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The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
• The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The Trio-CT® Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.

The provided text describes the submission of a medical device, the "Trio-CT® Triple Lumen Catheter w/ Curved Extensions," for FDA 510(k) clearance, asserting its substantial equivalence to a predicate device, the "Trio-CT™ Triple Lumen Catheter." The document focuses on regulatory compliance and does not detail a study proving the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study.

Therefore, many of the requested elements for an AI evaluation study, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI training sets, are not applicable to this document. This document pertains to the regulatory clearance of a physical medical device, not an AI software component.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its substantial equivalence.

Here's the relevant information based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the format typically used for performance studies (e.g., sensitivity, specificity thresholds). Instead, it compares the technical specifications and performance characteristics of the subject device to its predicate to demonstrate substantial equivalence. The "acceptance criteria" are implied to be that the subject device's performance is comparable to or better than the predicate device across various technical and performance specifications.

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

This information is not applicable. The document describes non-clinical testing for a physical medical device, not a test set for an AI algorithm. The performance testing was "Design validation performance testing... leveraged from the predicate device manufactured by Medical Components, Inc." and "Design verification performance testing was completed to confirm performance criteria of the subject device." No specific sample sizes for these tests are mentioned in the provided text, nor is data provenance in the context of patient data described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as this document does not concern an AI/algorithm where human expert ground truth would be established.

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

This information is not applicable.

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

This information is not applicable.

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

This information is not applicable.

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

The "ground truth" for this device's performance comes from adherence to established technical specifications and performance characteristics, and the results of various non-clinical tests. These include:

• Biocompatibility Evaluation: This involved specific tests like ISO Muscle Implantation, USP Rabbit Pyrogen, ASTM Hemolysis, SC5b-9 Complement Activation Assay, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous, Cytotoxicity Study, ISO Acute Systemic Toxicity, ISO Systemic Toxicity in Rat, Bacterial Reverse Mutation, Genotoxicity: Mouse Lymphoma Assay, Infrared Spectroscopy, Mechanical Hemolysis Testing, and In Vivo GLP 30 Day Thromboresistance Study. These tests provide "ground truth" regarding the material's safety and biological interactions.
• Performance Testing: This refers to design verification tests to confirm the device meets its specified technical characteristics (e.g., Catheter French Size, Inner Diameters, Priming Volume, Power Injection Pressure, Flow Rate vs. Pressure). The "ground truth" here is the direct measurement of these physical properties.

8. The sample size for the training set:

This information is not applicable. The document focuses on regulatory clearance of a physical medical device, not an AI algorithm.

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

This information is not applicable.

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Luer lock plug for capping male or female luer tapers for hemodialysis catheters.

The Medcomp® End cap is non-vented plastic cap with a male luer. The end connects directly to the female luer of the catheter.

The provided document is a 510(k) summary for a medical device called "End Cap". It details the device's description, indications for use, comparison to a predicate device, and performance data for demonstrating substantial equivalence.

However, the questions you've asked are specifically about the acceptance criteria and study proving the device meets acceptance criteria for an AI/ML-enabled medical device. The provided document is for a physical medical device (luer lock plug) and does not involve AI or machine learning. Therefore, the questions related to AI/ML device performance (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable to the content of this document.

The document discusses performance testing (bench testing) to ensure the physical device meets relevant standards, but this is different from the type of performance evaluation required for an AI/ML diagnostic or predictive device.

Here's how I can address the applicable parts of your request based on the provided document, interpreting "acceptance criteria" in the context of a physical device's regulatory submission:

The "acceptance criteria" for this device's submission revolves around demonstrating substantial equivalence to a legally marketed predicate device by meeting recognized consensual standards for physical device performance and biocompatibility.

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

For a physical device like the End Cap, acceptance criteria are typically defined by compliance with recognized international standards (ISO standards in this case) and demonstrating safe and effective performance. The "reported device performance" is essentially that the device passed these tests, confirming its compliance.

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The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.

The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

The provided document is a 510(k) summary for a medical device, the Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes. It states that the device is substantially equivalent to a previously cleared predicate device.

However, this document does not contain the kind of detailed information requested regarding acceptance criteria and a study proving device performance, particularly related to AI/software performance metrics like sensitivity, specificity, or human reader improvement. The "performance testing" referenced in the document (Table 6.2) refers to non-clinical bench testing and adherence to standards for physical properties, materials, packaging, and biocompatibility, not a clinical study or a study involving AI with human experts.

Therefore, I cannot provide an answer to your request based on the provided text. The document focuses on demonstrating substantial equivalence through non-clinical testing of the physical catheter and its materials.

