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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.

Important Note: The document states that the testing was performed and the device "met" the requirements. It doesn't provide specific numerical results or raw data for these tests, as is typical for a 510(k) summary (which summarizes the full testing report).

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

• Sample Size: Not explicitly stated for each test, but typically these tests involve a specific number of units of the device as defined by the standards themselves or internal quality protocols.
• Data Provenance: The testing was "Bench/Performance Data/Non-Clinical Testing" and "Biocompatibility evaluation." This implies laboratory testing performed by or for the manufacturer (Medcomp®, located in Harleysville, PA, USA). This is prospective testing, as it's specifically conducted to support the regulatory submission.

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. For a physical device, "ground truth" is established by adherence to engineering specifications and international standards, measured by calibrated equipment and qualified lab personnel, not clinical experts interpreting images or diagnostic data.

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

Not applicable. This is for AI/ML model output, not physical device performance 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

Not applicable. This device is not an AI/ML diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm.

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

For this physical device, the "ground truth" is adherence to the specifications outlined in the ISO standards, which define acceptable functional performance (e.g., specific force required, leak rate, biocompatibility). Compliance is measured mechanically or chemically, not via clinical or expert assessment of "truth" in a diagnostic sense.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model.

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

Not applicable. This is a physical device, not an AI/ML model.

In summary, the provided document pertains to a traditional physical medical device and therefore the acceptance criteria and study methods are fundamentally different from those for an AI/ML-enabled device. The "study" proving the device meets acceptance criteria is the successful completion of the specified bench testing and biocompatibility assessments in accordance with recognized standards, demonstrating the device's substantial equivalence to its predicate.

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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.

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

For this type of device, a "test set" in the AI sense is not applicable. The sample sizes for the various bench/performance/biocompatibility tests are typically determined by the standards themselves (e.g., specific number of catheters for tensile strength, or material samples for biocompatibility), and these details are not provided in this summary. The data provenance is from non-clinical bench testing and laboratory studies by the manufacturer (Medcomp®) to ISO and ASTM standards. It is not patient data from clinical trials.

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 device relates to verified diagnostic labels. For a physical medical device, the "ground truth" is established by the specifications of the device, the requirements of the standards, and the physical measurements/observations during testing. No external expert panel is described for establishing a "ground truth" for these engineering and biocompatibility tests.

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

Not applicable. This concept applies to human reader consensus for labeling data, which is not relevant here. The tests are defined by standard protocols with clear pass/fail criteria.

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

Not applicable. This is not an AI-assisted device. The "effectiveness" is demonstrated by meeting performance standards and clinical equivalence to a predicate device, not by improving human reader performance.

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

Not applicable. This is not an algorithm.

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

Not applicable in the AI sense. The "truth" for this device's performance is derived from:

• Engineering specifications and design.
• Compliance with recognized international standards (ISO, ASTM).
• Direct physical measurements and observations during bench testing (e.g., flow rates, tensile strength, Luer taper dimensions).
• Laboratory analysis for biocompatibility endpoints.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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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 Pro-PICC catheter with valve technology is indicated for short and long peripheral access to the central venous system for intravenous therapy and power injection media, and allow for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The Pro-PICC®07 with Valve Technology is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® Pro-PICC®CT (K091953 and K092347). The Pro-PICC®67 with Valve Technology is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each luer is a Bi-directional valve that can control fluid flow in two directions. The valve is normally closed but opens when flow is induced in either direction. Each extension is marked with the lumen gauge size, "Valved CT Catheter" or "Do Not Power Inject", and the maximum flow rates. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. 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 Pro-PICC® with Valve Technology catheter is available in additional French sizes and either a single, double, or triple lumen. The catheter has a usable length of 50cm to 60cm depending on French size with depth markings in 5cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in a variety of trav configurations with the necessary accessories to facilitate catheter insertion.

The provided text appears to be a 510(k) summary for a medical device (Medcomp® Pro-PICC® with Valve Technology), rather than a study report detailing acceptance criteria and performance data for an AI/algorithm-based device.

