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Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 4.0ml/s.

Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s.

The HydroPICC catheters are a family of peripherally inserted central catheters (PICC) made of radiopaque hydrophilic material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in catheter manufacturing. The catheters are provided in kit configurations with the necessary accessories for placement in clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp.

HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. These reductions were evaluated using in vitro and in vivo models. Pre-clinical evaluations do not necessarily predict clinical performance with respect to thrombus formation. HydroPICC 5F Dual Lumen Catheter Components include: HydroPICC 5Fr Dual Lumen Catheter Assembly, Dispensing Tube, 2 Channel Clip, and Guidewire Introducer and Straightener.

The provided FDA 510(k) clearance letter pertains to a medical device (PICC catheter), not an AI/Software as a Medical Device (SaMD) product. Therefore, the content of the letter does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD, such as:

• A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, etc.)
• Sample sizes used for test sets and data provenance (for image/data-driven AI)
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for ground truth
• MRMC comparative effectiveness study results or effect sizes
• Standalone algorithm performance
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for training set
• How ground truth for the training set was established

The 510(k) summary for the HydroPICC Catheter focuses on physical device performance characteristics. It mentions:

• Acceptance Criteria/Performance (Implied through testing): The device was tested to demonstrate acceptable performance for the modified power injection ratings and device length.
• Study Type: Non-clinical tests were performed, specifically "Power injection Cyclical and Static Burst testing as well as dimensional verification testing."
• Conclusion: These tests demonstrated that "the modifications to the power injection rating and the length do not adversely impact product performance."

In summary, this document does not contain the specific information you requested relating to the acceptance criteria and study proving performance for an AI/SaMD device. The information provided is for a physical medical device clearance based on engineering and performance bench testing.

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The CATHTONG III Tapered PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for the 4F single lumen catheters and the 5F dual lumen catheters. The maximum pressure of power injection with the CATHTONG III Tapered PICC Catheter may not exceed 325 psi. The CATHTONG III Tapered PICC Catheter is indicated for adult patients.

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The provided text is a 510(k) summary from the FDA for a medical device called the CATHTONG III Tapered PICC Catheter. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, this document does not contain information regarding a study that proves the device meets acceptance criteria, nor does it provide details on algorithm performance, expert consensus, ground truth establishment, or sample sizes related to AI/algorithm performance. These types of details are typically found in the clinical or non-clinical performance sections of a 510(k) submission, which are often redacted or not fully included in the publicly available summary letter.

Therefore, I cannot fulfill your request for information on acceptance criteria and study details based on the provided text. The document primarily focuses on the regulatory clearance process and the intended use of the catheter.

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The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for 4F single lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, training set sizes, or how training set ground truth was established for a medical device.

The document is an FDA 510(k) clearance letter for the CATHTONG™ II PICC Catheter. It states that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use, including maximum flow rate and injection limit setting. However, it does not provide the detailed study information you're requesting.

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The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrastration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for 5F dual lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.

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The provided document does not contain information about the acceptance criteria and study proving device performance in the context of an AI/ML powered device.

The document is an FDA 510(k) clearance letter for a medical device called the "CATHTONG™ II PICC Catheter." This is a physical, interventional medical device, not an AI/ML software device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, AUC).
• Sample size for a test set or training set.
• Data provenance for AI/ML models.
• Number of experts used to establish ground truth for AI/ML.
• Adjudication methods for AI/ML ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance of an algorithm.
• Type of ground truth used for AI/ML training/testing.

The information in the document pertains to the regulatory clearance of a physical medical catheter, including its indications for use, maximum flow rates, and injection limits. These are performance specifications for a hardware device, not evaluation metrics for an AI/ML algorithm.

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The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.

The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Piccolo® Potassium Test System is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternatively, the disc may also be used with serum.

The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed.

The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.

The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

Groshong™ NXT Peripherally Inserted Central Catheters are made from specially formulated and processed medical grade materials in a tray with accessories for reliable long- (greater than 30 days) or short- (less than 30 days) term vascular access.

