(75 days)
Synthes External Fixation Devices - MR Safe are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE
Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- Stabilization of soft tissues and fractures .
- Poyltrauma/multiple orthopedic trauma .
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic . fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints .
- Neutralization of fractures stabilized with limited internal fixation .
- Non-unions/septic non-unions .
- Intra-operative reductions/stabilization tool to assist with indirect reduction .
- Unilateral rectilinear bone segment transport or leg lengthening .
MEDIUM
Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
Synthes External Fixation Systems, MR Safe are a system of components that form a construct intended to treat stable and unstable fractures. All frame elements are made from non-magnetic materials and are intended for use in the MR environment. This line extension consists of Synthes Pin Clamps with Outrigger Posts and additional Curved Carbon Fiber Rods. These components are also intended for use in the MR environment.
Although the provided document discusses a 510(k) premarket notification for a medical device (Synthes External Fixation Component Line Extension - MR Safe), it does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria.
A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than providing detailed studies with specific acceptance criteria and performance data as might be found in a De Novo or PMA submission.
Therefore, for each of your requested points, the answer is that the information is not available in the provided text.
Here's a breakdown of why based on the document:
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A table of acceptance criteria and the reported device performance: The document only describes the device and its intended use, and states that substantial equivalence has been demonstrated. It does not provide any specific performance metrics or acceptance criteria a study would measure against.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No study is described, so no information on sample size or data provenance is present.
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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): Since no study is detailed, there's no mention of experts or ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: No study means no adjudication method is discussed.
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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: This device is an external fixation component, not an AI diagnostic tool, so an MRMC study related to AI assistance would not be applicable or expected. The document does not mention any such study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a physical medical device and not an algorithm, a standalone algorithm performance study is not relevant and not mentioned.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Without a study, there's no mention of ground truth.
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The sample size for the training set: This is not an AI/machine learning device, so the concept of a "training set" is not applicable, and none is mentioned.
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How the ground truth for the training set was established: See point 8.
In summary, the provided 510(k) summary and FDA clearance letter confirm the substantial equivalence of the Synthes External Fixation Component Line Extension - MR Safe to predicate devices, but they do not detail performance studies with acceptance criteria or ground truth establishment.
§ 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.