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BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements.

BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniVia™ RightFit enteral systems.

Enteral Extension Sets are intended to provide access from a feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in two configurations:

• Standard enteral extension sets, with a variation in tube length and diameter
• Bifurcated extension sets, which allow for medication or additional delivery without disrupting the feeding line with a variation in tube length

Enteral Extension Sets consists of flexible tubing with a purple strip on the tubing. The enteral connectors are purple in color for ease of identification of enteral feeding lines. The female connector has a tethered cap to cover the connector when not used to prevent fluid leakage. A clamp is present over the tube to stop the fluid flow as needed. Transitional Adapters allow for the connection of RightFit Enteral Extension Sets to non-enteral systems. The Transitional Adapters are available in two configurations:

• Enteral female to enteral female
• Enteral male to enteral male

The document you provided is a 510(k) summary for a medical device called "BD UniVia™ RightFit Extension Sets and Transitional Adapters." This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and it typically relies on non-clinical (bench) testing rather than clinical studies.

Therefore, many of the requested categories related to clinical trials, expert adjudication, and AI performance will not be applicable or present in this context.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

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

The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, specific numerical acceptance criteria and reported device performance values are not provided in this summary. It only lists the types of tests performed.

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 for Test Set: The document does not specify the sample sizes used for each of the in vitro tests.
• Data Provenance: The studies were in vitro (bench testing), not clinical. The document does not specify the country of origin of the data beyond stating the submitter (MPS Medical, Inc.) is located in Brea, CA, USA. This would be considered prospective bench testing conducted specifically for this submission.

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 device is not an AI/imaging device requiring expert interpretation for ground truth. It is a physical medical device. Ground truth for its performance is established through measured physical and chemical properties in controlled lab settings against established standards.

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

Not applicable. This device is not an AI/imaging device 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 device is not an AI-assisted diagnostic device.

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

Not applicable. This device is 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 based on pre-determined product specifications and external standard requirements (e.g., ISO standards for biocompatibility, sterilization, and transportation/shelf life, as well as internal functional specifications for physical properties).

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so 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 a machine learning model, there is no ground truth to establish for it in this context.

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This product is intended for short-term use

The NeoMed Gastrointestinal Tube and Accessories is a PVC single lumen catheter that is used to deliver liquid nutritional media. This NeoMed PVC feeding tube is designed to connect with other NeoMed accessories such as the NeoMed Extension tubing under FDA clearance K100288 and NeoMed oral syringe under FDA clearance K092908.

The device consists of the following main components: a feeding tube single lumen catheter and a one-piece molded enteral only connector hub with integral tethered connection closure plug. The catheter tubing has an orange radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The tip is closed. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration.

The provided text describes a 510(k) submission for the NeoMed Gastrointestinal Tube and Accessories, which seeks substantial equivalence to existing predicate devices. The study conducted to demonstrate this equivalence is primarily an engineering bench test study rather than a clinical study involving human patients or complex AI algorithms.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes "bench testing" and "design verification functional test results." It does not specify a "test set" in the context of patient data or algorithm performance. The testing involved physical tubes and components. No information is provided regarding the specific number of units tested for each functional test (tensile strength, dimensions, etc.), nor is there any mention of data provenance (e.g., country of origin) as the tests are laboratory-based engineering evaluations.

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

Not applicable. The study is a bench test, and there is no mention of experts establishing a "ground truth" for a test set in the context of clinical or image-based evaluations. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as this study does not involve human interpretation or subjective assessments that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This study is an engineering bench test for physical device characteristics and does not involve human readers, AI assistance, or comparative effectiveness in a clinical setting.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No. This device is a physical medical tube, not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used

The ground truth used for this study is based on engineering specifications, material properties, and functional performance standards derived from the intended use and comparison with predicate devices. For example, for dimensions, the ground truth would be the specified dimensions in the design; for tensile strength, it would be the minimum required strength; for biocompatibility, it would be successful compliance with ISO 10993-1.

8. Sample Size for the Training Set

Not applicable. This study does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This study does not involve a "training set" for which ground truth would need to be established.

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The Oral Enteral Syringe is intended for the delivery of liquid medication, formula and breast milk.

The Oral Enteral Syringe is intended as a single use, sterile, device for the delivery of liquid medication, formula and breast milk. The Oral Enteral Syringe comes in multiple volume sizes ranging from 1cc to 60cc [e.g., 1cc, 3cc, 10cc, 20cc, 30cc and 60cc]. The VR Medical Oral Enteral Syringe, as well as the predicate device [Phillips Children's Medical Venture Oral/ Enteral Syringe (K100099)] has 'labeling' on the device itself, i.e., highly visible labeling on side of barrel marked ORAL/ENTERAL ONLY, and the utilization of bright orange colorant for the plunger and cap that easily distinguishes the syringe for feeding and not other uses.

