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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 which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.

The Kentec Medical Enteral Feeding Extension Set (EFES) is a sterile disposable device for single patient use only. The device is designed to connect existing feeding tubes (nasogastric, oralgastric, 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 device consist of flexible PVC 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.

The basic set (OC-ENT-60) consists of tubing with a step connector (catheter tip) and an oral syringe connector not compatible with intravencus (I.V.) tubing or stopcocks. Other variations include:

• The basic set with shorter tubing (OC-ENT-36) t
• The basic set with step connector changed into oral syringe connector . (20C-ENT-60)
• The basic set with the addition of a "Y" site with an oral syringe connector . to allow the clinician to attach other equipment.

The provided documentation describes the Kentec Medical, Inc. Ameritus® Medical Enteral Feeding Extension Set (EFES) and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for AI/algorithm performance. The document focuses on regulatory approval (510(k)) based on non-clinical testing for device function and safety.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and regulatory submission.

However, I can extract information related to the device's functional performance and general non-clinical testing.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Specific Tests" performed and states that these tests "demonstrated the EFES met the acceptance criteria." Specific quantitative acceptance criteria or detailed performance results (e.g., exact tensile strength achieved, precise leakage rates) are not provided in this summary. Instead, the document relies on comparison to predicate devices and adherence to relevant standards.

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

The document does not explicitly state the numerical "sample size" for the various engineering tests (e.g., how many units were subjected to tensile testing). It states "EFES" was tested, implying representative samples of the manufactured device.

• Data Provenance: The tests were conducted internally by Kentec Medical, Inc. or contractors on their behalf. The manufacturing facility is in Kunshan, China. These are non-clinical, in-vitro engineering tests, not clinical studies involving human patients or retrospective/prospective data from healthcare settings.

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

Not Applicable. This is an engineering device submission. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant here. The ground truth for these tests is defined by engineering specifications, relevant ISO standards (e.g., ISO 80369-1, ISO 594), and comparison to predicate devices' known characteristics.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for expert consensus, which is not relevant to non-clinical engineering device testing. Test results are compared against predefined engineering specifications and standards.

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

No. MRMC studies are for evaluating the performance of diagnostic devices or algorithms with human readers. This device is an enteral feeding extension set, not a diagnostic algorithm.

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

Not Applicable. There is no algorithm involved in this device. The "standalone performance" refers to the device's functional performance as an engineered product, which was indeed tested (e.g., Luer connection testing, leakage, tensile strength, flow).

7. The Type of Ground Truth Used

The "ground truth" for these engineering tests is established by:

• Predefined engineering specifications for the device.
• Relevant international standards such as ISO 80369-1 (for small-bore connectors) and ISO 594 (for Luer connectors).
• The known functional and material characteristics of legally marketed predicate devices (NeoMed Enteral Only Extension Set K100288 and CORFLO Anti-I.V. Enteral Feeding Extension Set K083786/K083791).
• Analytical comparison and lab testing to objectively measure physical properties and fit.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/ML algorithm.

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

Not Applicable. There is no "training set" as this is not an AI/ML algorithm.

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The Amertius Entral™ 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 Ameritus Entral™ Feeding Tubes are composed of two families of Feeding Tubes each made with different materials: polyurethane and silicone. The two families of Feeding Tubes are all made with a single lumen catheter that is used to deliver fluids as prescribed by the physician including liquid nutritional media and/or medication.

The Ameritus Entral " Feeding Tubes are sterile, individually packaged, Latex Free and DEHP Free. The orange color coding provides easy visual recognition of the enteral connection. The Ameritus Entral "" Feeding Tubes are designed with a Radiopaque stripe for X-ray visualization to confirm proper feeding tube placement. French size and length clearly printed on the feeding tube as well as centimeter markings (approx.) to assist tube placement or check for migration. A Tethered plug for connector closure is incorporated to prevent air and fluid ingress when not in use.

The device consists of the following main components: A feeding tube single lumen catheter and a connector with molded closure plug.

This document is a 510(k) premarket notification for a medical device, the Ameritus Entral™ Feeding Tube. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove device performance against those criteria in a typical AI/software context.

Therefore, many of the requested points regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this document, as it describes a physical medical device (feeding tube) and its bench testing for functional equivalence.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds for performance. Instead, it states:

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 mentions "bench testing," "design verification," and "performance test results." However, it does not specify the sample size for these tests. There's no information on data provenance (country of origin, retrospective/prospective) because this isn't a data-driven AI study; it's a physical device validation.

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 is not applicable to this type of device and study. "Ground truth" in the context of feeding tube performance and equivalence involves engineering and functional testing, not expert interpretation of outputs like in AI. The "truth" is whether the tube physically performs its functions (e.g., fluid delivery, radiopacity) as expected and comparably to predicates.

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

This is not applicable. Adjudication methods like 2+1 are typically used in clinical or image-based studies where expert consensus is needed. Bench testing of a physical device does not involve such methods.

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 is not applicable. An MRMC study is relevant for diagnostic imaging AI systems and involves evaluating human reader performance with and without AI assistance. This document is for a physical feeding tube.

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

This is not applicable. This document describes a physical medical device. There is no algorithm.

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

The "ground truth" for this device's performance would be established through engineering specifications, physical measurements, and functional tests comparing the device's characteristics (e.g., flow rates, material integrity, radiopacity, resistance to kinking) directly against the predicate device and established industry standards. This is inherent to bench testing. The document doesn't explicitly state the methodology for establishing this "ground truth" but implies it through the mention of "bench testing," "design verification," and "performance test results."