Therefore, many of the requested categories for AI device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details, and how ground truth was established for training and test sets) are not applicable or cannot be extracted from this document.

However, I can extract information related to the performance data (bench/performance data) as described in the document, which pertains to the physical device rather than an AI algorithm.

Here's the information that can be extracted, with notes on where the requested AI-specific information is not available:

Acceptance Criteria and Study for Medcomp® Pro-PICC® with Valve Technology

1. Table of Acceptance Criteria and Reported Device Performance

Notes on AI-Specific Information (Not Applicable/Available from this document):

• This document describes a physical medical device (catheter), not an AI algorithm. Therefore, there are no specific AI-driven acceptance criteria for metrics like sensitivity, specificity, AUC, or F1-score that would be relevant for an AI system.
• The "performance" referred to in the document relates to the physical and functional characteristics of the catheter (e.g., pressure injection capabilities, material properties), not algorithmic performance.

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

• Not Applicable. This document is for a physical medical device, not an AI algorithm. There is no mention of a "test set" in the context of an AI algorithm's performance evaluation. The "testing" mentioned refers to bench testing of the physical catheter.

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

• Not Applicable. This document is for a physical medical device. "Ground truth" in the context of expert consensus for image or data interpretation is not relevant here.

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

• Not Applicable. This document is for a physical medical device. Adjudication methods are relevant for expert review in AI studies, not for physical device 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

• Not Applicable. This document is for a physical medical device. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant here.

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

• Not Applicable. This document is for a physical medical device. There is no "algorithm only" performance reported, as there is no AI algorithm.

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

• Not Applicable. For the bench and biocompatibility testing, the "ground truth" would be established by validated measurement techniques, chemical analyses, and adherence to relevant ISO standards, rather than expert consensus on image interpretation or pathology.

8. The sample size for the training set

• Not Applicable. This document describes a physical medical device, not an AI algorithm. There is no concept of a "training set" for this type of device submission.

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

• Not Applicable. As there is no training set for an AI algorithm, this question does not apply.

Summary of Relevant Information from the Document:

The document is a 510(k) premarket notification for a physical medical device, the Medcomp® Pro-PICC® with Valve Technology, a catheter. The core of the submission is to demonstrate substantial equivalence to existing predicate devices.

• Study Objective: To demonstrate that the Medcomp® Pro-PICC® with Valve Technology is substantially equivalent to legally marketed predicate devices.
• Study Types:
  • Bench/Performance Testing: Conducted in accordance with applicable international standards and FDA guidance documents, and internal engineering testing methods (specifically for pressure injection, where no FDA standard exists). The document states these tests "effectively demonstrate the proposed devices are equivalent to the predicate devices."
  • Biocompatibility Testing: All materials used were tested on the complete, finished device, demonstrating they meet the requirements of ISO 10993.
• Conclusion: The device meets performance criteria of design verification as specified by ISO standards, guidance documents, and internal test protocols. It has the same intended use, operation, and function as the predicates, with no differences raising new safety or effectiveness issues, thus demonstrating substantial equivalence.

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The Medcomp® Power Injectable Huber Needle Safety Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through implanted vascular access ports. The Medcomp® Power Injectable Huber Needle Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 19 gauge and 20 gauge non-coring Huber style needles and 2 ml/sec for 22 gauge noncoring Huber style needles.

The Power Injectable Safety Huber Needle is composed of a sharpened anti-coring Huber style needle for port septum access having a safety feature which is manually operated and will prevent accidental needle sticks when advanced which is connected to a conventional style extension set for attachment to standard IV/Drug infusion line sets.