The Oral Enteral Syringe incorporates safety connectors which eliminate the risk of IV administration through the feeding tube, i.e., the safety connectors will not mate with Luer Lock or Leur slip fittings.

The VR Medical Oral Enteral Syringe design incorporates various components, e.g., barrels, plungers, caps and end caps, which are comprised of commercially available materials with demonstrated acceptable biocompatibility, as listed below:
Barrel Material: Polypropylene 370Y
Piston Material: Thermoplastic Elastomer IR307
Plunger Material: Polypropylene 370Y
Plunger Colorant: Orange Pigment*
Cap Material: Polypropylene 370Y
Cap Colorant: Orange Pigment (P21024)
Barrel Gradation Ink: PPE Ink Series (on outside of barrel)
Nozzle Material: Polypropylene 370Y (molded with barrel)

The Oral Enteral Syringe does not contain natural rubber latex, DEHP, or BPA.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device: VR Medical Oral Enteral Syringe
Premarket Notification (510(k)) Number: K110853
Date of Submission: May 12, 2011
Date of Clearance: May 13, 2011

The document describes a 510(k) submission for the VR Medical Oral Enteral Syringe, asserting its substantial equivalence to predicate devices (Phillips Children's Medical Venture Oral/Enteral Syringe (K100099) and Wei Gao Group Medical Syringe (K072739)). The primary focus for substantial equivalence is on the device's design, materials, function, and safety, especially concerning its enteral-only design to prevent misconnections with IV lines.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a separate, quantified section with matching "reported device performance" values for all tests. Instead, it details various tests conducted, with the implicit acceptance criterion being that the VR Medical Syringe performs equivalently to the predicate or meets established standards. The summary below interprets the "Justification" column as the implied acceptance goal or comparison.

• VR Medical and Phillips Children's device tips are substantially equivalent.
• VR Medical device tip is not substantially equivalent to the Wei Gao Group Syringe tip (this is okay as the primary predicate is Phillips).
• VR Medical device tip is not compliant with ISO 594 standard's tip requirements.
• VR Medical device tip is not compliant with other small-bore connectors listed in ISO 80369-1 except Enteral feeding tips.
• The width of the VR Medical syringe tip (OD) is larger than the ISO 594 Female Luer Connector IV connector ID dimensions (4.27-4.31 mm), thus cannot physically fit an ISO 594 rigid female Luer connector.
• The VR Medical Oral Enteral Syringe's tip dimensions fit well within the female connector of three different commercially available feeding tubes (MPS Acacia, AMERITUS, NeoMed). |

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

The document does not specify the exact sample sizes for each test performed on the VR Medical Oral Enteral Syringe. It generally refers to "VR Medical Syringe tested" without providing the number of units.

The data provenance is primarily from in-vitro testing conducted by VR Medical Technology Co. (the applicant), based in China ("90 Gao Xin Road, ZhouZhuang Kunshan 215325, China"). The substantial equivalence also relies on retrospective data from predicate devices and referenced standards or regulations (e.g., K100099, K072739, ISO standards, 21 CFR sections). The testing described appears to be prospective for the VR Medical Syringe itself, conducted specifically for this 510(k) submission.

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

The document does not describe the use of medical experts to establish "ground truth" in the traditional sense for these engineering and performance tests. The "ground truth" for these tests is based on:

• Established engineering standards: ISO 7886-1, ISO 7886-2, ISO 80369-1.
• Regulatory precedents: 21 CFR sections for material safety (biocompatibility).
• Performance of predicate devices: K100099 serves as a benchmark for substantial equivalence.
• Analytical engineering evaluations: These would typically be performed by engineers with expertise in medical device design and testing. No specific number or qualifications are provided for these engineers.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus) is described, as the testing involves objective engineering measurements and comparisons against standards and predicate device performance rather than subjective interpretations by human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is typically relevant for interpretative devices (e.g., imaging devices where human readers interpret results) to assess reader performance with and without AI assistance. The VR Medical Oral Enteral Syringe is a mechanical device, not an interpretative one, so an MRMC study is not applicable.

6. Standalone (Algorithm Only Without Human-In-The-Loop Performance) Study

No standalone performance study of an algorithm was conducted. This device is a physical product, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for these tests is:

• Technical Specifications/Standards: ISO standards for syringe performance (e.g., volume accuracy, general requirements), ISO 80369-1 for small-bore connectors.
• Predicate Device Performance: The performance characteristics of the Phillips Children's Medical Venture Oral/Enteral Syringe (K100099) served as a benchmark for many tests, establishing a baseline of "safe and effective" performance.
• Regulatory Compliance: Specifically, 21 CFR for material biocompatibility and FDA's previous conclusions on colorants.
• Compatibility with Commercially Available Products: The ability of the syringe's tip to fit into existing enteral feeding tubes on the market.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm, so 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 device.

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