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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 VR Medical VCare 1000-300S Negative Pressure Wound Therapy System is an integrated wound management system, indicated for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

The VR Medical VCare 1000-300S System is an AC-Powered portable suction device, with battery backup, that provides localized negative pressure when used with the VR Medical Perme-Foam Dressing to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the disposable fluid collection canister, and a foam dressing kit. The kit consists of polyurethane foam, suction bell with connecting (drainage) tube and clamp, and polyurethane drape. The single-use foam dressing kit is packaged in a PE/PET peel pouch bag, which is gamma sterilized.

The Foam Dressing Kit (VR Medical Perme-Foam Dressing) can be sold alone or as a part of the VCare 1000-300S System in two sizes:

• Large foam dressing kit
• Medium foam dressing kit
• The Foam Dressing can be used for up to 72 hours of continuous use.

The provided text describes a 510(k) premarket notification for the VR Medical VCare 1000-300S System, a negative pressure wound therapy device. This document details the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets an acceptance criterion for diagnostic or screening performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" related to diagnostic performance (like sample size for test set, ground truth, experts, MRMC study, standalone performance) are not applicable or cannot be extracted from this document as it pertains to a medical device's physical and functional performance, safety, and equivalence, not its diagnostic or clinical efficacy in the traditional sense of an AI/imaging device.

However, I can extract information regarding the performance data (non-clinical tests) used to demonstrate substantial equivalence to predicate devices. While not "acceptance criteria" in the sense of a clinical trial's endpoint for AI performance, they serve as the "criteria" the device had to meet to be considered substantially equivalent.

Here's the information extracted and adapted to the best fit given the document's content:

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

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 does not specify sample sizes for "test sets" in the context of diagnostic accuracy. The testing described is bench testing for device functionality, safety, and biocompatibility. For biocompatibility, it states "Perme-Foam Dressing samples were tested," but does not explicitly state the number of samples.
• Data provenance is not provided, other than the manufacturer being in China. The testing appears to be non-clinical (bench testing) rather than clinical data from patients or a specific country.

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 is not a diagnostic device for which expert ground truth would be established. The "ground truth" for these tests are the standards themselves (e.g., IEC, ISO, functional specifications).

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

• Not applicable. Adjudication methods are typically for clinical case interpretation in diagnostic studies.

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 a negative pressure wound therapy device, not an AI-assisted diagnostic or imaging device.

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, and the testing focuses on its physical and functional performance, not diagnostic accuracy.

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

• For the non-clinical tests, the "ground truth" refers to the established engineering and safety standards (e.g., IEC 60601-1, ISO 10993 series) and the device's functional specifications (e.g., delivering specific negative pressure, battery life). For biocompatibility, the ground truth is the successful passing of the specified ISO standard tests.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of an AI algorithm.

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

• Not applicable. This device does not involve a "training set" in the context of an AI algorithm.

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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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The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

The Heat and Moisture Exchanger and Filter (HMEF) consists of a plastic body which incorporates an electrostatic/ mechanical filter pad. 22 mm female / 15 mm male connectors in accordance with ISO 5356 (Anaesthetic and respiratory equipment-Conical connectors- Part 1: Cones and sockets) and a luer lock connector which is only used for gas monitoring.

The VR Medical Heat and Moisture Exchanger and Filter (HMEF) is a disposable, single-use device intended to provide humidification during ventilator gas delivery and reduce cross-contamination between patients and equipment. The manufacturer provided a 510(k) premarket notification to demonstrate substantial equivalence to predicate devices. The study conducted was a non-clinical in-vitro test program comparing the performance of the VR Medical HMEF to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VR Medical HMEF are implied by its substantial equivalence to predicate devices, meaning its performance should be similar or within acceptable ranges of the predicate devices. The document provides performance data for two models of the VR Medical HMEF (VR003 and VR005).

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

• Sample Size: The document does not explicitly state the numerical sample size for each in-vitro test conducted on the VR Medical HMEF. However, it indicates that "design verification tests" were conducted.
• Data Provenance: The tests were conducted in-vitro, and at least some filtration efficiency testing was performed by "Nelson Lab." The country of origin for the HMEF manufacturer is China. The data would be considered prospective as it was generated specifically for the premarket notification.

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

This is not applicable as the study involved non-clinical in-vitro testing against established standards and metrics, not human expert assessment of a test set.

4. Adjudication Method for the Test Set

This is not applicable, as there was no test set requiring human adjudication. The performance was measured against objective, quantifiable physical and biological parameters.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The VR Medical HMEF is a physical medical device, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm-only) performance study was done. This concept is typically applicable to AI/ML software devices. The VR Medical HMEF is a physical medical device. The performance data presented are for the device itself.

7. Type of Ground Truth Used

The "ground truth" for this device, in the context of its performance testing, was established by recognized international standards and laboratory measurements. Examples include:

• Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE) testing by laboratories like Nelson Lab.
• Pressure Drop measurements.
• Internal Volume measurements.
• Moisture Loss according to ISO 9360.
• Conical Connectors performance according to ISO 5356.
• Biocompatibility according to ISO 10993-1.

8. Sample Size for the Training Set

This is not applicable. The VR Medical HMEF is a physical device, and its development and evaluation do not involve a "training set" in the context of AI/ML algorithms. Its design is based on engineering principles and material science.

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

This is not applicable, as there was no training set. The "ground truth" for the device's design and expected performance relies on established scientific and engineering principles, material specifications, and relevant international standards for medical devices of this type.

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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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