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The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.

The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System.

The EFES is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.

The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the qastro intestinal tract of neonatal, pediatric and is not intended for use beyond 30 days. They are sterile, individually packaged. The orange color coding provides easy visual recognition of the enteral connection. They are designed with a radiopague stripe for X-ray visualization to confirm proper feeding tube placement. They are marked with French size and markings to assist tube placement or check for migration. A tethered plug for connector closure is incorporated when not in use.

The Enteral Feeding Extension Sets ("EFES") are intended to provide access from the feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in multiple configurations: with and without an in-line Y port and lengths. The EFES are sterile disposable device for single patient use only. The EFES is designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector. The EFES consists of flexible tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors.

This document describes the premarket notification for the VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from various international and national standards relevant to enteral feeding devices and their connectors. The reported device performance is indicated by its successful completion of these tests, demonstrating compliance with the standards.

Table 1: Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test in the "test set" (bench testing). However, it refers to performance testing conducted in accordance with established international and national standards (e.g., ISO, EN, ASTM, ANSI/AAMI). These standards typically specify minimum sample sizes for different types of tests to ensure statistically significant results. The data provenance is from bench testing, which is a form of prospective data collection under controlled laboratory conditions, not from human subjects or retrospective clinical data. The country of origin of the data is not specified beyond the submitter being in China, implying the testing was performed there or by a contracted lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes technical performance and biocompatibility testing, not studies requiring expert interpretation of clinical data to establish ground truth. Therefore, there were no experts used to establish ground truth in the context of clinical interpretation, as the tests are against objective engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and a consensus or tie-breaker mechanism is needed. The described testing involves objective measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technical and biocompatibility testing of the device itself, not on evaluating the effectiveness of human readers using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance evaluation in this document is a standalone assessment of the device's physical and biological characteristics against engineering and safety standards. There is no algorithm or human-in-the-loop component being evaluated.

7. The Type of Ground Truth Used

The ground truth used for these tests are the established performance criteria and pass/fail thresholds defined within the referenced international and national consensus standards (e.g., ISO 80369-3, EN1615, ISO 10993-1, ASTM D3359-09, ANSI/AAMI ID54). These standards represent industry-accepted benchmarks for device safety and performance.

8. The Sample Size for the Training Set

Not applicable. This is a premarket notification for a physical medical device (feeding tube and extension set), not an artificial intelligence/machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

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The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) for patients in all age groups.

The Enteral Syringe with ENFit Connector (10 ml to 60 ml) and the Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) are both sterile, standard piston style enteral syringes with an integrated female ENFit compatible connector compliant to the requirements of ISO DIS 80369-3, First Edition, Small-bore Connectors for Liquids and Gases in Healthcare Applications – Part 3: Connectors for Enteral Applications and designed to be compatible with male ENFit connectors.

The Enteral Syringe with ENFit Connector has capacities of 10, 20, 30 and 60 ml and is available in two different connector confiqurations: Centerline and Offset.

The Enteral Syringe with ENFit Low Dose Tip is a low dose syringe and has capacities of 1. 3 and 5 ml. The ENFit Lose Dose tip is a modification of the ENFit connector designed for the delivery of low doses of fluids for enteral feeding.

The document describes the VR Medical Technology's Enteral Syringe with ENFit® Connector and Enteral Syringe with ENFit® Low Dose Tip. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria in the context of an effectiveness study for an AI/ML device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of device submission. This document focuses on demonstrating compliance with recognized standards and biocompatibility.

Here's an analysis based on the provided text:

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

The document does not present a formal table comparing acceptance criteria to device performance in the way typically seen for AI/ML device effectiveness studies. Instead, it lists various performance tests conducted according to international standards (ISO). The "acceptance criteria" are implied by compliance with these standards, and the "reported device performance" is indicated by the statement that these tests were "conducted" and supported a conclusion of substantial equivalence.

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

This information is not provided in the document. For physical device testing against standards, specific sample sizes are typically defined within the test protocols associated with the ISO standards, but these details are not presented here. Data provenance is also not relevant in the context of these physical performance tests.

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)

This information is not applicable as this is a physical device, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on patient data. The "ground truth" here is compliance with engineering and safety standards.

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

This information is not applicable as this is a physical device, not an AI/ML diagnostic or prognostic tool.

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

This information is not applicable as this device is a physical enteral syringe, not an AI/ML system or a medical imaging device that would involve human readers.

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

This information is not applicable as this device is a physical enteral syringe, not an algorithm.

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

The "ground truth" in this context is the predefined requirements and specifications within the referenced ISO standards (ISO 10993-5, ISO 10993-10, ISO 7886-1, ISO DIS 80369-3, ISO 14971) and demonstrated through the physical performance and biocompatibility testing. In the case of the Usability Study, the "ground truth" would be the successful and safe use of the device by representative users.

8. The sample size for the training set

This information is not applicable as this is a physical device, not an AI/ML system that requires a "training set."

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

This information is not applicable as this is a physical device, not an AI/ML system.

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