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510(k) Data Aggregation
(206 days)
Acumed Wrist Plating System
The Acumed Wrist Plating System provides fixation for fractures, fusions, or osteotomies of the distal radius and ulna.
Acumed Wrist Plating System is a set of plates, screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Congruent Bone Plate Systems, per K012655, K120903 and K102998.
Acumed Wrist Plating System plates and screws are designed to provide fixation for fractures of the distal radius and ulna. The system provides plates and screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the plates and screws are manufactured from titanium alloy per ASTM F136 and pure titanium per ASTM F67, are single use and are provided both sterile and non-sterile.
The Acumed Wrist Plating System plates and screws are an extension of the Congruent Bone Plate family with new lengths and the addition of new size plates and screws. Plates and screws are intended for single patient use only.
Instruments supplied with the Acumed Wrist Plating System are intended to aid removal. Instruments are supplied sterile and non-sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also provided to house non-sterile implants and instruments.
The Acumed Wrist Plating System is a medical device designed to provide fixation for fractures, fusions, or osteotomies of the distal radius and ulna. The FDA determined that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in a dedicated table with specific pass/fail values. Instead, it refers to FDA guidance documents and international standards, implying that the device's performance met the requirements outlined in these documents.
| Acceptance Criteria (Implied from referenced standards) | Reported Device Performance |
|---|---|
| Mechanical Strength (e.g., bending, torsion) for plates (ASTM F382-17) | "Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements) |
| Torsional Yield Strength for screws (ASTM F543 Annex A1) | "Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements) |
| Driving Torque for screws (ASTM F543 Annex 2) | "Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements) |
| Axial Pullout Force for screws (ASTM F543 Annex 3) | "Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements) |
| Self-Tapping Performance for screws (ASTM F543-17 Annex 4) | "Performance data demonstrates that the Acumed Wrist Plating System plates and screws are equivalent to the designated predicate devices when used as intended." (Implicitly passed by meeting standard requirements) |
| Sterilization effectiveness (ISO 17665-1, ISO 11137-1) | "Sterilization (ISO 17665-1)", "Sterilization (ISO 11137-1)" (Implicitly passed by meeting standard requirements) |
| Packaging integrity (ISO 11607-1) | "Packaging (ISO 11607-1)" (Implicitly passed by meeting standard requirements) |
| Biocompatibility (ISO 10993-1) | "Biocompatibility (ISO 10993-1)" (Implicitly passed by meeting standard requirements) |
| Screw Lifetime Verification | "Screw Lifetime Verification Testing" (Implicitly passed by meeting internal and/or standard requirements) |
| Self-Drilling Verification | "Self-Drilling Verification Testing" (Implicitly passed by meeting internal and/or standard requirements) |
| MRI Compatibility (Magnetically Induced Displacement Force - ASTM F2052, Magnetically Induced Torque - ASTM F2213, MR Image Artifact - ASTM F2119, MRI Safety Labelling - ASTM F2503) | "Magnetically Induced Displacement Force (ASTM F2052)", "Magnetically Induced Torque (ASTM F2213)", "MR Image Artifact (ASTM F2119)", "MRI Safety Labelling (ASTM F2503)" (Implicitly passed by meeting standard requirements and allowing for appropriate labeling) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test. The testing was non-clinical, indicating that it involved laboratory-based evaluations of the device's physical and mechanical properties, not human or animal subjects. Therefore, the concept of "country of origin of the data" or "retrospective or prospective" is not directly applicable in the same way it would be for a clinical study involving patients. The data provenance is from laboratory testing conducted by or for Acumed LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study was non-clinical testing of the device's physical and mechanical properties. "Ground truth" in the context of expert review typically refers to clinical diagnosis or evaluation, which was not the nature of these tests. Standards like ASTM and ISO set the "ground truth" or performance benchmarks through established methodologies and consensus from experts in materials science, engineering, and medical device safety.
4. Adjudication Method for the Test Set
This information is not applicable as the study was non-clinical testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert opinions, which is not relevant for objective laboratory measurements defined by standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The FDA 510(k) summary explicitly states: "Clinical testing was not necessary." This indicates that the regulatory pathway for this device did not require human-in-the-loop performance studies or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study for an algorithm was not performed. This device is a physical implant (plates and screws), not a software or AI-driven diagnostic tool.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by recognized industry standards (ASTM and ISO), along with internal engineering specifications. These standards define the methodologies for testing, acceptable limits, and performance requirements for medical devices like bone fixation systems. The device's performance was compared against the requirements and specifications outlined in these standards and FDA guidance for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the device design would refer to engineering principles and prior device iterations, but not data sets used to train a model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of machine learning for this physical device. The design and manufacturing processes are guided by established engineering principles, biocompatibility requirements, and material science, all based on widely accepted scientific and regulatory standards.
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