(34 days)
The U & I Spinal Hook and Rod System intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The U & I Spinal Hook and Rod System can be used in coniunction with the OPTIMA Spinal System or the GLOBAL Spinal Fixation System.
The U&I America, Spinal Hook System ™ is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors, and a transverse (cross) linking mechanism. The Spinal Hook System ™ implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The U&I America, Spinal Hook System ™ can be used in the posterior plane providing unilateral and bilateral modes of fixation.
The U&I America, Spinal Hook System ™ design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic (spinal) location and orientation.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Spinal Hook System ™ implants.
The U&I America, Spinal Hook System™ is a spinal fixation system. Based on the provided 510(k) summary, the device's acceptance criteria and the study proving it meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical equivalence to predicate devices | "Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." |
| Material conformity to industry standards | Fabricated from titanium alloy (Ti-6AL-4V ELI) that conforms to ASTM F 136. |
| Design equivalence to predicate devices | "The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices." |
| Operational principles equivalence to predicate devices | "The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles." |
| Safe and effective for stated indications | "From the foregoing, we conclude that the subject U&I America, Spinal Hook System ™ device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document refers to "Bench testing as listed in Section XII". However, the specific sample size used for the test set is not explicitly stated in the provided text. The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be laboratory data (bench testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable or provided as the device is a physical medical device (spinal implant) and its performance is evaluated through mechanical bench testing, not through expert review of medical images or patient data.
4. Adjudication Method for the Test Set:
This information is not applicable or provided as the evaluation is based on objective bench testing against ASTM standards, not on subjective human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MrMC comparative effectiveness study was done. This type of study is typically used for AI-powered diagnostic devices where human readers' performance with and without AI assistance is compared. This document describes a physical spinal implant device tested through bench testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This information is not applicable or provided. As above, this pertains to AI/software performance, not a physical implant. The "performance" described is the mechanical integrity and material properties of the device itself.
7. Type of Ground Truth Used:
The ground truth used for the device's performance evaluation is established mechanical standards (ASTM F1717) and material specifications (ASTM F136). The performance is compared to these objective standards and to the performance of legally marketed predicate devices.
8. Sample Size for the Training Set:
This concept is not applicable to this type of medical device (physical spinal implant). Training sets are used for machine learning algorithms. The manufacturing process of a physical device does not involve a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as in point 8.
§ 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.