Groshong™ Valve Function

The Groshong™ catheter incorporates the patented, 3-position, pressure-sensitive Groshong™ valve. The valve is located near the rounded, closed, radiopaque catheter tip and allows fluid infusion and blood aspiration. When not in use, the valve restricts blood backflow and air embolism by remaining closed.

The Groshong™ valve is designed to remain closed between -7- and 80-mm Hg. Since the normal central venous pressure range in the superior vena cava is 0 to 5 mm Hg, the valve remains closed at normal central venous pressure. Pressure in the superior vena cava must exceed 80 mm Hg to open the valve inward. Also, negative pressure (vacuum) will cause the valve to open inward, allowing blood aspiration.

Positive pressure into the catheter (gravity, pump, syringe) will open the valve outward, allowing fluid infusion. The need for the anticoagulant effect of heparin is eliminated because the closed valve prevents blood from entering the catheter and clotting. If the catheter is aspirated, pulling the valve inward, it must be flushed with normal saline to clear blood from the lumen and allow the valve to return to its normal, closed position.

The provided text is a 510(k) summary for the Groshong™ NXT PICC Catheter. It outlines the device's characteristics, its similarities to a predicate device, and the testing performed to demonstrate substantial equivalence. However, it does not contain detailed acceptance criteria, specific reported device performance values, or information about a study proving the device meets these criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (also named Groshong™ NXT PICC Catheter, K034020), rather than establishing and meeting novel acceptance criteria for the new device and then detailing a study specifically proving the new device's performance against them. The premise is that because the new device is largely similar to the predicate and differences have been evaluated not to raise new safety/effectiveness concerns, its performance is considered substantially equivalent.

Therefore, many of the requested items cannot be extracted from this document, as it's designed for a different purpose (510(k) clearance based on substantial equivalence) than a detailed clinical or performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided directly from the text. The document lists performance tests and reference standards (e.g., ISO 10555-1, ASTM F640), but it does not specify quantitative acceptance criteria or the reported performance values for the "subject device" against these criteria. It only states that the tests were "conducted per guidance documents, industry standards, and in-house protocols to establish the performance of the device, thereby leading to a conclusion of substantial equivalence."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document mentions "Verification and validation tests" and "Performance tests for Subject Device," but does not specify sample sizes for these tests, the country of origin of the data, or whether the data was retrospective or prospective. These would typically be detailed in a separate test report, not the 510(k) summary.

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 / Cannot be provided. This type of information is relevant for studies involving expert review, such as image analysis for AI devices. The Groshong™ NXT PICC Catheter is an intravascular catheter, and the performance tests mentioned (e.g., biocompatibility, sterility, radiopacity) do not typically involve human expert interpretation in the way an AI diagnostic device would.

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

• Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in studies involving human interpretation or outcome assessment, not for the technical performance testing of a catheter.

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 medical catheter, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a medical catheter, not an algorithm.

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

• Limited information. For the physical and material tests, the "ground truth" would be the established scientific principles and specifications defined by the referenced ISO and ASTM standards. For example, for biocompatibility, the ground truth is adherence to ISO 10993-1. For radiopacity, it's meeting the criteria of ASTM F640. There isn't "expert consensus" or "pathology" in the sense of a diagnostic outcome for this type of device performance testing.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set is involved.

Summary of what is available from the text:

The document describes the Groshong™ NXT PICC Catheter and states that its technological characteristics are substantially equivalent to a predicate device (K034020) with the same name. The key differences evaluated were:

• A change to the inner lumen geometry (from round to rectangular).
• A material and formulation change to the catheter silicone and catheter silicone colorant.

These differences were evaluated through risk assessment and performance tests. The document asserts these changes "do not raise new or different questions of safety or effectiveness."

