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510(k) Data Aggregation
(297 days)
The metallic locking bone plate and screw are intents with age above 21 as indicated fixation of fractures, including ulna, radius, humerus, femur, tibia, clavicle, and fibula for the following indications:
- ostcotomies, mal-unions, and non-unions;
- single, segmental, and comminuted fractures;
- normal bone density and osteopenic bone.
The proposed device, metallic Locking Bone Plate and Screw 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 manufactured with 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.
This document is a 510(k) premarket notification approval for a medical device: "Metallic Locking Bone Plate and Screw". It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and material biocompatibility, rather than providing details on a study proving the device meets acceptance criteria regarding clinical outcomes or diagnostic performance.
Therefore, many of the requested elements are not applicable to the information contained in this FDA letter and summary. However, I can extract the relevant information based on the document's content.
Device Name: Metallic Locking Bone Plate and Screw
Purpose of the Submission: To demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (indirectly inferred from testing standards) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Mechanical performance meeting established standards for metallic bone plates (e.g., bend testing, screw properties) | Complies with ASTM F382 - 99(2008) Standard Specification and Test Method for Metallic Bone Plates (bend testing). |
| Complies with ASTM F543 - 13 Standard Specification and Test Methods for Metallic Medical Bone Screws. | |
| Biocompatibility of materials | Made of pure titanium and Ti-6Al-4V, complying with ASTM F1472 and ASTM F67. Materials are "well-characterized" and have been "employed successfully in human implant applications in contact with soft tissue and bone for over a decade." |
| Sterilization requirements | Provided un-sterilized; "shall be sterilized prior to use by healthcare provider." |
| Single-use requirement | "The proposed devices shall never be reused." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical or diagnostic performance data or sample sizes for mechanical testing. The performance data provided is based on non-clinical bench testing and material specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for mechanical performance is established by recognized engineering standards (ASTM). Biocompatibility is based on material science and established historical use, not expert consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or diagnostic test set requiring expert adjudication was conducted.
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 passive implantable device, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
The ground truth for this device's performance relies on:
- Engineering Standards: Bench testing results compared against established ASTM standards for metallic bone plates and screws.
- Material Specifications and Historical Use: Biocompatibility is established by the use of materials (pure titanium and Ti-6Al-4V) that conform to ASTM standards (F1472, F67) and have a long history of successful implantation in humans.
8. The sample size for the training set
Not applicable. No "training set" in the context of machine learning or clinical trials was used. The device design and performance are based on engineering principles and material science, informed by prior knowledge and testing of similar devices and materials.
9. How the ground truth for the training set was established
Not applicable. There was no training set. The "ground truth" for the device's design and materials is derived from established engineering and material science principles, as well as the performance of predicate devices.
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(228 days)
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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