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Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory.

The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.

The Kangaroo OMNI™ Enteral Feeding Pump, Kangaroo OMNI™ Feeding Sets and Kangaroo™ Accessories consist of an enteral feeding pump and disposable enteral feeding sets along with accessories that deliver fluids via rotary peristaltic tension loop pumping to provide hydration and nutrition for those who do not have the ability to orally ingest food or drinks.

This document is a 510(k) Summary for the Kangaroo OMNI™ Enteral Feeding Pump and related accessories. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment.

The "Performance Testing" section primarily focuses on engineering and regulatory compliance tests for the physical device, not software performance related to AI or diagnostic accuracy. It mentions software verification and validation but within the context of general medical device software guidance, not AI-specific performance metrics like sensitivity, specificity, or accuracy for a diagnostic task.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI-powered device using the provided text. The document describes a traditional medical device (an enteral feeding pump) and its associated accessories, and the testing outlined is typical for such a device (electrical safety, EMC, human factors, biocompatibility, battery testing, and essential performance requirements like flow rate accuracy and alarm detection).

Specifically, the document does not contain the following information relevant to AI device studies:

• A table of acceptance criteria and reported device performance (for an AI component): While there's a table comparing features, it lists physical and operational characteristics of the pump, not AI performance metrics.
• Sample size used for the test set and data provenance: Not applicable as it's not an AI test set.
• Number of experts used to establish ground truth and qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document states "Clinical Testing: Not Applicable," further indicating that this submission does not involve clinical performance data for a diagnostic or AI-driven device.

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Cardinal Health™ RoyalSilk™ Surgical Gown is a single use, disposable medical device intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70).

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I am sorry, but based on the provided text, there is no information about a medical device that uses AI or machine learning, nor any details about a study to prove its performance or acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Cardinal Health LLC regarding their RoyalSilk Surgical Gown and RoyalSilk Scrub Nurse Gown. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The content focuses on regulatory information, such as:

• The trade/device name and regulation number
• General controls provisions of the Act
• Requirements for registration, listing, labeling, and medical device reporting
• Information about the regulation entitled "Misbranding by reference to premarket notification"
• Links to FDA resources for medical devices
• Indications for Use for the surgical gowns, specifically stating that the Cardinal Health RoyalSilk Surgical Gown meets the requirements of AAMI Level 3 barrier protection per ANSI/AAMI PB70:2012.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or AI performance, as these topics are not present in the provided text.

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