8. The sample size for the training set

This is not applicable. There is no training set as this is not an AI/machine learning device.

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

This is not applicable. There is no training set.

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Single Use Only - Disposable

The NEONATAL PEDIATRIC ECG ELECRODE is intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on the surface of the body,

NEONATAL PEDIATRIC ECG ELECTRODE

The provided document, K050443, is a 510(k) summary for a Neonatal Pediatric ECG Electrode manufactured by Kentec Medical, Inc. This submission is for a medical device cleared via the regulatory pathway of substantial equivalence to a previously cleared predicate device, rather than an AI/ML-driven diagnostic or therapeutic device. As such, many of the requested fields related to AI/ML device performance studies (e.g., ground truth, MRMC studies, training set details) are not applicable to this type of traditional medical device submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating "Common Technological Characteristics" and passing "NON-CLINICAL TEST" standards, primarily related to device safety and performance as an ECG electrode. The submission claims substantial equivalence to the predicate device K011564, "Neolead" by Neotech Products.

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

Not applicable in the context of an AI/ML performance study. This submission refers to non-clinical testing against standards. Test sets for patient data or clinical performance are not described in this 510(k) summary. The "test set" in this context refers to the physical electrode devices tested against the ANSI/AAMI standards. The document does not specify the number of electrodes tested.

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 expert consensus is not relevant for this type of device. The "ground truth" for an ECG electrode is its ability to maintain electrical contact and provide a clear signal according to established standards. This is assessed through physical and electrical testing, not expert interpretation of outputs in the same way an AI diagnostic would be.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of data/images in AI/ML performance studies. Testing against ANSI/AAMI standards for an ECG electrode primarily involves objective measurements conducted in a laboratory setting.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML device, so an MRMC comparative effectiveness study is not applicable. The device is a physical electrode, not a tool to assist human readers.

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

Not applicable. This is a hardware medical device (an ECG electrode), not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is compliance with recognized industry standards for ECG electrodes (ANSI/AAMI EC12-1991) and general safety of medical electrical equipment (ANSI/AAMI EC53:1995/(R)2001). This is established through laboratory and bench testing, not expert consensus, pathology, or outcomes data in the sense of a diagnostic claim.

8. The sample size for the training set

Not applicable. This is a hardware medical device; there is no "training set" for an algorithm.

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

Not applicable. As there is no training set, there is no corresponding ground truth to be established.

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There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.

When operating in the air or manual mode, a skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.

When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature probe, connected between the controller and the infant, to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.

There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.

When operating in the air or manual mode, the skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.

When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.

The thermistor tip which gets taped to the infant is made of a material whose resistance to electrical flow changes when the tip materials temperature changes. Two small wires run from the plug end at the incubator or warmer to the thermistor tip. One wire to each side.

A very small current goes to the tip and depending on how warm the tip is has to do with how much current returns via the other wire to the plug. That current is computed into temperatures.

These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves.

The provided text outlines the safety and effectiveness summary for a Reusable Temperature SENSOR (probe) called "Accutemp-Probe". However, it is a 510(k) submission for substantial equivalence to a predicate device, not a study demonstrating performance against specific acceptance criteria.

The document claims substantial equivalence based on the device's technological characteristics and intended use being the same as the predicate device (Air Shields/Ohmeda). It does not present specific performance criteria or the results of a study designed to meet such criteria in the format requested.

Therefore, many of the requested sections regarding a study cannot be directly extracted from this document.

Here's a breakdown of what can be inferred or stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as a table of performance metrics with specific thresholds. The acceptance criteria for this submission appear to be demonstrating substantial equivalence to a predicate device, primarily based on the device functioning and intended use being identical, and fitting the Steinhart-Hart equation for thermistor curves.
• Reported Device Performance:
  • Functionality: "The thermistor tip which gets taped to the infant is made of a material whose resistance to electrical flow changes when the tip materials temperature changes. Two small wires run from the plug end at the incubator or warmer to the thermistor tip. One wire to each side. A very small current goes to the tip and depending on how warm the tip is has to do with how much current returns via the other wire to the plug. That current is computed into temperatures."
  • Scientific Basis: "These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves."
  • Comparison to Predicate: "None [technological characteristics difference] – other than, possibly, the color." and "This product looks like and has identical indications for use as the disposable products we now sell under 510(k) # 960080, issued May 1, 1996. This product differs only in its durability. It uses heavier wire and a disc type tip (which primarily identifies it as a reusable unit.)"

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

• Not Applicable. The document does not describe a performance study with a test set. This is a 510(k) premarket notification claiming substantial equivalence, not a clinical or performance validation study with a test set of data.

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

• Not Applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or adjudication method is described.

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

• No. This type of study is not described. The device is a temperature sensor, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

• Not Applicable. The device is a physical temperature sensor, not an algorithm. Its performance is based on its physical properties and adherence to established thermistor curve standards.

7. Type of Ground Truth Used:

• Not Applicable. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily the technological characteristics and intended use of the predicate device (Air Shields/Ohmeda) and adherence to a recognized scientific standard (Steinhart-Hart equation). No "expert consensus," "pathology," or "outcomes data" ground truth is mentioned in the context of a performance study.

8. Sample Size for the Training Set:

• Not Applicable. The document does not describe a training set as this is not an AI/machine learning device. The design principles are based on established physics of thermistors.

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

• Not Applicable. There is no training set mentioned.

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