(86 days)
The FORZA Ti Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.
The FORZA Ti Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system.
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA Ti Spacer System.
FORZA Ti Spacer System is comprised of a variety of 3D Titanium printed implants (conforming to ASTM F3001) that have porous end plates and a functional gradient porous structure. The implant superior and inferior Titanium plate surface provides increased stability for the implant. The titanium porous structure have open macroscopic 3D pores with a microscopic roughened surface and nano-scale features. FORZA Ti Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
FORZA Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. FORZA Ti implants are provided sterile.
The Orthofix FORZA® Ti Spacer System is an intervertebral body fusion device. Based on the provided FDA 510(k) summary, the device's acceptance criteria and the study proving it meets these criteria are described below:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance (FORZA® Ti Spacer System) |
|---|---|
| Mechanical testing per ASTM F2077 (static and dynamic axial compression, static and dynamic compression shear) | Passed, results demonstrated substantial equivalence to predicate. |
| Subsidence testing per ASTM F2267 | Passed, results demonstrated substantial equivalence to predicate. |
| Characterization of particles per ASTM F1877 | Passed, results demonstrated substantial equivalence to predicate. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical trial data provenance (e.g., country of origin, retrospective/prospective) for this device. The evaluation of this device for 510(k) clearance was based on mechanical testing, not clinical data from patients. Therefore, the "sample size" refers to the number of devices or materials tested during these mechanical evaluations. The exact number of units tested for each specific mechanical test (ASTM F2077, F2267, F1877) is not explicitly stated in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device's evaluation was based on mechanical engineering standards (ASTM) for performance testing, not on human expert interpretation of clinical images or patient data to establish ground truth.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to resolve discrepancies in image interpretation or clinical diagnosis. This device was evaluated through mechanical testing against established 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
This information is not applicable. The device is a surgical implant (intervertebral body fusion device), not an imaging or diagnostic AI tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance was established by recognized engineering and materials standards (ASTM F2077, ASTM F2267, ASTM F1877). Successful adherence to these standards, and demonstration of substantial equivalence to a predicate device that also meets these standards, constitutes the "ground truth" for its safety and effectiveness in its intended mechanical function.
8. The sample size for the training set
This information is not applicable. This device is not an AI algorithm and does not involve a training set in the machine learning sense. The tests are mechanical evaluations of the physical product.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
§ 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.