(84 days)
The Prow Fusion is intended to be used for spinal fusion.
The Prow-Fusion Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Prow Fusion device.
The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.
The Prow Fusion Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use Prow Fusion implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the Prow Fusion Delivery System) used for its implantation. The implant is made from PEEK enriched with carbon fibers (CFPEEK) and titanium alloy. The implant features multiple CFPEEK mid segments and titanium end segments. The segments are serrated on the superior and inferior surfaces and are attached with titanium pins.
The Prow Fusion intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by ultra high molecular weight poly ethylene (UHMWPE) suture. The suture is used to pull the distal segment proximally to form a ring-shaped, closed-configuration implant in the disc space.
The NLT SPINE Prow Fusion device is an intervertebral body fusion device. The acceptance criteria and the study that proves the device meets the acceptance criteria are summarized below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|---|---|
| Mechanical Performance | ASTM F2077 | "Equivalent performance and safety as compared to the claimed predicates" | Conducted and compared to predicate devices | Performance data per ASTM F2077 |
| - Static axial compression | Comparable to predicate devices | Met requirements | Performance data per ASTM F2077 | |
| - Static compression shear | Comparable to predicate devices | Met requirements | Performance data per ASTM F2077 | |
| - Static torsion | Comparable to predicate devices | Met requirements | Performance data per ASTM F2077 | |
| - Dynamic axial compression | Comparable to predicate devices | Met requirements | Performance data per ASTM F2077 | |
| - Dynamic compression shear | Comparable to predicate devices | Met requirements | Performance data per ASTM F2077 | |
| - Dynamic torsion | Comparable to predicate devices | Met requirements | Performance data per ASTM F2077 | |
| ASTM F2267 (Subsidence) | Comparable to predicate devices | Met requirements | Performance data per ASTM F2267 | |
| Expulsion Testing | Comparable to predicate devices | Met requirements | Expulsion and wear testing | |
| Wear Testing | Comparable to predicate devices | Met requirements | Expulsion and wear testing | |
| Clinical/Usability | Cadaver Testing | "Can be used as intended by the intended user population per its labeling following a standard training program." | Demonstrated substantial equivalence to predicates | Cadaver testing |
| Substantial Equivalence | Overall Safety & Effectiveness | "As safe and effective as its predicate devices." | "Substantially similar indications for use and technological characteristics," and "equivalent performance and safety as compared to the claimed predicates." | Comparison to predicate devices, performance testing |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each mechanical test (ASTM F2077, F2267, expulsion, wear testing). These are typically laboratory studies, and the provenance would be laboratory-generated data, not human patient data, unless explicitly stated otherwise.
For the cadaver testing, the sample size is also not specified. Cadaver testing is a prospective evaluation of device usability. The geographic origin of the cadavers or the testing facility is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. For mechanical testing, the "ground truth" is defined by the ASTM standards themselves and the test results obtained. For cadaver testing, the "ground truth" (that the device can be used as intended) would be established by the observations and assessments of the performing surgeons or evaluators, whose specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
This information is not provided. For mechanical testing, adjudication typically involves adherence to standard operating procedures and data analysis. For cadaver testing, the method of assessing "can be used as intended" is not described, so an adjudication method is not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and mechanical testing, not through a human-in-the-loop study comparing human reader performance with and without AI assistance.
6. If a Standalone Performance Study Was Done:
Yes, standalone performance (algorithm only performance, in this context, refers to the device's mechanical and functional performance independent of a specific human-in-the-loop clinical trial) was done. The ASTM F2077 and F2267 tests, expulsion, and wear testing evaluate the device's inherent mechanical properties and durability.
7. The Type of Ground Truth Used:
- Mechanical Performance Tests (ASTM F2077, F2267, expulsion, wear): The ground truth is based on engineering principles and established industry standards for intervertebral body fusion devices, with "acceptance" being defined by meeting requirements comparable to predicate devices.
- Cadaver Testing: The ground truth is based on the functional demonstration of the device's intended use by the intended user population, verifying that the device can be properly implanted and functions as expected in a simulated surgical environment.
8. The Sample Size for the Training Set:
This information is not applicable. This device is not an AI/ML (Artificial Intelligence/Machine Learning) device requiring a "training set" in the conventional sense. The "training" for this device would refer to the standard engineering design and iterative testing processes, not a dataset for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no "training set" in the AI/ML context for this device. The design and validation of the device rely on engineering principles, material science, and established biomechanical testing methods.
§ 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.