Search Results

The Bard® Snare Retrieval Kit is intended for use to percutaneously remove all Bard optional vena cava filters with a retrieval hook.

The Bard® Snare Retrieval Kit is intended to percutaneously remove Bard filters from the vena cava.
The Bard® Snare Retrieval Kit consists of a Nitinol Snare with 6 French Snare Catheter Assembly and a 11 French O.D Retrieval Sheath with 9 French Dilator Assembly.
The nitinol snare has a 20 mm diameter (fully expanded) radiopaque loop and comes preloaded in the snare catheter. The snare catheter, retrieval sheath, and access sheath have radiopaque marker bands at the distal ends for enhanced fluoroscopic visualization.

This document is a 510(k) summary for the Bard® Snare Retrieval Kit, a medical device intended for percutaneous removal of Bard optional vena cava filters with a retrieval hook. It is a submission to the FDA seeking clearance for market.

The document does not describe an acceptance criteria and study proving a device meets said criteria in the context of an AI/ML algorithm or software. Instead, it describes the process of establishing substantial equivalence for a physical medical device (the Bard® Snare Retrieval Kit) to a legally marketed predicate device (Günther™ Tulip™ Vena Cava Filter Retrieval Set).

Therefore none of the requested information regarding AI/ML performance acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details can be extracted from this document.

The "Functional and Safety Testing" section states: "To verify that device design meets functional and performance requirements, representative samples of the device underwent bench testing in accordance with applicable standards and guidance. These data provide an acceptable assurance of the safety and effectiveness of the Bard® Snare Retrieval Kit and demonstrate the device is equivalent to the predicate."

The "Non-Clinical Tests Submitted" section lists the types of tests performed:

• Performance Testing: Catheter Tensile Strength, Catheter Liquid Leakage, Catheter Corrosion Resistance, Snare Assembly Torque Strength, Snare Simulated Use.
• Biocompatibility Testing: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation - Intracutaneous Reactivity (ISO10993-10), Acute Systemic Toxicity (ISO10993-11), Pyrogenicity (ISO 10993-11), Hemocompatibility Thromboresistance Coagulation (ISO 10993-4).

However, the specific acceptance criteria for each of these tests and their corresponding quantitative performance results are not provided in this summary. The summary only states that these tests were performed to show substantial equivalence to the predicate device.

Ask a specific question about this device

The NovaGold Guidewire is intended for use in selective cannulation of the billary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic devices during endoscopic procedures.

The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.

This document is a 510(k) summary for the NovaGold™ High Performance Guidewire. It describes a medical device and its intended use, and argues for its substantial equivalence to a predicate device. The information provided is for regulatory clearance and does not detail a clinical study proving performance against acceptance criteria in the way requested.

Therefore, many of the requested points cannot be directly answered from the provided text as it focuses on bench testing and comparative characteristics rather than a clinical study with human subjects, established ground truth, or expert review for diagnostic performance.

However, I can extract information related to the functional and safety testing as described:

1. Table of acceptance criteria and reported device performance:

The document states that "representative samples of the device underwent bench testing in accordance to applicable standards and guidances" to "verify that device design met functional and performance requirements." It then lists the types of tests performed. However, it does not explicitly state specific numerical acceptance criteria or the quantitative results (reported device performance) for each test. It only concludes that the data provided "an acceptable assurance of the safety and effectiveness" and demonstrated equivalence to the predicate.

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

• Sample size for test set: Not specified beyond "representative samples of the device."
• Data provenance: Bench testing results, no country of origin is mentioned for the bench tests. The tests are non-clinical, so the concept of "retrospective or prospective" doesn't directly apply in the same way it would to human clinical data.

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

This information is not provided as the tests performed were non-clinical bench tests on the device itself, not diagnostic performance evaluations requiring expert assessment of medical images or patient outcomes.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical bench testing.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a guidewire, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

No, this device is a guidewire, not an algorithm, so this is not applicable.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" would be engineering specifications and established performance standards for guidewires, against which the device's physical and mechanical properties were measured. It is not expert consensus, pathology, or outcomes data, as those apply to clinical/diagnostic studies.

8. The sample size for the training set:

Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as this device does not involve a training set.

