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The CORGRIP Nasogastric/Nasointestinal (NGNI) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal or displacement of the tubes for adult patients.

The CORGRIP NG/NI Tube Retention System is an accessary to prevent unwanted displacement or removal of nasogastric/nasojejunal tubes for adult patients by retaining the tube to the patient's nasal septum. The device consists of three main components: insertion (delivery) catheter, retrieval catheter, and tube clamp.

The catheters are placed in either nare of the patient and the clinician maneuvers the catheters to connect the magnets at the back of the patient's nasal septum. Both catheters have a flexible tip to aid in magnet connection. Once connection is made the magnet on the insertion catheter is pulled through the nare by the retrieval catheter. Both catheters are then removed from each nare until the ends of the umbilical tape are exiting either nare. The umbilical tape is then secured to the feeding tube with the provided clamp.

The proposed device adds the option of a 14, 16 and 18 Fr clamp.

The provided text describes a medical device, the CORGRIP NG/NI Tube Retention System, and its performance data. However, it does not describe an acceptance criteria table or a study proving that an AI device meets acceptance criteria. The document is a 510(k) premarket notification for a physical medical device, not an AI or software as a medical device (SaMD) product.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details based on the provided text.

The closest relevant information from the document pertains to the performance testing of the physical clamps of the CORGRIP NG/NI Tube Retention System. Here's what can be extracted about that, structured to clarify that it's not AI-related:

1. Acceptance Criteria and Reported Device Performance (for the physical device's clamps):

For the remaining AI-specific questions, the information is NOT available in the provided document:

2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device, not an AI device tested on data. The clamps were tested in a laboratory setting with "Covidien Salem Sump™ Dual Lumen Stomach Tubes." No specific sample size for these tubes is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical clamp involves engineering and mechanical testing, not clinical expert consensus.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This device does not involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For the physical clamp testing, the "ground truth" would be established engineering and design specifications for grip strength, occlusion, etc., measured through lab tests.
8. The sample size for the training set: Not applicable (no AI training set).
9. How the ground truth for the training set was established: Not applicable (no AI training set).

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The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is a closed reservoir system intended to allow the evacuation of excess gas (gastric distention/bloating) and drainage/collection of enteral feeding formula and gastrointestinal tract contents from patients utilizing an enteral device. The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is for use with neonates, pediatric, and adult patients.

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This document is an FDA 510(k) clearance letter for the FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory clearance, not detailed performance study data.

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The CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is indicated for use with CORPAK MedSystems enteral feeding tubes of 8 Fr and greater to prevent inadvertent removal or displacement of the tubes for adult patients.

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This document is a 510(k) clearance letter from the FDA for a medical device called CORGRIP. It states that the device is substantially equivalent to legally marketed predicate devices. However, the letter itself does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot provide the requested information based on the text provided. The document confirms the FDA clearance but does not detail the technical performance studies that likely underpinned that approval.

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The Electromagnetic Transmitting Stylet has been specifically designed for use with the CORTRAK 2 Enteral Access System (EAS), and is intended to aid in the confirmation of NG decompression tubes.

Electromagnetic Transmitting Stylet

I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for an "Electromagnetic Transmitting Stylet" and only specifies the device's indications for use and the regulatory pathway. It does not include details about device performance, studies, or acceptance criteria.

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The CORTRAK 2 System is an electrical device designed to aid qualified operators in the placement of the CORPAK MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK 2 can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.

The CORTRAK 2 System is an electrical device.

This document is a 510(k) clearance letter from the FDA for the CORTRAK 2 Enteral Access Device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices and outlines general regulatory obligations.

Therefore, I cannot provide the requested information based on the provided text.

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The Farrell Valve is a reservoir system intended to allow the evacuation of excess gas(gastric distention/bloating) and enteral feeding formula from the stomach of patients receiving enteral formula via feeding tubes and sets. Farrell Valve with CORFLO ANTI IV Connectors is for use with pediatric patients.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "FARRELL VALVE with CORFLO® ANTI IV Connectors". It does not contain information about acceptance criteria, study details, or device performance metrics typically found in a clinical study report or a summary of safety and effectiveness.

Therefore, I cannot provide the requested information from this document. This letter primarily certifies that the device is substantially equivalent to a predicate device and can be legally marketed, subject to general controls and existing regulations.

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The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device accepting standard enteral step connectors. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.

CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S

The provided document is a 510(k) clearance letter from the FDA for a medical device: CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S.

**This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

The letter is a regulatory document confirming that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new premarket approval application (PMA). This determination is based on the safety and effectiveness information submitted in the 510(k) premarket notification, but the letter itself does not describe the specific studies or data generated to support that substantial equivalence. These details would typically be found in the original 510(k) submission itself if it were publicly available.

Therefore, I cannot provide the requested table and information based on the text provided.

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The CORFLO Anti-I.V. Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device acccepting a standard enteral step connector. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.

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The provided text is a 510(k) clearance letter from the FDA for a device called "CORFLO Anti-I.V. Enteral Feeding Extension Set Model # 20-1060AIV-S." This document describes the FDA's determination of substantial equivalence to a predicate device, allowing the product to be marketed.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to the Anti IV Enteral feeding tube. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.

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I am sorry, but the provided text from the FDA 510(k) K083786 for the "CORFLO Anti-IV Enteral Feeding Extension Set" does not contain any information regarding acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

This document is a clearance letter for a traditional medical device (an enteral feeding extension set), not an AI/ML device. The letter focuses on:

• Substantial equivalence to a legally marketed predicate device.
• Regulatory classifications and general controls.
• Contact information for various FDA departments.
• Indications for Use.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions you've asked (about sample sizes, ground truth, experts, MRMC studies, etc.) are highly specific to the evaluation of AI/ML algorithms, which is not applicable to this particular document.

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