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The Enteral Pump Set is intended to dispense liquid nutrients from enteral formula containers with SpikeRight™ port via VIASYS MedSystems Enteral Pumps.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Enteral Pump Set Model 20-1010AIV." This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the provided document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications. The document is solely a regulatory approval letter and an indications for use statement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input, as this information is not present in the provided text.

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The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. Prior to commencing the delivery of food, confirmation of correct tube placement by acceptable hospital protocol is required.

The CORTRAK™ System is an electrical device.

The provided document is a 510(k) clearance letter from the FDA for the CORTRAK™ System. It states that the device is substantially equivalent to a legally marketed predicate device. While it includes the intended use and regulatory information, it does not contain any details about acceptance criteria, specific device performance, or a study that proves the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding, Prior to commencing the delivery of food, confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.

The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding.

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving such criteria are met. The document is an FDA 510(k) clearance letter for the CORTRAK™ Enteral Access Device, indicating that the device has been found substantially equivalent to a predicate device.

The letter discusses:

• The device name and regulation details.
• The FDA's determination of substantial equivalence.
• General controls and regulations applicable to the device.
• Contact information for further inquiries.
• The "Indications for Use" for the CORTRAK™ System.

It does not include details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or study types (retrospective/prospective).
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Training set sample size.
9. How ground truth for the training set was established.

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The Anti-I.V. Enteral Feeding System is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentric route. The Anti-I.V. Enteral Feeding Tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentic route. The Anti-I.V. Enteral Feeding Extension Set is intended to be connected to the nutritional source to the Anti-I.V. Enteral Feeding Tube. The Anti-I.V. Enteral Feeding System is for pediatric and neonatal use only.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Anti-I.V. Enteral Feeding System". This document establishes that the device is substantially equivalent to a predicate device already on the market. It is not a study report and does not contain the detailed information necessary to describe acceptance criteria, device performance, or the methodologies of a study as requested in your prompt.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance: This letter is a notification of clearance, not a performance report.
2. Sample size used for the test set and data provenance: No study details are provided.
3. Number of experts and their qualifications for ground truth: No study details are provided.
4. Adjudication method for the test set: No study details are provided.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: This type of study is not mentioned.
6. Standalone (algorithm only) performance: This device is a physical medical device, not an algorithm.
7. Type of ground truth used: No study details are provided.
8. Sample size for the training set: Not applicable for this type of device and document.
9. How ground truth for the training set was established: Not applicable for this type of device and document.

In summary, the provided FDA 510(k) clearance letter confirms that the "Anti-I.V. Enteral Feeding System" is cleared for marketing based on substantial equivalence to predicate devices, but it does not describe the specific studies, acceptance criteria, or performance metrics in the way you've outlined for AI/algorithm-based devices.

To obtain the information you requested, you would typically need to refer to the original 510(k) submission document or any referenced clinical study reports, which are not included in this FDA clearance letter.

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The PULMANEX® Disposable Manometer is designed to provide visual indication of a pediatric/infant/neonate's airway pressure during ventilation. It may be attached to the manometer port on manual ventilation devices such as resuscitation bags or hyperinflation bags.

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The provided text is a 510(k) clearance letter for the PULMANEX® Disposable Pressure Manometer. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert ground truth establishment, or AI-related details. The letter confirms substantial equivalence to a predicate device but does not detail the testing or validation studies performed.

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

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The FreedomAire II Surgical Helmet is intended to be worn by operating room personnel in order to provide a barrier between the operating environment and operating room personnel from in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM

I'm sorry, but without further details about specific studies or tests conducted on the "STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM" as described in the provided text, I cannot generate the requested information regarding acceptance criteria and performance data. The document provided is a 510(k) clearance letter from the FDA, which confirms substantial equivalence to a predicate device but does not typically include detailed study results or acceptance criteria tables.

To fulfill your request, I would need additional documentation that specifically outlines:

• Acceptance Criteria: What quantitative or qualitative benchmarks the device was required to meet.
• Study Design: The methodology, sample sizes, and specific outcomes measured in any performance studies.
• Data Provenance: The origin and nature of the data collected.
• Ground Truth Establishment: How the "truth" was determined for evaluation, including expert involvement.
• MRMC Studies or Standalone Performance: Whether these specific types of studies were conducted and their results.

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The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of feeding tubes of 8 FF or larger in the stomach or small bowel of patients requiring enteral feeding. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.

Not Found

This document is extremely limited in the information it provides regarding the acceptance criteria and study details. It is a 510(k) clearance letter for the CORTRAKT™ device and does not include the detailed study results or acceptance criteria.

Therefore, I cannot provide the requested information from the provided document. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics.

To answer your questions, one would need to review the actual 510(k) submission (K041987) which would contain the performance data and the specifics of the studies conducted. This document only serves as the FDA's clearance notice.

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