Ask a specific question about this device

To facilitate the placement of devices during diagnostic or interventional procedures.

NeoMetrics guidewires are constructed using stainless steel and nickel titanium alloys. Configurations include a single tip or dual tip, retracted core or fixed core, and straight or J-tipped. The guidewire is packaged in a spiral hoop fitted with a "J"-Straightener, where applicable to aid in insertion of the guidewire into the puncture needle.

This document is a 510(k) Summary for the Neometrics Spring Coil Guidewire (K143135). It demonstrates substantial equivalence to a predicate device, focusing on bench testing rather than clinical study data relevant to AI/algorithm performance. Therefore, I cannot provide a detailed answer to your request as it pertains to AI/algorithm acceptance criteria and studies.

Based on the provided document, here's what can be extracted and why the rest cannot be answered:

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

Explanation: The document states, "To verify that device design met functional and performance requirements, representative samples of the device underwent bench testing in accordance to applicable standards and guidances." It then lists the types of performance tests conducted. While specific numerical acceptance criteria and detailed performance results are not provided in this summary, the conclusion states that "These data demonstrates that the Spring Coil Guidewire is equivalent to the predicate." implying all tests met their respective acceptance criteria.

The following questions cannot be answered from the provided document because it describes a traditional medical device (a guidewire) and its premarket notification, which relies on bench testing and substantial equivalence to a predicate, not an AI/algorithm-based device and its associated clinical/performance studies.

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not applicable, as this is bench testing of physical device properties, not a study on an algorithm with a test set of 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. Ground truth for a physical guidewire is established through objective measurements and material science standards during bench testing.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for bench testing.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance - Not applicable as this is not an AI-assisted device or an imaging/diagnostic device involving human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable as this is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - For bench testing, ground truth is based on engineering specifications, material standards, and physical measurements.
• 8. The sample size for the training set - Not applicable, as there is no AI algorithm being trained.
• 9. How the ground truth for the training set was established - Not applicable, as there is no AI algorithm being trained.

Ask a specific question about this device

The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.

The provided document describes a 510(k) premarket notification for a medical device called the NovaGold™ High Performance Guidewire. This document specifically states that the submission is for establishing substantial equivalence to a predicate device, rather than a study demonstrating clinical effectiveness with acceptance criteria.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The provided text focuses on:

• Predicate Device: K122816; Endscopic Wire Guide manufactured by Wilson-Cook Medical.
• Device Description: Steerable, metallic core with PTFE polymer coating, hydrophilic coating over the distal portion, radiopaque floppy tip.
• Intended Use: Selective cannulation of biliary ducts (common bile, pancreatic, cystic, right and left hepatic ducts) and aiding in placement of diagnostic/therapeutic devices during endoscopic procedures.
• Functional and Safety Testing: Bench testing according to applicable standards and guidances, providing assurance of safety and effectiveness, and demonstrating equivalence to the predicate.
• Comparative Technology Characteristics: Similarities to predicate in intended use, operating principle, packaging/sterilization, nominal diameter, similar lengths, Nitinol alloy core wires, distal radiopaque tip, and lubricious coatings.
• Non-Clinical Tests Submitted:
  • Biocompatibility: Cytotoxicity (L-929 MEM Elution, Colony Microassay by Elution), Guinea Pig Maximization Sensitization, Irritation (Intracutaneous Reactivity), Chemical Characterization.
  • Bench testing: Coating adherence, corrosion resistance, dimensional measurements, fracture resistance, tensile strength, torqueability.
  • Shelf Life Testing: 13-month accelerated aging.

The conclusion is that the NovaGold guidewire is equivalent to the predicate device based on equivalent intended use and no differences raising new safety/effectiveness questions. This is a common approach for 510(k) clearances for devices that do not introduce novel technology or a new intended use.

Ask a specific question about this device

The Neo ERCP Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

The Neo ERCP Guidewire is constructed of a core wire of nickel titanium based alloy, a proximal polymer jacket and a radiopaque distal tip. It also features a hydrophilic coating and either straight or angled distal tip configurations. The distal end of the guidewire has a radiopaque distal tip (10cm). The wire family has two models, the Phantom refers to .025" OD models and the Palomino refers to .035" OD models. Both the Phantom and Palomino come in 260cm and 480cm lengths.

