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For nasogastric oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Nutrifit is a combined system of feeding tubes and extension sets. The feeding tubes are available in several configurations: Not made with DEHP PVC and Polyurethane (PUR). The PUR versions are available without stylet. All tubes include centimeter numerical markings from 5 to 35 cm for the 40, 50 and 75 cm feeding tubes and markings from 5 to 70 cm for the 90, 125 and 160 cm feeding tubes.

The Nutrifit devices are single-use, disposable devices intention in adults and children. Nutrifit PVC feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 5 days. Nutrifit PUR feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 29 days.

The Nutrifit accessories for this submission sets, which enable longer connections for the feeding tubes. They allow greater freedom of movement and greater flexibility and are available with or without a pinch clamp.

Nutrift is ENFit compliant, meeting requirements for design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories as detailed in ISO 80369-3.

The provided text is a 510(k) summary for the Vygon USA Nutrifit device, a gastrointestinal tube and accessories. It asserts the device's substantial equivalence to a predicate device (Nutrisafe 2) based on non-clinical performance bench testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set for any of the bench tests mentioned. It states "Adequate non-clinical performance bench testing was conducted" and "The VYGON's Nutrifit device met all predetermined acceptance criteria."
The data provenance is from non-clinical performance bench testing conducted by Vygon; the country of origin is not explicitly stated but implied to be internal testing by the manufacturer. The data is prospective for this device's evaluation.

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

This information is not provided in the document. The tests performed are engineering/performance-based bench tests, not clinical evaluations requiring expert interpretation of ground truth in the traditional sense (e.g., medical image interpretation). The "ground truth" for these tests would be the established specifications and standards (e.g., ISO 80369-3).

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective, performance-based bench tests against defined specifications, not subjective assessments requiring adjudication by multiple experts.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Bench Testing was conducted in order to support this submission." There is no mention of human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The Nutrifit is a medical device (tubing and accessories), not an AI algorithm or software. The testing focuses on its physical performance and safety characteristics.

7. The Type of Ground Truth Used

The ground truth used for the performance testing cited is based on established engineering specifications, international standards (ISO 80369-3), and FDA guidance protocols (e.g., "Gravity Flow Rate Testing in Enteral Tube"). This falls under objective technical standards rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable as the Nutrifit device is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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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 InnerSense Esophageal Temperature Probe/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician for up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.

The InnerSense Esophageal Temperature Probe/ Feeding Tube is a single- use, disposable, sterile device designed for nasogastric or orogastric placement in neonatal or pediatric patients. It is used to continuously monitor esophageal temperature, deliver oral medications and/or provide enteral feeding to a patient for up to 30 days. The InnerSense Esophageal Temperature Probe/ Feeding Tube can be used in neonates or children solely for temperature monitoring; it is not intended to be exclusively used for children who require enteral feeding. The device should be applied only under direct supervision of a licensed physician or healthcare provider and be safely connected only to an enteral giving set or syringe and the compatible patient monitor.

