(29 days)
The PROW FUSION Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through SI in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of 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 and titanium alloy. The implant features 4 PEEK mid segments and titanium end segments has coarse surface 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 PEEK strip is used to pull the distal segment proximally to form a ring-shaped, closed-configuration implant in the disc space.
This document is a 510(k) Summary for the PROW FUSION intervertebral body fusion device. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, much of the requested information regarding acceptance criteria, specific study design details, ground truth establishment, expert involvement, and reader studies is not typically found in this type of regulatory submission.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a formal table of acceptance criteria with specific quantitative thresholds or a direct report of the device's performance against such criteria. The "Performance Data" section broadly states that "Performance testing, including static axial compression testing per ASTM F2077, cadaver testing, and deployment force testing demonstrated that the PROW FUSION is substantially equivalent to its predicate PROW FUSION (K130254)."
The acceptance criterion, by inference, is that the device demonstrates substantial equivalence in its performance characteristics to the predicate device (K130254). The reported "performance" is that this substantial equivalence was demonstrated through the stated tests.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Static axial compression performance equivalent to predicate (per ASTM F2077). | Demonstrated substantial equivalence. |
| Cadaveric performance equivalent to predicate. | Demonstrated substantial equivalence. |
| Deployment force performance equivalent to predicate. | Demonstrated substantial equivalence. |
| No new questions of safety and effectiveness compared to the predicate regarding modifications (intermediate diameter/heights, instrumentation). | No new questions of safety and effectiveness raised. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes (e.g., number of test articles, cadavers) used for the static axial compression testing, cadaver testing, or deployment force testing. It also does not state the provenance of any data (e.g., country of origin, retrospective/prospective). This level of detail is usually found in the full technical report, not the 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a mechanical device performance test, the concept of "ground truth" and "experts" as in clinical or interpretive studies (e.g., radiologists) is not applicable. The "ground truth" for mechanical testing is derived from the objective physical measurements and engineering specifications, often interpreted against established standards (like ASTM F2077).
4. Adjudication Method for the Test Set
Not applicable for mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms where human readers interpret results, and the document describes an intervertebral body fusion device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an algorithm, so this question is not applicable. The performance testing conducted (static axial compression, cadaver testing, deployment force) can be considered "standalone" in the sense that it assesses the device's physical properties and function without human intervention in its operation during the test, but it is not "algorithm only" performance.
7. The Type of Ground Truth Used
For the performance testing:
- Static axial compression testing: The ground truth is established by the specified mechanical properties and failure criteria outlined in the ASTM F2077 standard, and comparison to the predicate device's performance under the same standard.
- Cadaver testing: The ground truth would be based on the observed mechanical stability, insertion characteristics, or other defined metrics within the cadaveric model, compared to the predicate.
- Deployment force testing: The ground truth would be the measured forces and comparison to predicate or specified engineering targets.
8. The Sample Size for the Training Set
This device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.