(111 days)
The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.
The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion procedures and are used as single placement devices in the disc space, and are designed with a large hollow region in the center to house autograft bone. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone.
The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.
An implant holding feature has been incorporated into the anterior surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELD).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Typically defined as comparison to predicate devices) | Reported Device Performance |
|---|---|---|
| Static Compression | Performance comparable to predicate interbody devices. | Substantially equivalent to predicate interbody devices. |
| Static Compression-Shear | Performance comparable to predicate interbody devices. | Substantially equivalent to predicate interbody devices. |
| Static Torsion | Performance comparable to predicate interbody devices. | Substantially equivalent to predicate interbody devices. |
| Subsidence | Performance comparable to predicate interbody devices. | Substantially equivalent to predicate interbody devices. |
| Expulsion | Performance comparable to predicate interbody devices. | Substantially equivalent to predicate interbody devices. |
| Dynamic Compression | Performance comparable to predicate interbody devices. | Substantially equivalent to predicate interbody devices. |
| Dynamic Compression-Shear | Performance comparable to predicate interbody devices. | Substantially equivalent to predicate interbody devices. |
| Dynamic Torsion | Performance comparable to predicate interbody devices. | Substantially equivalent to predicate interbody devices. |
2. Sample Size for Test Set and Data Provenance
The provided document describes mechanical performance testing, not clinical studies involving human patients or data. Therefore, the concept of a "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) and sample size (number of cases/patients) is not applicable here.
The document states that mechanical testing was performed on "the subject Endoskeleton® TCS IBD and predicate devices." The specific number of devices tested for each mechanical test is not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device underwent mechanical testing, not a study requiring expert-established ground truth for clinical outcomes or image interpretation.
4. Adjudication Method for the Test Set
Not applicable. This device underwent mechanical testing, not a study requiring adjudication of clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This document describes the 510(k) submission for a medical device (intervertebral body fusion device) primarily based on mechanical performance and substantial equivalence to predicate devices, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. As noted above, this is a physical medical device, not an algorithm or AI model.
7. Type of Ground Truth Used
The "ground truth" for the mechanical performance testing was based on the results obtained from testing the substantially equivalent predicate devices according to established ASTM standards (ASTM F2077 and ASTM F2267). The subject device's performance was then compared to these predicate device results to demonstrate substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device undergoing mechanical testing, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI model, there is no training set or associated ground truth establishment.
§ 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.