Performance Tests Conducted (Verification / Validation Method and Reference Standards):

• Performance:
  • ISO 10555-1:2013/Amd 1:2017: Intravascular Catheters - Sterile and Single-Use Intravascular Catheters - Part 1: General Requirements
  • ISO 10555-3:2013: Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
  • ASMT F640-12: Standard Test Methods for Determining Radiopacity for Medical Use
  • ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
  • ASTM F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
  • ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• Biocompatibility Evaluations:
  • ISO 10993-1:2018: Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process
  • USP: Particulate Matters in Injections (method 1 Light Obscuration Particle Count Test)
• Sterilization:
  • ANSI AAMI ISO 11135:2014C: Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.

In conclusion, while the document confirms tests were done according to established standards to support substantial equivalence, it does not provide the detailed study information or quantitative acceptance criteria and results as typically found in a clinical study report for an AI device.

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The Piccolo Medical SmartPICC System is indicated in adult patients for the positioning of Peripherally Inserted Central Catheters (PICC) with minimum lumen of 0.021". The SmartPICC system provides real-time catheter tip location information by using the patient's cardiac electrical activity (intravascular ECG signal). The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system includes a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation.

Note: Use of the intravascular ECG (ivECG) technique to replace x-ray/fluoroscopy confirmation of tip placement is limited, but not contraindicated, for patients where alterations of cardiac rhythm change the presentation of the P-wave such as in atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and chronic obstructive pulmonary disease (COPD). In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional confirmation method (x-ray or fluoroscopy) is required to confirm catheter tip location.

The Piccolo Medical SmartPICC System is a device used by clinicians for guidance and positioning of commercially available central venous catheters. The reusable SmartPICC System consists of a computer tablet with data processing and display capabilities, a SmartPICC Controller data acquisition module, and a Kit that includes a single use sterile SmartPICC Stylet to enable the use of ivECG confirmation of final PICC tip location by the clinician who is placing the catheter. The SmartPICC System has a supplemental ionic dilution navigation feature to provide qualitative blood flow direction information which requires 5% Dextrose infusion utilizing a mechanical syringe driver, a sterile 20 ml disposable syringe, and tubing with extension set to provide constant flow rate infusion to the SmartPICC Stylet distal tip.

Additional components associated with the reusable system include a USB cable to connect the tablet to the controller and an external ECG (xECG) Trunk Cable to connect the xECG leads to the controller.

Additional accessories in the Stylet Kit include:

• Sterile Drape Clip to secure Stylet hub to sterile patient drape
• Sterile cover for the tablet
• Sterile scissors for opening sterile tubing pouch
• xECG Electrodes and Leads
• Instructions for Use

The Piccolo Medical SmartPICC System is intended to help position Peripherally Inserted Central Catheters (PICC) in adult patients by providing real-time catheter tip location information using intravascular ECG (ivECG) signals. It also includes a supplemental ionic dilution feature for qualitative blood flow information to assist catheter navigation.

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

1. Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage accuracy or precision target) for the performance of the SmartPICC system. Instead, the "Summary of Human Factors Testing" states that the simulated use testing "adequately reviewed" the device's application to ensure "safe, effective use" and demonstrated "suitability for its intended purpose." This suggests that the acceptance criteria for this study were likely qualitative and focused on the device's ability to facilitate correct PICC tip placement and user comprehension of the device's output.

While no precise performance metrics are given, the overall conclusion is that the device should "perform as intended" and is "substantially equivalent" to the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample size for the "Simulated Use / Human Factors Testing." It only mentions "Human Factors Testing."
• Data Provenance: The document does not specify the country of origin of the data nor if it was retrospective or prospective. Given it was "Simulated Use," it was likely prospective, but the location is not mentioned.

3. Number of Experts and Qualifications for Ground Truth in Test Set

The document does not specify the number of experts used to establish ground truth for the human factors/simulated use testing, nor does it detail their qualifications. It only states that the testing was conducted to evaluate the application of the system.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the "Simulated Use / Human Factors Testing."

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with AI assistance versus without. The study described is a "Simulated Use / Human Factors Testing," which focuses on the device's application and user interaction, not a reader study of clinical images.

