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Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters:
Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device. Certain catheters may incorporate a lumen for balloon inflation.

Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.

Needle / Cannula (Introducer):
The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits.

The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.

The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle is then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

The provided FDA 510(k) clearance letter and summary describe the Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer). The submission is a "Special 510(k)" primarily focused on removing a warning label related to unknown electromagnetic compatibility (EMC) with low-frequency emissions.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The core of this Special 510(k) is the demonstration of electromagnetic compatibility, specifically concerning immunity to proximity magnetic fields, to justify the removal of a previous warning label.

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

• Sample Size: The document does not explicitly state a numerical sample size (e.g., "N=X devices were tested"). It refers to "representative external pulse generator equipment and the sample Temporary Pacing Electrode devices." This typically implies a limited number of devices/systems sufficient to represent the product line for EMC testing as per regulatory guidelines for in-vitro/bench testing.
• Data Provenance: The study was a bench (in-vitro) test performed to a recognized international standard (IEC 60601-1-2). There is no patient data involved, so there is no country of origin or retrospective/prospective distinction.

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

Not applicable. This was a bench-top engineering test evaluating electromagnetic compatibility against a defined international standard (IEC 60601-1-2). "Ground truth" in the clinical sense (e.g., diagnosis by experts) is not relevant here. The "ground truth" is the established test methodology and performance limits defined by the IEC standard.

4. Adjudication Method for the Test Set

Not applicable. As a bench test against objective standards, there is no expert adjudication process like those used in clinical studies for diagnostic accuracy. The results are objectively measured against the specified limits of the IEC standard.

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

Not applicable. This device is a passive pacing electrode catheter and introducer, not an AI-powered diagnostic or therapeutic tool with a human-in-the-loop component.

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

Not applicable. The device is a medical hardware component, not an algorithm. The testing focused on the physical and electrical compatibility of the hardware with relevant external equipment.

7. The Type of Ground Truth Used

The "ground truth" for this study is compliance with international consensus standards for electromagnetic compatibility, specifically IEC 60601-1-2 (Edition 4.1): 2020, with particular focus on Clause 8.11 and the methods specified in IEC 61000-4-39 (2017). This standard defines objective tests and acceptance limits for device performance under various electromagnetic conditions.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

Not applicable, as there is no training set.

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Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device.

Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Pacing Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits. The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.

The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle in then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

The provided text is a 510(k) Summary for a medical device (Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)). It describes the device, its intended use, and comparability to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.

The text focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of Technological Characteristics: Tables comparing the subject device and the predicate device in terms of design, materials, and dimensions.
• Performance Data Summary: A list of various performance tests conducted (e.g., biocompatibility, electrical safety, mechanical tests, functional testing to standards like ISO 10555-1, IEC 60601-1, ISO 80369 series, ISO 11070). The document states that the devices met the requirements of the above standards and performance endpoints.

Therefore, I cannot provide the specific details requested in your prompt (a detailed table of acceptance criteria and reported device performance with numerical values, sample sizes for test sets, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment).

The document explicitly states that the device "met the requirements of the above standards and performance endpoints," implying that the acceptance criteria are defined by these referenced standards and internal specifications, but the specific numerical acceptance criteria and the quantitative results are not disclosed in this summary.

If you have a document that contains the detailed study results and acceptance criteria, please provide it.

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The Provena™ Midline Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use with power injectors.

Provena™ Midline Catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter is designed with kink-resistant, reverse taper design. Catheters are packaged in a tray with accessories for reliable short term (less than 30 days) vascular access. The Provena™ Midline Catheters are suitable for use with power-injectors.

The provided FDA 510(k) summary for the Provena™ Midline Catheter does not describe a study involving an AI/Machine Learning device or an analysis of clinical images. Instead, it details a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device through material, dimensional, and performance characteristic comparisons.

Therefore, many of the requested details regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment) are not applicable to the content provided.

However, I can extract and present the device performance characteristics and the type of testing performed to demonstrate substantial equivalence, which serves as a form of "acceptance criteria" for a non-AI/ML device in this context.

