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The MED-RX® Oral/Enteral Syringes are to be used by a healthcare professional to measure and administer oral medication and enteral nutrition. The MED-RX® Oral/Enteral Syringes are sterile, single use, and for pediatric use only.

The MED-RX® Oral/Enteral Syringe is available in two configurations, an enteral tip syringe and an overmolded enteral tip syringe. Both configurations of the MED-RX® Oral/Enteral Syringe are available in various volumes, from 1 to 60mL. All MED-RX® Oral/Enteral Syringe feature graduation markings along the barrel of the syringe, are provided with a tip cap, and are incompatible with standard luer devices. The MED-RX® Oral/Enteral Syringes are provided sterile, and are single use and disposable.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Benlan™ MED-RX® Oral/Enteral Syringes:

The provided text is a 510(k) Summary for a medical device and therefore describes a regulatory submission for substantial equivalence, not a clinical study proving device performance against specific acceptance criteria in the context of diagnostic accuracy or clinical outcomes.

The "acceptance criteria" and "device performance" in this document refer to various functional, material, and safety tests to demonstrate that the device is as safe and effective as a legally marketed predicate device. The document does not describe a study evaluating the device's clinical performance with human readers, AI, or diagnostic accuracy metrics.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of document.

Here's how the provided information maps to your request:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details (As applicable to this type of regulatory submission)

2. Sample size used for the test set and the data provenance:

• Sample Size (for functional and biocompatibility tests): The document states "All bench testing was successfully completed on both configurations of the MED-RX® Oral/Enteral Syringe: the overmold enteral tip syringe and the enteral tip syringe." It also states "Both configurations of the MED-RX® Oral/Enteral Syringe were tested for biocompatibility." Specific numerical sample sizes for each test are not provided.
• Data Provenance: The tests were conducted by the manufacturer, Benlan™ (located in Oakville, ON, Canada, as per the submission contact information). These are laboratory/bench tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This device is a syringe, and the testing involves functional, material, and biological safety evaluations, not diagnostic image interpretation or complex clinical decision-making requiring "experts" to establish ground truth in the traditional sense of a clinical study. The "ground truth" for these tests are objective measurements (e.g., cytotoxicity, leakage, material properties) as defined by the relevant ISO standards.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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:

• No. This is a physical medical device (syringe) and not an AI or diagnostic imaging device. An MRMC study is not relevant to its regulatory approval in this context.

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

• No. This is a physical medical device (syringe) and not an AI or algorithm-based device.

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

• For functional performance tests, the ground truth is derived from whether the device met pre-defined engineering specifications and performed as expected (e.g., no leakage, proper functionality, incompatibility with luer devices). These are objective criteria.
• For biocompatibility tests, the ground truth is established by the accepted scientific standards and methodologies outlined in the ISO standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and intracutaneous reactivity). The "truth" is whether the biological response meets the criteria for non-toxicity, non-sensitization, etc., as per the standard.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

In summary: The provided document is a 510(k) summary for a non-active, non-diagnostic medical device. The "acceptance criteria" and "study" refer to engineering, functional, and biological safety testing designed to demonstrate substantial equivalence to a predicate device, rather than a clinical trial evaluating diagnostic or treatment efficacy that would typically involve human readers, AI, or complex outcome measures.

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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 MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe.

The MED-RX Transfer Set is offered in four (4) different models: 10-1227TS, 10-1300TS, 10-1305TS, and 10-1306TS. The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe. The MED-RX Transfer Sets each consist of a spike, tubing, and either a valve (swabbable or dual check) or 3-way stopcock. All sets but the 10-1306TS also have a pinch clamp. The tube is made of polyvinyl chloride (PVC) and is available in lengths from 18″ – 44″. The MED-RX Transfer Sets are provided sterile and are not to be resterilized.

This is a 510(k) premarket notification for a medical device (MED-RX Transfer Set), not an AI/ML device. Therefore, the requested information about acceptance criteria and study details related to AI/ML device performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC study, standalone performance, training set size, ground truth for training set) is not applicable and not available in the provided document.

The document describes the acceptance criteria and study results for the physical and functional performance of the MED-RX Transfer Set, which is an intravascular administration set. The study aims to demonstrate substantial equivalence to predicate devices (Medrad Transfer Set K022431 and Medrad Swabbable Valve Transfer Set K031808), not to prove AI/ML performance.

Here's a breakdown of the acceptance criteria and study results based on the provided text, modified to fit the context of a medical device (not AI/ML):

1. Table of Acceptance Criteria and 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)

• Sample Size: The document does not specify the exact sample sizes (N value) for each individual non-clinical performance and biocompatibility test. It generally states that "samples met" or "product code X was determined," implying that sufficient samples were tested to meet the respective standards.
• Data Provenance: Not explicitly stated, but the testing would have been conducted by Benlan Inc. (located in Oakville, ON, Canada) or its designated testing facilities, following international (ISO, ASTM, USP) and national (ANSI/AAMI) standards. The nature of these tests is prospective: samples of the MED-RX Transfer Set are deliberately subjected to these tests to evaluate their performance against established criteria.

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 question is not applicable. The "ground truth" for a medical device like a transfer set is established by objective, standardized laboratory testing procedures as defined by the international and national standards listed (e.g., ISO, ASTM, USP, ANSI/AAMI). It does not involve expert interpretation or consensus in the way an AI/ML diagnostic algorithm's output would. The results are quantitative (e.g., force applied, levels of contamination, presence/absence of hemolysis) or qualitative (pass/fail) based on predefined thresholds in the standards.

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

Not applicable. As described above, the tests are objective, standardized laboratory assessments, not subjective evaluations requiring expert adjudication.

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 is not an AI/ML device; it is a physical medical device. MRMC studies are used for evaluating diagnostic performance, often involving human readers and AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is derived from objective, standardized test methods and criteria defined by established international and national standards (e.g., ISO 8536-4 for infusion equipment, ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135 for sterilization). These standards specify the test conditions, measurement methods, and acceptable limits or outcomes for various performance parameters (e.g., leakage, tensile strength, sterility, biocompatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for this physical medical device.

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These extension sets are sterile, single use, medical devices intended for use in LV. therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. does not cause or promote new intended uses for these devices.

The Med-RX® Extension Sets consist mainly of a fluid delivery tubing provided with capped luer connectors at the proximal ends. The extension sets can thus be connected to an I.V. administration sets whereby extending infusion site(s) of a primary I.V. catheter. The fluid delivery tubing can vary in lengths as well as bore sizes, i.e. standard bore, mini-bore and micro-bore. The extension sets may include pinch or slide clamps.

The provided text describes a 510(k) summary for the Med-Rx® Extension Sets, but it does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (Medex Extension Sets) based on materials, packaging, sterilization, and intended use. It does not include:

1. A table of acceptance criteria and reported device performance: This document primarily details intended use, classification, and claims of substantial equivalence, not performance metrics.
2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or type of ground truth for a test set.
3. Sample size or ground truth establishment for a training set.

The document states: "There are no differences in the characteristics of the subject device and the predicate(s)." This statement, along with the subsequent FDA letter granting substantial equivalence, indicates that the approval was based on the device being comparable to a pre-existing, legally marketed product, rather than on new performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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