6. Standalone Performance Study

The document does not describe a standalone (algorithm only without human-in-the-loop) performance study evaluating the accuracy of the ivECG signal interpretation or ionic dilution feature in isolation. The human factors testing involved the device being used by humans.

7. Type of Ground Truth Used (Test Set)

For the "Simulated Use / Human Factors Testing," the type of ground truth used is not explicitly stated. However, since the test aimed to confirm "PICC tip position," it can be inferred that the ground truth would have been the actual, verified PICC tip position established by a gold standard method during the simulation, although the specific method is not detailed. The comparison to chest x-ray or fluoroscopy confirmation suggests these are the accepted gold standards the device aims to emulate or provide an alternative to.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The text indicates that "Clinical testing was determined to be not applicable for this 510(k) submission. Bench testing was sufficient to demonstrate substantial equivalence of the Smart PICC System to the predicate device." This suggests the device's performance was not primarily established through a machine learning model requiring a large training set, but rather through engineering and human factors validation demonstrating equivalence to a predicate device.

9. How Ground Truth for the Training Set Was Established

As no training set is described, the method for establishing ground truth for a training set is not applicable or provided in this document.

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The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.

For Lateral Plates - non-unions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

For Medial Plates - intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.

The Piccolo Composite Proximal Tibia Plate System comprises implants (pre-contoured lateral and medial plates (in left and right configurations), and screws) in different dimensions, and instruments.

The Piccolo Composite proximal tibia plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and incorporate tantalum markers. The screws are made of titanium alloy.

The provided text is a 510(k) summary for a medical device (Piccolo Composite Proximal Tibia Plate System) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing. It does not contain information about studies involving human readers, AI, or diagnostic performance metrics typically associated with acceptance criteria for such studies.

Therefore, many of the requested sections about acceptance criteria, human reader performance, AI, and ground truth establishment cannot be answered from the provided document.

Here's a breakdown of what can be extracted and what cannot:

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)

This information is not provided in the document. The performance testing described is mechanical, not clinical, and thus terms like "test set" for human or AI performance or "data provenance" in this context are not applicable.

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 provided. The "ground truth" in this context refers to engineering standards and comparisons to predicate devices, not expert human interpretation.

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

This information is not provided. Arbitration methods are typically used for clinical studies with human observers, which is not the type of study described.

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

There is no indication that an MRMC comparative effectiveness study was done. This document describes the mechanical testing of a bone plate system, not a diagnostic or AI-assisted device. Therefore, no information on AI assistance or human reader improvement is available.

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

There is no indication that a standalone algorithm performance study was done. The device is a physical bone plate system, not an algorithm.

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

The "ground truth" for the mechanical performance testing appears to be established engineering standards (ASTM F 382) and performance data from legally marketed predicate devices.

8. The sample size for the training set

This information is not provided. The concept of a "training set" is not applicable to the mechanical performance testing described for this physical device.

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

This information is not provided. The concept of a "training set" and its ground truth is not applicable to the mechanical performance testing described for this physical device.

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The Biowy PICC catheter S Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi. The catheter is available in a kit configuration.

The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters. The catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device. The Catheter is provided in a kit with multiple components that includes a stylet, torque adapter and T-lock to facilitate catheter insertion and flushing which are subject to this submission. The stylet has a torque adapter at the end to facilitate handling and withdrawal of the stylet. The catheter and other components in the kit are unchanged from the predicate device.

This document is a 510(k) Pre-market Notification for a medical device (Biowy PICC Catheter S Kit), not a study proving a device meets AI-related acceptance criteria. Therefore, most of the requested information regarding AI acceptance criteria and study design for AI performance evaluation is not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device (Biowy PICC Catheter K173956) based on non-clinical bench testing for the physical catheter and its new accessories.

