(65 days)
The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.
The Precision Spine Interspinous Plate System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.
The screws are available in multiple variations of fixed or variable angle. All lengths are provided in Ø4.0mm for primary use, or Ø4.5 mm rescue use. They have self-drilling and selftapping threads. The screws are type II anodized in varying colors depending on the length and diameter. The plate has a tear drop shaped anti-back out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation to stop implant dislocation/ migration.
This document describes the Precision Spine Interspinous Plate System, a medical device. As such, acceptance criteria and performance data are related to the mechanical and biomechanical properties of the device, not to an AI/ML algorithm. Therefore, many of the requested categories in your prompt are not applicable.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria for biomechanical tests. Instead, it states that the device's strength was found to be "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the acceptance criteria are implicitly met by demonstrating substantial equivalence to the performance of predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biomechanical Static Strength | Sufficient for intended use; substantially equivalent to predicate devices. |
| Biomechanical Dynamic Strength | Sufficient for intended use; substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the biomechanical tests.
- Data Provenance: The tests were conducted internally by Precision Spine or a contracted lab, as it falls under "Performance Data" from the manufacturer. It is a prospective study design as the tests are conducted to demonstrate performance of the new device. The country of origin of the data is not specified, but the manufacturer is based in Pearl, MS, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical implant, and its performance is evaluated through engineering tests (static and dynamic biomechanical testing), not through expert clinical interpretation or ground truth derived from expert consensus on medical images or patient outcomes.
4. Adjudication method for the test set:
- Not Applicable. As above, this is a physical device subject to engineering and biomechanical testing, not clinical adjudication of interpretations.
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 device is a physical implant, not an AI/ML algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical implant, not an AI/ML algorithm.
7. The type of ground truth used:
- Engineering/Biomechanical Testing Standards: The "ground truth" for the device's performance is established by the results of standardized biomechanical static and dynamic testing. The implicit "ground truth" for substantial equivalence is the performance observed in predicate devices, which likely also underwent similar testing against established standards.
8. The sample size for the training set:
- Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a 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.