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The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.

The EasyPass Guidewire consists of a Nitinol core wire with a proximal 2-color spiral patterned PTFE jacket and a copolymer distal section. The distal stainless steel spring section of the guidewire provides flexibility and incorporates a hydrophilic coating. The EasyPass Guidewire is a sterile packed, disposable instrument intended for single-patient use only.

This document is a 510(k) premarket notification for the EasyPass Guidewire. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined and statistically proven.

Therefore, the requested information cannot be fully provided in the typical format for a study proving device meets acceptance criteria. However, I can extract the relevant information regarding the performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, "acceptance criteria" are not explicitly stated in a quantitative manner with pass/fail thresholds for specific performance metrics in the way one might expect for a de novo or PMA submission. Instead, the performance is demonstrated by comparing the device to a predicate and showing it meets "the same performance requirements." The "acceptance criteria" are therefore implicitly that the device performs equivalently to the predicate device in the specified tests.

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

The document does not specify the exact sample sizes (N) used for each non-clinical performance test. It only states that these tests were conducted. The data provenance is "non-clinical performance data" generated from bench testing and biocompatibility assessments of the proposed EasyPass Guidewire. There is no information regarding the country of origin or whether it's retrospective/prospective as these are not clinical tests.

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

Not applicable. This document describes non-clinical testing (bench and biocompatibility), not studies involving expert evaluation of clinical data or images.

4. Adjudication method for the test set

Not applicable. No expert adjudication was described for these non-clinical tests.

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

Not applicable. This device is a medical guidewire, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

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

Not applicable. This device is a medical guidewire, not an algorithm.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" would be established by the standardized methods and specifications relevant to each test (e.g., ISO 10993 for biocompatibility, material specifications for fracture/bend/tensile tests, etc.). The goal was to demonstrate performance equivalent to the predicate device.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. (See #8)

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The Radifocus Glidewire Endoscopic Wire is intended to be used for selective cannulation of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

The Radifocus Glidewire Endoscopic Wire is an endoscopic guide wire that is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire, and a polyurethane containing tungsten and hydrophilic polymer that are applied to the entire wire. There are two shaft configurations: standard and stiff; the stiff shaft has a slightly thicker core wire than that of the standard shaft. The wire distal segment comes in angled or straight configurations and is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into an endoscope or catheter.

This document is a 510(k) premarket notification for a medical device called the Radifocus Glidewire Endoscopic Wire. It is a submission to the FDA demonstrating substantial equivalence to a predicate device, not a study describing acceptance criteria and device performance in the context of an AI-based system. Therefore, most of the requested information regarding AI study specifics like sample sizes for test and training sets, expert consensus, MRMC studies, and standalone performance is not applicable to this document.

However, I can extract and describe the acceptance criteria and the studies that prove the device meets these criteria, as presented in the document, which are related to the physical performance and safety of the guidewire.

Acceptance Criteria and Device Performance for the Radifocus Glidewire Endoscopic Wire

The device is a medical guidewire (non-AI), so the acceptance criteria are based on physical performance, biocompatibility, and sterility, rather than diagnostic accuracy or AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the specific questions you asked for an AI study, the following are not applicable to this 510(k) submission for a non-AI medical device (guidewire):

2. Sample sizes used for the test set and the data provenance: Not applicable. Device is a physical guidewire, not an AI system processing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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.
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 concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to the physical and chemical properties meeting specified standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

However, to address the core of "the study that proves the device meets the acceptance criteria" based on the document:

The studies that prove the device meets the acceptance criteria are non-clinical bench tests and material assessments. These include:

• Performance Testing per ISO 11070: 2014: This standard covers "Sterile single-use intravascular introducers, dilators and guidewires." Tests performed included Radiodetectability, Fracture Test, Flexing Test, and Peak Tensile Force of Guidewire. These tests were conducted on both non-aged and accelerated aged samples.
• Performance Testing per Terumo's Internal Standards: These tests included Flexibility Test of Distal Tip, Torque transmission, Sliding Resistance/Coating, Integrity (Product appearance), and Bending Strength. These were based on the predicate device's expected performance.
• Biocompatibility Testing: Assessed in accordance with ISO 10993-1, classifying the device and confirming material compatibility through comparison to the predicate device's established safety record and identical material composition.
• Sterilization Validation: Demonstrated compliance with ISO 11135 for Ethylene Oxide sterilization, ensuring a Sterility Assurance Level (SAL) of 10^-6 (although the document stated 10^-9, which is a higher level of assurance) and meeting residual EO/ECH limits per ISO 10993-7 for limited exposure devices.
• Pyrogen Testing Validation: Conducted using Limulus Amebocyte Lysate (LAL) testing (Photometric Quantitative Method) in accordance with USP and FDA guidance.
• Risk Analysis: Performed according to ISO 14971 to identify and mitigate potential risks.

