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The AngioDynamics, Inc. Morpheus™ CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections term penpherar aboob to the ocharing, infusion, or therapy use a 4 French or larger catheter.

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I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) clearance letter from the FDA for a medical device (AngioDynamics, Incorporated Morpheus™ CT PICC and Procedure Kit). This type of document primarily confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.

It does not contain:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
3. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. Information about the type of ground truth used, or the sample size and ground truth establishment for a training set.

The letter focuses on regulatory compliance and the determination of substantial equivalence, not on the specific performance study details that would be found in a clinical study report or a more detailed technical submission.

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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, parenteral nutrition, and blood sampling.

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I apologize, but this document is a 510(k) clearance letter from the FDA to AngioDynamics, Inc. for their Morpheus PICC and Procedure Kit.

It is a regulatory document granting market clearance and does not contain any information about a clinical study, acceptance criteria, or device performance metrics as they relate to a study's results.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning its safety and effectiveness are considered to be at the same level as devices already on the market, but it does not detail the specific performance metrics or studies used to demonstrate this equivalence, other than the general statement of "special 510(k) device modification" which implies some changes were made and reviewed.

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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,

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The provided text is a 510(k) clearance letter from the FDA for a medical device: the AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit.

This type of document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it pertains to AI/ML device testing. It is a regulatory approval document confirming substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information based on the given input. The document confirms:

• Device Name: AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit
• Intended Use: Short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
• Regulatory Clearance: 510(k) clearance, indicating substantial equivalence to a legally marketed predicate device.

To answer your questions, one would typically need access to the full 510(k) submission, which would include performance data if it were a novel device requiring such studies, or if it were an AI/ML powered device, which this clearly is not.

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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:

1. 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.

2. 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.

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. This document does not describe a study involving expert truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. This document does not describe a study involving 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 is a medical device (PICC and Procedure Kit), not an AI diagnostic medical device. No MRMC study is mentioned or relevant here.

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

   • Not Applicable. This is not an algorithm-based device.

7. 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.

8. 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.

9. 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.

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