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The Pilot TLS is indicated for use in positioning of PICCs. The Pilot TLS provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. Pilot TLS is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limited, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-wave:

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-Driven Rhythm
• Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

Pilot TLS is designed to support quidance and tip positioning of Peripherally Inserted Central Catheters (PICCs) of at least 3 Fr in size. Pilot TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation for adults. The device includes a medical tablet preloaded with Pilot software, a Pilot TLS module, an ECG cable accessory, and a Vygocard accessory.

The device is only provided in one configuration, and non-sterile. The system is composed of:

• . A medical tablet with a kickstand attached on the back
• . The medical tablet's power supply
• . A Pilot TLS module attached to a USB-A cable
• A stabilization base (option to maintain the black ECG lead for its connection to Vygocard saline connector
• An ECG cable with 4 leads (red, white, green, black)
• 2 USB flash drives

Vygocard is an accessory provided sterile.

This document, a 510(k) Premarket Notification for the "Pilot TLS" device, primarily focuses on demonstrating substantial equivalence to a predicate device, the "C3 Wave," rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

However, based on the provided text, here's what can be extracted and inferred regarding performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists various non-clinical tests conducted to verify performance requirements. These tests are generally designed to ensure compliance with standards and safety, not necessarily to quantify specific performance metrics against a defined acceptance criterion for a clinical study.

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

The document does not provide details on a specific test set size for clinical performance evaluation. It explicitly states: "No human clinical data was provided to support substantial equivalence."

The "human factors study" mentioned could be considered a usability test set, but details about its size or provenance (country, retrospective/prospective) are not disclosed in this document.

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

As "No human clinical data was provided," there is no information about experts used to establish ground truth for a clinical test set. For the human factors study, the participants are referred to as "independent clinician participants," but their number or specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

Not applicable, as "No human clinical data was provided" for a clinical test set that would require ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, the document explicitly states: "No human clinical data was provided to support substantial equivalence." Therefore, no MRMC study or effect size for AI assistance is reported.

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

The document describes the "Pilot TLS" as a device providing "real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity." This implies human interaction as "displaying" information requires interpretation by a user. The software verification and validation would test the algorithm's functionality, but a formal "standalone" performance study in a clinical context (without human interaction) is not described. The device is intended as an "alternative method to chest X-ray or fluoroscopy confirmation," which inherently involves a human interpreting the device's output.

7. The Type of Ground Truth Used

Given the statement "No human clinical data was provided to support substantial equivalence," there is no mention of ground truth established through expert consensus, pathology, or outcomes data for clinical performance. The comparison to chest X-ray or fluoroscopy implies these are the traditional "ground truth" methods for PICC tip placement confirmation, but no data is presented where the Pilot TLS's output is validated against these.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of a machine learning algorithm, and thus no training set sample size is mentioned. This device relies on "identification of a maximum P-wave in the patient's intravascular ECG signal," which is a known physiological principle, not a machine learning model requiring a training set in the typical sense.

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

Not applicable, as no training set for a machine learning model is mentioned.

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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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Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen injuries. It is designed to provide compressive hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.

The Hepatostat Set® is an absorbable compression device which allows to perform any type of hepatic resection, large or small, without any significant bleeding. It is made of four pre-perforated absorbable strips. These strips are connected together by twenty Safil® polyfilament ligatures introduced through the liver by a special tubular needle holder. Each suture is terminated by a stainless steel dart and already inserted into a stainless steel tubular needle holder, fitted to the liver thickness. Two clamps enable to bring together two strips.

The provided text describes a 510(k) premarket notification for the "Hepatostat" device, which is an absorbable compression system. The submission expands the intended use of a previously cleared device (K061796).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific quantitative acceptance criteria (e.g., success rates, hemostasis time limits) or detailed reported device performance metrics from a clinical study in a table format.

The closest statement to device performance is:

• "Performance testing demonstrates that the Hepatostat is substantially equivalent to the predicate devices, and safe and effective to use, when used in accordance with the supplied instructions for use."

This is a general statement of equivalence and safety/efficacy rather than specific metrics against defined criteria.

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

• Sample Size for Test Set: Not specified. The document only mentions "Animal testing has been conducted to demonstrate the safety and efficacy for use in splenic and nephric resection." It does not provide the number of animals or specific cases.
• Data Provenance: Animal testing. The country of origin is not specified, but the applicant is Vygon Corporation in the USA. The testing would be considered prospective as it was conducted to support the expanded indication.

