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SmartGUIDE guidewire is intended for general intravascular and peripheral vascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. SmartGUIDE is intended to be used only by physicians trained in percutaneous, intravascular techniques and procedures.

SmartGUIDE is a deflectable quidewire for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. The device is available with a nominal outer diameter of 0.014" (0.36 mm) and overall length of 200 cm. The device is available sterile and is for single use only.

The provided text describes the SmartGUIDE deflectable hydrophilic guidewire (K222690), a medical device, and its substantial equivalence to a predicate device. It details various tests conducted to demonstrate its safety and effectiveness, but it does not pertain to an Artificial Intelligence (AI) or machine learning device.

Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test sets and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this document.

However, I can extract and present the acceptance criteria and performance data for the physical medical device as described in the provided text.

Here is the information based on the provided document:

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

For the SmartGUIDE deflectable hydrophilic guidewire, the acceptance criteria are generally implied by conformity to established standards and guidance documents (e.g., FDA Guidewire Guidance, ISO 11070) and comparative equivalence to a predicate device. The "reported device performance" is consistently "Pass" or "Pass / Equivalent," indicating that the device met these criteria.

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

• This document describes a non-AI/ML medical device.
• Sample Size (Pre-Clinical Animal Study): Not explicitly stated, but it was a "controlled good laboratory practice (GLP) study in domestic swine." The number of animals used is not specified.
• Data Provenance: The pre-clinical animal study was conducted as a "controlled good laboratory practice (GLP) study in domestic swine." No country of origin is listed for the study data. It is a prospective study in animals.
• For bench and biocompatibility testing, sample sizes are also not explicitly stated, but these are standard laboratory tests.

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 study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the device's performance comes from validated laboratory tests and the observation of physical and physiological responses in animal studies.

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

• Not applicable as this is not an AI/ML device study involving human interpretation with adjudication. The assessment of device performance in bench and animal studies relies on established measurement protocols and scientific observation.

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. No MRMC study was performed.

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 bench testing: Established physical and mechanical measurement standards and validated laboratory protocols (e.g., measuring forces, observing fractures, checking coating integrity).
• For biocompatibility: Standardized in vitro and in vivo toxicology tests (e.g., cytotoxicity, sensitization, hemolysis) with predefined acceptance criteria as per ISO 10993.
• For pre-clinical animal testing: Direct physiological observation, macroscopic and microscopic evaluation of tissues and organs (pathology), and assessment of device functionality and complications in vivo.

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 Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

The provided text describes the 510(k) premarket notification for the Mirage™ and X-pedion™ Hydrophilic Guidewires, asserting their substantial equivalence to a predicate device. The information primarily focuses on bench testing rather than AI/ML algorithm performance. Therefore, many of the requested details, such as those related to AI model training, expert ground truth, and human reader studies, are not applicable or cannot be extracted from this document.

Here's the relevant information based on the provided text:

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

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

The document does not specify the exact sample sizes (number of guidewires) used for each bench test. The data provenance is from non-clinical bench testing conducted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (the applicant).

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

Not applicable. This is a medical device clearance based on substantial equivalence demonstrated through non-clinical bench testing, not an AI/ML algorithm requiring expert-established ground truth. The "ground truth" for these tests would be the physical properties and performance measurements of the guidewires against engineering specifications.

4. Adjudication method for the test set

Not applicable, as this is bench testing of physical device properties, not a study involving human interpretation of data where adjudication would be necessary.

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

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

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

Not applicable. This is for a physical medical guidewire.

7. The type of ground truth used

The "ground truth" for the bench tests would be the physical and mechanical specifications for guidewires, as referenced by standards such as ISO 11070 and USP , as well as internal quality procedures (QP50324, TM0047). The tests evaluated observed performance against these predefined criteria.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device.

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

Not applicable. There is no training set for a physical medical device.

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The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

The provided text describes the 510(k) premarket notification for the Mirage™ Hydrophilic Guidewire and X-pedion™ Hydrophilic Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, rather than a study on an AI/ML-based medical device.

Therefore, the information required to answer most of your questions about acceptance criteria for an AI/ML device, sample sizes for AI test sets, expert ground truthing, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not present in this document.

However, I can extract information related to the acceptance criteria and performance data for the physical medical device as described:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):

The document details numerous non-clinical bench tests performed to demonstrate the safety and performance of the guidewires. The results consistently state that "The Mirage™ and X-pedion™ Hydrophilic Guidewires met the acceptance criteria for [Test Name]."