Here's a breakdown based on the provided document, addressing the applicable points:

Device: Provena™ Midline Catheter (Non-AI/ML Device)

1. A Table of Acceptance Criteria and the Reported Device Performance (as demonstrated by testing against the predicate):

This table compares the characteristics of the subject device (Provena™ Midline Catheter) to the predicate device (PowerMidline™ Catheter) to demonstrate substantial equivalence, rather than defining specific statistical performance metrics against a clinical ground truth as would be done for an AI/ML device. The "reported device performance" is the equivalency shown through these characteristics and the results of specified performance tests.

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

• Sample Size: Not applicable in the context of clinical data for AI/ML. The "test set" here refers to the physical devices for engineering performance testing. Numbers of units tested for each engineering test (e.g., burst pressure, tensile strength) are not specified in this summary but would be part of the underlying design verification documentation.
• Data Provenance: The 'data' for this submission is primarily engineering test results on newly manufactured devices. There is no mention of patient data (e.g., country of origin, retrospective/prospective).

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

• Not applicable as this is not an AI/ML device requiring clinical image interpretation or ground truth establishment by experts. The "ground truth" for this device's performance is established by engineering specifications and industry standards.

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

• Not applicable as there is no human interpretation of data requiring adjudication for this device type.

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

• No, an MRMC study was not done as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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

• The "ground truth" for this device's substantial equivalence is based on:
  • Engineering Specifications: Defined physical and performance characteristics.
  • Industry Standards: Compliance with standards like ISO 10555-1 (Sterile, single-use intravascular catheters) and USP 788 (Particulate Matter Testing).
  • Risk Analysis: Performed in accordance with BS EN ISO 14971 (Risk Management for Medical Devices).

8. The sample size for the training set:

• Not applicable as 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 as this is not an AI/ML device.

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The Caterpillar and Caterpillar Micro Arterial Embolization Devices are indicated for arterial embolization in the peripheral vasculature. The Caterpillar Micro Arterial Embolization Devices are contraindicated for use in vessels subject to cyclic bending, such as highly locomotive joints or muscle beds.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices are self-expanding arterial occlusion plugs. The devices consist of the following components and are intended to be a permanent implant: cobalt-chrome stem, nickel-titanium fibers, platinum-iridium radiopaque marker bands, and a polyurethane and polyethylene occlusion membrane.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device Systems are packaged as a single unit with the implant, loader, dispenser hoop, detachable delivery wire, and torque tool. The Caterpillar™M Micro delivery wire is coated with a hydrophilic coating. While the Caterpillar™ delivery wire has a PTFE hydrophobic coating. The system is provided sterile and non-pyrogenic and is intended for single use only.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device is designed for a specific arterial diameter range. The artery diameter range and required delivery catheter (ID)) for deployment are provided in the table below.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices). This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy through a clinical trial with specific performance metrics against a defined acceptance criterion. The "acceptance criteria" referred to in the document are primarily related to general design verification and safety testing, not specific clinical performance endpoints in the way you might find for an AI algorithm.

Therefore, the answers below will reflect the nature of this type of regulatory submission. There is no information provided in this document regarding AI algorithms, human-in-the-loop performance, or AI-specific ground truth methodologies.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table of specific numerical acceptance criteria with corresponding performance values for clinical efficacy. Instead, it lists types of tests performed and states that the device "met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs." The animal study concluded that "the study device performance was equivalent or superior to control devices across each of the evaluated endpoints."

Here's an interpretation based on the provided information, focusing on categories of testing:

Regarding aspects typically related to AI performance, the document does not contain information on the following:

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

• No "test set" in the context of an AI algorithm. Performance data was generated through various bench tests and one pre-clinical animal study.
• Animal Study Sample Size: Not explicitly stated, but implies multiple animals to evaluate chronic effects and comparisons.
• Data Provenance: Non-clinical (bench) and pre-clinical (animal) studies. No human data (clinical data) is mentioned as a "test set" for performance evaluation in this 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 for this type of device submission. "Ground truth" in the context of an AI algorithm is not relevant here. For the animal study, evaluations would typically be done by veterinary specialists, pathologists, and dedicated study personnel according to a protocol.

