(63 days)
This product is mended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive osteolority and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular microgradhia. The device is monded to provide temporary stubilization and gradual lengthening of the crawial, midfacial, or mandibular bones.
This device is a distraction system consisting of the following major components; distractor frame, extension rods, connector forks, distraction port or flexible shaft and distraction key. Depending on the frame is connected to either a distraction port or a flexible shaft, which is covered with a protective sheath.
Here's a breakdown of the acceptance criteria and the study that proves the Guerrero - Bell Distractor meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Metric) | Reported Device Performance (Guerrero - Bell Distractor) | Related Predicate Device(s) for Comparison |
|---|---|---|
| Frame Stiffness (Static Cantilever Bend Test) | Significantly greater than | MULTI-GUIDE™ distractor |
| Significantly greater than | Vazquez-Diner Distractor | |
| Yield Strength (Static Cantilever Bend Test) | Significantly greater than | MULTI-GUIDE™ distractor |
| Lower than | Vazquez-Diner Distractor |
Note on Yield Strength: The submission explicitly states, "It is not anticipated that this difference will have any relevance in the clinical setting because of the low forces observed in patients who are treated with all of these devices." This implies that even though the yield strength was lower than one of the predicates, it still met an implicit (but not explicitly stated as a numerical threshold) clinical relevance criterion.
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes in vitro mechanical testing, not a clinical study involving human or animal subjects. Therefore, the concept of "test set" in terms of patient data or clinical samples (and associated provenance) is not directly applicable.
- Test Set: Multiple instances of the Guerrero - Bell Distractor, Vazquez-Diner Distractor, and MULTI-GUIDE™ distractor were used for the static cantilever bend testing. The exact number of devices tested for each model is not specified, but the use of "average yield strength" implies multiple samples.
- Data Provenance: Not applicable as it's mechanical in vitro testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for mechanical testing is established by engineering standards and measurement accuracy, not expert consensus on clinical findings.
4. Adjudication Method for the Test Set
Not applicable. This concept applies to clinical studies where ambiguity in observation or diagnosis requires external review. For mechanical testing, the results are directly measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a clinical study involving multiple human readers interpreting medical images or data. The study described is mechanical in vitro testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a conceptual sense. The testing performed on the device was "standalone" in that it assessed the mechanical properties of the device itself, without human interaction influencing its performance during the test (other than setting up the experiment). This is not an AI algorithm, so the "algorithm only" part is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this study was objective mechanical measurements (e.g., force, displacement) obtained through standardized engineering testing (static cantilever bend testing).
8. The Sample Size for the Training Set
Not applicable. This refers to the data used to train an AI algorithm. The described study is mechanical testing of a medical device, not an AI product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.