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The Duo-Flow Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

The Duo-Flow Side x Side Double Lumen Catheter is a non-implanted hemodialysis catheter with two lumens. The red adapter connects to the proximal lumen for "arterial" outflow, and the blue adapter connects to the distal lumen for "venous" return. The catheter is available in various sizes and configurations (curved or straight extensions).

This document describes the premarket notification (510(k)) for the Medcomp® Duo-Flow® Side x Side Double Lumen Catheter. It outlines the device's characteristics, its intended use, and its substantial equivalence to a predicate device.

Key Point: The provided text does not describe an AI/ML medical device. It pertains to a physical medical device (a catheter) and therefore, the concepts of AI-specific acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone performance, and training sets for an AI model are not applicable.

The document primarily focuses on demonstrating the substantial equivalence of the Duo-Flow® Side x Side Double Lumen Catheter to a legally marketed predicate device (Mahurkar™ Acute Dual Lumen Catheter). This is a common pathway for medical device clearance in the US, where new devices are compared to existing ones that have already been cleared for marketing.

Instead of AI-specific performance metrics, the document details:

• Indications for Use: What the device is intended for (short-term central venous access for hemodialysis, apheresis, and infusion).
• Comparison to Predicate Device: A detailed table (Table 6.1) comparing various attributes of the subject device to the predicate device, including indications for use, definition, location of use, French size, catheter configuration, lengths, duration of use, sterilization method, number of lumens, patient population, insertion site, and kit type. The goal is to show that the new device is fundamentally similar to the predicate.
• Bench/Performance Data/Non-Clinical Testing: This section (Table 6.2) lists the applicable standards and performance testing conducted on the physical device to ensure its safety and effectiveness. These are primarily engineering and material tests, not clinical performance studies comparing diagnostic accuracy.
  • ISO 10555-1: Intravascular catheters (Air Leak, Liquid Leak, Peak Tensile Force, Gravity Flow)
  • ISO 11607-1 & -2: Packaging for terminally sterilized medical devices (Transit and Shelf Life testing)
  • ISTA 3A: Packaged products for parcel delivery system shipment (Transit Testing)
  • ISO 594-1 & -2: Conical fittings (Luer) for syringes, needles, etc. (Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking)
• Biocompatibility: Tests conducted according to ISO 10993 standards to ensure the device is safe for biological contact. These include cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, subacute toxicity, genotoxicity, implantation, and hemocompatibility.

Therefore, to directly answer your request based on the provided text, while acknowledging that it's not an AI device:

1. Table of acceptance criteria and the reported device performance:

Since this is a physical medical device and not an AI/ML diagnostic tool, the "acceptance criteria" are based on meeting established engineering and biocompatibility standards, and demonstrating substantial equivalence to a predicate device. Performance is measured by successful completion of these non-clinical tests.

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The Trio-CT™ Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.

The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The Trio-CT™ Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.

The provided text describes a medical device, the Trio-CT™ Triple Lumen Catheter, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria for a study proving device performance in the context of an AI/algorithm-based medical device.

The document is a 510(k) summary for a physical medical device (a catheter) and discusses its non-clinical testing, biocompatibility, and comparison to a predicate device. It lacks the specific details requested regarding acceptance criteria, study design for AI evaluation, ground truth establishment for AI, or sample sizes related to AI performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/algorithm. Based on the provided text, such a study was not conducted or reported for this device.

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The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.

The 12F Tri-Flow Triple Lumen Catheter is a short term dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (clear) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, blood draws and infusion of medications.

The provided text describes a 510(k) premarket notification for a medical device, the "12F Tri-Flow Triple Lumen Catheter." It focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study or performance data akin to what would be provided for an AI/CADe device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device performance study based on AI or CADe functionality cannot be extracted from this document, as the document details a traditional medical device submission based on comparison to a predicate device and bench/non-clinical testing.

The document's "Bench/Performance Data/Non-Clinical Testing" section (page 5-6) lists various ISO and ASTM standards and the "Performance Testing" conducted against them. These are primarily related to the physical, chemical, and biological properties of the catheter, such as:

• Air Leak, Catheter Leak, Extension-Hub, Extrusion-Hub, Gravity Flow (against ISO 10555-1)
• Shipping and Shelf Life testing (against ISO 11607-1, ISO 11607-2)
• Gauging (against ISO 594-1)
• Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding Stress Cracking (against ISO 594-2)
• Biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility against ISO 10993 series and USP/OECD guidelines).

These are not "device performance" in the context of an AI-powered diagnostic or therapeutic device where sensitivity, specificity, accuracy, or human reader improvement are measured.

