(53 days)
Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
The proposed products, Locking Bone Plates and Screws, contain (1) locking plats with various specifications, (2) locking screws with various specifications and (3) Various specific instruments.
The bone plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.
Locking Screws are available in two kinds, which are self-dapping and self-drilling. Both of them share the same dimensions and materials.
These devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10th by hospital prior to use.
The requested information is detailed below, based on the provided text:
Acceptance Criteria and Device Performance Study
The submission focuses on establishing substantial equivalence for medical implants (Locking Bone Plates and Screws) rather than a diagnostic AI device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical and material specifications, and regulatory standards, rather than diagnostic metrics like accuracy, sensitivity, or specificity. The study confirming these criteria is a series of bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Predicate Device K101400/K100721) | Reported Device Performance (Proposed Device) |
|---|---|---|
| General & Safety | ||
| Product Code | Plate: HRS, Screw: HWC | Same |
| Regulation No. | Plate: 21 CFR 888.3030, Screw: 21 CFR 888.3040 | Same |
| Class | Class II | Same |
| Intended Use | Similar to predicate | Similar |
| Sterilization Method | Autoclave | Autoclave |
| Sterility Assurance Level (SAL) | 10⁻⁶ | 10⁻⁶ |
| Physical Specifications - Locking Bone Plates | ||
| Number of Holes | Similar to predicate | 2-24 |
| Length | Similar to predicate | 26-312 mm |
| Thickness | Similar to predicate | 3.3 / 3.6 / 4.2 mm |
| Width | Similar to predicate | 11 / 12.5 / 13.5 mm |
| Material | Titanium conforms to ASTM F67-06 | Titanium conforms to ASTM F67-06 |
| Physical Specifications - Locking Bone Screws | ||
| Diameters | Similar to predicate | 3.5, 4.5, 5.0 |
| Lengths | Same as predicate | 10~120mm |
| Material | Ti6Al4V ELI conforms to ASTM F136 | Ti6Al4V ELI conforms to ASTM F136 |
| Mechanical Performance (Bone Plates) | ||
| Test items | Static four point bending, Dynamic four point bending | Same |
| Test standard | ASTM F 382-99 | ASTM F 382-99 |
| Mechanical Performance (Bone Screws) | ||
| Test items | Torsional properties, Driving torque, Pull-out test | Same |
| Test standard | ASTM F543-07 | ASTM F543-07 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of individual plates/screws, but rather through the scope of the specifications (e.g., bone plate lengths from 26-312mm). The testing was conducted on samples representative of the proposed device's various specifications.
- Data Provenance: The tests were "Bench tests" conducted by the manufacturer, Weigao Orthopaedic Device Co., Ltd. in Weihai, Shandong, China. The data is retrospective in the sense that it's a pre-market submission based on completed testing, but it's not clinical data; it's engineering test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the submission describes a medical device (bone plates and screws), not an AI/diagnostic device that would require expert consensus for ground truth on disease states. The "ground truth" here is defined by established engineering and material standards (ASTM and ISO).
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods are typically for clinical or AI performance studies involving interpretations, not for engineering bench tests where outcomes are measured against predefined specifications.
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. No MRMC study was conducted as this is a submission for a medical implant, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for a physical medical device, not a standalone AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device type is based on established industry standards and specifications:
- ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates.
- ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws.
- ANSI/AAMI/ISO17665-1: 2006 for sterilization.
- Material specifications: ASTM F67-06 for Titanium and ASTM F136 for Ti6Al4V ELI.
The performance of the proposed device was compared against the specifications and mechanical performance of the predicate devices, which are also compliant with these standards.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is a submission for a physical medical device, not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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.