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

• Not applicable. The ground truth was established through animal testing, which would involve direct observation of hemostasis and tissue response, likely by veterinary surgeons or animal researchers, rather than human expert interpretation of images or clinical outcomes in humans.

4. Adjudication Method for the Test Set:

• Not applicable. As the ground truth was established through direct observation in animal studies, an adjudication method for human expert review is not relevant.

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, an MRMC comparative effectiveness study was not done. The device described is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, questions regarding human reader improvement with AI assistance are not relevant to this submission.

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

• No, a standalone algorithm performance study was not done. As stated above, this is a physical surgical device, not an algorithm.

7. The Type of Ground Truth Used:

• The ground truth used was direct observation of hemostasis and tissue response in animal studies. This is a form of outcomes data in an animal model.

8. The Sample Size for the Training Set:

• Not applicable. The document describes animal testing done for performance demonstration to support regulatory submission, not machine learning model training.

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

• Not applicable, as no machine learning model training is described.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria, as described in the document, is animal testing.

• Purpose: To demonstrate the safety and efficacy of the Hepatostat for use in splenic and nephric resection.
• Methodology (implied): Direct surgical application of the Hepatostat device in animals undergoing splenic and nephric resections. Observation of hemostasis achievement and potentially post-operative recovery and tissue resorption.
• Results (stated generally): "Performance testing demonstrates that the Hepatostat is substantially equivalent to the predicate devices, and safe and effective to use..."

The document suggests that the acceptance criterion for this animal testing was simply to demonstrate safety and efficacy and substantial equivalence to the previously cleared Hepatostat (K061796) for the expanded indications. Specific quantitative acceptance criteria or detailed results of the animal study are not provided in this 510(k) summary.

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LATEX-FREE BIONECTOR is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. Latexfree Bionector is a Male/Female Luer, neutral displacement device. It does not displace fluid upon either connection or disconnection. Latex-free Bionector may be flushed with saline only or heparinized saline, in accordance with hospital protocol. The Latex-free Bionector is MR Conditional.

The Latex-free Bionector is a multi-purpose, closed, needle-free IV connector to be used for the purpose of sampling, injection, or continuous infusion of fluids or drugs. The Latex-free Bionector has a disinfectable membrane (disinfection must be carried out before and after use) which closes automatically when the infusion line or the syringe is disconnected.

The provided text describes a medical device, the Latex-free Bionector, and its FDA 510(k) premarket notification. However, it does not contain any information regarding acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert involvement, adjudication methods), comparative effectiveness studies, standalone performance, or ground truth establishment relevant to the request.

The document primarily focuses on:

• Device Description and Intended Use: What the Latex-free Bionector is and what it's used for.
• Regulatory Classification: Its classification details and predicate device.
• Summary of Design Control Activities: Stating that biocompatibility data, performance testing, and risk assessment were conducted, demonstrating substantial equivalence to predicate devices.
• FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study that proves the device meets those criteria, as this information is not present in the provided text.

The document states "Performance testing demonstrates that the device is substantially equivalent to the predicate devices," but it does not elaborate on what specific performance tests were performed, what the acceptance criteria for those tests were, or what the results of those tests were.

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Hepatostat Set is a compression system acting as a tourniquet on the hepatic tissue. It is intended to reduce the risk of bleeding and to achieve hemostasis in hepatic resections (from large to small superficial hepatectomy). It can also be used for traumatic liver injuries.

The Hepatostat Set is an absorbable compression device which was developed for the purpose of hepatic resection, large or small, without any significant bleeding. It consists of four pre-perforated absorbable strips which are sutured together with Safil polyfilament ligatures introduced through the liver with a tubular needle.

This document describes a 510(k) premarket notification for the "Hepatostat Set," an absorbable compression device intended for hepatic resection and traumatic liver injuries to reduce bleeding and achieve hemostasis. The submission references Biocompatibility and implant testing, performance testing, and risk assessment as the studies demonstrating safety and effectiveness.

However, the provided text does not contain the detailed acceptance criteria or numerical performance data typically found in a clinical study report for AI/ML devices. It focuses on the regulatory submission process for a physical medical device. Therefore, I will create a table outlining the stated acceptance criteria (which are more general compliance requirements for this type of device) and the reported device performance based on the information provided.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a traditional medical device (not an AI/ML device), the "acceptance criteria" are framed as regulatory and performance standards, and "device performance" refers to its ability to meet those standards as demonstrated by various tests.