{
  "1. A table of acceptance criteria and the reported device performance": "| Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) | Notes on Comparison                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Status |\n|----------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|\n| **Temperature Accuracy Range:**         |                                               |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |        |\n| ± 0.1°C from 25°- 45°C                 | ± 0.1°C from 32°- 43°C                      | The thermistor type is identical. The minor difference in range is due to different testing standards (EN 12470-4 for predicate, ISO 80601-2-56 for proposed). The proposed device meets the clinical accuracy range of ISO 80601-2-56, applicable to the indicated patient population, and is considered substantially equivalent.                                                                                                                                                     | Met    |\n| **Feeding Connector Materials:**        |                                               |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |         |\n| Polyvinyl Chloride (PVC)-Orange colorant | Polyurethane-Orange colorant; Polyurethane-Purple colorant | Tested in accordance with ISO 10993. Biocompatibility testing proved the patient-contacting materials for the proposed device have the same toxicological, sensitization, irritation, and acute toxicity profile as the previously cleared device, deemed substantially equivalent. | Met    |\n| **Catheter Materials:**                 |                                               |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |         |\n| Clear Polyurethane-Orange colorant + ink | Clear Polyurethane-White (TiO2) + ink       | Tested in accordance with ISO 10993. Biocompatibility testing proved the patient-contacting materials for the proposed device have the same toxicological, sensitization, irritation, implantation, and acute toxicity profile as the previously cleared device, deemed substantially equivalent. | Met    |\n| **Distal Tip:**                         |                                               |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |         |\n| One lateral eye, one end eye in catheter tip | 2 offset lateral eyes, closed catheter tip  | Tested in accordance with EN 1615 and ISO 80601-2-56. Results showed equivalent tensile strength properties to the predicate device and equivalent performance. All tests passed, deemed substantially equivalent.                                                                                                                                                             | Met    |",
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document describes bench testing and verification, not clinical studies with a test set of patient data. Therefore, this information is not applicable in this context. The testing involved materials and performance criteria based on ISO and EN standards.",
  "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. The ground truth for the performance testing was established by adherence to recognized international standards (e.g., ISO, EN) for medical device evaluation, rather than expert consensus on a test set of cases.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The device's performance was evaluated through bench testing against established standards, not through clinical adjudication by experts on a test set.",
  "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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (esophageal temperature probe/feeding tube), not an AI diagnostic or assistance tool that would involve human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This device is a physical medical device and does not involve an algorithm for standalone performance evaluation.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth for the device's performance was established through adherence to recognized international standards for medical devices, specifically: \n- **ISO 80601-2-56:2009** for clinical thermometers.\n- **EN1615: 2000** for enteral feeding catheters.\n- **ISO 80369-1-1: 2010** for small-bore connectors.\n- **ISO 11607-1-1: 2006** for packaging.\n- **ISO 10993 series** for biological evaluation (cytotoxicity, local effects, residuals, irritation, systemic toxicity, chemical characterization).",
  "8. The sample size for the training set": "Not applicable. This device is a physical medical device, not a machine learning or AI model that requires a training set.",
  "9. How the ground truth for the training set was established": "Not applicable. This device is a physical medical device and does not involve a training set."
}

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The InnerSense Esophageal Temperature/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician for up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.

Philips' InnerSense Esophageal Temperature/Feeding Tube is a disposable, single-use, sterile device designed for nasogastric placement in neonatal and pediatric patients. It is used to continuously monitor esophageal temperature, deliver oral medications, and/or provide enteral feeding to a patient for up to 30 days. It should be used only under direct supervision of a licensed physician or healthcare provider, according to the hospital standard of care. Note: the temperature probe is auto-located in the distal esophagus when device is placed in accordance with the Insertion steps provided in the Application section of the IFU.

The provided 510(k) summary for the InnerSense Esophageal Temperature / Feeding Tube ([K120815](https://www.accessdata.fda.gov/cdrh_docs/reviews/[K120815](https://510k.innolitics.com/search/K120815).pdf)) describes extensive verification of functional performance. However, it does not explicitly define specific numerical acceptance criteria with pass/fail thresholds in the same way one might find for a diagnostic algorithm's sensitivity or specificity. Instead, the document outlines categories of tests performed and attests to their successful completion.

Here's an interpretation of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the successful completion of various performance tests, aligned with established medical device standards. The "reported device performance" is the statement that these tests were successfully completed.

The study that proves the device meets the acceptance criteria is the "Extensive verification of functional performance" which was "successfully completed." This verification involved subjecting the device to numerous tests as outlined above and by the listed international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993 series, EN 12470-4, ISO 80369-1).

Additional Information Not Found in the Provided Text:

The provided 510(k) summary focuses on device design and in vitro performance testing against engineering standards. It does not contain information related to human user studies or AI/algorithm performance. Therefore, the following points cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable in the context of in vitro device performance verification against engineering standards. The "test set" would refer to the physical units of the device that underwent testing. The document does not specify the number of devices tested, nor does it refer to data provenance in terms of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for in vitro engineering tests is established by calibrated instrumentation and adherence to standard protocols, not by expert human interpretation in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for clinical endpoints or image interpretation, not for in vitro device performance tests.
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 a physical medical device (temperature/feeding tube), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm for diagnosis or interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the in vitro performance tests, the "ground truth" would be established by the reference standards and calibrated equipment used during testing (e.g., a reference thermometer for temperature accuracy, a force gauge for tensile strength).
8. The sample size for the training set: Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the engineering and biocompatibility testing of a physical medical device, not a software algorithm or AI system. As such, many of the requested criteria related to AI/algorithm evaluation are not relevant or addressed in this submission.

