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The All Safe Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The All Safe Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries. The All Safe Huber Safety Infusion Sets are also indicated for power injection of contrast media into the central venous system with implanted vascular ports indicated for power injection. The maximum recommended infusion rate at 11.8 cps is 5 ml/sec for 19 and 20 gauge. Maximum pressure is 325 psi for all gauge sizes.

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I am sorry, but the provided text from the FDA 510(k) summary for the "All Safe Huber Safety Infusion Set" does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the specific details outlined in your request (sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, or training set information).

The document is primarily a notification of a substantial equivalence determination by the FDA for a medical device. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It details the device's indications for use and classification.

To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a more detailed 510(k) summary that includes information about specific performance tests and their results against predefined acceptance criteria.

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The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus NIS®-6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi. The Nexus NIS®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure device. It has a pre-slit septum which does not require the use of a stainless steel needle.

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Nexus NIS-6P". It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. This document primarily focuses on the FDA's regulatory review and determination of substantial equivalence for the device.

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The NIVTS-LACV (Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve) are intended to administer IV fluids/medication to the patient's vascular system through a needle-free device system that aids in the elimination of needle-stick injury.

The Nexus Luer-Accessible One-Way Check Valve (LACV) is designed to allow fluid flow in one direction and stop or check fluid flow in the opposite direction.

Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve

I am sorry, but to answer your request, I need extensive details on "acceptance criteria" and "device performance" that are not present in the given text. The provided document is an FDA 510(k) clearance letter for a medical device (Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve). It confirms that the device is "substantially equivalent" to legally marketed predicate devices.

However, the document does NOT contain:

• Specific acceptance criteria: It doesn't list quantitative or qualitative criteria that the device had to meet (e.g., "flow rate must be X mL/min with Y% accuracy" or "check valve must prevent backflow in Z% of trials").
• Reported device performance data: It doesn't provide any tables or descriptions of how the device actually performed in any tests against such criteria.
• Details of a study: There's no mention of a clinical or non-clinical study, its design, sample sizes, data provenance, ground truth establishment, or expert evaluations. The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, which sometimes involves performance testing against recognized standards, but the results of those tests are not typically included in the clearance letter itself.

Therefore, I cannot fulfill your request for details about acceptance criteria and study data based on the provided text.

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The Nexus TKO®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients.

The Nexus TKO®6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi.

The Nexus TKO®-6P incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing.

The Nexus TKO®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Nexus TKO®-6P, Luer Activated Device), which describes the device's indications for use and regulatory classification. However, it does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other study-related information.

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The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus TKO®-6 incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing. The Nexus TKO®6 has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

The Nexus TKO®-6 is a luer-activated, normally closed, bi-directional, anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus TKO®-6 incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing. The Nexus TKO®6 has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

This document is a 510(k) premarket notification approval letter from the FDA for a medical device called the "Nexus Luer-Activated Device, Nexus TKO®-6." It confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device.

However, this document does not contain information about acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report proving a device meets acceptance criteria.

The letter explicitly 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... You may, therefore, market the device, subject to the general controls provisions of the Act." This means the device met the requirements for 510(k) clearance, which is primarily about demonstrating substantial equivalence, not necessarily meeting a predefined set of performance acceptance criteria through clinical studies detailed in the provided text.

Therefore,Based on the provided FDA 510(k) clearance letter, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. This document is an approval letter, not a study report. It states that the device is "substantially equivalent" to a predicate device, which is the basis for its clearance, rather than detailing a specific study with acceptance criteria and performance metrics.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information about standalone (algorithm only) performance.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Therefore, I am unable to provide the requested information from the given text.

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The Nexus Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities that utilize infusion systems to administer IV fluids, medications, blood and blood products to the patient's vascular system and may be safely used with power injectors at pressures up to 325 psi. The needle-free design allows the user to add medication into the primary line and may also aid in the prevention of needle stick injuries.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device (Nexus Pressure Rated Extension Sets), confirming its substantial equivalence to a predicate device for marketing. It outlines regulatory requirements and contact information but does not contain detailed study results, performance data, or an explicit list of acceptance criteria for the device itself.

Therefore, I cannot provide the requested table and study details.

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The NIVTS-P (Nexus IV Tubing Sets – Pre-Pierced) are intended for use to administer IV fluids/medication to the patient's vascular system through a needle.

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The provided text is a 510(k) premarket notification letter from the FDA to Nexus Medical, LLC, regarding their "Nexus Intravenous Tubing Sets-Pre-Pierced" device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt for evaluating an AI/ML medical device.

This document is a regulatory approval letter for a physical medical device (intravenous tubing sets), not a software or AI/ML device. Therefore, the requested information (such as AI performance metrics, MRMC studies, or training set details) is not applicable and not present in the provided text.

Based on the input:

1. A table of acceptance criteria and the reported device performance: Not available. This document is a regulatory clearance letter, not a performance study report.
2. Sample size used for the test set and the data provenance: Not available. No information on a "test set" for performance evaluation is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. The concept of "ground truth" as relevant to AI/ML performance evaluation is not discussed.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory clearance for an intravascular administration set and does not contain the type of information requested for evaluating an AI/ML medical device's performance study.

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The NIS is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS device may aid in the prevention of needle stick injuries.

The NIS is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids.

The provided text is a 510(k) premarket notification letter from the FDA to Nexus Medical, L.L.C. regarding their Nexus Injection Site, NIS-8 device. This document confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory requirements.

Crucially, this document does not contain any information about acceptance criteria or specific study results for the device's performance.

Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement based on the provided text. The letter focuses solely on the regulatory approval process and not on the technical performance data that would typically be included in a premarket submission.

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The Nexus I.V. Needless Access Cannula are intended for use to administer IV fluids / medication to the patients vascular system through a needle free system that aids in the prevention of necdle stick injuries.

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I am sorry, but the provided text does not contain any information regarding the acceptance criteria, device performance, or study details. The document is an FDA 510(k) clearance letter for an "I.V. Needless Access Cannula for Intravascular Administration," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The letter mentions:

• Trade/Device Name: I.V. Needless Access Cannula for Intravascular Administration
• Regulation Number: 21 CFR 880.5440
• Regulation Name: Intravascular Administration Set
• Regulatory Class: II
• Product Code: FPA
• Indications for Use: To administer IV fluids/medication to the patients' vascular system through a needle-free system that aids in the prevention of needle stick injuries.
• 510(k) Number: K081123

However, it does not include any data from studies, acceptance criteria, sample sizes, expert qualifications, or ground truth information that would allow me to answer your specific questions about device performance and the study details. This type of information is typically found in the 510(k) summary or in the full 510(k) submission, neither of which is provided here.

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The Nexus I.V. Vial Access Device is intended for use to aid healthcare professionals in mixing and transferring I.V. fluids / medication from a rubber-stopper medication vial to another device, through a needle-free system that aids in the elimination of needle stick injuries.

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The provided document is a 510(k) clearance letter from the FDA for a medical device. It does not contain any information about the acceptance criteria or a study that proves the device meets those criteria.

The letter states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer (Nexus Medical, LLC) in their 510(k) submission, which would include performance data, but that specific data and the acceptance criteria themselves are not detailed in this clearance letter.

Therefore, I cannot answer your request for a table of acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth information based on the provided text.

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