Since the provided document is a 510(k) summary for a physical medical device and NOT an AI/ML device, the following points address what would typically be included for an AI/ML device but are not applicable or present in this specific document.

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

• Not applicable for this device. This information is typically for AI/ML performance evaluation using real-world data. For this physical device, "test set" would refer to samples used in laboratory and animal in vivo studies, but specific numbers and provenance of "data" in the context of AI are not present.

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

• Not applicable for this device. Ground truth for AI/ML models is often established by human experts labeling data. For this physical device, "ground truth" would relate to biological outcomes (e.g., hemostasis, tissue reaction) observed in pre-clinical studies, assessed by pathologists or researchers, not a consensus of experts on a dataset.

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

• Not applicable for this device. This term refers to how disagreements among annotators are resolved in AI/ML dataset creation.

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 for this device. MRMC studies are specific to evaluating AI/ML systems that assist human operators in tasks like image interpretation.

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

• Not applicable for this device. This refers to the performance of an AI/ML algorithm independently.

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

• For the biological studies mentioned (biocompatibility, implantation, hemostasis, absorption), the ground truth would be established through:
  • Histopathology: for tissue reactions, inflammation, and degradation in implantation studies.
  • Chemical analysis: for degradation products and absorption rates.
  • Direct observation/measurement: of hemostasis efficacy in in vivo models.
• The document doesn't explicitly detail the methodology of "ground truth" for these pre-clinical studies but implies standard methods for material and medical device testing.

8. The sample size for the training set:

• Not applicable for this device. This information is for AI/ML model development.

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

• Not applicable for this device. This information is for AI/ML model development.

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The Vygon Multicath Expert Catheter is intended for use in patients who require Short-term (less than 30 days) I.V. iherapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids. The catheters are manufactured with a Pellethane-based AgION™ antimicrobial. The AglON™ uses silver as the antimicrobial agent.

The Multicath Expert catheters are a line of multilumen catheters which have an antimicrobial function. The polyurethane catheters are impregnated with the silver ion-based antimicrobial agent AgION™ and are available in 2-, 3-, 4-, or 5-lumen catheters. Silver has been shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains. The expert technology is based on an antimicrobial substance which is both mineral and bio-inert. It is neither an antibiotic nor an organic antiseptic; and the silver ions are released in low, non-toxic concentrations. Expert catheters release silver ions from their internal and external surfaces, and silver ions are released very gradually over an extended period of time, ensuring long-term efficacy. Biocompatibility and performance testing demonstrates the safety and efficacy of these devices.

The Vygon Multicath Expert Catheter is cleared via the 510(k) pathway, which means it demonstrates substantial equivalence to predicate devices rather than fulfilling specific acceptance criteria in a clinical study. The provided document does not contain details about a study with acceptance criteria and a reported device performance as would be expected for a de novo device or a device with new indications requiring clinical efficacy data.

Instead, the submission focuses on demonstrating that the only change—the addition of the AgION™ silver ion-based antimicrobial agent—does not adversely affect the safety and efficacy of the device compared to its predicate.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for an AI device) are mentioned because this is a 510(k) submission for a physical medical device (intravascular catheter) with an antimicrobial coating. The "acceptance criteria" are implied by the regulatory requirements for showing substantial equivalence.

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

The document does not describe a "test set" in the context of an AI/algorithm-driven device. The evaluation of the Multicath Expert is based on:

• Biocompatibility testing: This typically involves in vitro and sometimes in vivo animal studies, but the sample sizes are not specified here.
• Performance testing: This refers to mechanical and functional testing (e.g., flow rates, tensile strength) to ensure the catheter's core functionality is maintained despite the coating. Sample sizes for these engineering tests are not provided.
• Risk assessment: An analytical process, not a data-driven test set.

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

Not applicable. This is not an AI/algorithm device requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable.

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

Not applicable. This is not an AI 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.

7. The Type of Ground Truth Used:

Not applicable in the AI/algorithm sense. The "ground truth" for this device's safety and efficacy is derived from:

• Biocompatibility standards: established methods for evaluating biological harm.
• Performance specifications: engineering and functional requirements for catheters.
• Predicate device's known safety and efficacy: the established performance of the already-marketed Multicath (K870067).