In summary, none of the specific questions regarding acceptance criteria, study design, sample sizes, expert involvement, or ground truth for an AI/CADe device performance study can be answered from the provided text. The document pertains to a K181175 submission for a physical medical device (catheter) based on substantial equivalence and non-clinical bench testing.

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The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.

The Symetrex™ Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

Here's a breakdown of the acceptance criteria and study information for the Symetrex™ Long Term Hemodialysis Catheter with Sideholes, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily demonstrated through equivalence to the predicate device and compliance with various ISO and ASTM standards. The document doesn't explicitly state quantitative acceptance criteria in all cases, but rather reports the device performance against established standards through "performance testing."

Key performance aspects are outlined in the comparison to the predicate device and in the performance standards section.

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

The document does not specify the sample sizes used for the performance testing (test set) for the device. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are primarily in vitro (Recirculation) or bench/laboratory testing (physical, mechanical, packaging, luer fittings, biocompatibility).

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

This information is not provided in the document. The studies described are non-clinical, benchtop, and in vitro tests governed by engineering and scientific standards, rather than clinical trials requiring expert-established ground truth in the medical diagnostic sense.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and therefore not provided in the document. The studies are non-clinical hardware tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to a physical medical device (catheter), not an AI-powered diagnostic system. Therefore, the concept of "human readers improve with AI" is not relevant here.

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 catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical performance testing and biocompatibility studies, the "ground truth" is established by:

• Engineering and Scientific Standards: Compliance with relevant ISO and ASTM standards (e.g., ISO 10555-1 for intravascular catheters, ISO 11607-1 for packaging, ISO 594-1/2 for luer fittings, and various ISO 10993 parts for biocompatibility).
• Measurement and Comparison: Direct measurement of physical properties (e.g., priming volumes) and comparison to the predicate device.
• Established Test Methods: In vitro testing for recirculation rates.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this physical medical device. The device is not learning-based.

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

This information is not applicable as there is no "training set" for this physical medical device.

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The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central catheters (PICC). The C3 Wave provides real-time catheter tip location by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contrindicated, 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.

C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a guide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.

The C3 Wave system must only be operated by a skilled nurse, physician, or trained medical professional who has been qualified in placement of PICC's and trained in the proper use of this device.

This document details the substantial equivalence review for the Medcomp C3 Wave System (K180567), which is an update to a previously cleared device (K170934). The current submission focuses on expanding accessory pack offerings, specifically adding a larger drape and revising the packaging system. Therefore, the "study" described relates to the testing performed to ensure the safety and effectiveness of these modifications, rather than a clinical efficacy study of the core device functionality.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All testing was completed and is the subject of this submission" and concludes that the device raises "no new questions of safety or effectiveness compared to the predicate device." This implies that all acceptance criteria for the non-clinical testing performed on the modified accessory pack were met. Specific numerical performance metrics for each test (beyond the EO residuals) are not detailed in this summary.

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

The provided text describes non-clinical laboratory testing performed on the modified accessory pack. It does not mention a "test set" in the context of patient data or clinical performance. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or not provided for this specific submission, as it focuses on accessory modifications rather than the primary device's clinical performance.

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

This information is not applicable or not provided as the submission focuses on non-clinical testing of device accessories (drape and packaging), not on clinical performance requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable or not provided for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not performed or described in this document. The C3 Wave System is an ECG-based positioning aid for PICC lines, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. This submission specifically addresses modifications to accessory packs.

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

A standalone performance study of an algorithm is not discussed or applicable to this submission. The C3 Wave System is a device that provides real-time data to a human operator (skilled nurse, physician, or trained medical professional) to aid in PICC placement. The submission pertains to modifications to non-electronic accessories.

7. The Type of Ground Truth Used

For the non-clinical testing of accessories, the "ground truth" would be established by standardized laboratory testing procedures and the specifications of relevant international and national consensus standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135 for sterilization, ASTM F1929 and F1140 for packaging). This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable or not provided. Since the submission refers to modifications of accessories and non-clinical testing, there is no "training set" in the context of machine learning or AI algorithms.

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

This information is not applicable or not provided as there is no "training set" in the context of this submission.

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The Arch-Flo CT Midline is indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. This catheter may be inserted via basilic, cephalic, or median cubital vein.

The Arch-Flo'™ CT Midline is available in a 4F Single Lumen configuration. The catheter lumen terminates through an extension to a female luer-lock connector. The extension has an in-line clamp to control fluid flow and is marked POWER INJECTABLE MIDLINE along with the lumen gauge size. The transition between lumen and extension is housed within a molded hub. The hub is marked MIDLINE to identify that the catheter is not centrally placed. The tip of the lumen is notched to increase the exposed area of the lumen. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.

