(75 days)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
The Ballista instruments are intended to be used with the 5.5 Polaris implants. The Ballista instruments when used with the Ballista cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.
The Accu Vision Instruments, when used with the Polaris Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, The Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
This submission is a line extension to Polaris Spinal System to add 6.35 titanium uniplanar screws to the system.
The provided document describes a 510(k) premarket notification for the Biomet Spine Polaris Spinal System, specifically a line extension to add 6.35 titanium uniplanar screws. This document focuses on demonstrating substantial equivalence to existing predicate devices through mechanical testing, rather than presenting a study of an AI/ML device meeting acceptance criteria.
Therefore, most of the requested information regarding AI/ML device performance, ground truth establishment, expert adjudication, and comparative effectiveness studies is not applicable to this document.
Here's an analysis based on the provided text, focusing on the mechanical testing performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that mechanical testing was conducted "in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004." It also mentions "ASTM 1717-04, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model."
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Meets mechanical test requirements based on ASTM 1717-04 for static compression bending, static torsion, and dynamic compression bending fatigue. | "met all mechanical test requirements based on the worst-case construct testing." |
| Substantially equivalent to other spinal systems currently on the market regarding mechanical performance. | "verifies that the subject device is substantially equivalent to other spinal systems currently on the market" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the mechanical tests. It refers to "worst-case construct testing," implying that representative samples of the new 6.35 titanium uniplanar screws within the Polaris Spinal System were tested.
- Sample Size: Not explicitly stated, but based on "worst-case construct testing" in accordance with industry standards.
- Data Provenance: The testing was conducted by Biomet Spine or a contracted lab, likely in the United States (given the applicant's address and FDA submission). It is a prospective test specifically designed to support the 510(k) submission for the new components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the "ground truth" for mechanical testing is defined by established engineering standards (ASTM 1717-04) and FDA guidance for spinal systems, not expert human interpretation. The "ground truth" in this context is whether the physical properties of the device meet the specified mechanical performance thresholds.
4. Adjudication Method for the Test Set
This question is not applicable. Mechanical tests are objective measurements against defined criteria. There is no human adjudication process in the same way there would be for image interpretation or clinical outcomes.
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
This question is not applicable. This is a submission for a medical device (spinal fixation system), not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a submission for a medical device (spinal fixation system), not an AI/ML algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is mechanical endurance and strength defined by established industry standards (ASTM 1717-04) and FDA guidance for spinal systems. The device must meet these predefined physical performance specifications to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of mechanical testing for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. Similarly, there is no "training set" or corresponding ground truth establishment process in this context.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.