(201 days)
The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.
The SternaLock® 360 Sternal Closure System is comprised of rigid fixation and cerclage technologies to approximate the sternal halves, provide bone compression, and rigidly fixate bone in one device. The cerclage aids in distributing forces around the sternal bone as well as reducing loss of fixation due to cut-through in bone. Implantable components include a metallic plate pre-assembled to a polymer-coated metallic band; the plate is rigidly fixated to bone through locking screws. The SternaLock® 360 plates are manufactured from Commercially Pure Titanium: the band is manufactured from Commercially Pure Titanium and coated with Parvlene-C: the band locking mechanism is manufactured from Titanium Alloy (Ti-6Al-4V); the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V); and the needle (not implantable) is manufactured from Stainless Steel.
This document describes the SternaLock® 360 Sternal Closure System and its substantial equivalence to a predicate device (K121302, Biomet Microfixation Sternal Closure System). The submission is a 510(k) premarket notification, which means the device seeks to demonstrate that it is as safe and effective as a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance data and states that "All non-clinical performance testing passed according to the acceptance criteria and the proposed device was found to be statistically equivalent or stronger in all testing than the predicate device." However, the specific quantitative acceptance criteria values for each test are not explicitly detailed in this summary. Instead, it broadly states that the new device met or exceeded the performance of the predicate.
| Test Type | Acceptance Criteria (Not explicitly stated in quantitative terms) | Reported Device Performance |
|---|---|---|
| Single Implant Static Testing | (Implicitly: Performance equivalent to or better than predicate) | Passed acceptance criteria; statistically equivalent or stronger than predicate. |
| Single Implant Fatigue Testing | (Implicitly: Performance equivalent to or better than predicate) | Passed acceptance criteria; statistically equivalent or stronger than predicate. |
| 3-Implant Construct Static Testing | (Implicitly: Performance equivalent to or better than predicate) | Passed acceptance criteria; statistically equivalent or stronger than predicate. |
| 3-Implant Construct Fatigue Testing | (Implicitly: Performance equivalent to or better than predicate) | Passed acceptance criteria; statistically equivalent or stronger than predicate. |
| MR Compatibility Testing | (Implicitly: Meets established MR compatibility standards) | Passed acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical performance data from mechanical testing. The "test set" in this context refers to the samples of the device components and configurations used in these mechanical tests.
- Sample Size: The exact number of samples for each test type (Single Implant Static, Single Implant Fatigue, 3-Implant Construct Static, 3-Implant Construct Fatigue) is not specified in this summary. It mentions "a single SternaLock® 360 banded-box plate was compared to a single SternaLock® Blu box-shape plate" and "A recommended configuration for SternaLock® 360 (banded-box, banded-box) was compared to a recommended configuration for SternaLock® Blu (L-shape, X-shape, X-shape)." This implies at least a few samples for each configuration for comparison, but the precise numbers are not provided.
- Data Provenance: The data is from non-clinical (mechanical) testing performed by Biomet Microfixation. No information about country of origin for data or retrospective/prospective nature is applicable as it's not clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This section is not applicable as the study described is a non-clinical, mechanical performance study comparing the device to a predicate. It does not involve human expert interpretation or ground truth establishment in the clinical diagnostic sense.
4. Adjudication Method for the Test Set:
This section is not applicable as the study described is a non-clinical, mechanical performance study. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation or similar studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
This section is not applicable as the device is a physical medical implant (Sternal Closure System), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used:
For the non-clinical performance studies, the "ground truth" or reference for comparison was the mechanical performance of the legally marketed predicate device (K121302, Biomet Microfixation Sternal Closure System). The goal was to demonstrate equivalence or superiority in mechanical properties.
8. The Sample Size for the Training Set:
This section is not applicable as the device is a physical medical implant and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable as the device is a physical medical implant and not an AI/ML algorithm.
§ 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.