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The Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector are intended for enteral feeding to deliver enteral nutrition, liquid or medication to patient from an enteral feeding syringe or feeding set designed with a connector for enteral applications.

The device is intended for pediatric patients who require enteral feeding.

The Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit Connector are sterile, disposable medical devices designed to deliver nutrition to patients who cannot obtain nutrition by mouth, are unable to chew or swallow safely, or need nutritional supplementation. The device is designed with a single lumen Polyvinyl Chloride (PVC) or Polyurethane (PU) tubes with ENFit male small bore connector at proximal end.

The provided text is a 510(k) premarket notification for a medical device (feeding tubes) and does not contain information about the acceptance criteria and study proving a device meets acceptance criteria in the context of an AI/ML algorithm or software validation. The document describes the substantial equivalence of new feeding tubes with an ENFit connector to previously marketed predicate devices, focusing on manufacturing, materials, and physical properties.

Therefore, I cannot extract the information required by your request, as it pertains to a different type of device validation (e.g., for AI models) than what is described in this regulatory filing.

Specifically, the document does NOT contain:

• A table of acceptance criteria and reported device performance for an AI/ML system.
• Information on sample size, data provenance, number/qualifications of experts, or adjudication methods for a test set in the context of AI/ML validation.
• Details on MRMC comparative effectiveness studies or standalone AI performance.
• The type of ground truth used (expert consensus, pathology, outcomes data) in an AI context.
• Training set details (sample size, ground truth establishment) for an AI model.

The "Nonclinical testing" section primarily discusses bench testing for physical aspects of the feeding tubes (biocompatibility, stability, dimensional analysis, fluid leakage, tensile strength, etc.) and risk assessments related to the ENFit connector. The "Clinical testing" section explicitly states: "Clinical evaluations were not relied upon for the determination of substantial equivalence to the predicate device based on the device classification, sufficient safety and functional performance information provided in the submission."

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The MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.

The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician. Accessories to be offered alongside the MED-RX Pediatric Feeding Tubes include MED-RX Enteral Extension Sets of various configurations. The MED-RX Enteral Extension Set is intended to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tubes and Enteral Extension Sets feature non-luer enteral only connectors to decrease the risk of accidental misconnection. All devices are sterile, single-use, and latex free. The MED-RX Pediatric Feeding Tube and Accessories are for pediatric use only. Accessories may be sold with MED-RX Pediatric Feeding Tubes or separately.

The provided document is a 510(k) premarket notification for a medical device (MED-RX Pediatric Feeding Tube and Accessories). It describes non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets clinical acceptance criteria with respect to AI/algorithm performance. Therefore, many of the requested points, such as those related to AI/algorithm performance, ground truth, expert review, and MRMC studies, are not applicable to this document.

However, I can extract information related to the device's non-clinical acceptance criteria and the summary results of those tests.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It states "The MED-RX Pediatric Feeding Tubes and MED-RX Enteral Extension Sets have successfully completed all required performance testing."
The data provenance is not explicitly stated in terms of country of origin of the data or retrospective/prospective nature. These are non-clinical bench tests performed by the manufacturer and a contract lab (Wuxi AppTec for Latex Content).

3. 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 applicable. This document describes non-clinical, physical, and biocompatibility testing, not a study involving expert human review or ground truth derived from clinical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As above, this pertains to non-clinical testing.

5. 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. This document does not describe a study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document does not describe an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" or reference for passing/failing is defined by established regulatory standards (e.g., ISO, ANSI/AAMI standards) and specific quantitative criteria (e.g., tensile force in lbf, pressure in kPa, latex percentage).

8. The sample size for the training set

Not applicable. There is no "training set" as this is a non-AI/algorithm device submission.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" or corresponding ground truth as this is a non-AI/algorithm device submission.

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The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to

The Infant Feeding Tube is a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

This document describes a 510(k) premarket notification for a medical device, the "Infant Feeding Tube." The submission seeks to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new clinical claim. Therefore, many of the requested categories related to clinical study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable in this context.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are typically the characteristics and performance of the predicate device. The "reported device performance" demonstrates that the new device meets or is equivalent to these characteristics.

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