(15 days)
CORTRAK* 2 Equilateral Enteral Access System is an electrical device designed to aid qualified operators in the placement of Avanos NG feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK* 2 Equilateral Enteral Access System can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.
CORTRAK* 2 Equilateral Enteral Access System (EAS) device is designed to track the path of an 8 Fr or greater Avanos feeding tube tip during the patient placement procedure. A coil winding at the distal end of the transmitting stylet acts as a transmitter, and its signal is detected by the externally-positioned receiver unit. The received signals are input to the attached All-In-One Monitor unit. The resulting raw data is processed, recorded, and presented to the operator in a meaningful and intuitive screen tracing. The CORTRAK*2 Equilateral EAS device is an electrical device that does not contact the patient, is not sterilized, and is reusable. Like the predicate device, it is intended to be use in clinical environment.
The provided document describes a device modification for the CORTRAK® 2 Equilateral Enteral Access System. However, it does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance or clinical effectiveness.
The document focuses on demonstrating substantial equivalence to a predicate device (K113351) by showing that the changes made (updated PC Single Board Computer, Display Processor Module, Operating System, GUI, removal of USB boot, removal of battery conditioning requirement) do not alter the intended use, safety, or effectiveness.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as it is not present in the provided text.
Here is what I can extract based on the information provided, explaining why certain sections cannot be filled:
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A table of acceptance criteria and the reported device performance
- Not Available. The document outlines "nonclinical testing" which focuses on compliance with standards (IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 62304) to demonstrate that the modified device continues to meet performance specifications and that the changes do not raise new safety or effectiveness issues. It does not present specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics against such criteria. The "Results" column in the table only states "Pass" for compliance with these standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The nonclinical testing mentioned does not involve a "test set" in the context of clinical performance or diagnostic accuracy. It refers to engineering and software verification tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available. Ground truth establishment by experts is not relevant to the type of nonclinical testing described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. Adjudication methods are not relevant to the nonclinical testing described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. The device described (CORTRAK® 2 Equilateral Enteral Access System) is an electrical device designed to aid operators in placing feeding tubes and confirming placement. It is not an AI-assisted diagnostic tool that would typically involve human readers or MRMC studies for improved diagnostic effectiveness. The changes are technical updates to electronics and software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. As mentioned above, this device "aids qualified operators." It is not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth in the context of diagnostic/clinical performance is not discussed. The nonclinical testing refers to compliance with engineering and quality standards.
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The sample size for the training set
- Not Available. The document does not describe the development of an AI algorithm or a "training set."
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How the ground truth for the training set was established
- Not Available. As there is no described AI algorithm or training set, this information is not present.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.