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The OnFlex™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

The OnFlex™ Mesh is a self-expanding, non-absorbable, sterile device made from monofilament polypropylene mesh and has a lightweight large pore design. This construction allows a prompt fibroblastic response through the interstices of the mesh as observed in a preclinical model, which may not correlate to performance in humans. The OnFlex™ Mesh has an anatomical shape design to cover potential defect areas. The OnFlex™ Mesh also contains a pocket on the larger medial apex of the mesh to facilitate insertion and positioning of the device.

The OnFlex™ Mesh contains SorbaFlex™ Memory Technology comprised of an absorbable PDO monofilament which forms an interrupted ring. SorbaFlex™ Memory Technology provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament is folded and welded onto itself at the ends. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 – 8 months. The PDO monofilament is dyed violet by adding D & C Violet No. 2. The interrupted ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the interrupted recoil ring during the degradation process. The interrupted ring, contained in the mesh tube, is sewn between two layers of mesh with polytetrafluoroethylene (PTFE) monofilament.

The OnFlex™ Mesh has a blue limit line at the lateral portion of the mesh, composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant, to provide visual feedback for where the device can be tailored. The OnFlex™ Mesh can be tailored at the opening of the interrupted ring or outside of the blue limit line.

The OnFlex™ Mesh is offered in two sizes: medium (0115410) and large (0115411). The OnFlex™ Mesh is considered a tissue contacting permanent implant.

The provided FDA 510(k) clearance letter for the OnFlex™ Mesh (K251955) indicates that this is a Special 510(k) submitted to notify the FDA of changes to the device labeling only. The device itself remains identical to its predicate, OnFlex™ Mesh (K142711), cleared in 2015.

Therefore, the submission explicitly states: "No non-clinical or clinical testing was provided in support of this Special 510(k)."

This means that the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, as no new testing was performed for this specific submission. The substantial equivalence is based on the device's identity to its predicate and the conclusion that the labeling changes do not affect safety or effectiveness.

Because no new studies were conducted or presented in this document for the K251955 submission, I cannot provide the requested information. The document focuses solely on demonstrating that the labeling updates do not alter the substantial equivalence to the original predicate device (K142711).

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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.

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The GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, or femoral vein, Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.

The Glidepath™ 10F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in overthe-guidewire placement. The dialysis catheters are offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include the smaller lumen diameter, 10 F, and shorter lengths, 10 cm to 23 cm. Additionally, Glidepath™ 10F Long-Term Hemodialysis Catheter has been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.

The provided text describes the regulatory clearance of a medical device, the GlidePath 10F Long-Term Hemodialysis Catheter, and its substantial equivalence to predicate devices. However, the document does not contain the specific details required to answer all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria, especially in the context of an AI/ML device.

This document is a 510(k) summary for a physical medical catheter, not an AI/ML device. Therefore, questions relating to AI/ML device performance (e.g., test sets, ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to the information provided.

The document discusses performance data for the physical catheter, but these tests are related to mechanical and physical properties of the device, not diagnostic accuracy or AI performance.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

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

The document lists various in vitro tests performed to demonstrate substantial equivalence, and states that the "subject device... meets all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not provide a table detailing the specific acceptance criteria (e.g., numerical thresholds for flow rates, tensile strength) or the reported numerical performance data for the GlidePath 10F Long-Term Hemodialysis Catheter against those criteria. It only lists the types of tests performed.

Note: The phrase "Met predetermined acceptance criteria" is inferred from the statement "The subject device... meets all predetermined acceptance criteria of design verification and validation." Specific numerical values for the criteria or the device's performance are not provided.

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

The document does not specify sample sizes for the "test set" in the context of diagnostic performance, nor does it describe data provenance for patient data. The "performance data" refers to in vitro mechanical/physical tests on the device itself, not a clinical study on patient data.

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 is not an AI/ML device or a diagnostic device relying on expert interpretation for ground truth.

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

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:

Not applicable, 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.):

For the physical device performance tests, the "ground truth" or reference is established by the specifications in applicable standards, guidance documents, and internal test protocols. For example, a "burst" test would have a specified pressure it must withstand, and the device either passes or fails that engineering specification.

