(70 days)
The MAGELLAN™ Intramedullary Femoral Nail System is indicated for use in long bone shaft fractures of the femur which require stabilization of the axis of the bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck fractures, comminuted fractures, segmental fractures, fractures with bone loss, proximal and distal fractures, nonunions and malunions, and bone lengthening.
The MAGELLAN™ Intramedullary Femoral Nail System is a modular system consisting of femoral nails, femoral rod inserts, nail caps, locking screws, and instrumentation for fixation. The system is made of 316 LVM stainless steel conforming to ASTM F 138. The nail is available in six outer diameters and eight lengths. The nail may be crosslocked dynamically or statically, locked antegrade, and also has reconstruction capabilities. This MAGELLAN™ Magnetic distal targeting instrumentation system is designed to locate and lock in place the distal screw holes of the Magellan Intramedullary Femoral Nail without the use of radiographic equipment. The system includes reamers for preparing the intramedullary canal for nail placement; a targeting compass and magnetic target insert that locate the distal screw holes, and targeting Steinmann pins and drill bits (two sizes) that create the proximal and distal screw holes. This instrument system is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.
The provided text describes the "MAGELLAN™ Intramedullary Nail System" and its intended use, but it does not detail specific acceptance criteria or a study that formally proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices through mechanical testing.
Here's an analysis based on the information provided:
- A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies an acceptance criterion of "appropriate strength for clinical usage" and performing "similarly to the Russell-Taylor System." These are qualitative rather than quantitative metrics.
- Reported Device Performance: "Testing and theoretical data show that the MAGELLAN™ nail device has appropriate strength for clinical usage, and will perform similarly to the Russell-Taylor System."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Appropriate strength for clinical usage | Achieved: "appropriate strength for clinical usage" |
| Performance similar to Russell-Taylor System | Achieved: "perform similarly to the Russell-Taylor System" |
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Sample size used for the test set and the data provenance
- The document mentions "Testing and theoretical data" but does not specify a sample size for a test set. It refers to generic mechanical testing rather than a clinical study evaluating diagnostic or treatment outcomes over a patient population.
- Data provenance: Not specified, but given the nature of mechanical testing for strength, it would typically be laboratory-based rather than from specific countries or retrospective/prospective patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The "ground truth" here would relate to mechanical properties, which are typically established by engineering standards and measurements, not expert medical opinion in a clinical context.
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Adjudication method for the test set
- Not applicable/Not provided. Since no clinical study or expert review for a "test set" in the context of diagnostic performance is described, adjudication methods like 2+1 or 3+1 are irrelevant to the information presented.
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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. The document describes a medical device (intramedullary nail system) and an instrument system for targeting. It does not involve AI or human readers, and therefore no MRMC study or effect size related to AI assistance is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical implant and an associated instrument system, not an algorithm.
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The type of ground truth used
- The "ground truth" for the performance evaluation described appears to be mechanical strength standards and comparative performance against a predicate device (Russell-Taylor System). This implies engineering benchmarks and material property measurements.
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The sample size for the training set
- Not applicable/Not provided. The concept of a "training set" is relevant to machine learning algorithms. This document describes a physical medical device, not an AI model.
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How the ground truth for the training set was established
- Not applicable/Not provided. As there's no mention of a training set, the establishment of its ground truth is not discussed.
In summary, the provided text is a 510(k) summary for a medical device (intramedullary nail system), which focuses on demonstrating substantial equivalence to existing predicate devices primarily through mechanical testing and theoretical data regarding strength. It does not contain the kind of detailed information about acceptance criteria or performance studies typically associated with diagnostic or AI-driven medical devices regarding sensitivity, specificity, or clinical outcomes from patient data.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.