(69 days)
The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
When used as non pedicular fixation system:
The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:
- Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis
- Fracture
- Spinal deformities such as scoliosis, kyphosis, lordosis
- Tumor
- Revision of failed fusion attempts
- Pseudarthrosis
- Spinal stenosis
When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.
The subject ISSYS LP Polyaxial Spinal Fixation System includes 5.5 mm diameter rods (preformed rod or straight rod configuration) in addition to the selection of the cleared 6.0 mm and 6.35 mm diameter rods. It is to be used with both the Polyaxial and Monoaxial screws.
This is a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, much of the requested information regarding AI device performance, such as sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies, is not applicable. The provided document focuses on demonstrating substantial equivalence to predicate devices through material, design, and performance data for a new component (5.5 mm diameter rod) of an existing spinal fixation system.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (How the device performed) |
|---|---|
| Compliance with FDA's Guidance For Spinal System 510(k) | "Engineering analysis and testing to demonstrate compliance with FDA's Guidance For Spinal System 510(k) May 3, 2004 was completed for the ISSYS LP Spinal Fixation System, included the subject component." |
| Material Properties | "Manufactured from ASTM F-136 implant grade titanium alloy." This implicitly implies the material meets the acceptance criteria for implant grade titanium alloy as defined by ASTM F-136. |
| Mechanical Performance as per ASTM F 1717 | "Performance data per ASTM F 1717 were submitted to characterize the subject ISSYS™ LP Spinal Fixation System components address in this notification." This indicates that the device's mechanical performance was tested according to this standard, and the submitted data (though not detailed here) would demonstrate compliance with the standard's requirements for spinal implant constructs. |
| Substantial Equivalence to Predicate Devices (Material) | "Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of material..." |
| Substantial Equivalence to Predicate Devices (Design) | "Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of... design..." |
| Substantial Equivalence to Predicate Devices (Indications) | "Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of... indications for use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission is for a physical medical device (spinal fixation system component), not a diagnostic algorithm that uses a "test set" of data in the typical sense. The "testing" refers to mechanical and material characterization.
- Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance refers to materials testing and engineering analysis performed according to recognized standards (ASTM F-136, ASTM F 1717). This would typically be conducted in a laboratory setting by the manufacturer or contracted labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is not an AI/ML device requiring expert-established ground truth from clinical data. The "ground truth" for this device relates to established engineering standards for material properties and mechanical performance.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication method" as would be used for clinical data interpretation. Compliance is assessed against engineering standards.
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 not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this medical device submission is based on:
- Established engineering and material standards: Specifically, ASTM F-136 for material composition (implant grade titanium alloy) and ASTM F 1717 for mechanical performance of spinal implant constructs.
- FDA Guidance: The device's design and testing adhered to the "FDA's Guidance For Spinal System 510(k) May 3, 2004."
- Predicate Device Characteristics: The core of a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices in terms of material, design, and indications for use. The characteristics of these predicate devices serve as a benchmark.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device.
§ 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.