-SA). It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove performance against specific acceptance criteria for an AI/software device.
Therefore, many of the requested categories for AI/software device studies are not applicable or cannot be extracted from this document, as this is a hardware device submission.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the typical sense for an AI/software device (e.g., sensitivity, specificity, AUC thresholds). Instead, it refers to performance standards for a physical medical implant.
| Acceptance Criteria (Performance Standards) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F2077 (Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion) | Testing completed per standard |
| ASTM F2267-04 (Subsidence Testing) | Testing completed per standard |
| Expulsion testing | Testing completed per accepted industry standard |
| MR Conditional testing (from predicate K173159): | |
| ASTM F2119 (MR Image Artifact) | Testing completed per standard |
| ASTM F2052 (MR Induced Displacement Force) | Testing completed per standard |
| ASTM F2213 (MR Induced Torque) | Testing completed per standard |
| ASTM F2182 (RF-induced Heating) | Testing completed per standard |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The "test set" would refer to the physical devices tested according to the ASTM standards. The document doesn't provide details on the number of devices or units tested for each standard. Data provenance is not relevant in the context of device mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in this context, would be the physical properties and structural integrity of the device, established through standardized engineering tests, not expert human review of data.
4. Adjudication method for the test set
Not applicable. Testing is based on objective measurements against engineering standards.
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 interbody fusion device, not an AI/software product that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The "ground truth" for the device's performance is established by the specified ASTM and industry standards for mechanical and MR conditional testing. Compliance with these standards indicates the device performs as expected for its intended physical function.
8. The sample size for the training set
Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.