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The I.V. Extension Set is an accessory device used for infusion of medication intravenously into the patient.

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The provided text is a 510(k) clearance letter from the FDA for an "I.V. Extension Set." This document does not contain any information regarding acceptance criteria, device performance details, or any study results.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details regulatory requirements but does not include any technical or performance specifications or clinical study summaries.

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

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This Device is a Safety Hypodermic Syringe for injection of medicine to patients. This device aids in the prevention of needlestick injuries.

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The provided document is a 510(k) clearance letter from the FDA for a safety syringe, not a study report for an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth establishment.

Specifically, the document:

1. Does not describe acceptance criteria for an AI/ML device.
2. Does not report device performance against any such criteria.
3. Does not detail any study involving AI/ML.
4. Does not mention sample sizes, data provenance, expert qualifications, or adjudication methods.
5. Does not refer to MRMC comparative effectiveness studies or standalone algorithm performance.
6. Does not discuss ground truth types or how ground truth was established.
7. Does not specify training set sizes.

The document is a regulatory approval for a physical medical device (a safety syringe) based on substantial equivalence to a predicate device, as opposed to performance against specific efficacy or accuracy metrics typically associated with AI/ML device studies.

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This Primary Solution set is used for infusion of I.V. solutions and/or medication to a patient intravenously. This safety feature may aid in the prevention of needle stick injury.

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The provided text is a U.S. FDA 510(k) clearance letter for the "Exel Primary Solution Set," an intravascular administration set. This type of document does not contain the detailed information requested regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies that would generate the data you're asking for. The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, I cannot provide the requested information based on the given input because it is not present in this document.

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THIS DEVICE IS A SAFETY HYPODERMIC SYRINGE FOR INJECTION OF MEDICATION TO PATIENTS. =THIS DEVICE AIDS IN PREVENTION OF NEEDLE STICK INJURIES=

EXEL SECURE TOUCH SAFETY SYRINGE

This document is a 510(k) clearance letter from the FDA for a medical device called the "EXEL Secure Touch Safety Syringe." It does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, or any of the other specific details requested in your prompt regarding artificial intelligence (AI) and its performance.

The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a new premarket approval application (PMA). This implies that its safety and effectiveness are established through its similarity to existing, approved devices, rather than through a standalone study with performance metrics in the way your prompt describes for an AI-powered device.

Therefore, I cannot provide the requested information from this document. The information you are looking for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in a detailed clinical study report or a 510(k) summary, which is not provided in this regulatory letter.

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This device is an integral part of blood collection (intravenously) used in connection with luer adapter for collection of whole blood into tubes.

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This document is a 510(k) premarket notification decision letter from the FDA for the "EXEL Vaculet Blood Collection Set". It is an administrative document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request based on the provided text. The document confirms that the device is substantially equivalent to a predicate device, which is a regulatory determination, not a performance study.

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This product is intended to be used to collect blood for various blood tests. The EXELINT SecureTouch Vaculet Safety Blood Collection Set aids in the prevention of accidental needle stick injuries.

EXEL Secure Touch Safety Vaculet Blood Collection Set

The provided text is a 510(k) Premarket Notification from the FDA for a blood collection set. It does not contain information about acceptance criteria or a study that proves a device meets those criteria, as typically seen for AI/ML devices or complex diagnostic tools.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, or how training ground truth was established).

This document is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report.

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THIS DEVICE IS USED FOR INJECTIONOF INSULIN VIA PEN NEEDLE/DEVICE FOR USE BY DIABETIC PATIENTS .

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The provided text is a US FDA 510(k) clearance letter for the Exel Comfortpoint Insulin Pen Needle. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth, or any of the other specific details requested in your prompt.

The letter is a regulatory approval document and focuses on:

• Confirmation of substantial equivalence.
• Instructions regarding general controls provisions of the Act (registration, listing, GMP, labeling, etc.).
• Contact information for various FDA offices.
• The "Indications for Use" for the device.

Therefore, I cannot fulfill your request for information about acceptance criteria and the study proving the device meets those criteria based on the provided text. This type of information would typically be found in the 510(k) submission itself, or in supporting technical documentation, which is not included here.

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Huber Infusion Sets are used for infusion of medication to a patient. This particular device is used for Oncology/Chemotherapy treatment.

Huber Infusion Set with Needleless Injection Site

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a letter from the FDA regarding a 510(k) premarket notification for an "Exel Huber Infusion Set with Needleless Injection Site." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed, subject to general controls and other regulations.

The document does not detail any performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. It primarily focuses on the regulatory approval process.

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THIS DEVICE IS AN A.V. FISTULA NEEDLE SET PART OF EXTRACORPORIAL ARTICICAL IS THE FOR SYSTEM FOR THE TREATHENTS WITH RENAL PALLURE TO PROVIDE ACCESS TO THE PATIENT'S BLOOD VESSEL FOR HEMODIALYSIS.

EXEL A.V. FISTULA NEEDLE SET

This is a 510(k) premarket notification for a medical device called the "EXEL A.V. Fistula Needle" and does not contain information about acceptance criteria or a study proving its performance. The document is an FDA letter confirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include details on specific performance metrics, clinical studies, or the types of information requested in the prompt.

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

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Ask a specific question about this device