(153 days)
The FORZATM 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 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The FORZATM Spacer System is intended for use with autograft and supplemental fixation system. As an example, the supplemental fixation system that may be used is the Orthofix Inc. Firebird™ Pedicle Screw System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZATM Spacer System.
The FORZA Spacer System consists of implants, trials, and instruments. The FORZA Spacer System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F-2026 with Tantalum markers as described by ASTM F-560. PEEK was utilized due to its radiolucent properties, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, Tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively. The implants are offered in two geometric shapes: straight and curved, and offered in lordotic profiles to restore the natural curvature of the spine. Both the curved and straight implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.
The FORZA Spacer System is intended for intervertebral body fusion to aid in the surgical correction and stabilization of the spine.
The FORZA Spacer System is not intended to be used as a stand-alone device. The FORZA Spacer System must be used with supplemental fixation system. The FORZATM Spacer System implants are provided sterile. The FORZATM Spacer System trials and instruments are provided non-sterile.
The Orthofix Inc. FORZA™ Spacer System is an intervertebral body fusion device. The acceptance criteria and the study proving it meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (FORZA™ Spacer System) |
|---|---|---|
| Function/Design | Restore biomechanical integrity of the spinal column by providing fusion at one or two contiguous levels in the lumbar spine (L2-S1), used with autograft material and supplemental fixation system. | Restores biomechanical integrity of the spinal column by providing fusion at one or two contiguous levels in the lumbar spine (L2-S1). Intended for use with autograft and supplemental fixation system. |
| Implant Width | Comparable to predicate devices (9-11mm for PILLAR, 9-15mm for Lumbar I/F Cage). | 9-11mm |
| Implant Length | Comparable to predicate devices (23-33mm for PILLAR, 21-25mm for Lumbar I/F Cage). | 23-33mm |
| Implant Heights | Comparable to predicate devices (6-16mm for PILLAR, 9-17mm for Lumbar I/F Cage). | 6-16mm |
| Lordotic Angles | Comparable to predicate devices (0 and 8° for PILLAR, Parallel and Wedged for Lumbar I/F Cage). | 0, 4 and 8° |
| Configuration | Hollow Cage for use with supplemental fixation. | Hollow Cage for use with supplemental fixation. |
| Material | Biocompatible and mechanically suitable (PEEK with Tantalum or Titanium markers). | Polyetheretherketone (PEEK, ASTM F-2026) with Tantalum markers (ASTM F-560). |
| Static Compression | Meet or exceed performance of predicate devices as per ASTM F2077-03. | Test results demonstrated substantial equivalence. |
| Dynamic Compression | Meet or exceed performance of predicate devices as per ASTM F2077-03. | Test results demonstrated substantial equivalence. |
| Subsidence | Meet or exceed performance of predicate devices as per ASTM F2267-04. | Test results demonstrated substantial equivalence. |
| Sterility | Demonstrated sterility for pre-sterilized implants. | Addressed with sterilization verification testing. |
2. Sample Size Used for the Test Set and Data Provenance
- The document describes non-clinical mechanical testing.
- Sample Size for Test Set: Not explicitly stated as a number of devices/implants, but it refers to "mechanical testing of the Orthofix Inc. FORZATM Spacer System." The testing was conducted "in accordance to ASTM F2077-03 standard for Static & Dynamic Compression testing and ASTM F2267-04 standards for Subsidence testing." ASTM standards typically specify the number of samples required for such tests.
- Data Provenance: The data is generated from laboratory mechanical testing of the device itself. It is not patient data, thus, country of origin or retrospective/prospective designation are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable as the ground truth for mechanical testing is established by adherence to universally accepted engineering standards (ASTM F2077-03 and ASTM F2267-04) and the physical properties of the materials and device design, not by expert human interpretation of medical data.
4. Adjudication Method for the Test Set
- This information is not applicable as the test set involves mechanical engineering tests against objective standards, not interpretation by human adjudicators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (intervertebral spacer) and relies on mechanical testing and comparison to predicate devices, not on a study with human readers interpreting imaging or clinical outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- This information is not applicable. This device is a physical implant, not an algorithm or a software device. Therefore, the concept of "standalone performance" in the context of AI algorithms does not apply.
7. The Type of Ground Truth Used
- The ground truth for the mechanical performance testing is established by objective engineering standards and specifications. Specifically, the device's performance was compared against the requirements and methodologies outlined in:
- ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices) for Static and Dynamic Compression.
- ASTM F2267-04 (Standard Test Method for Measuring the Compressive Properties of PEEK and Tantalum Markers) for Subsidence.
- The "ground truth" for substantial equivalence is also derived from the established characteristics and performance of the identified predicate devices.
8. The Sample Size for the Training Set
- This information is not applicable as there is no "training set" in the context of a physical medical device submission based on mechanical testing and predicate device comparison. Device design and manufacturing processes are iteratively developed, but this is not analogous to an AI training set.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the same reasons as #8.
§ 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.