(77 days)
The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for long bone in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions.
This system can be used for palmar, ventral, dorsal or orthogonal application.
The Flower Small and Medium Implants set consists of the following components and accessories: pure titanium small straight plates, small and medium reconstruction plates, medium osteosynthesis plates, proximal humerus plates, distal radius plates, L-shaped plates, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments.
This submission is for a medical device called the "Flower Small and Medium Implant Set," which is a bone plating system. It's a 510(k) premarket notification for modifications to an already cleared device (K123562).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength for Intended Use (Implicit, based on substantial equivalence to predicate devices) | Adequate and Substantially Equivalent Mechanical Strength. The submission states that "Flower Orthopedics has conducted engineering analysis to demonstrate that the modifications to the Flower Small and Medium Implants set provides adequate and substantially equivalent mechanical strength for its intended use." This is considered sufficient to demonstrate compliance by the FDA for the purpose of 510(k) clearance, as it addresses the primary functional requirement for bone plating systems. |
2. Sample size used for the test set and the data provenance
The provided text does not mention a clinical study or a test set involving patients or medical images. The performance data is based on "engineering analysis." Therefore, sample size and data provenance in the context of clinical or imaging data are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical or image-based ground truth was established as there was no test set or clinical study. The ground truth for this device's performance is derived from engineering principles and comparison to predicate devices, rather than expert consensus on diagnostic interpretations.
4. Adjudication method for the test set
Not applicable. No test set was used that required expert adjudication.
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 is a submission for a bone plating system, not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm or an AI system.
7. The type of ground truth used
The "ground truth" for the device's acceptable performance is based on engineering analysis and comparison to the mechanical properties of legally marketed predicate devices. The implicit ground truth is that if the modified device possesses "adequate and substantially equivalent mechanical strength" to its predicates, it meets the safety and effectiveness requirements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "training" for the device's design and engineering would be the existing knowledge and data from predicate devices and biomechanical principles, but not in the context of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, the method for establishing its ground truth is also 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.