(251 days)
Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.
The proposed product, Locking Plate System, contains (1) Locking Plates, (2) Locking screws and (3) various specific instruments. The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.
The provided text describes a 510(k) submission for a Locking Plate System. This is a medical device for bone fixation, and the documentation focuses on demonstrating its substantial equivalence to previously cleared devices through non-clinical testing. No acceptance criteria for device performance in the context of diagnostic accuracy, image quality, or clinical effectiveness (as would be applicable to AI/ML software or imaging devices) are provided.
Instead, the "acceptance criteria" here refer to the device's ability to meet established ASTM standards for metallic bone plates and screws, as well as material specifications. The "study that proves the device meets the acceptance criteria" refers to non-clinical bench testing performed according to these ASTM standards.
Here's the information extracted from the document, framed in the context of device performance in a non-clinical setting:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|
| ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates | Static and Dynamic Performance were tested per ASTM F 382 |
| ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws | Torsional, Driving Torque, and Pull-out Strength performance were tested per ASTM F543 |
| ASTM F67-13,Standard Specification for Unalloyed Titanium for Surgical Implant Applications (Materials) | Conforms to standard (Titanium) |
| ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications (Materials) | Conforms to standard (Titanium alloy) |
| ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. | Device is provided un-sterilized, but sterilizable via autoclave to achieve SAL of 10-6 prior to use. (This is a process requirement for users, implying the device can withstand this process based on its material properties and design). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not explicitly state the sample sizes (e.g., number of plates or screws tested) for the non-clinical bench tests.
- The data provenance is from non-clinical (bench) testing performed by the manufacturer, Beijing Keyi Medical Device Technology Co., Ltd., based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable to this type of submission. Performance is judged against engineering standards, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as there is no human interpretation or adjudication involved for the non-clinical bench tests against specified engineering standards.
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
- No MRMC or studies involving human readers or AI assistance were performed. This device is a passive metallic implant, not an AI/ML diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is defined by the specifications and methodologies outlined in the referenced ASTM international standards. These standards set physical and mechanical requirements (e.g., strength, torque, pull-out force) that the device must meet.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable as there is no training set.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.