The provided document describes a 510(k) submission for a medical device called the "Neo ERCP Guidewire." This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria for device performance. Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, and human reader performance with AI assistance is not typically found or required in a Traditional 510(k) submission like this one.

Here's why and what can be extracted from the document:

Traditional 510(k) Focus:
A Traditional 510(k) submission (like K123439) primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This usually involves:

• Comparison of technological characteristics: Showing similarities in design, materials, manufacturing processes, and fundamental operating principles.
• Bench testing: Verifying that the proposed device performs comparably to the predicate device or meets relevant standards for its intended use, typically through non-clinical (laboratory) tests. This is to ensure the new device doesn't raise new questions of safety or effectiveness.
• Biocompatibility, sterility, shelf-life, and packaging studies: To ensure the device is safe for patient contact and remains sterile and functional over time.

Information Not Found (and why):

• Acceptance Criteria for Device Performance and Reported Performance Table: This document does not present specific clinical performance metrics (e.g., sensitivity, specificity, accuracy) with associated acceptance criteria, as it's not a clinical performance study. The "performance" referred to in this document relates to bench testing (e.g., tensile strength, flexibility), not clinical outcomes or diagnostic accuracy.
• Sample Size for Test Set and Data Provenance: Not applicable for a Traditional 510(k) based on bench testing. There is no "test set" in the sense of patient data.
• Number of Experts, Qualifications, and Adjudication Method: These concepts are related to establishing ground truth for clinical studies, which are not part of this submission type.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is a type of clinical study often done for diagnostic imaging devices to evaluate human reader performance with and without AI. It is not relevant to a guidewire submission.
• Standalone (algorithm-only) performance: This refers to AI-driven diagnostic accuracy and is not applicable to a physical medical device like a guidewire.
• Type of Ground Truth Used (expert consensus, pathology, outcomes data): Ground truth is established for clinical studies. For a guidewire, "performance" is assessed through engineering and material tests, not clinical ground truth.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: These are terms related to AI/ML development and are not relevant to this device or submission type.

What is available in the provided document (related to your prompt's themes):

While the document doesn't fit the clinical study paradigm implied by your questions, it does describe the type of testing and comparisons performed to support substantial equivalence.

Here's a breakdown of the closest relevant information:

1. Acceptance Criteria and Reported Device Performance (as interpreted for a 510(k) bench study):

The "acceptance criteria" for a 510(k) of this nature are typically defined by meeting established engineering standards and demonstrating comparable performance to the predicate device in specific bench tests. The "reported device performance" indicates that the device met these criteria.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not specified in terms of units for many bench tests, and the concept of "test set" for patient data is not applicable. For destructive tests, a sufficient number of samples would be used to ensure statistical validity for engineering testing, but explicit numbers for each test are not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data. The data originates from internal laboratory bench testing conducted by NeoMetrics, Inc.

3. Number of Experts, Qualifications, and Adjudication Method:

• Not applicable as this is not a clinical study involving human judgment on patient data. Engineering tests are evaluated against predefined standards and specifications.

4. Adjudication Method:

• Not applicable.

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

• No. This is a physical medical device, not a diagnostic AI system, so such a study would not be performed.

6. Standalone (algorithm only) performance:

• No. This is a physical medical device with no AI component.

7. Type of Ground Truth Used:

• For bench testing, the "ground truth" is typically defined by:
  • Validated engineering standards: (e.g., ISO 11070, ASTM F 2096-04, ASTM F 88-09).
  • Predicate device characteristics: The performance of the predicate device (JagWire - K922302) serves as a benchmark for comparison.
  • Internal product specifications: The manufacturer's own defined performance requirements for the guidewire.

8. Sample Size for Training Set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable.

Ask a specific question about this device

The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not intended for use in the coronary or cerebral vasculature.

The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with or without lubricious coatings. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 40 to 145 cm. with a variety of coil material options available.

This document describes the VascuPuncture™ PICC Guidewire by NeoMetrics, Inc. and its 510(k) premarket notification. However, it does not contain the detailed acceptance criteria or results from a study proving the device meets those criteria in the format explicitly requested for AI/medical device performance evaluation.