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For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.

The Nutrisafe 2 silicone feeding tubes are utilizing a different formulation of silicone material I he Nutrisate 2 silicone feeding tubes. The feeding tubes. The feeding tubes are available in several than the catisting Nutrioure is a unique connection does not incorporate a luer, reducing SIZCS, and the leveling system connains an IV administration set or other medical delivery the fisk of madvertenity connection reduces the risk of involuntary disconnection; voluntary systems: "The is achieved by simply unscrewing the hub connections.

The Nutrisafe 2 Feeding Tube's acceptance criteria and the study proving its performance are detailed below. It's important to note that this device is a medical device, and the provided text from a 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing, rather than a clinical study with human subjects, AI systems, or extensive statistical performance metrics typically found for diagnostic or AI-driven medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "test set" sample size in terms of the number of feeding tubes or components used for the non-clinical bench testing. It broadly states that "Non-Clinical verification... was conducted through in-vitro bench testing."
• Data Provenance: The data is from in-vitro bench testing, meaning it was conducted in a laboratory setting. The country of origin for the data is not explicitly stated, but the submission is to the US FDA, implying the tests were conducted either by the applicant (Vygon Corp. in Montgomeryville, PA, USA) or a certified laboratory for the purpose of US market approval. The testing is retrospective in the sense that it evaluates the performance of the manufactured device in a controlled environment as part of the market submission process, rather than a prospective clinical trial.

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

This section is not applicable as the provided information describes non-clinical bench testing of a physical medical device, not a diagnostic or AI-driven system requiring expert-established ground truth from images or clinical data. The "ground truth" here is determined by engineering specifications and physical measurements, and the conformity to these is assessed by technical personnel.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on a diagnosis or interpretation, which is not relevant to the described non-clinical bench 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

This section is not applicable. The provided document is for a physical medical device (feeding tube) and does not involve AI assistance, human readers, or image interpretation. Therefore, an MRMC study or effect size calculation with AI assistance is not relevant.

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

This section is not applicable. The device is a physical feeding tube, not an algorithm or software. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for this premarket notification is based on engineering specifications and intended use requirements. The non-clinical bench testing verified that the Nutrisafe 2 Feeding Tube, despite a change in silicone material formulation, continued to meet these established specifications and its intended use, which includes safety features related to connection types.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of this device's non-clinical verification. Training sets are relevant for machine learning algorithms, which are not part of this submission. Device manufacturers conduct design and development activities where prototypes might be tested, but this is distinct from an "AI training set."

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

This section is not applicable as there is no training set for this device.

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For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.

The Nutrisafe 2 feeding tubes are a product line extension to the existing Nutrisafe 2 feeding tubes. The subject feeding tubes are available in several sizes and in two materials. The feeding system contains a unique connection that does not incorporate a luer, reducing the risk of inadvertently connecting to intravenous connectors. The locking connection reduces the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.

The provided text describes a 510(k) premarket notification for a medical device, the Nutrisafe 2 Feeding Tube, and its substantial equivalence to a predicate device. However, it does not involve an AI/ML device or a study that evaluates its performance against acceptance criteria in the way described in your request. The document focuses on the regulatory clearance process for a common medical device (feeding tube) based on its technological characteristics and intended use, rather than an AI algorithm's diagnostic or predictive capabilities.

Therefore, many of the requested categories in your prompt are not applicable to the provided information. I will, however, outline what can be extracted from the text in relation to your request.

Summary of Provided Information Regarding Acceptance Criteria and Study:

The provided document, K100163, is a 510(k) summary for a medical device (Nutrisafe 2 Feeding Tube), which is a product line extension. This type of regulatory submission assesses substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria of an AI model.

The "study" mentioned is a non-clinical verification through in-vitro bench testing. This type of testing ensures the device meets its specifications and intended use, primarily focusing on physical and functional characteristics suitable for a feeding tube, such as the integrity of the connection system, material compatibility, and flow rates. It does not involve human subjects, comparison to AI, or expert adjudication of outcomes.