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

• Not applicable for this type of device submission. This is relevant for AI image review. For the animal study, endpoints would be assessed according to pre-defined criteria, likely by the study investigators and possibly independently reviewed by a pathologist for tissue samples.

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 MRMC study was done, as this is not an AI device. This section is entirely irrelevant to the provided document.

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

• Not applicable, as this is not an AI device.

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

• Not applicable for an AI device. For the non-clinical and pre-clinical animal studies, "ground truth" would be established by:
  • Bench Testing: Engineering measurements, adherence to specifications, validated test methods.
  • Animal Study: Direct observation by study personnel, pathology findings following necropsy, physiological measurements, imaging results, and histological analysis.

8. The sample size for the training set

• Not applicable, as this is not an AI device. No training set exists.

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

• Not applicable, as this is not an AI device. No training set exists.

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The WavelinQ 4F EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

The WavelinQ™ 4F EndoAVF System consists of two single-use disposable magnetic catheters: a venous catheter and an arterial catheter. The venous catheter contains an array of magnets positioned on either side of a radiofrequency (RF) cutting electrode contained within an isolative housing. The arterial catheter contains a matching array of magnets positioned on either side of an electrode "backstop". The backstop serves as a mechanical stop for the cutting electrode to contact following the creation of the AVF. The magnets in the two catheters serve to align and appose the arterial backstop of the arterial catheter with the RF electrode of the venous catheter when positioned in the target AVF location. Radiofrequency energy can then be delivered through the electrode for cutting tissue and AVF creation.

The arterial and venous catheters are both comprised of braid reinforced Pebax catheter shafts. These shafts provide flexibility for device delivery and torquability to aid in rotational alignment and positioning. Both catheters include a soft, radiopaque, rapid exchange style Pebax tip for atraumatic device navigation with radiographic visibility. These tips allow the catheters to track over a standard guide wire 0.014" or smaller. The catheters include a handle/hub to facilitate device delivery, positioning and alignment.

The provided text describes the performance data for the WavelinQ™ 4F EndoAVF System, a medical device for creating arteriovenous fistulas (AVFs) for hemodialysis access. It is not an AI/ML device, so the typical AI/ML acceptance criteria and study information (like sample size for training data, number of experts for ground truth, MRMC study, or standalone performance of an algorithm) are not applicable or detailed in the document.

The document primarily focuses on demonstrating the device's substantial equivalence to a predicate device through clinical performance data, rather than showing how an algorithm meets specific acceptance criteria based on AI/ML metrics.

Therefore, I cannot extract information related to:

• A table of acceptance criteria and reported device performance specific to AI/ML metrics. The document lists clinical endpoints and their outcomes.
• Sample size used for the test set and data provenance in the context of AI/ML validation. The study uses a pooled clinical cohort.
• Number of experts used to establish ground truth or their qualifications for an AI/ML test set.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone performance of an algorithm.
• Sample size for the training set for an AI/ML algorithm.
• How ground truth for the training set was established for an AI/ML algorithm.

However, I can provide the available information regarding the clinical study and its outcomes as presented in the document:

Clinical Study for WavelinQ™ 4F EndoAVF System

The study was conducted to confirm that the WavelinQ™ 4F EndoAVF System is a substantially equivalent treatment option for patients in need of hemodialysis access.

