(78 days)
Biomet Microfixation SternaLock Blu Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures
Biomet Microfixation Sternal Closure System contains plates and 2.4mm and 2.7mm diameter self-drilling screw with maximum length of 20mm. The screw is designed so that a predrilled hole is not required, but may be used.
The provided text describes a 510(k) premarket notification for the Biomet Microfixation Sternal Closure System. The acceptance criteria and the study proving it meets these criteria are outlined in the "Substantial Equivalence" section of the document.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Requirement) | Reported Device Performance |
|---|---|
| Meet or exceed parameters of predicates for Torsional insertion and fracture test. | Exceeded Requirements |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "mechanical testing" and "the devices" which implies a sample of devices were tested, but the specific number is not provided.
- Data Provenance: Not explicitly stated. However, given that it's mechanical testing of a medical device, it would be considered prospective testing performed in a controlled laboratory setting. The origin isn't specified beyond being conducted by Biomet Microfixation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for this type of mechanical testing is based on established engineering parameters and predicate device performance, not expert human interpretation.
- Qualifications of Experts: N/A
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. The tests are objective mechanical measurements, not subjective evaluations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This is a medical device (sternal closure system) involving physical implantation and mechanical performance, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
- Effect Size: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- The ground truth for the mechanical testing (Torsional insertion and fracture test) was based on: Established engineering parameters and the performance characteristics of predicate devices. The new device was required to "Meet or exceed parameters of predicates."
8. The sample size for the training set:
- Sample Size: Not applicable. This document describes mechanical testing for a physical implant, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.