(193 days)
PROW FUSION-V is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
PROW FUSION-V is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.
PROW FUSION-V is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-V is provided in different shapes to fit the anatomical needs of a wide variety of patients and can expand to the desired height or the desired lordosis.
Protrusions on the superior and inferior surfaces of each device grip the endplates of the adiacent vertebrae to resist expulsion. The devices require the use of commercially available supplemental spinal fixation systems.
PROW FUSION-V is manufactured from titanium alloy per ASTM F136.
PROW FUSION-V is to be filled with autogenous bone graft material.
The provided document describes a 510(k) premarket notification for a medical device called "PROW FUSION-V." This type of document is a submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Crucially, a 510(k) submission for an intervertebral body fusion device focuses heavily on mechanical testing and material equivalence rather than clinical study results involving human patients or complex AI algorithm performance. The "Performance Data" section explicitly states that mechanical testing (static and dynamic compression, compression-shear, subsidence) was conducted according to ASTM standards and FDA guidance. A cadaveric study was also done.
Therefore, the information required to answer your specific questions relating to AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for training sets, and expert adjudication as would be found in a study validating a diagnostic AI/ML device, is not present in this document.
Based on the provided document, here's what can be inferred about the "acceptance criteria" and "study" for this type of device:
Acceptance Criteria and Device Performance (Based on the document's focus)
Given that this is a 510(k) for an intervertebral body fusion device, the acceptance criteria relate to its mechanical properties and biocompatibility, demonstrating that it functions similarly to predicate devices.
| Acceptance Criteria (Implied for a 510(k) spinal implant) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Mechanical Performance: | |
| Static Compression Strength (ASTM F2077) | Demonstrated in accordance with ASTM F2077 |
| Dynamic Compression (Fatigue) (ASTM F2077) | Demonstrated in accordance with ASTM F2077 |
| Static Compression-Shear (ASTM F2077) | Demonstrated in accordance with ASTM F2077 |
| Dynamic Compression-Shear (Fatigue) (ASTM F2077) | Demonstrated in accordance with ASTM F2077 |
| Subsidence (ASTM F2267) | Demonstrated in accordance with ASTM F2267 |
| Max Expansion Force | Testing performed |
| Device Functionality in Use: | |
| Proper Placement | Evaluated in cadaveric study |
| Graft Containment | Evaluated in cadaveric study |
| No damage to vertebral endplate | Evaluated in cadaveric study |
| Material Properties/Biocompatibility: | |
| Manufactured from medical-grade material (ASTM F136) | Manufactured from titanium alloy per ASTM F136 |
| Wear Particle Assessment | Testing performed |
| Substantial Equivalence: | |
| Similar technical characteristics, performance, and intended use as predicates | Claimed: "PROW FUSION-V is similar to the predicates with respect to technical characteristics, performance and intended use." |
Absence of Information for AI/ML Device Validation Questions:
The following information is not available in the provided document, as it pertains to the validation of AI/ML algorithms, which is not the subject of this 510(k) for an intervertebral body fusion device.
- Sample sizes used for the test set and the data provenance: Not applicable to this type of mechanical and cadaveric testing. No "test set" in the context of an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a spinal implant is defined by its mechanical properties and successful implantation in cadavers, not expert interpretation of diagnostic images.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This device is not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For this device, ground truth is largely defined by engineering standards (e.g., ASTM F2077, ASTM F2267 for mechanical properties) and anatomical/surgical considerations (evaluated in cadaveric study). It is not "expert consensus, pathology, or outcomes data" in the typical AI/ML sense.
- The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is for a physical medical device (spinal implant) and its regulatory submission (510(k)) primarily relies on non-clinical (mechanical and cadaveric) testing to demonstrate substantial equivalence, rather than clinical studies or AI/ML algorithm validation. Therefore, most of your specific questions related to AI/ML device validation cannot be answered from this text.
§ 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.