1. Table of Acceptance Criteria (Clinical Endpoints) and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets in the same way an AI/ML study would define performance thresholds. Instead, it describes "Primary effectiveness endpoints" and "Primary safety endpoints" and reports the observed rates. While not explicitly stated as "acceptance criteria," these are the performance outcomes the device demonstrated.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Ninety-one (91) total subjects were included in the global analysis.
• Data Provenance: Data were collected from three sources: the EASE Study, the EASE-2 Study, and the EU Post-Market Study (4F cohort).
  • Countries of Origin: Paraguay (EASE and EASE-2), Germany, and the United Kingdom (EU Post-Market Study).
  • Type of Study: Clinical studies. The text states "Data from three sources... was collected and analyzed." This implies prospective collection for the original studies but analyzed retrospectively as a pooled global analysis for this submission.

3. Number of Experts and Qualifications for Ground Truth

• The document does not describe details about a "ground truth" establishment by experts in the context of an AI/ML algorithm or image interpretation.
• For clinical outcomes, procedural success was confirmed intraoperatively with fistulography or postoperative duplex ultrasonography. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC). The qualifications of these individuals are not specified beyond their roles.

4. Adjudication Method for the Test Set

• For adverse events, "Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC)." This implies a form of expert review and adjudication for adverse event reporting, but not in the context of establishing a truth standard for an AI algorithm's output.

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

• No, this was not an MRMC study and AI assistance was not involved. The study focused on the clinical performance of a medical device (WavelinQ™ 4F EndoAVF System) for creating AVFs, not on evaluating human readers' performance with or without AI assistance.

6. Standalone Performance

• Not applicable for an AI algorithm. This document describes the performance of a physical medical device. The "performance data" presented are the clinical outcomes of using the device in patients, not the performance of a standalone algorithm.

7. Type of Ground Truth Used

• The "ground truth" for the device's performance is based on clinical outcomes observed in patients, confirmed by standard medical procedures (e.g., fistulography, duplex ultrasonography for success, and independent review for safety events). It is not pathology or expert consensus on image interpretation for an AI system.

8. Sample Size for the Training Set

• Not applicable. This document describes a clinical study of a medical device, not the development or training of an AI algorithm.

9. How Ground Truth for the Training Set Was Established

• Not applicable. This document describes a clinical study of a medical device, not the development or training of an AI algorithm.

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The BARD® Vertus™ Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine in adult and pediatric patients of compatible anatomical size. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.

The BARD® Vertus™ Foley Catheter is a biocompatible, hydrogel-coated, synthetic polyisoprene Foley catheter used in the drainage of urine. The catheter consists of a shaft with eyelets near the tip, balloon, drainage funnel and inflation arm with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon, once inflated, retains the catheter within the bladder. The shaft has two lumens: one to allow for urine drainage and the second for balloon inflation. The two-way valve, upon activation, permits flow in either direction and allows for inflation and deflation of the balloon. The cap retains the valve and provides identification for the catheter. The catheter will be offered in multiple French sizes to accommodate differing patient anatomies. The product is provided sterile via ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products - ethylene oxide - Requirements for development, validation and routine control of a sterilized process for medical devices). The catheter is a single use, prescription-only device.

The provided document does not contain information about an AI/ML medical device and therefore does not describe acceptance criteria or a study proving its performance.

The document is a 510(k) premarket notification for a BARD® Vertus™ Foley Catheter, which is a physical medical device (a urological catheter). The review focuses on its substantial equivalence to a predicate device (BARD® LubriGuard™ Foley Catheter) based on:

• Indications for Use: Both are for drainage, collection, and measurement of urine.
• Technological Characteristics: Both are made of synthetic polyisoprene, hydrogel-coated, and have the same design features (shaft, eyelets, balloon, drainage funnel, inflation arm).
• Performance Data: This primarily involves biocompatibility testing (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity) and non-clinical functional performance testing (e.g., compliance with ASTM F623-99/(R)2013 for Foley Catheters, and coefficient of friction for lubricity).

There is no mention of any AI or machine learning component, nor any study involving human readers, ground truth establishment by experts, or any of the criteria typically associated with AI/ML device performance evaluation as outlined in your prompt's requirements.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The Atlas® Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Atlas® Gold PTA Dilatation Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. The over-the-wire catheter is compatible with .035" guidewire and is available in 80 cm and 120 cm working lengths. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A rewrapping tool is also provided on the catheter shaft to aid in re-wrap/refolding of the balloon. This product is not manufactured with any natural rubber latex.