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" for this type of device.

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

Not applicable.

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

The Nutrisafe 2 is a complete system of feeding tubes and accessories. The feeding tubes are available in several configurations and in three materials: DEHP-free PVC, Polyurethane, and Silicone. One of the benefits of the Nutrisafe 2 is that the connection does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system. The Nutrisafe 2 feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.

The provided 510(k) summary for the Nutrisafe 2 describes a medical device, not a software algorithm or AI device. Therefore, many of the requested categories related to acceptance criteria, ground truth, and studies for AI/algorithm performance are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as the device is a physical feeding tube system, not an algorithm or AI device that relies on a test set of data. The studies conducted were physical materials and performance tests.

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

This information is not applicable for a physical medical device. "Ground truth" in the context of AI refers to verified labels on data. For the Nutrisafe 2, evaluations would involve standard engineering and biological testing methods.

4. Adjudication Method for the Test Set

This information is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are used in studies involving expert review of data, typically for AI performance evaluation.

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 the device is a physical feeding tube system, not an AI-assisted diagnostic or therapeutic tool.

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

This information is not applicable as the device is a physical feeding tube system, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the Nutrisafe 2 is derived from physical and biological testing standards and requirements, interpreted as meeting manufacturer specifications and safety/efficacy goals. This includes:

• Biocompatibility standards: Demonstrating non-irritant and non-toxic properties.
• Performance standards: Verifying the functional aspects like the locking connection and prevention of incorrect luer connections.
• Risk assessment standards: Compliance with ISO 14971.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical feeding tube system, not an AI algorithm that requires a training set. Material and design choices are based on engineering principles and existing medical knowledge, not machine learning training.

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

This information is not applicable for the same reasons as above.

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The Vygon LIFECATH S PICC and Midline catheters are intended for use in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid.

The Lifecath S peripherally inserted central catheters and midline catheters are fabricated of barium impregnated silicone elastomer. The catheters are supplied with a guidewire to aid in insertion. The 60 cm PICC is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. The 20 cm midline catheter is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. Both catheters have a fixation hub and an extravascular extension line. The catheters are marked every centimeter from the hub to the proximal tip. The fixation hub is marked with the catheter French size, and the extension lines are marked with the gauge size. A clamp is attached to each extension line, and is marked with the priming volume.

This FDA 510(k) submission (K062425) does not describe a study related to a software or AI/ML-driven medical device. Instead, it concerns the Vygon Lifecath S PICC and Midline catheters, which are physical medical devices.

Therefore, most of the requested information about acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, training sets, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to this submission.

The document indicates that the device met acceptance criteria by demonstrating "substantial equivalence" to predicate devices through:

1. Biocompatibility data: Showing materials are non-irritant and non-toxic.
2. Performance testing: Demonstrating that the device performs similarly to predicate devices.
3. Risk Assessment: Conducted in compliance with ISO 14971.

The conclusion states that based on these activities, the Lifecath S is substantially equivalent to the predicate devices and is safe and effective for its intended use.

Summary of inapplicable AI/ML-specific criteria:

• Table of acceptance criteria and reported device performance (for AI/ML): Not applicable, as this is a physical medical device. The "performance" here refers to physical characteristics and biocompatibility, not AI model metrics.
• Sample size and data provenance (for AI/ML test set): Not applicable.
• Number of experts and qualifications (for AI/ML ground truth): Not applicable.
• Adjudication method (for AI/ML test set): Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone performance (AI algorithm only): Not applicable.
• Type of ground truth (for AI/ML): Not applicable.
• Sample size for training set (for AI/ML): Not applicable.
• How ground truth for training set was established (for AI/ML): Not applicable.

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The primary indication of the Leaderflex catheter is pressure monitoring in peripheral arteries. The device may also be used for venous access in pediatric patients.

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This document is a FDA 510(k) clearance letter for the Vygon Leader-Flex intravascular catheter. It declares the device substantially equivalent to a legally marketed predicate device. This type of document does not contain the information requested in your prompt regarding acceptance criteria and performance study details.

The letter is a regulatory document confirming market clearance, not a clinical study report. Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance
• 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 their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on the regulatory equivalence of the device, stating its intended use is for "pressure monitoring in peripheral arteries" and "venous access in pediatric patients."

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