(55 days)
The Spinal Simplicity HA Minuteman G3 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:
- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
- spondylolisthesis;
- trauma (i.e., fracture or dislocation); and/or
- tumor.
The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).
The HA Minuteman G3 MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include several spikes at the ends of each Plate for attachment to the spinous processes. The HA Minuteman G3 device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3 is made from Ti6Al4V (per ASTM F1472) and Ti6Al4V ELI (per ASTM F136) and has a hydroxyapatite coating (per ASTM F1185) at the distal regions of the plate.
The FDA Premarket Notification (510(k)) K151741 for the Spinal Simplicity HA Minuteman G3 MIS Fusion Plate does not contain the typical information about acceptance criteria and study design for AI/Software as a Medical Device (SaMD) as requested in the prompt. This document pertains to a physical medical device (spinal implant) and focuses on demonstrating substantial equivalence to a predicate device based on material characterization and mechanical testing, not software performance.
Therefore, I cannot fulfill the request for information on acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the content of the provided document.
The document discusses the following:
1. A table of acceptance criteria and the reported device performance:
This information is not presented in a table format for a "device performance" in the way one would for a diagnostic AI. Instead, the document describes characterization of the HA powder and coating, and mechanical testing.
| Acceptance Criteria (Implied) | Reported Performance |
|---|---|
| HA powder characterization: Particle size, Ca/P ratio, elemental analysis, solubility, dissolution products/rates, XRD pattern (ASTM F2024), FTIR spectra | "functioned as intended and the results observed were as expected." |
| HA coating characterization: Porosity, thickness (via SEM), Ca/P ratio, elemental analysis, static shear strength (ASTM F1160), static tensile strength (ASTM 1147), solubility, dissolution products/rates, XRD pattern (ASTM F2024), FTIR spectra | "functioned as intended and the results observed were as expected." |
| Mechanical strength: Substantially equivalent to predicate device (per ASTM F1717) | "demonstrated that the HA Minuteman G3 presents substantially equivalent mechanical strength compared to the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is not a study involving patient data or test sets for an AI. The testing described relates to material properties and mechanical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This document does not describe a study involving expert assessment or ground truth establishment in the context of an AI/SaMD.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here would be established scientific standards for material characterization and mechanical testing.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.