These non-clinical tests collectively demonstrate that the Radifocus Glidewire Endoscopic Wire is safe and effective and substantially equivalent to the predicate device, fulfilling the regulatory requirements for the 510(k) submission. No clinical trials were conducted or required for this submission.

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The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.

The Orchestra® Hydrophilic Guidewire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.

The provided text describes a 510(k) premarket notification for the Orchestra Hydrophilic Guidewire. The document states that the device is substantially equivalent to a previously cleared device (K131072) and details the nonclinical tests performed to support this claim, specifically focusing on a modification to the hydrogel coating. However, the document does not contain acceptance criteria or performance metrics that would typically be reported as "reported device performance." It also does not detail a specific "study" in the sense of a standalone algorithm or a comparative effectiveness study with human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets those criteria, as this information is not present in the provided text.

Based on the information available, here are the details related to the nonclinical testing mentioned:

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

  • Not provided. The document states that "all current product requirements and specifications were met" for the modified coating. However, the specific requirements and their numerical acceptance criteria are not detailed, nor are the specific performance results for each criterion.

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

  • Not provided. The document states "Bench testing was also performed by Coloplast to evaluate performance of the modified hydrophilic coating."
  • The nature of the tests (e.g., durability, reliability) suggests laboratory testing, not human patient data.

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

  • Not applicable. This was bench testing, not a clinical study requiring expert ground truth for interpretation of medical data.

• 4. Adjudication method for the test set:

  • Not applicable. This was 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. This is a medical device (guidewire), not an AI/imaging diagnostic device.

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

  • No. This is a medical device (guidewire), not an algorithm.

• 7. The type of ground truth used:

  • Not applicable. The "ground truth" for bench testing would be the physical/chemical properties and functional performance measured against predefined specifications.

• 8. The sample size for the training set:

  • Not applicable. This is bench testing for a physical device, not a machine learning model.

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

  • Not applicable. This is bench testing for a physical device, not a machine learning model.

In summary, the provided document focuses on a change to a medical guidewire's coating and confirms that the modified device continues to meet existing product requirements through bench testing. It does not provide the specific details of a study with acceptance criteria and performance data as requested in the format of a clinical or AI diagnostic study.

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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.

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This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.

The Acrobat Calibrated Tip Wire Guide is a modification to the existing Endoscopic Wire Guides currently marketed by Wilson-Cook Medical, Inc. The modified wire guide is compatible with a .025", .035" inch or larger inner diameter accessory and available in 205cm, 260cm and 450cm lengths. The wire guide features include marks at 5cm to 25cm at the distal end that provide reference points to indicate movement of wire guide while in use. The distal tip consists of an 11.5cm or 27cm hydrophilic slip-coating.

The provided document is a 510(k) premarket notification for a medical device (Acrobat Wire Guide) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way one would expect for a study proving device meeting acceptance criteria.

The document primarily states:

• Device: Acrobat Wire Guide
• Purpose: To assist in cannulation of biliary and pancreatic ducts and aid in bridging difficult strictures during ERCP.
• Comparison: It is a modification of an existing device (Endoscopic Wire Guide, K122816).
• Performance Data: "Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provided reasonable assurance that the modified device is as safe and effective as the predicate device."
• Conclusion: The device is "substantially equivalent to the named predicate in terms of its intended use, performance characteristics tested."

Therefore, based solely on the provided text, the specific details required for your request (tables of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) are not present.

The document discusses "design verification and/or validation testing" and "risk analysis," which are general terms in medical device development. It does not provide the results or the specific criteria used in these tests for the Acrobat Wire Guide.

If this were a document about a new, novel AI device, it would typically contain the requested information in much greater detail. However, this is a 510(k) for a modified guidewire, where the focus is on demonstrating that the modifications do not negatively impact safety and effectiveness compared to an already cleared device, rather than a full de novo performance study.