Here's the information that can be extracted, and where the requested information is not applicable (N/A) because the document describes a traditional medical device clearance, not an AI/ML powered device:

Device: Biowy PICC Catheter S Kit (K192246)
Type of Device: Percutaneous, implanted, long-term intravascular catheter (PICC)

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Tests" and "Results" which indicate whether the device "Passed" or "Met requirements" for various physical and material properties. These are not acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).

Since this is not an AI-powered device, the following points are Not Applicable (N/A) to the information provided in the document:

2. Sample size used for the test set and the data provenance: N/A (No AI test set described)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No AI ground truth establishment described)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No AI test set described)

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: N/A (Not an AI-assisted device)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI algorithm)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Ground truth as understood for AI performance is not relevant here. "Ground truth" for this device's performance is based on physical property testing and material standards.)

8. The sample size for the training set: N/A (No AI training set described)

9. How the ground truth for the training set was established: N/A (No AI training set described)

Summary for this document: The provided text is a 510(k) premarket notification for a physical medical device. It demonstrates substantial equivalence through non-clinical bench testing of the device's physical properties and materials against established medical device standards. It does not involve artificial intelligence, machine learning, or associated performance metrics and study designs that would typically address the questions posed about AI acceptance criteria and studies.

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HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to; the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.

HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5mL/sec.

The HydroPICC is a peripherally inserted central catheter (PICC) intended for short or long-term use. The HydroPICC is a 4Fr, 55cm long catheter suitable for periodic access to the superior vena cava (SVC) while maintaining a reduced level of thrombus accumulation. HydroPICC is supplied in a kit with the necessary accessories to insert and maintain the catheter.

This document is a 510(k) K193015 Premarket Notification for the HydroPICC (Model 142) intravascular catheter, asserting its substantial equivalence to a previously cleared predicate device, HydroPICC (Model 141, K172885).

The submission focuses heavily on demonstrating equivalence and does NOT include a study involving AI assistance for human readers, nor a standalone AI algorithm performance study. Therefore, most of the requested information regarding AI study design, ground truth establishment for AI, expert involvement, and MRMC studies is not present in this document.

The document describes performance testing for a medical device (intravascular catheter), not an AI algorithm. The acceptance criteria and performance data described relate to physical and mechanical properties of the catheter, as distinct from the performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML medical devices.

Here's the breakdown of the information that CAN be extracted, followed by a clear statement of what is NOT in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The subject devices met all predetermined acceptance criteria derived from the applicable guidance documents, standards and in-house protocols," but it does not provide a specific table with numerical acceptance criteria and reported performance values. Instead, it lists the types of tests performed and the standards followed.

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 each individual test. It merely states that "The subject devices met all predetermined acceptance criteria." The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned for this engineering/performance testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This document describes the testing of a medical device (catheter), not the performance of an AI algorithm based on expert-labeled data.

4. Adjudication Method for the Test Set

Not applicable. This is for medical device performance (physical, mechanical, safety), not for AI algorithm evaluation requiring expert consensus/adjudication.

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

No MRMC comparative effectiveness study was done because this submission is not for an AI/ML medical device and does not involve human readers interpreting images with or without AI assistance.

6. Standalone Algorithm Performance

No standalone algorithm performance study was done relevant to AI/ML, as this is not an AI/ML device.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing is established by engineering standards and specifications (e.g., ISO, ASTM standards, FDA guidance documents, and internal protocols) for physical and mechanical properties, not expert consensus on medical images, pathology, or outcomes data in the context of an AI study.

8. Sample Size for the Training Set

Not applicable. This document describes testing for a manufactured medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reason as point 8.

Summary of what is NOT in the document regarding acceptance criteria and studies for an AI/ML device:

The provided document is a 510(k) premarket notification for a physical medical device (intravascular catheter). It details the substantial equivalence to a predicate device and describes the various engineering and performance tests conducted to ensure the device meets safety and performance standards. It does not contain any information about an AI/ML device, its acceptance criteria, expert consensus, ground truth establishment, or any studies related to its performance (standalone or human-in-the-loop). Therefore, the specific requirements of the prompt regarding AI are not addressed by this document.

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