(106 days)
The Life Spine Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Laminoplasty System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
The Life Spine Laminoplasty System consists of plates screws in various diameters and lengths to support a laminoplasty procedure. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.
The provided text describes the 510(k) premarket notification for the Life Spine Laminoplasty System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through material composition and mechanical performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Test Standard & Result) |
|---|---|
| Material Composition | Material: Titanium alloy 6AL-4V-ELI per ASTM F-136. |
| Criterion Met: Same material used in predicate devices. | |
| Static Four Point Bending Strength | Test Standard: ASTM F2193-02 (part of the testing performed). Result: Not explicitly stated, but implies meeting predicate performance for substantial equivalence. |
| Dynamic Four Point Bending Performance | Test Standard: ASTM F2193-02 (part of the testing performed). Result: Not explicitly stated, but implies meeting predicate performance for substantial equivalence. |
| Static Screw Pull-Out Strength | Test Standard: ASTM F543 (part of the testing performed). Result: Not explicitly stated, but implies meeting predicate performance for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text details mechanical performance testing to demonstrate substantial equivalence, not a clinical study on human subjects. Therefore, the concepts of "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) are not applicable here.
- Sample Size for Mechanical Testing: Not explicitly stated. For mechanical testing, the "sample size" would refer to the number of devices or components tested to achieve statistical significance according to the ASTM standards.
- Data Provenance: Not applicable as this is engineering performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" here is mechanical performance according to established ASTM standards, which are engineering metrics, not interpretations by medical experts.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements against a standard, not subject to adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (spinal fixation system), and the testing described is mechanical performance testing to ensure the device itself meets structural and material requirements for its intended use, demonstrating equivalence to already cleared devices. It is not an AI-enabled diagnostic tool requiring human reader performance analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering standards and established performance of predicate devices. The device's material properties and mechanical performance (e.g., strength, durability) are compared against the requirements of ASTM F2193-02 (Four Point Bending) and ASTM F543 (Screw Pull-Out) and the known performance characteristics of the predicate devices (Medtronic Centerpiece, Stryker Escalate, Synthes Arch).
8. The Sample Size for the Training Set
Not applicable. This submission does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned or implied in this submission.
§ 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.