To answer your request based on the absence of information:

1. Table of acceptance criteria and reported device performance: Not provided in the document. The document states "Results from design validation and/or verification testing provided reasonable assurance that the modified device is as safe and effective as the predicate device," but no specific criteria or performance values are reported.
2. Sample size used for the test set and data provenance: Not provided. The document mentions "Design verification and/or validation testing" but does not detail the sample sizes or data sources.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/Not provided. The document does not describe studies involving human readers or ground truth establishment in this context.
4. Adjudication method: Not applicable/Not provided.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable/Not provided. This type of study is more relevant for diagnostic imaging devices with AI assistance, not typically for a wire guide.
6. Standalone (algorithm only) performance: Not applicable/Not provided. This is a physical device, not a software algorithm in the context of standalone performance.
7. Type of ground truth used: Not applicable/Not provided. The "testing" referred to for this device would likely involve mechanical and material property testing, rather than establishing a clinical "ground truth" as you might see for a diagnostic device.
8. Sample size for the training set: Not applicable/Not provided. This device (a guidewire) does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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Indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The guidewires are designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.

The Jagtail™ High Performance Guidewire Extension attached to the extendable Jagwire™ 260 cm Guidewire is designed for use during endoscopic biliary procedures for non-rapid exchange catheter introduction and exchanges. The attachment of the Jagtail High Performance Guidewire Extension to the extendable Jagwire 260 cm guidewire creates an extended guidewire that can be used to exchange out a non-rapid exchange biliary catheter without removing the original guidewire from the associated duct. When the exchange is completed, the Jagtail High Performance Guidewire Extension can be detached and the original, extendable Jagwire 260 cm guidewire can be used in a conventional manner.

Jagwire™ High Performance Guidewire, and Jagwire™ High Performance Extendable Guidewire:
The Boston Scientific Jagwire™ High Performance Guidewire is constructed of a metal alloy core, which is encapsulated in a striped PTFE jacket with a 5 cm hydrophilic radiopaque distal tip. The striped jacket provides endoscopically visible movement markings.

Jagtail™ High Performance Guidewire Extension:
The Boston Scientific Jagtail™ High Performance Guidewire Extension is a 200 cm long guidewire extension constructed of a stainless steel core with a connector at the distal end. The shaft is coated with a PTFE sleeve. The Jagtail High Performance Guidewire Extension is exclusively compatible with the Jagwire High Performance Extendable Guidewire, 260 cm. The distal end of the Jagtail High Performance Guidewire Extension is inserted into the proximal end of the extendable Jagwire 260 cm guidewire with the use of the alignment tool. The alignment tool is then removed from the Jagtail High Performance Guidewire Extension.

The provided document is a 510(k) premarket notification for a medical device called "Jagwire™ High Performance Guidewire" and its extensions. It is not an AI/ML device, therefore, a lot of the metrics that you requested are not relevant here. However, I will extract and provide the relevant information.

The document discusses the regulatory approval for a guidewire, which is a physical medical device used in endoscopic biliary procedures. The "acceptance criteria" and "study" described in the document relate to the physical and biological performance of this guidewire, rather than an AI/ML algorithm's diagnostic or predictive capabilities.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a "sample size" in the context of an algorithm's test set or data provenance (e.g., country of origin, retrospective/prospective) because this applies to a physical device, not a data-driven model.

• Sample Size for Testing: Not explicitly stated as "sample size" in the context of a dataset. Instead, it refers to multiple units of the physical device or its components tested.
• Data Provenance: Not applicable as it's not a data-driven study, but rather a performance evaluation of a manufactured device.

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

This information is not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic studies, not for the physical performance testing of a medical guidewire. The performance was assessed against established engineering and biocompatibility standards.

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

This information is not applicable. Adjudication methods are used in diagnostic studies to resolve discrepancies in expert opinions for ground truth establishment. For physical device testing, the results are typically quantitative measurements against predefined specifications.

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 is not an AI/ML device, so no MRMC comparative effectiveness study involving human readers or AI assistance was performed.

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

This is not an AI/ML device, so no standalone algorithm performance was evaluated.

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

The "ground truth" for this device's performance is established by engineering specifications, material science standards (e.g., biocompatibility standards like ISO 10993-1), and mechanical performance metrics. The device is deemed acceptable if it meets these predefined physical and biological requirements.

8. The sample size for the training set:

This information is not applicable. The device is a physical product, not an AI/ML model, so there is no "training set."

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

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

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To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers. The PREDICATE™ III GUIDEWIRE family is bound by the following parameters: Lengths: 30cm – 500cm, Outside Diameter: 0.018" to 0.038", Tips: Straight or Shaped with various flexibilities, Coil Length: Full length, 2cm to 30cm.

