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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.

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.

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

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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The Flower Rearfoot Plating Set is intended to be used for internal fixation of fractures and reconstructions of bones of the rearfoot, including the calcaneus. Examples of these internal fixations and reconstructions include, but are not limited to extra-articular fractures, intra-articular fractures, joint depression fractures, tongue type fractures, severely comminuted fractures and osteotomies.

The Flower Rearfoot Plating Set consists of the following components and accessories: calcaneal plates, MIS calcaneal plates, and calcaneal step osteotomy plates, all made of pure titanium compliant with ASTM F67. The system accepts locking and non-locking screws cleared via K123562 and K131657. The device is provided with general purpose instruments.

The provided text describes a 510(k) premarket notification for the "Flower Rearfoot Plating Set," a medical device for internal fixation of rearfoot fractures and reconstructions.

However, the document does not contain the kind of information requested in the prompt, such as acceptance criteria, reported device performance in a clinical study, sample sizes, ground truth establishment methods, expert qualifications, or details about any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance study.

The primary purpose of this 510(k) summary is to demonstrate substantial equivalence to predicate devices through engineering analysis and Finite Element Analysis (FEA), focusing on mechanical strength and technological characteristics rather than clinical performance metrics in humans or AI-assisted diagnostic improvements.

Therefore, I cannot populate the requested table or answer the questions related to clinical study design, ground truth, or AI performance based on the provided text.

The information available from the text is:

• Device Name: Flower Rearfoot Plating Set
• Intended Use/Indications for Use: Internal fixation of fractures and reconstructions of bones of the rearfoot, including the calcaneus (e.g., extra-articular, intra-articular, joint depression, tongue type, severely comminuted fractures, and osteotomies).
• Method of Performance Demonstration:
  • Engineering analysis to demonstrate appropriate mechanical strength.
  • Finite Element Analysis (FEA) to compare physiological loading of the subject device and predicate devices, confirming at least equivalent strength.
• Ground Truth (for mechanical testing): The "ground truth" in this context is the expected mechanical behavior and strength of the predicate devices. The study aimed to show the subject device's mechanical equivalence to these established devices through engineering principles and simulation.

In summary, the provided document does not contain the information necessary to address the prompt's request for clinical acceptance criteria, device performance, or details of a study involving human readers or AI in a diagnostic context.

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The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults and adolescents (12-21) in whom the growth plates have fused, and particularly in osteopenic bone. Specifically,

• . Distal Medial and Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• . Distal Tibia A-Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• . Straight and Distal Lateral Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

The Flower Ankle Plating Set consists of the following components and accessories: distal medial tibia plates, distal lateral tibia plates, distal tibia A-plate, straight fibula plate, distal lateral fibula plate, all made of pure titanium compliant with ASTM F67. The system accepts locking and non-locking screws cleared via K123562 and K131657. The device is provided with general purpose instruments.

Here's an analysis of the provided text regarding the Flower Ankle Plating Set, focusing on the requested information about acceptance criteria and study details:

Summary of Acceptance Criteria and Device Performance (Based on provided text)

The document focuses on demonstrating substantial equivalence to predicate devices rather than setting specific numeric acceptance criteria for clinical performance. The "acceptance criteria" are implied by adherence to recognized standards and an engineering analysis confirming mechanical strength, which are used to show the device functions "as intended" and is equivalent to previously cleared devices.

Details of the Study:

The provided document describes a 510(k) Premarket Notification, which generally does not require clinical studies to demonstrate safety and effectiveness for devices seeking substantial equivalence to existing predicate devices. Instead, it relies on performance testing (benchtop, materials, biocompatibility) and engineering analysis.

1. Sample sized used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. No clinical test set data is presented. The "test set" refers to the components of the Flower Ankle Plating Set and materials that underwent physical, chemical, and biological testing according to the listed standards.
   • Data Provenance: Not applicable for clinical data. The performance data is derived from laboratory testing against recognized standards for materials (e.g., ASTM, ISO) and an engineering analysis. The location of these labs or the specific origin of these test results (e.g., specific country) is not detailed beyond the standards themselves being international.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There was no clinical "ground truth" established by experts in the context of this 510(k) submission, as it was not a clinical study requiring such ground truth for diagnostic or prognostic performance. The "ground truth" for the material and mechanical tests is defined by the passing criteria within the specified ASTM and ISO standards.

3. Adjudication method for the test set:

   • Not applicable. As there were no human readers or clinical expert interpretations involved in establishing ground truth for a test set, no adjudication method was used. The adjudication for the standard tests would be the pass/fail criteria of those specific test methodologies.

4. 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. An MRMC comparative effectiveness study was not performed. This device is a surgical implant (ankle plating set), not an AI-powered diagnostic or assistive tool.

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

   • No. This device is a surgical implant. "Standalone algorithm performance" is not relevant to this type of medical device submission.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • The "ground truth" for this device's submission is based on adherence to recognized material and mechanical engineering standards (ASTM, ISO) and an engineering analysis demonstrating mechanical strength. The "ground truth" for safety and effectiveness is established by demonstrating substantial equivalence to predicate devices that have already been cleared.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of an algorithm or AI.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set was used for an algorithm.

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