The provided text focuses on the device's substantial equivalence to predicate devices based on:

• Functional and performance characteristics demonstrated through equivalence with the predicate device and testing of representative device samples as part of Design Verification Testing.
• Biocompatibility demonstrated through successful completion of Biocompatibility Testing in accordance with ISO 10993.
• Shelf Life demonstrated through successful completion of accelerated aging studies and subsequent testing in accordance with ISO 11070.

This information is typical for a 510(k) submission for a conventional medical device like a guidewire, which relies on demonstrating equivalence to an already legally marketed predicate device rather than on clinical AI performance metrics.

Therefore, I cannot populate the requested table and study details as they are not present in the provided text.

Specifically, the following information is NOT present in the provided document:

1. A table of acceptance criteria and the reported device performance: While general areas of testing (functional, performance, biocompatibility, shelf life) are mentioned, specific acceptance criteria (e.g., tensile strength minimum, kink resistance maximum) and their corresponding reported values are absent.
2. Sample size used for the test set and the data provenance: No information on the number of guidewires tested or where the test data was generated (e.g., country, retrospective/prospective).
3. Number of experts used to establish the ground truth and their qualifications: Not applicable, as this is not an AI device relying on expert-annotated ground truth.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable, as this is a physical medical device, not an AI model requiring ground truth for diagnosis/detection.
8. The sample size for the training set: Not applicable, as there is no AI model or "training set" for this device.
9. How the ground truth for the training set was established: Not applicable.

The document states that the conclusion of substantial equivalence is based upon "functional design, indications for use, principles of operation, risk analysis, and performance characteristics." The "performance characteristics" are demonstrated through "testing of representative device samples as part of Design Verification Testing" and compliance with ISO standards for biocompatibility and shelf life. This indicates that bench testing was performed for mechanical and material properties, rather than clinical studies with human participants for diagnostic performance.

Ask a specific question about this device

Ask a specific question about this device

Neometrics' ACCUWELL™ Total Galactose kits are intended to be used for the quantitative measurment of Total Galactose in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newborns for galactosemia.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is a clearance letter from the FDA for a medical device (Accuwell™ Total Galactose kits) and an "Indications For Use" statement. It does not contain any scientific study data or performance metrics.

Ask a specific question about this device

Neometrics' ACCUWELL™ Phenylalanine kits are intended to be used for the quantitative measurement of phenylalanine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen for phenylketonuria disease.

Not Found

I am sorry, but based on the provided document, I cannot answer questions 1-9. The document is a 510(k) clearance letter from the FDA for the ACCUWELL™ Phenylalanine device, dated December 5, 1997. It primarily discusses the regulatory approval and classification of the device.

The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This type of document does not contain specific details about:

• Detailed acceptance criteria and reported device performance (beyond the general statement of substantial equivalence).
• Sample sizes used for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or types of ground truth used in testing that informed the substantial equivalence.
• Training set details (sample size, ground truth establishment methods).

These details would typically be found in the 510(k) submission itself, which is not provided in this excerpt. The included "Statement of Indications for Use" only describes what the device is intended for.

Ask a specific question about this device

Neometrics' Accuwell™ T4 EIA kits are intended to be used for the quantitative measurement of Thyroxine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newboros for congenital hypothyroidism.

Not Found

This FDA 510(k) clearance letter (K972974) for the Accuwell™ T4-EIA kit does not contain specific details about acceptance criteria, the study that demonstrates the device meets these criteria, or any of the detailed information requested in the prompt regarding AI/algorithm performance.

The document is a clearance letter stating that the FDA has found the Accuwell™ T4-EIA kit to be "substantially equivalent" to predicate devices already on the market. It outlines the regulatory classification, general controls, and other regulatory requirements. The "Statement of Indications for Use" provides the intended purpose of the device (quantitative measurement of Thyroxine in neonatal dried blood spot samples for congenital hypothyroidism screening).

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or AI-specific performance metrics based on the provided text. This document predates the widespread use of AI in medical devices and focuses on traditional in vitro diagnostic device clearance.

Ask a specific question about this device