(90 days)
The BioSorbFX System is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating comminuted fractures of the naseothmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; trauma of the midface and craniofacial skeleton, and reconstructive procedures of the midface or craniofacial skeleton. The BioSorbFX System is used to stabilize bone during healing in conjunction with appropriate postoperative immobilization. The BioSorbFX System includes an instrumentation set containing bone taps, screwdrivers and plate benders.
The BioSorbFX System is not intended for use in: 1) the mandible; 2) full load bearing procedures; 3) areas with active infection; or 4) patient conditions, including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
The BioSorbFX System contains various plates, meshes and screws that are made from poly-L/D,L-lactide ("P(L/DL)LA") copolymer, which consists of 70 molar percent poly-L lactide and 30 molar percent poly-D,L-lactide. Plates and meshes are provided as either straight-edged or scalloped edged of varying thickness, lengths, and shapes (e.g., rectangular, straight line, X-, L-, and C-shape). The plates are sized to be secured to the midface or craniofacial skeleton with a 1.5mm or 2.0mm bioabsorbable fastener (i.e., threaded screw). The BioSorbFX System is supplied pyrogen free and sterile following gamma radiation sterilization and is not intended to be resterilized by the user.
The BioSorbFX System is used in standard surgical procedures for reconstructive surgery or in the treatment of fractures of the midface and craniofacial skeletons. In conjunction with adequate surgical technique, the appropriate sized bioabsorbable craniofacial plates are used to stabilize bone fragments by attachment of the plate to the bones with plate fasteners (i.e., threaded screws). The BioSorbFX fasteners are inserted through the predrilled, counter sunk plate holes following drilling, pre-tapping, and flushing of the corresponding holes in the midface or craniofacial skeleton using standard surgical technique. The BioSorbFX fastener holds the BioSorbFX plate securely in place to allow for biological healing of the midface or craniofacial skeleton fracture or reconstruction. The plate remains securely fastened to the midface or craniofacial skeleton throughout the healing period, after which the plate and fasteners gradually degrade and are completely absorbed by the body. Thus, there is no need to surgically remove the devices.
Here's an analysis of the provided text regarding the BioSorbFX 1.5/2.0 Bioabsorbable Fixation System, focusing on acceptance criteria and study information.
Executive Summary:
The provided 510(k) summary for the BioSorbFX 1.5/2.0 Bioabsorbable Fixation System does not contain explicit acceptance criteria or a description of a clinical study that proves the device meets specific performance criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that the device is deemed safe and effective because it is similar in intended use, technological characteristics, and principles of operation to devices already legally marketed.
The key arguments for substantial equivalence are:
- Identical material: The BioSorbFX System uses the same P(L/DL)LA copolymer as other FDA-cleared Bionx products (e.g., Biodegradable Threaded Suture Anchor, BioSorb Endobrow Screw) and the Synthes, Inc. Resorbable Fixation System.
- Similar intended use and principles of operation: It’s intended for craniofacial trauma and reconstructive procedures, similar to the Synthes Resorbable Fixation System and the Walter Lorenz Surgical, Inc. LactoSorb® Trauma Plating System.
- Similar technological characteristics: It offers a variety of plate sizes/shapes and fasteners (1.5mm and 2.0mm diameters) and customized instrumentation sets, mirroring the predicate devices.
Therefore, the answers to most of your specific questions related to acceptance criteria and a study design will be "Not Applicable" or "Not Provided" in this document, as the regulatory pathway chosen was substantial equivalence, not a direct demonstration through a new clinical trial with pre-defined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated within this 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance acceptance criteria based on new clinical data. | The device meets the criteria for substantial equivalence to legally marketed predicate devices, implying comparable safety and effectiveness. Specifically: |
- Made of P(L/DL)LA copolymer (70% poly-L lactide, 30% poly-D,L-lactide).
- Intended for trauma and reconstructive procedures in the midface and craniofacial skeleton.
- Stabilizes bone during healing and gradually degrades/absorbs.
- Operates similar to predicate devices by attaching plates with fasteners.
- Materials are biocompatible and maintain sufficient physical integrity and mechanical holding properties within the bone for healing. |
| (Implied) Biocompatibility | P(L/DL)LA material is "biocompatible" and shown to maintain "sufficient physical integrity and mechanical holding properties." |
| (Implied) Mechanical strength/stability for healing period | "Maintain sufficient physical integrity and mechanical holding properties within the bone for a sufficient period of time during the biological healing process." |
| (Implied) Complete absorption | Device "gradually degrade and are completely absorbed by the body." |
2. Sample size used for the test set and the data provenance
Not applicable. The 510(k) summary does not describe a new clinical "test set" or a new clinical study with human subjects for the BioSorbFX System. The evidence provided is primarily based on the material properties and comparison to predicate devices, which would have had their own studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new clinical study or test set requiring expert ground truth establishment for this device is described in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No new clinical study or test set requiring an adjudication method is described.
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
Not applicable. This device is a bioabsorbable fixation system, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its regulatory pathway based on this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable to a new study for this device. The "ground truth" for the substantial equivalence argument relies on the established safety and effectiveness of the predicate devices and the known properties of the P(L/DL)LA material, which would have been established through preclinical and clinical data for those antecedent products/materials (e.g., biocompatibility testing, mechanical testing, animal studies, and clinical outcomes for the predicate devices).
8. The sample size for the training set
Not applicable. No new "training set" for an algorithm is relevant to this device's submission.
9. How the ground truth for the training set was established
Not applicable. No new "training set" for an algorithm is relevant to this device's submission.
§ 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.