(100 days)
The Life Spine Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.
This device is not intended for spinal indications or acetabular cup surgeries. The safety and effectiveness of this device when implanted in the spine have not been established.
The device is a straight or tapered hollow box with a fenestrated surface on many sides. The geometry is designed to contain bone cement. The exterior surface of the device has teeth to prevent the device from migrating from the desired location. The device is manufactured from PEEK-OPTIMA®. The device is made in a variety of sizes. The responsible surgeon will determine the correct size of the device in accordance with the anatomical size of the individual patient.
This document is a 510(k) summary for a medical device (Life Spine Cement Restrictor), which primarily establishes substantial equivalence to a predicate device rather than presenting a study demonstrating performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not directly applicable or available in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. For a 510(k) submission, the primary "acceptance criterion" is typically demonstrating substantial equivalence to a legally marketed predicate device, not meeting specific performance metrics defined by the applicant. The document states:
"This is designated as a non-load bearing Class II device under CFR 21 878.3300 and no mechanical tests are required."
"The biocompatibility of this material for implantable contact over 30 days has been certified to ISO 10993 by the manufacturer of PEEK-OPTIMA®, Invibio."
So, the "performance" described is about material compliance and biocompatibility already established for the material itself, not the specific device's performance through new testing.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/provided. No specific test set data is presented for direct evaluation of the device's performance against acceptance criteria in a study. The demonstration of safety and effectiveness relies on substantial equivalence and material certifications.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/provided. There was no study requiring expert ground truth establishment for this 510(k) submission.
4. Adjudication Method
This information is not applicable/provided. No studies requiring adjudication were conducted for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable/provided. This device is a physical implant, not an AI or imaging-based diagnostic tool, so an MRMC study is irrelevant.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
This information is not applicable/provided. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used
This information is not applicable/provided for the device itself. The "ground truth" here is the established safety and effectiveness of the predicate device and the material from which both are made, as demonstrated by the predicate device's market history and the material manufacturer's certifications.
8. Sample Size for the Training Set
This information is not applicable/provided. There was no "training set" as this is not an AI/algorithmic device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. No training set was used.
Summary of Device Acceptance and "Study" (as described in the document):
The acceptance of the Life Spine Cement Restrictor is based on demonstrating substantial equivalence to a previously cleared device, the SIGNUS Medical RABEA™ Cement Restrictor, regarding its intended use, design, function, and materials.
The "study" or evidence provided to meet this acceptance criterion is:
- Comparison to a Predicate Device: The Life Spine Cement Restrictor is compared in design, function, and materials to the legally marketed SIGNUS Medical RABEA™ Cement Restrictor (K993077).
- Material Certification: Both devices are manufactured from PEEK-OPTIMA®. The biocompatibility of this material for implantable contact over 30 days was certified to ISO 10993 by the material manufacturer, Invibio. This certification, held in a Device Master File by the FDA, serves as evidence for the material's safety.
- Regulatory Classification: The device is classified as a non-load bearing Class II device (CFR 21 878.3300), which means no mechanical tests were explicitly required for this submission.
Therefore, the "acceptance criteria" were met by showing:
- The device is materially and functionally equivalent to a previously cleared device.
- The material used is biocompatible according to established standards (ISO 10993), as certified by the material manufacturer.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.