The proximal end of the needle cannula is adhesively sealed to the molded housing which contains a glue well and fluid thru hole thru hole leads to the distal end of the extension line set that is also adhesively bonded in the molded housing. The distal end of the extension tubing contains a female luer connector with removable dust cap on the proximal end creating a fluid path from the needle tip thru the female luer. The infusion set is also offered in a configuration where the extension tubing contains a Y-Site connector with removable dust cap placed midway between the needle and the female luer connector. The extension tubing contains purple pigment to indicate its use for high pressure. The Y portion of the connector is a molded female luer that is sealed with a removable dust cap. A non-removable pinch clamp is located between the female luer and needle cannula. On line sets with a Y-Site connector, two pinch clamps are present located between the female luer and the Y-Site and the Y-Site and the needle cannula. The pinch clamps are designed that when engaged, fluid flow is restricted thru the extension tubing.

The needle cannula is constructed with a Huber style anti-coring needle tip. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

The molded wing housing is of plastic construction and contains rigid protruding wings.

The molded wing housing is snap fitted into the molded housing via a securement post. The wing housing is of plastic construction with a protruding wing designed flush with the under surface of the housing. The wing housing contains a thru hole that easily slides over the needle cannula. The wing housing contains a torsion spring that is positioned on a post and is orientated in a positioning channel. The torsion spring is in a compressed state until the molded housing is removed from the wing housing at which time the torsion spring is automatically activated. The wing housing consists of a base to which the securement bag is adhesively bonded.

The molded housing is connected to the wing housing via the securement bag. The securement bag (a polyester film lamination) is adhesively bonded to the molded housing and the wing housing. The securement bag is compressed (accordion style) between the molded housing and wing housing and is of length sufficient to activate the torsion spring and to prevent the needle tip from entering the securement bag area.

In normal operation, the molded housing is activated during removal of the needle from the patient. The wing housing is held firmly in place while the molded housing is disengaged. The molded housing is disengaged from the wing housing by grasping the elevated portion of the molded housing and sliding the molded housing in an upward direction. The molded housing will disengage from the wing housing and will advance until the torsion spring is past the needle tip at which time the torsion spring will snap over the needle access hole. Upon spring activation, there will be an audible click sound as the spring snaps against the wing housing. The securement bag prevents the molded housing from advancing off the needle cannula and the torsion spring prevents the needle from advancing out of the housing.

Prior to use, the exposed portion of the needle cannula, including the sharpened needle tip area, is coated with a silicone fluid to render the needle lubricious and to reduce the insertion (penetration) and drag force to industry acceptable values.

Each needle size has I.D. Rings located within the pinch clamp to identify the appropriate infusion rate for the noted needle gauge size. Components will be assembled by the manufacturer into standard configurations with or without the "Y-Site" and packaged.

The provided text describes a medical device, the Medcomp Power Injectable Safety Huber Needle, and its FDA 510(k) clearance. However, the document does not contain the information requested in your prompt regarding acceptance criteria for a study proving device performance, sample sizes, expert qualifications, or details of efficacy studies (MRMC or standalone).

The document is a regulatory approval letter and a summary of the device for FDA submission. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics.

Here's what can be extracted based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The data appears to be from "Bench / Performance Data" (laboratory testing), not a clinical study.

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 as this document does not describe a study involving expert-established ground truth for a test set. The performance data mentioned relates to engineering tests (pressure testing).

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

• Not applicable. This document does not describe a study involving adjudication of a test set.

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. The document explicitly states: "Clinical studies were not deemed necessary since no changes have been made to the design, packaging, sterilization or indications for use that would have any effect on the safety and effectiveness of the device when compared to the legally marketed predicate device." This device is a physical medical needle, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

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

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

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

• For the "Bench / Performance Data" mentioned, the "ground truth" would be the direct measurements obtained from the physical pressure testing of the needles, adhering to established engineering standards relevant to pressure ratings for such devices. No medical "ground truth" (like pathology or expert consensus) is discussed for this type of device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI device that requires a training set with established ground truth.

In summary, the provided document is a regulatory submission for a physical medical device (needle) and focuses on demonstrating substantial equivalence through bench testing, not on clinical efficacy studies with detailed acceptance criteria, expert reviews, or AI performance metrics as requested in your prompt.