This document describes the premarket notification (510(k)) for the Atlas® Gold PTA Dilatation Catheter (K181323). The information provided is sufficient to answer some but not all of the requested categories, as this is a medical device clearance document rather than a detailed clinical study report for an AI/software as a medical device (SaMD). The core of this submission is to demonstrate substantial equivalence to a predicate device, with an expanded indication for use.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (for the expanded indication - venous system use):

The primary acceptance criterion mentioned is related to safety for the expanded indication in the venous system.

Study Proving the Device Meets Acceptance Criteria:

1. Sample Size and Data Provenance:

   • Sample Size: 61 patients for post-stent dilatation and 20 patients for pre-dilatation. (Total 81 patient procedures where the device was used).
   • Data Provenance: Retrospective, investigator-sponsored clinical study. Location of data origin (country) is not explicitly stated, but it's part of a US FDA submission. The study covered data between September 1, 2013, and May 30, 2017.

2. Number of Experts and Qualifications for Ground Truth:

   • This document describes a clinical study of a physical medical device (catheter), not an AI/SaMD. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or algorithm performance is not applicable here. The "ground truth" implicitly relies on standard clinical assessment during the procedures and follow-up, observed by the investigators.

3. Adjudication Method for the Test Set:

   • Not specified, as this is a device performance study, not an AI/SaMD study involving human reader variability in interpretation.

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

   • Not applicable. This study is for a physical medical device, not an AI/SaMD requiring assessment of human reader improvement with AI assistance.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This study is for a physical medical device; there is no standalone algorithm to evaluate.

6. Type of Ground Truth Used:

   • The "ground truth" for this study is based on clinical outcomes and observations during the procedure. Specifically, it's defined by the occurrence (or absence) of major adverse events (acute thrombosis, perforation, device-related complications) and measurements of luminal area.

7. Sample Size for the Training Set:

   • Not applicable. This is a clinical validation study for a physical device, not an AI model that requires a training set. The device itself was developed and manufactured based on established engineering and quality system processes.

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

   • Not applicable for the same reason as above. The "training" for such a device comes from engineering design, materials science, and in-vitro/in-vivo testing during the development phase, not from a "training set" of data in the AI sense.

Additional Information from the Document:

• Identicality to Predicate: The key argument for substantial equivalence is that the subject device (Atlas® Gold PTA Dilatation Catheter) is identical to its predicate device (Atlas® Gold PTA Dilatation Catheter, K122984) in manufacturing and design.
• Only Differences: The only differences are an expanded indications for use to include the venous system and the inclusion of the retrospective clinical study results in the labeling.
• Clinical Literature Review: The submission also included reviews of 46 published clinical articles involving over 4000 patients, demonstrating that PTA catheters are generally safe for use in the venous system, with known and low rates of adverse events.

In summary, this submission relies on demonstrating the safety and effectiveness of using an already cleared and identical physical device for an expanded indication based on a retrospective clinical study showing favorable outcomes against defined safety benchmarks, supplemented by existing literature. It's not a study designed to evaluate an AI/software component.

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The True® Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.

The True® Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables continuous hemodynamic flow through its central orifice. The catheter is 110 cm long and has two lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque markers are located on the guidewire lumen. These bands are positioned at the proximal and distal balloon shoulders. These markers are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum guidewire size are indicated on the package label.

The provided text describes a 510(k) premarket notification for the True® Flow Valvuloplasty Perfusion Catheter, which claims substantial equivalence to a previously cleared predicate device (K152613). The core of the information regarding device performance and acceptance criteria comes from a post-market clinical study conducted on the predicate device, the TRUE-FLOW study.