Here's how the information aligns (or doesn't align) with your request categories:

1. Table of Acceptance Criteria and Reported Device Performance: This kind of quantitative data (e.g., sensitivity, specificity, AUC) is not present because this is a physical medical device, not an AI/ML diagnostic tool. The general "acceptance criteria" for this device would be its ability to meet specifications for a feeding tube as determined by the in-vitro bench testing.

   Metric/Criteria	Reported Device Performance
   All Specifications and Intended Use	"meets all specifications and intended use."

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. The "test set" here would refer to the physical samples of the Nutrisafe 2 Feeding Tubes used in the in-vitro bench testing. The document does not specify the number of tubes tested, nor their manufacturing origin beyond "Vygon, Montgomeryville, PA 18936." This was in-vitro testing, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of an AI/ML model, refers to validated diagnoses or outcomes. For a physical feeding tube, "ground truth" is established by engineering standards and functional tests. No external experts or adjudication were involved in establishing "ground truth" for the device's functional performance beyond the internal verification process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This method is used for resolving discrepancies in expert labeling or diagnoses for AI/ML validation datasets.

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 study type is for evaluating the impact of AI assistance on human diagnostic performance. The Nutrisafe 2 Feeding Tube is a standalone medical device, not an AI component.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to the performance of an AI algorithm alone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" for its performance is derived from engineering specifications and in-vitro functional and safety testing results. For example, the "locking connection reduces the risk of involuntary disconnection" is a functional characteristic tested against design requirements.

8. The sample size for the training set: Not applicable. This device does not have a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a traditional medical device (feeding tube) and its regulatory clearance based on substantial equivalence and non-clinical bench testing, not an AI/ML device. Therefore, most of the detailed questions regarding AI/ML study methodologies are not relevant to this specific premarket notification.

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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.

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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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 GUARDIAN CONNECTION™ is designed to be used with standard adult tapered feeding tube connectors to secure the connection.

The Guardian Connection is a non-sterile, reusable, plastic "Ushaped" clip designed to hold the connectors of an enteric feeding tube and an enteric feeding set together to help prevent inadvertent disconnection. The product is specifically designed to accommodate the non-IV tapered male conical stepped connectors and mating non-IV tapered female connectors commonly found on standard adult enteric feeding tubes and sets. The Guardian Connection clips around the outside of these connectors, and helps to prevent them from being pulled apart by tensile force.

The provided FDA 510(k) summary for the Guardian Connection™ device focuses on its substantial equivalence to a predicate device based on technological characteristics and bench testing. It does not contain information about acceptance criteria and a study in the context of diagnostic performance metrics like sensitivity, specificity, or AUC, as it is a physical medical device (a clip for feeding tubes), not a diagnostic algorithm.

Therefore, many of the requested categories are not applicable to this particular device submission.

Here's a breakdown of the relevant information from the document in relation to your request, and where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from testing description):

• The device should secure the connection between an enteric feeding tube and a nutrient delivery set.
• The device should "break away" at a tensile force of approximately two pounds.

Reported Device Performance:

Regarding the study proving the device meets the acceptance criteria:

The document states: "Bench testing was performed on the Guardian Connector to show that the device performs as intended. No clinical testing was performed on this device."

The following questions are not applicable to this 510(k) submission as it is for a physical medical device (a clip) and not an AI/diagnostic algorithm:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

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

The Oral/Enteral Syringes are intended for the delivery of liquid medication, formula, and breast milk. The syringes incorporate safety connectors that mate with the Respironics Enteral Only Extension Set, but will not mate with Luer lock or Luer slip fittings. The safety connectors prevent inadvertent connection of the enteral system to an IV system or an IV system to the enteral system. The Oral/Enteral Syringe barrels, plungers and end caps are comprised of Polypropylene, and the pistons are comprised of Silicone.

The provided text describes a 510(k) premarket notification for "Oral/Enteral Syringes." However, it is a submission for a medical device (syringes), not an AI/ML powered device. As such, the information you requested regarding acceptance criteria and studies that apply to AI/ML powered devices, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through design verification tests related to the physical and functional properties of the syringes.

Here's the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):

2. Sample size used for the test set and the data provenance: Not applicable (this is a physical device, not an AI/ML model evaluated on a test set of data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical properties and functional performance as described by engineering and regulatory standards, not expert consensus on data interpretation.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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