(101 days)
The RESORB-X® SF is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethomoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midface fractures; and reconstructive procedures of the midface or craniofacial skeleton. The RESORB-X® SF pins are designed only to be inserted with the RESORB-X® SF Sonotrode device.
The RESORB-X® SF is NOT intended for use in the mandible or full load-bearing situations, nor in areas of active infection or for patients with conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
The RESORB-X® SF Sonotrode is NOT intended for any other use and is only intended for use for insertion of the RESORB-X® SF pins.
The RESORB-X® SF consists of RESORB-X® Pins made of Poly (D, L) - Lactide-Acid (PDLLA) of various diameters and lengths that are implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention. The RESORB-X® SF pins are designed to be used in conjunction with the previously cleared RESORB-X® Resorbable Plating System plates (K011590).
This is a medical device 510(k) premarket notification for the RESORB-X® SF, a bone plate system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study on device performance against specific acceptance criteria. Therefore, most of the requested information regarding AI/algorithm performance and clinical study details is not present in this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly stated) | Reported Device Performance |
|---|---|
| Mechanical strength (higher strength than predicate screws) | "The RESORB-X® SF pins have more favorable results (higher strength) than the previously cleared RESORB-X® screws." (Quantitative data is not provided in this summary, but referenced as being in section F-3.) |
| Limited heat transfer to surrounding bone | "The heat that is transferred to the surrounding bone is not significant and is shown in section F-3." (Quantitative data is not provided in this summary, but referenced as being in section F-3.) |
| No adverse effect on molecular weight, resorption, or strength retention due to insertion process | "The limited duration and low temperature exposure used during insertion does not affect the molecular weight, the resorption or the strength retention of the product as shown in section F-3 and does not adversely affect the product." (Quantitative data is not provided in this summary, but referenced as being in section F-3.) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (RESORB-X® SF) and its technological characteristics, primarily comparing it to predicate devices. It does not mention or describe a "test set" in the context of an AI/algorithm study. The studies referenced are mechanical tests.
- Test Set Sample Size: Not applicable in the context of an AI/algorithm study. For mechanical tests, the sample size is not specified in the provided text, only that "Mechanical tests have been preformed".
- Data Provenance: Not applicable in the context of an AI/algorithm study. The mechanical tests would typically be performed in a laboratory setting. No information on country of origin or retrospective/prospective nature is provided for these mechanical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes a mechanical device and its performance through mechanical testing, not an AI/algorithm where expert ground truth would be established.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe an AI/algorithm study requiring adjudication of a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is not mentioned or implied in this document. This submission pertains to a physical medical device (bone plate system), not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only) Performance Study
No. This document describes a physical medical device. It does not involve an algorithm, and therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
For the mechanical tests mentioned, the "ground truth" would likely be physical measurements and material properties (e.g., tensile strength, shear strength, temperature measurements, molecular weight analysis) obtained through standard laboratory testing protocols. It's not "expert consensus, pathology, or outcomes data" in the typical sense of AI/clinical studies.
8. Sample Size for the Training Set
This information is not applicable as this is not an AI/machine learning device. The device is a physical bone plate system.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as this is not an AI/machine learning device.
§ 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.