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The Medcomp@ 6F Triple Pro-Line® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs, and parenteral nutrition solutions. as well as blood withdrawal, allows for central venous pressure monitoring and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec.

The Pro-Line of Power Injectable CVC triple lumen is an open-ended triple lumen catheter designed for power injection through one designated lumen. The power injectable central venous catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated 17ga. power injectable extension line and clamp material are purple in color to differentiate it from the clear 19ga. non-power injectable extensions. The purple lumen identifies it as a power injectable catheter. The center extension is also printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.

The catheter has a usable length of 60 cm with numerical markings every 5 cm and depth markings in 1 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile with the necessary accessories to facilitate catheter insertion.

The provided text describes a medical device, the Medcomp® Pro-Line CT Power Injectable CVC, and its submission for 510(k) clearance. It does not describe an AI/ML-driven device or diagnostic software. Therefore, the requested information regarding acceptance criteria for device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details is not applicable to the provided document.

The document discusses the substantial equivalence of the Medcomp® Pro-Line CT Power Injectable CVC to predicate devices based on:

• Intended Use: Short or long-term central venous access for IV fluids, blood products, drugs, parenteral nutrition, blood withdrawal, CVP monitoring, and power injection of contrast media (max 5cc/sec).
• Technological Characteristics: Basic design, materials, performance, labeling, manufacturing process, and sterilization.
• Bench/Performance Data: Conducted in accordance with applicable international standards and internal engineering protocols, to demonstrate substantial equivalence.
• Biocompatibility: Materials meet ISO 10993 requirements, with testing previously submitted for other Medcomp devices.

"Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device." This statement directly indicates that performance criteria based on clinical outcomes, or metrics that would necessitate human expert review or an MRMC study, were not part of the clearance process for this specific medical device.

Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluation within this document.

The document is a 510(k) premarket notification for a traditional medical device (catheter), not an AI/ML diagnostic or treatment planning system.

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The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children.

The Medcomp 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique. The purpose of the device is to facilitate the insertion of a peripheral, mid-line, or central venous catheter. The introducer is inserted over a .010 inch diameter guidewire that has been placed into the target vessel using a needle or IV catheter. Upon placement of the introducer, the guidewire is removed. When the catheter is ready for insertion, the dilator of the introducer is withdrawn from the sheath and the catheter is threaded into the vein through the sheath. When the catheter has been placed, the sheath is simultaneously split and withdrawn leaving the catheter in place. The Vascu-Sheath Tearaway Introducer is packaged sterile in either a pouch or a variety of tray configurations with additional accessories to facilitate catheter insertion.

The Medcomp Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children. The study demonstrates that this device is substantially equivalent to legally marketed predicate devices through performance testing.

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

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

The document does not specify the exact sample sizes used for each individual performance test (Freedom from Liquid Leakage, Force at Break, Simulated Use, Guidewire Passage, Accelerated Aging). It simply states that "Performance testing of the proposed devices was conducted." The provenance of the data is from internal engineering protocols and testing conducted by Medcomp. No specific country of origin is mentioned beyond Medcomp's location in Harleysville, PA, USA. The testing appears to be retrospective in the sense that it was performed on finished products, but the studies themselves are not characterized as retrospective or prospective clinical trials.

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

Not applicable. This device is not an AI/CADe device that requires expert review for ground truth establishment. The performance criteria are objective engineering and material science tests.

4. Adjudication method for the test set

Not applicable. As noted above, this device is not an AI/CADe device. The acceptance criteria are based on objective, quantifiable engineering and biocompatibility standards.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI-assisted device.

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

The ground truth for the performance tests consists of predefined engineering specifications, thresholds for physical properties (e.g., force at break), and established international standards for biocompatibility (ISO 10993) and risk management (ISO 14971:2000).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product and therefore does not have a training set in that context.

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

Not applicable. This device is not an AI/machine learning product.

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