The provided text describes a 510(k) premarket notification for the Predicate III Guidewire. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the acceptance criteria were met, but it does not explicitly list the specific quantitative acceptance criteria for each test. Instead, it states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met."

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

• Sample Size: The document does not specify the exact sample size for the test set (number of guidewires tested). It refers to "Test devices" being manufactured and inspected.
• Data Provenance: The study was conducted by Lake Region Medical for their Predicate III Guidewire. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as this is a bench and biocompatibility study of a medical device.

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

This information is not applicable as the evaluation primarily involved bench testing and biocompatibility analysis, not expert-based assessment for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation primarily involved bench testing and biocompatibility analysis, not expert-based assessment requiring 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 information is not applicable. The document describes the premarket notification for a physical medical device (guidewire), not an AI-based diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable for the same reason as point 5. This is a physical guidewire, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the design input summary requirements and applicable standards (e.g., ISO for biocompatibility and specific tests). For bench testing, the ground truth would be the expected physical, mechanical, and material properties of the guidewire. For biocompatibility, the ground truth is adherence to established biological safety limits.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

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

This information is not applicable for the same reason as point 8.

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Mandrel Guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers. The Mandrel guidewire family is bound by the following parameters: Lengths: 20cm to 500cm, Outside Diameter: 0.014" To 0.35", Tips: Straight or shaped with various flexibilities, Coil Length: 2cm to 30cm.

This document describes a 510(k) submission for Mandrel Guidewires with the addition of Tungsten as a material option. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met" and that "the conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary."

The document lists the following tests performed to ensure compliance with the design input summary:

Note: The specific numerical or descriptive acceptance criteria for each test are not provided in this summary, nor are the detailed results. The device performance is generally stated as "complies with design input summary" or "complies with pre-defined acceptance criteria."

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

The document states that "Test devices were manufactured and inspected according to established requirements." However, it does not provide the specific sample size used for the bench testing or biocompatibility testing. The data provenance is internal to Lake Region Medical through their "formal quality systems." There is no mention of country of origin for data or whether the study was retrospective or prospective in the standard sense (as this is a device modification submission, not a clinical trial). The data is generated from laboratory testing.

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

This type of information is not applicable to this device submission. The tests conducted are primarily physical, mechanical, and biological evaluations of the device itself, rather than diagnostic interpretations requiring expert consensus for ground truth. The "ground truth" for these tests would be the established engineering specifications and ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable for the type of testing described (bench and biocompatibility). Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a material modification to a guidewire, and the testing focuses on the device's physical, mechanical, and biological properties, not its interpretive performance in a diagnostic context.

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

This question is not applicable. The device is a physical medical guidewire, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on established engineering design input summaries, internal specifications, and relevant ISO standards for material properties, mechanical performance, and biocompatibility.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this device submission. The device is not an AI model requiring a dataset for training.

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

This question is not applicable as there is no training set for this device.

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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.

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The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.

The Orchestra® Hydrophilic Guide Wire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.

The provided text describes the 510(k) summary for the Coloplast Orchestra® Hydrophilic Guidewire, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria through an AI-based system.

Therefore, the information requested about acceptance criteria, device performance from an AI study, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text, as this device submission is for a physical medical product, not an AI/ML-driven solution.

The document states:

• Device Description: The Orchestra® Hydrophilic Guidewire is a metallic core wire with a polymer coating and a hydrophilic coating over a radiopaque polymer jacket, supplied sterile and non-pyrogenic.
• Intended Use: To facilitate the placement of devices through the urinary tract during endourological procedures.
• Predicate Device: Radifocus® Guidewire M from Terumo Medical Corp (K923607).
• Nonclinical Tests: Product performance testing compared the subject device to the predicate device and included: visual control, dimensional test, tensile test on guidewire, flexibility test for guidewire, X-rays opacity test, guidewire fracture test, guidewire flexibility damage resistance test, and oxidation test, and friction test.

Key takeaway regarding your request:
The document does not include information about AI/ML models, their acceptance criteria, performance metrics (like sensitivity, specificity), study designs for AI evaluation, sample sizes for AI testing or training, expert adjudication, or MRMC studies because the device in question is a physical guidewire, not an AI software. The "study" mentioned is a series of non-clinical, physical performance tests comparing the new device to a predicate device to establish substantial equivalence.

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