(49 days)
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.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Compliance with ASTM F67 | Met |
| Compliance with ISO 5832-2 | Met |
| Compliance with ASTM F136 | Met |
| Compliance with ISO 5832-3 | Met |
| Compliance with ISO 7153-1 | Met |
| Compliance with ISO 10993-1 | Met |
| Compliance with ISO 10993-5 | Met |
| Compliance with ISO 11137-1 | Met |
| Appropriate Mechanical Strength (Engineering Analysis) | "functioned as intended" and "demonstrate substantial equivalence with the cited predicate 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable, as no training set was used for an algorithm.
§ 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.