(308 days)
Comus Locking Plate systems can be used for adult patients with age above 21 as indicated for fixation of Bone fracture in ulna, radius, humerus, femur and tibia.
The proposed device Comus Locking Plate systems are a combination of plates and screws, which can be used for adult patients with age above 21 as indicated for fixation of fractures. The plate is made of Titanium, which meet ASTM F67, and the screw is made of titanium allov (Ti-6A-14V ELI) which conforms to ASTM F136, which both are widely used for surgical implants with well-known biocompatibility and mechanical properties.
The provided text describes a 510(k) premarket notification for the "Comus Locking Plate systems." This is a medical device for bone fixation, and the documentation focuses on demonstrating its substantial equivalence to previously cleared predicate devices, not on proving effectiveness through clinical trials with specified acceptance criteria as one might expect for a novel AI/software medical device.
Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test sets, expert qualifications, MRMC studies, training set details) are not applicable or not present in this type of submission.
Here's a breakdown based on the provided information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the chosen ASTM standards and the demonstration of "substantial equivalence" to predicate devices. The reported performance is that the subject device's mechanical testing results were "comparable" to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Meets ASTM F382-14 (Static four-point bending of plate) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Meets ASTM F382-14 (Dynamic four-point bending of plate) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Meets ASTM F543-17 (Torsional properties of screw) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Meets ASTM F543-17 (Driving torque of screw) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Meets ASTM F543-17 (Pull-out test of screw) | Subject device performance (Comus Locking Plates) comparable to predicate. |
| Biocompatibility of materials (Titanium, Ti-6A-4V ELI) | Materials meet ASTM F67 and ASTM F136; widely used with known biocompatibility. Risk analysis and validation confirm production process does not affect biological performance. |
| Same indications for use as predicate devices | Comus Locking Plate systems have the same indications for use as predicates (adult patients > 21 for bone fracture fixation in ulna, radius, humerus, femur, tibia). |
| Similar patient population as predicate devices | Comus Locking Plate systems have similar patient population as predicates. |
| Similar material as predicate devices | Comus Locking Plate systems use similar materials as predicates. |
| Similar sterilization method as predicate devices | Comus Locking Plate systems use similar sterilization method as predicates. |
| Similar design specifications (bone position, geometric shape) | Similar bone positions (cortical/cancellous), similar plate geometric shape, similar number of holes, similar screw design structure, similar size/dimension ranges (though subject device has a smaller size dimension range). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the mechanical tests (e.g., how many plates/screws were tested for each criterion). The data provenance is from non-clinical comparative performance tests conducted by or for the manufacturer, Jiangsu Trauhui Medical Instrument Co., Ltd. The specifics of where the testing was physically conducted (e.g., in China) are not detailed but can be inferred to be related to the manufacturer's location. This is retrospective in the sense that it's comparing a new device to existing predicate devices based on established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, expert consensus, or clinical experts are not used for this type of mechanical and material comparative study. The "truth" is established by adherence to recognized ASTM standards and direct comparison of physical properties.
4. Adjudication method for the test set
This is not applicable. There is no adjudication in the context of mechanical performance testing. The results are quantitative measurements against predefined 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
This is not applicable. This submission is for a physical medical device (locking plates and screws), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or software device.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Mechanical Testing Standards: Adherence to ASTM F382-14 and ASTM F543-17.
- Material Standards: Adherence to ASTM F67 and ASTM F136 for biocompatibility and material properties.
- Comparison to Predicate Devices: Demonstrating that the subject device's performance, materials, and design are substantially equivalent (comparable) to legally marketed predicate devices.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of mechanical device testing.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.