(263 days)
The Spinal Simplicity Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
· Lumbar spinal stenosis;
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- · spondylolisthesis;
- · trauma (i.e., fracture or dislocation); and/or
• tumor.
The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
The Minuteman G5 consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include gripping features on the boneinterfacing surfaces of each Plate for attachment to the spinous processes. The Minuteman G5 device is available in multiple sizes to accommodate varying patient anatomy. The Minuteman G5 is made from titanium alloy Ti6A14V ELI and has a hydroxyapatite coating on the distal regions of the device.
The provided text is a 510(k) premarket notification for a medical device called the "Minuteman G5 MIS Fusion Plate." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with strict acceptance criteria often seen with novel Class III devices or AI/imaging software.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/imaging software device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance (for an AI system)
- Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for an AI study.
- Information on MRMC comparative effectiveness studies or standalone performance for an AI system.
- Details about training sets or how ground truth was established for training (relevant for AI).
Instead, this document focuses on mechanical performance testing for a physical implantable device. The "Performance Data" section discusses:
- Mechanical Testing: ASTM F1717 Static Axial Compression, ASTM F1717 Dynamic Axial Compression, Custom Static Plate Dissociation, and Cadaveric Fatigue Testing.
- Device Material: Titanium alloy Ti6Al4V ELI with a hydroxyapatite coating.
- Comparison to Predicate: The data "demonstrates that the subject Minuteman G5 device presents substantially equivalent mechanical performance compared to the predicate device."
To answer your request based on the provided text, while acknowledging it's not about AI/imaging software and thus most of your specific questions are not applicable:
Acceptance Criteria and Study for Minuteman G5 MIS Fusion Plate (Based on Provided Document)
The "Minuteman G5 MIS Fusion Plate" is a physical implantable medical device, not an AI or imaging software. Its acceptance criteria and study proving it meets them are primarily based on demonstrating substantial equivalence to an existing predicate device through mechanical performance testing, rather than clinical efficacy or accuracy in the way an AI system would be evaluated.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of specific acceptance criteria values (e.g., "Load X must withstand Y N of force") or exact reported performance values. Instead, it indicates that the device's performance in standard mechanical tests was substantially equivalent to the predicate device.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Mechanical Performance | Substantially equivalent to predicate device (Spinal Simplicity's HA Posterior Fusion Plate (K212781)). |
| ASTM F1717 Static Axial Compression | Deemed equivalent to predicate. |
| ASTM F1717 Dynamic Axial Compression | Deemed equivalent to predicate. |
| Custom Static Plate Dissociation | Deemed equivalent to predicate. |
| Cadaveric Fatigue Testing | Deemed equivalent to predicate. |
| Biocompatibility/Sterility | Will undergo bacterial endotoxin testing; made from Ti6Al4V ELI with HA coating. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the mechanical tests (e.g., number of devices tested for ASTM F1717). The data provenance is implied to be from laboratory mechanical testing and cadaveric testing, typical for orthopedic implants. No country of origin for data is specified, but as an FDA submission, the tests would conform to U.S. or international standards recognized by the FDA. The data is inherently prospective in the context of device testing before market clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This question is not applicable to a physical mechanical device test. There is no concept of "experts establishing ground truth" in the way an AI algorithm analyzes medical images. The "ground truth" for mechanical testing is defined by the physical properties measured under specified test conditions according to ASTM standards.
4. Adjudication Method for the Test Set
Not applicable. Mechanical tests follow predefined protocols and objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
Not applicable. This is a study type for AI/imaging software, not for a physical implantable device.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was Done
Not applicable. This concept pertains to AI algorithms.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established by objective mechanical performance metrics (e.g., load to failure, fatigue life) measured according to industry-standard test protocols (ASTM F1717, Custom Static Plate Dissociation, Cadaveric Fatigue Testing). The "ground truth" is that the device performs mechanically equal to or better than the predicate device under these standardized conditions.
8. The Sample Size for the Training Set
Not applicable. There is no AI model or "training set" for this physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable since there is no AI model or training set.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.