(82 days)
The AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Not Found
This document is not a study report but rather an FDA 510(k) clearance letter for the AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance criteria through a detailed clinical or technical study as described in the prompt. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics will not be found in this type of document.
Here's what can be extracted from the provided text, and where information is inherently missing:
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A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not describe specific performance acceptance criteria or report on device performance based on a study against such criteria. The FDA clearance is based on substantial equivalence to a predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not mention any specific test set, sample size, or data provenance from a device performance study.
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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)
- Not Applicable. This document does not describe a study involving expert truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This document does not describe a study involving adjudication.
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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
- Not Applicable. This is a medical device (PICC and Procedure Kit), not an AI diagnostic medical device. No MRMC study is mentioned or relevant here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth is mentioned as this is a device clearance based on substantial equivalence.
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The sample size for the training set
- Not Applicable. No training set for an algorithm is mentioned as this is a medical device and not an AI/machine learning product.
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How the ground truth for the training set was established
- Not Applicable. No training set information is available or relevant.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for the AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit. This type of clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
The clearance letter does not contain information about specific performance acceptance criteria or a study designed to prove the device meets such criteria in the way requested for an AI/diagnostic device. Instead, the basis for clearance is the demonstration of substantial equivalence, which typically involves comparing the new device's technological characteristics, materials, and intended use to an existing predicate device, often through bench testing and sometimes limited clinical data, but not typically a formal study with detailed acceptance criteria and ground truth as outlined in the prompt.
The "Indications for Use" section (Page 3) states: "The AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling." These are the clinical statements of what the device is intended for, not performance criteria.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”