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The Flower Upper Extremity Plating Set is intended to be used for fixation of fractures, fusions, or osteotomies of the clavicle, humerus, radius and ulna.

Device Description

The Flower Upper Extremity Plating Set consists of the following components and accessories: midshaft clavicle plates, distal clavicle plates, medial distal humerus plates, lateral distal humeral plates, posterior lateral distal humerus plates, olecranon plates, variable angle locking screws, variable angle non-locking screws. The plates are all made of pure titanium compliant with ASTM F67, the screws are made of titanium alloy compliant with ASTM F136. The system accepts locking and non-locking screws cleared via K123562 and K131657, the locking and non-locking screws included in this submission extend the length range of the previously cleared screws. The device is provided with general purpose instruments, including appropriately sized trials.

AI/ML Overview

The provided FDA 510(k) summary for the Flower Upper Extremity Plating Set describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document primarily focuses on regulatory approval based on design and material equivalence to existing devices and adherence to general performance standards, rather than a clinical study evaluating its performance against specific acceptance criteria in a patient population.

Therefore, much of the requested information about clinical study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document as it pertains to a pre-market clinical performance evaluation, which is not the focus of this 510(k) summary for this type of device.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Criteria	Acceptance Criteria	Reported Device Performance
Material Compliance	Compliance with specified ASTM/ISO standards for pure titanium and titanium alloy.	The plates are made of pure titanium compliant with ASTM F67 (ISO 5832-2). The screws are made of titanium alloy compliant with ASTM F136 (ISO 5832-3).
Biocompatibility	Compliance with ISO 10993 series for biological evaluation.	Compliance with ISO 10993-1 (risk management process for evaluation and testing) and ISO 10993-5 (in vitro cytotoxicity). (Implied that the device passed these tests given the substantial equivalence claim).
Sterilization	Compliance with ISO 11137-1 for radiation sterilization.	Compliance with ISO 11137-1. (Implied that the device passed these tests given the substantial equivalence claim).
Mechanical Strength (Engineering Analysis)	Appropriate mechanical strength for the claimed intended use.	An engineering analysis was performed to demonstrate appropriate mechanical strength. The device functioned as intended.
Functionality	Device functions as intended.	The Flower Upper Extremity Plating Set functioned as intended.
Substantial Equivalence	Device is substantially equivalent to predicate devices.	The device is substantially equivalent to the identified predicate devices in intended uses/indications, technological characteristics, and principles of operation. Claims no new risks.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No clinical test set or patient data is mentioned in this 510(k) summary. The "testing" primarily refers to material, biocompatibility, and sterilization standards, and an engineering analysis, not clinical performance data.

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)

Not applicable. The ground truth for this submission is based on adherence to recognized material and performance standards and comparison to predicate devices, not on expert consensus from clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring 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 device is a metallic bone fixation appliance, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical fixation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is compliance with recognized engineering, material, and biocompatibility standards (e.g., ASTM F67, F136, ISO 10993, ISO 11137), and the established performance and safety profiles of the cited predicate devices.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device submission.

9. How the ground truth for the training set was established

Not applicable, as no training set is relevant here.

In summary:

This 510(k) notification for the Flower Upper Extremity Plating Set demonstrates substantial equivalence based on bench testing, material conformity, and design similarity to already approved devices. It does not involve a clinical study with patient data, expert reviews, or AI performance metrics as it's a traditional implantable medical device.

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