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

Acceptance Criteria and Reported Device Performance

The text describes two primary endpoints for the TRUE-FLOW study, which effectively serve as performance and safety acceptance criteria for the device's functionality during balloon aortic valvuloplasty.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: 24 subjects were included in the analysis population. 25 subjects were initially enrolled, but one withdrew consent post-discharge.
   • Data Provenance: The study (TRUE-FLOW) was a post-market clinical study conducted on the predicate device. The text does not specify the country of origin, but given the FDA submission, it implicitly aligns with US regulatory requirements and likely US-based data, though this is not explicitly stated. It was a prospective, observational study.

2. Number of Experts and Qualifications for Ground Truth:

   • The text does not provide information on the number or qualifications of experts used to establish ground truth for the test set. It describes clinical outcomes observed by the study, presumably by the treating physicians and study investigators, but there's no mention of independent expert review for ground truth establishment per se.

3. Adjudication Method for the Test Set:

   • The text does not specify any explicit adjudication method (e.g., 2+1, 3+1). Decisions regarding "successful dilatation" and "freedom from adverse events" would have been part of the study's pre-defined endpoints and data collection protocols, likely adjudicated by the study investigators or a clinical events committee, but the method is not detailed.

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

   • No, an MRMC comparative effectiveness study was not done. This study was a clinical performance and safety study of the device itself, not an evaluation of human readers' performance with or without AI assistance. The device is a physical catheter, not an AI diagnostic tool.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. The device is a physical medical device (catheter) used in a medical procedure, not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.

6. Type of Ground Truth Used:

   • The ground truth for the performance and safety endpoints was based on clinical outcomes data from the patients undergoing the procedure. This includes observed success of aortic valve dilatation and the absence of pre-defined device-related or procedure-related adverse events.

7. Training Set Sample Size:

   • Not applicable. This study is not a machine learning model, so there is no concept of a "training set" in the context of this device. The data mentioned is for clinical validation of the device's performance and safety.

8. How Ground Truth for Training Set Was Established:

   • Not applicable, as there is no training set for a physical medical device.

In summary, the provided document focuses on the clinical performance and safety evaluation of a physical medical device. It outlines the specific performance and safety criteria (endpoints) that the device needed to meet and presents the observed outcomes from a prospective clinical study of the predicate device. The concepts of AI-related ground truth establishment, expert adjudication, MRMC studies, or training sets are not relevant to this type of device submission.

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The hypodermic Pinpoint™ GT Needle is intended for the injection into or the withdrawal of body fluids from parts of the body below the surface of the skin. The needle is to be used with syringes for general purpose fluid injection. The needle tip is echogenic and may be used with ultrasound to provide a visual representation of the needle tip throughout the insertion, medication administration and aspiration process.

Bard Access Systems, Inc's hypodermic Pinpoint™ GT Needles are designed to inject medication or aspirate fluid. The hypodermic Pinpoint™ GT Needles contain a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The hypodermic Pinpoint™ GT Needles, when used with an ultrasound system equipped with Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion, medication administration and aspiration process. There are four (4) hypodermic Pinpoint™ GT Needle configurations included in this submission, as shown in the table below.

The provided document describes the hypodermic Pinpoint™ GT Needle and its journey through FDA 510(k) premarket notification. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new performance claim or the efficacy of an AI algorithm. Therefore, many of the requested elements pertaining to AI model validation (e.g., sample size for training set, number of experts for ground truth, MRMC study, effect size of AI assistance) are not applicable to this document.

The document outlines acceptance criteria primarily through a list of performance tests designed to show the device meets engineering and safety standards, and is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study (verification and validation tests) as provided in the document:

Acceptance Criteria and Reported Device Performance

The document states: "The subject device configurations met all predetermined acceptance criteria derived from the above listed verification tests and demonstrated substantially equivalent performance as compared to the cited predicate device."

This implies that for each performance test listed, there were predefined acceptance criteria, and the device successfully met them. However, the specific quantitative acceptance criteria and the numerical reported device performance are not explicitly detailed in the provided text. Instead, the document lists the types of tests conducted and the standards utilized, indicating that the device passed these tests.

Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study design is described as "Verification and validation tests... designed and performed in accordance with Design Controls as per 21 CFR §820.30." The tests conducted are listed in the table above, referencing various ISO and ASTM standards, as well as USP standards and internal protocols.

Information Not Applicable or Not Provided in the Document:

Many of the requested details are specific to the validation of AI/ML algorithms and are not relevant to the approval of a physical medical device like this needle, which underwent a 510(k) submission based on substantial equivalence.

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

   • Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with the referenced standards (e.g., ISO, ASTM). The document lists four needle configurations (18G x 2.75", 19°; 21G x 3", 30°; 22G x 2", 30°; 24G x 1.5", 30°) which would have been tested.
   • Data Provenance: Not specified, but generally, device performance testing is conducted by the manufacturer (Bard Access Systems, Inc. in Salt Lake City, Utah) in controlled laboratory environments. This would be prospective testing on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a needle is established through engineering and material science measurements against predefined specifications, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for physical device testing. Test results are objective measurements against 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 device is a hypodermic needle, not an AI diagnostic tool. The "echogenic" feature simply means it's visible on ultrasound, and the optional "passive magnet" feature works with a separate "Pinpoint™ GT Needle Technology" system (which is explicitly stated as "not the subject of this submission"). The needle itself does not involve AI assistance to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device involved engineering specifications, material properties, and performance standards (e.g., tensile strength, dimensional accuracy, biocompatibility, leakage).

8. The sample size for the training set: Not applicable. There is no AI model being trained as part of this submission.

9. How the ground truth for the training set was established: Not applicable. There is no AI model being trained as part of this submission.

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The PowerGlide ST™ Midline Catheter is inserted into a patient's vascular system for short term use to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide ST™ Midline Catheter is suitable for use with power injectors.

Bard Access Systems, Inc.'s PowerGlide ST™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (<30 days) to sample blood and administer fluids intravenously. The subject device consists of a single lumen, radiopaque, body softening polyurethane catheter rated for power injection, and a dilator (when applicable). Additional procedural kit accessories (e.g. introducer needle and guidewire) are included to facilitate catheter placement. The PowerGlide ST™ Midline Catheter is offered in 18, 20, and 22 gauge sizes. The 18 and 20 gauge devices are offered in 8 cm or 10 cm lengths with an integrated dilator. The 22 gauge device is offered in only an 8 cm length and does not include a dilator.

This document describes the premarket notification for a medical device, the PowerGlide ST™ Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical effectiveness through novel AI or diagnostic algorithms. Therefore, many of the requested criteria related to AI performance, ground truth establishment, expert readers, and MRMC studies are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text:

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

The document lists performance tests and states that the "subject device met all predetermined acceptance criteria". However, the specific quantitative acceptance criteria values and the exact reported performance results for each test are not disclosed in this summary. It only indicates that the device passed.

Biocompatibility Tests:

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the described physical and biological performance tests. It also does not discuss data provenance (e.g., country of origin, retrospective/prospective) as these are non-clinical, in-vitro/bench tests on device components, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this medical device submission is based on engineering specifications, physical/chemical properties, and biological safety standards (ISO standards). It does not involve expert interpretations of medical images or diagnoses that would require human expert consensus.

4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, where there's a need to resolve discrepancies between human readers or between AI and human reads. This document describes bench testing and biocompatibility assessments which do not involve this type of adjudication.

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 question is not applicable. This submission is for a physical medical device (catheter) and does not involve AI or human readers for diagnostic purposes. Therefore, an MRMC study and effects on human reader performance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical medical catheter, not an algorithm.

7. The type of ground truth used
The "ground truth" for this device's acceptance is based on:

• Engineering design specifications: The physical dimensions and properties of the dilator and catheter.
• Industry Standards (ISO/BS EN ISO): Established international and national standards for medical devices, specifically for intravascular catheters, luer connectors, and biocompatibility.
• Bard internal standards and procedures: Proprietary testing methods and acceptance criteria used by the manufacturer.

8. The sample size for the training set
This question is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.

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