8. The sample size for the training set:

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

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.

| Product Name | Product
Reference | Target Artery
Diameter (mm) | Delivery Catheter
Compatibility: Inner
Diameter (in/mm) | Marker to
Marker
Length
(mm)1 | Maximum
Deployed
Length
(mm)2 | Delivery
Wire
Length
(cm) |
|-----------------------|----------------------|--------------------------------|---------------------------------------------------------------|----------------------------------------|----------------------------------------|------------------------------------|
| Caterpillar™
Micro | 027 | 1.5 - 4 | 0.027 / 0.686 | 7 | 16 | 170 |
| Caterpillar™ | 038 | 3 - 6 | 0.038 / 0.965 | 17 | 26 | 155 |
| Caterpillar™ | 056 | 5 - 7 | 0.056/ 1.422 | 18 | 37 | 155 |

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:

• Chronic ovine study also addressed subchronic toxicity, implantation, chronic toxicity, and in vivo thrombogenicity.
• Chemical characterization testing and toxicological assessment evaluated genotoxicity, chronic toxicity, and carcinogenicity. |
  | In Vivo Performance (Animal Study): | A chronic ovine study found that "the study device performance was equivalent or superior to control devices across each of the evaluated endpoints," which included:
• Migration resistance
• Ease of delivery
• Occlusion efficiency
• Recanalization
• Deliverability
• Hemostasis after procedure
• Thrombogenicity
• Device safety
• Freedom from complications |

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 Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias, including hiatal hernias.

The Phasix™ ST Mesh is a fully resorbable mesh with a resorbable hydrogel coating. It is a sterile mesh prosthesis designed for the reinforcement and reconstruction of soft tissue deficiencies. Phasix ™ ST Mesh is co-knitted using poly-4-hydroxybuterate (P4HB) and polyglycolic acid (PGA) fibers. P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and then knitted into a surgical mesh. P4HB degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to reinforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected healing period. Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months indicates loss in mechanical integrity and strength. While fiber segments were observed at 18 months, they continued to degrade. Phasix™ ST Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral side of the mesh is a resorbable hydrogel coating, separating the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

The provided text describes a 510(k) premarket notification for the "Phasix ST Mesh," a surgical mesh. The document details the device's description, indications for use, technological comparison to predicate devices, and performance data from various studies.

Here's an analysis of the requested information based on the provided text, categorized by the questions asked:

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

The document does not explicitly state formal "acceptance criteria" in a quantitative sense with specific thresholds. Instead, the performance data is presented as a demonstration that the device's characteristics are "comparable" to a predicate device or that differences "do not adversely affect safety and performance."

Therefore, I will interpret "acceptance criteria" as implied benchmarks for comparability to the predicate devices and summarize the reported performance in relation to these comparisons.

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

The document refers to two retrospective clinical studies. Combining them gives a total number of patients whose data was reviewed.

• Sample Size for the Test Set (Clinical Studies):
  • Study 1: 50 patients
  • Study 2: 180 patients
  • Total: 230 patients
• Data Provenance:
  • Both studies are explicitly stated as retrospective reviews.
  • Both studies were conducted at a single institution. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S. company (Davol Inc., Warwick, RI), making it highly probable the studies were conducted in the United States.

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)

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study data (e.g., for diagnosing recurrences or assessing complications). For retrospective reviews, the data is typically pulled from existing medical records, where diagnoses and assessments would have been made by the treating clinicians. The study design does not specify a separate "ground truth" adjudication panel.

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

The document does not describe any specific adjudication method (like 2+1 or 3+1 consensus) for the clinical study data. As indicated in point 3, the studies are retrospective reviews, implying that the outcomes (recurrences, complications) were determined based on existing clinical records by the treating physicians or the physicians performing the follow-up procedures (EGD, UGI, BS).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

The Phasix ST Mesh is a physical surgical implant, not an AI software/device that assists human readers/clinicians in interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device.

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

No, a standalone (algorithm-only) performance study was not done, as the device is a physical surgical mesh and not an algorithm or AI software.

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

For the clinical studies, the "ground truth" for assessing device safety and performance appears to be based on:

• Clinical outcomes data: This includes objective follow-up data (Esophagogastroduodenoscopy (EGD), Upper Gastrointestinal (UGI) series, Barium Swallow (BS)) and non-objective follow-up (unspecified clinical assessments).
• Medical records: The retrospective nature of the studies means that existing medical records were reviewed for reported complications, recurrences, and successful repairs.

For the animal studies, the "ground truth" involved histological and mechanical assessments conducted by researchers to characterize mechanical strength, tissue response, and resorption profile.

8. The sample size for the training set

This question is not applicable in the context of this device submission. The Phasix ST Mesh is a physical medical device (surgical mesh), not an AI algorithm or a device that requires a "training set" in the machine learning sense. The performance data consists of biocompatibility testing, animal studies, bench testing, and retrospective clinical reviews, none of which utilize a "training set."

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

As in point 8, this question is not applicable because there is no "training set" for this physical medical device.

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