(163 days)
The Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-L5) as an adjunct to anterior interbody fusion and bone graft. The indications for the spinous process plate include spinal trauma, degenerative spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.
The Tandem system consists of spinous process plates and interconnecting male and female grommets. The implants are used in combination with a vertebral body replacement device such as the Spinal Concepts, Inc. InFix System. The plates feature a slim profile, several rows of spikes, and holes on each end with a spherical seat for grommet attachment. The spikes around the plate holes resist plate rotation after implantation, while a row of spikes over the intraspinous ligament aids in fixation to any optional bone graft.
It appears there might be a misunderstanding regarding the nature of the provided document. The text is a 510(k) summary for a medical device (Spinal Concepts, Inc. Tandem Spinous Process Plate System), which is a premarket notification to the FDA.
This document describes a mechanical surgical implant and its regulatory approval process, not an AI or software-based device that would typically have "acceptance criteria" and be "proven to meet the acceptance criteria" through clinical studies in the way you've outlined with terms like "test set," "ground truth," "MRMC," or "standalone performance."
For this type of device, "acceptance criteria" are generally related to its physical and functional properties, and "proof" comes from mechanical testing and demonstrating substantial equivalence to a predicate device.
Given this context, I cannot provide the information in the format requested as it's not applicable to this document. However, I can extract the relevant information pertaining to the device's assessment from the provided text:
Summary of Device Assessment from K040096: Spinal Concepts, Inc. Tandem Spinous Process Plate System
1. Acceptance Criteria and Reported Device Performance (as inferred for a mechanical device):
| Acceptance Criteria (Inferred for a Mechanical Implant) | Reported Device Performance (from K040096) |
|---|---|
| Functional requirements under normal physiologic loads | "Mechanical testing demonstrated that the Tandem System exhibits the functional requirements to support its use as a spinous process plate system under normal physiologic loads in the spine." |
| Substantial Equivalence to Predicate Device | The FDA determined the device is "substantially equivalent...to legally marketed predicate devices." |
| Adherence to relevant regulations | The FDA states the device is subject to general controls and warns of other requirements (registration, listing, GMP, labeling, etc.). |
2. Sample size used for the test set and the data provenance:
- Not applicable in the way specified. For this mechanical device, the "test set" would refer to physical prototypes or samples subjected to mechanical stress tests. The document does not specify the number of samples used in these tests.
- Data Provenance: The mechanical test data would be generated in a lab setting, likely by the manufacturer (Spinal Concepts, Inc.). The exact country of origin for the testing is not specified, but the manufacturer is based in Austin, TX, USA. The testing would be prospective in the sense that the device was tested to demonstrate its capabilities before widespread use.
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. The "ground truth" for a mechanical device like this is established through engineering principles, material science, and biomechanical standards, not expert consensus on images or clinical outcomes in the same way an AI device would be evaluated. The mechanical performance itself (e.g., load-bearing capacity, fatigue resistance) is the "ground truth" being measured.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant to mechanical testing results. Mechanical test results are typically quantitative and objective measurements.
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. This is a mechanical surgical implant, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This concept is for AI algorithms, not mechanical implants. The device itself (the implant) is the "standalone" product that undergoes testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical devices, the "ground truth" or standard of comparison is typically based on established engineering standards, biomechanical principles, and the performance of predicate devices. The document states:
- "Mechanical testing demonstrated that the Tandem System exhibits the functional requirements to support its use as a spinous process plate system under normal physiologic loads in the spine." This suggests mechanical properties (strength, stability) as the core "ground truth."
- The FDA determined "substantial equivalence" to a "legally marketed predicate device" (Meurig-Williams Plate). The performance characteristics of the predicate device serve as a benchmark for "ground truth."
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of a mechanical device undergoing mechanical testing or a 510(k) review for substantial equivalence. "Training set" refers to data used to train an AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As there is no "training set" as defined for AI or statistical models, there is no ground truth established for it.
In summary, this document is for a traditional medical device, a surgical implant, and its regulatory clearance is based on mechanical performance and substantial equivalence, not the kind of AI/algorithm performance analysis detailed in your questions.
§ 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.