(68 days)
BASIS™ Screws and Hooks are intended for posterior, non-cervical fixation for the following indications: spinal stenosis; spondylolisthesis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); trauma (i.e., fracture or dislocation); pseudarthrosis; tumor; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
The BASIS™ Spinal System consists of a variety of shapes and sizes of hooks, screws and rods as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
BASIS™ hooks are intended for posterior use only.
The BASIS™ Spinal System implant components are made from medical grade titanium and titanium alloy.
This document is a 510(k) premarket notification for the BASIS™ Spinal System, which seeks to demonstrate substantial equivalence to previously cleared devices. It is not a study that proves the device meets specific acceptance criteria through performance evaluation. Therefore, most of the requested information regarding acceptance criteria and study design is not present in this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not contain acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity) or reported performance metrics. It's a regulatory submission focused on substantial equivalence based on product description and indications for use.
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 a 510(k) submission, which typically relies on comparisons to predicate devices and engineering/bench testing, not clinical performance studies with test sets in the manner of an AI/diagnostic device.
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. No ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is described.
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 spinal implant system, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (spinal implant), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" in the context of diagnostic or AI performance evaluation is not relevant to this 510(k) submission. The "truth" in this context refers to the safety and effectiveness of the device as established through comparison to legally marketed predicate devices and adherence to regulatory standards for medical implants.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there's no ground truth for it.
Summary of what the document does provide:
- Device Name: BASIS™ Spinal System
- Manufacturer: Medtronic Sofamor Danek, Inc. USA
- Regulatory Status: 510(k) premarket notification (K050484), determined substantially equivalent (May 4, 2005)
- Predicate Devices: CD HORIZON® Spinal System screws, hooks and Rods (K042025, K020709 and K981676)
- Indications for Use (Key "Acceptance Criteria" in the context of 510(k) for equivalence): These are the conditions for which the device is intended to be used, and they must be substantially equivalent to the predicate device.
- BASIS™ Screws and Hooks (posterior, non-cervical fixation): spinal stenosis; spondylolisthesis; curvatures (scoliosis, kyphosis, lordosis); trauma (fracture or dislocation); pseudarthrosis; tumor; and/or failed previous fusion.
- BASIS™ Components (except hooks, as anterolateral thoracic/lumbar, or anterior cervical system): spinal stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion.
- Materials: Medical grade titanium and titanium alloy.
The "study that proves the device meets the acceptance criteria" in the context of a 510(k) is the demonstration of substantial equivalence to predicate devices, not a separate clinical performance study with specific metrics like sensitivity or specificity. The entire submission acts as the "proof" that it meets the regulatory "acceptance criteria" for market clearance.
§ 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.