The provided text describes a 510(k) premarket notification for a medical device called "Arch-Flo CT Midline." This document primarily focuses on establishing substantial equivalence to a predicate device through comparison and performance testing. It does not contain information about acceptance criteria and studies related to the performance of an AI/algorithm-based device.

The device in question is an "Intravascular Catheter," which is a traditional medical device, not an AI or software-based application. Therefore, the specific questions regarding AI device performance (like the number of experts for ground truth, MRMC studies, standalone performance with AI, training set details, etc.) are not applicable to the content provided.

However, I can extract the general "acceptance criteria" (or performance data) for the physical device based on the bench/performance data and comparison to the predicate device.

Here's the information that can be extracted, interpreted based on the context of a traditional medical device submission:

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

The document describes performance data for the Arch-Flo CT Midline and compares it to the predicate device, CT Midline (K141151). The "acceptance criteria" are implied by the standards the device was tested against and by demonstrating similar or superior performance to the predicate device.

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The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, 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.

C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a quide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.

Here's an analysis of the acceptance criteria and study information for the C3 Wave System, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" as a separate table with specific numerical targets. However, the outcome of the clinical study serves as the primary performance metric for the expanded indications for use.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

Here's a breakdown of the study information as requested:

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

• Sample Size: 303 PICCs were placed. Each PICC placement likely represents a single case in the test set.
• Data Provenance: Retrospective, as indicated by the completion of "Clinical Surveys" and data collection from "two healthcare facilities." The study design involved obtaining an X-ray after the C3 Wave System was used, implying a comparison against established practice. Given it's a 510(k) submission, the data is typically from a clinical trial conducted for regulatory purposes. The specific country of origin is not mentioned, but "two healthcare facilities" implies clinical settings.

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

• Number of Experts: Not explicitly stated how many individual experts independently reviewed each X-ray for ground truth. However, the process refers to "established hospital protocol (e.g., Chest X-Ray, Fluoroscopy)," which implies that the interpretation of the chest X-rays to determine "acceptable tip location" was performed by qualified medical professionals as part of standard clinical practice. This would typically involve radiologists or trained clinicians responsible for interpreting such images.
• Qualifications of Experts: Not specifically detailed. It can be inferred that the chest X-rays were interpreted by clinicians or radiologists according to "clinical judgement and established hospital protocol."

4. Adjudication method for the test set:

• Adjudication Method: Not explicitly detailed. The study mentions that a "subsequent portable chest x-ray was to be obtained... to ascertain acceptable tip location of PICC." This implies that the chest X-ray served as the gold standard against which the C3 Wave System's positioning results were compared. There's no mention of a formal adjudicated consensus process if multiple readers were involved in interpreting the X-rays; it likely followed standard clinical practice for X-ray interpretation.

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:

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs without AI assistance.
• Nature of Study: This study evaluated the C3 Wave System as a standalone alternative to chest X-ray or fluoroscopy, not as an AI-assistance tool for human readers. The "success rate" refers to the device's ability to correctly identify tip placement compared to the X-ray, not an improvement in human reader performance.

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

• Standalone Performance: Yes, the clinical study primarily evaluated the C3 Wave System for its standalone ability to determine PICC tip location. The system provides real-time electrical activity display, and the "clinician was to complete an electronic survey document to capture specific data points within each procedure including insertion related assessments" which implies the system's output (ECG display) was used by the clinician to guide placement, and then the system's output was judged against the X-ray. The 98% success rate reflects the system's performance in guiding tip placement without requiring an X-ray for initial confirmation.

7. The type of ground truth used:

• Ground Truth: Expert Consensus (implied by clinical practice) / Imaging (Chest X-ray). The "acceptable tip location of PICC" was ascertained by a "subsequent portable chest x-ray," which is then interpreted by medical professionals according to "clinical judgement and established hospital protocol." The X-ray image and its interpretation serve as the ground truth.

8. The sample size for the training set:

• Training Set Sample Size: The document does not provide information about the sample size used for training the C3 Wave System's algorithms. As it's an ECG-based system, its "training" might involve developing and refining the algorithms that interpret ECG changes to infer catheter tip position, which could be based on prior physiological models or data, but specific data for algorithmic training is not present in this summary.

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

• Training Set Ground Truth Establishment: This information is not provided in the document. Without details on the training set, how its ground truth was established cannot be determined from this summary.

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