(134 days)
The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.
The Suspension™ Clavicle Fracture Fixation System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from 316L Stainless Steel.
The device consists of the following implantable components (some or all of which may be used based on the nature of the injury):
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- Three (3) Sizes of Clavicle Fracture Plate for Each Shoulder (i.e. small, medium, and large; each with Left & Right).
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- Eight (8) Lengths each of 2.7mm Non-Locking & Locking Bone Screws.
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- Eight (8) Lengths each of 3.5mm Non-Locking & Locking Bone Screws.
Implantable components are included in a surgical tray that must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but these components are for single use only.
The implants are used with instrumentation including:
- Hex Driver .
- o Handle and a 2.5mm hex driver for hand tightening bone screws
- Assorted Drill bits .
- o To create pilot holes for bone screws. The drill bits are compatible with most AO connections.
- Drill Guide Assemblies .
Here's an analysis of the provided 510(k) summary regarding the Suspension™ Clavicle Fracture Fixation System, focusing on acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance | Study Type/Evidence |
|---|---|---|---|---|
| Biocompatibility | Material Selection | Material is commonly used for orthopedic implants with a long history of biocompatibility. | 316L Stainless Steel is commonly used for orthopedic implants with a long history of biocompatibility. | Material analysis, common knowledge in orthopedics |
| Mechanical Performance | Torsional Strength | Equivalent to predicate device. | Performed in a manner equivalent to predicate devices. | Non-clinical testing |
| Mechanical Performance | Torsional Break | Equivalent to predicate device. | Performed in a manner equivalent to predicate devices. | Non-clinical testing |
| Mechanical Performance | Four Point Bending | Equivalent to predicate device. | Performed in a manner equivalent to predicate devices. | Non-clinical testing |
| Mechanical Performance | Screw Driving Torque | Equivalent to predicate device. | Performed in a manner equivalent to predicate devices. | Non-clinical testing |
| Comparative Analysis | Predicate Comparison | Substantially equivalent to predicate device (Smith & Nephew Peri-Loc locking bone plates, locking and non-locking bone screws for the upper extremity - K061352) in materials, sterility, and performance. | "The subject devices are substantially equivalent to the predicate devices. Both the subject device and predicate device have indications for clavicle... The devices are composed of the same materials, and have the same sterility. The devices are used with 3.5mm and 2.7mm locking or non-locking screws." | Predicate Device Comparison Analysis |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing (e.g., mechanical tests like torsional strength, bending, screw driving torque) and a predicate device comparison analysis. These types of tests typically do not involve human subject data or "test sets" in the sense of clinical trials. The sample sizes for these mechanical tests are not specified in the summary, but would refer to the number of devices or components tested. The data provenance is internal to the manufacturer's testing facility.
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 evaluations were based on engineering and material science principles, and comparison to a predicate device, not on expert consensus of clinical data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as there was no clinical test set requiring ground truth adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. This device is a physical orthopedic implant, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical mechanical tests, the "ground truth" is defined by established engineering standards and comparative performance against the legally marketed predicate device. For the predicate comparison, the ground truth is the established safety and effectiveness profile of the predicate device (Smith & Nephew Peri-Loc locking bone plates, locking and non-locking bone screws for the upper extremity - K061352).
8. The Sample Size for the Training Set
This information is not applicable. This is a physical orthopedic implant, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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.