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510(k) Data Aggregation
(228 days)
Metallic Locking Bone Plate and Screw System
The Metallic Locking Bone Plate and Screw System are intents with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
The proposed device, Metallic Locking Bone Plate and Screw System consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is made of Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67.
The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.
The provided document is a 510(k) Premarket Notification Submission for the "Metallic Locking Bone Plate and Screw System." It details the device's characteristics, intended use, and comparison to predicate devices to establish substantial equivalence.
Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device meets design specifications and is substantially equivalent to the predicate device based on bench testing. The acceptance criteria are defined by industry standards for metallic bone fixation devices.
| Acceptance Criteria (Standard) | Reported Device Performance (Test) |
|---|---|
| For Metallic Bone Plates (ASTM F382-99 (2008)) | |
| Static four-point bending strength | Static four-point bending test conducted |
| Dynamic four-point bending endurance | Dynamic four-point bending test conducted |
| For Metallic Medical Bone Screws (ASTM F543-07) | |
| Torsional properties (e.g., torque to failure) | Torsional properties test conducted |
| Driving torque characteristics (e.g., maximum driving torque) | Driving torque test conducted |
| Pull-out strength | Pull-out test conducted |
Note: The document explicitly states "No clinical performance testing" and "No clinical studies to support substantial equivalence." The "Reported Device Performance" column indicates that these tests were conducted and the conclusion is that the device "should perform as intended." Specific numerical results or statistical analyses from these tests are not provided in this summary document. The acceptance criteria for these tests are the requirements outlined in the ASTM standards themselves.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size used for the bench tests (e.g., how many plates or screws were tested for each performance metric).
- Data Provenance: The tests are bench tests, not clinical studies. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the same way it would be for patient data. The tests were likely conducted by the manufacturer, Changzhou Dingjian Medical Appliance Co., Ltd., in China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This question is not applicable to the context of this document. The "ground truth" for material and mechanical performance is established by the specifications in the ASTM standards and the physical properties of the device, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set:
This is not applicable as the test set involves bench testing against predefined engineering standards, not human interpretation or clinical adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing" and "The subject of this premarket submission, metallic locking bone plate system, does not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device is a physical medical implant (bone plate and screw system), not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation in this submission is the mechanical and material specifications outlined in the referenced ASTM F382 (for plates) and ASTM F543 (for screws) standards. Compliance with these established engineering standards serves as the basis for performance evaluation for non-clinical aspects.
8. The Sample Size for the Training Set:
This question is not applicable. There is no concept of a "training set" for a physical medical device in this type of premarket notification for substantial equivalence based on bench testing.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the reasons stated above.
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