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Since this is a 510(k) submission for a non-AI/ML medical device, the following information is not applicable or not provided in the document:

1. Sample sizes used for the test set and the data provenance: Not an AI device, so no "test set" in the AI sense. Bench tests follow specific standards, implying sample sizes per those standards, but not explicitly stated here.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth for a physical device is established via standardized physical and chemical tests, not expert human interpretation of data for AI.
3. Adjudication method for the test set: Not applicable for non-AI bench testing.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For a physical guidewire, "ground truth" is typically defined by adherence to engineering specifications, material properties, and performance under simulated clinical conditions, verified through empirical testing following established ISO and USP standards.
7. The sample size for the training set: Not applicable; this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable; this is not an AI/ML device.

In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not an AI/ML device requiring clinical validation for diagnostic or prognostic purposes.

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The pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire is intended for use in the neuro vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in peripheral or coronary arteries.

The pORTAL Steerable Hydrophilic Guidewire is a disposable medical device designed for single use only. It is designed to selectively introduce and position catheters and other interventional devices within target vessels. In order to achieve this purpose, the guidewire must be capable of being steered through blood vessels. This necessitates pushing and torqueing capability within the product. The design of the distal section of the guides steerability, while maintaining the flexibility necessary to negotiate the tortuous path of the blood vessel network. Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessels. Two accessories are provided within the package. These are a Torquer device and an introducer Needle. Both can be used to aid in the use of the device.

The pORTAL EXT Extension Wire is intended to interface with pORTAL Steerable Hydrophilic Guidewire. It is provided sterile and is sold separately in its own packaging configuration. The 115cm extension wire provides a facility to extend the overall length of the pORTAL quidewire to 315cm (see table 1 for dimensional specifications). This enable length to be extended during use to aid with over-the wire exchange. This facilitates introduction and positioning of catheters and other interventional devices within the target anatomy, while the guidewire retains its working position at the location of intervention. The stiffness of the extension wire is comparable to the proximal, unground section of the pORTAL Guidewire.

This is a 510(k) summary for a medical device (guidewire and extension wire), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details (sample size, provenance, expert adjudication, MRMC study, standalone performance, ground truth, training set), which are relevant for AI/ML device evaluations, are not applicable here.

Instead, the document details engineering bench testing and biocompatibility testing to demonstrate substantial equivalence to predicate devices. Here's what can be extracted from the provided text, formatted to address as many of your points as possible given the non-AI context:

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

The document provides a series of tables (Table 4, 5, 6, 7, 8, 9, 10, 11) detailing biocompatibility, performance, sterility, packaging integrity, and shelf-life testing. The "Results" column in these tables can be interpreted as the device performance relative to an implicit or explicit acceptance criterion. The acceptance criteria themselves are explicitly stated (e.g., "within specification," "meets acceptance criteria," "no evidence of damage").

Here is a summary table, combining some of the provided information, focusing on the guidewire as an example:

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 explicitly state the sample sizes for each bench test conducted. It typically refers to "All devices," "All samples," or plural forms like "guidewires tested." Medical device bench testing often uses a representative sample per test, but the exact number isn't quantified here.

Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of non-clinical, bench testing. The tests are conducted in a controlled laboratory environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is not an AI/ML diagnostic tool requiring expert interpretation for ground truth. The "ground truth" for these tests is established by objective physical measurements and standardized test methods (e.g., ISO, ASTM standards, USP limits for pyrogenicity).

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

Not applicable. Adjudication methods are typically associated with human interpretation of data, such as in clinical trials or AI/ML evaluations. Bench testing results are typically objectively measured and compared 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

Not applicable. MRMC studies are designed to evaluate the performance of AI-assisted human readers in diagnostic tasks. This device is a physical guidewire and extension wire, not an AI/ML product.

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

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

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

The "ground truth" in this context is defined by:

• Standardized Test Methods: Adherence to recognized national and international standards (e.g., AAMI/ANSI/ISO 10993-1:2009 for biocompatibility, ISO 11070 for guidewires, ASTM F1929, ASTM F88, ASTM F2096 for packaging, USP for pyrogenicity).
• Engineering Specifications: Internal design specifications that the device must meet (referred to by phrases like "meets specification," "within acceptable limits").
• Predicate Device Comparison: Performance often compared to that of the already-marketed predicate devices to demonstrate "equivalent" or "better" performance.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable, as there is no training set for this type of medical device.

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

The TXM Hydrophilic Guidewire is a hydrophilic coated device which is constructed with a nitinol inner core which is covered with a polyurethane outer layer coated with a lubricious coating to minimize friction during use. The TXM Hydrophilic Guidewire outer diameter is 0.035" and is available in a variety of lengths ranging from 80 cm to 260 cm. The TXM Hydrophilic Guidewire is also constructed in stiff and standard shaft configuration with straight or angled distal tip. The device is supplied sterile and is intended for single use only.

This is a 510(k) premarket notification for a medical device (TXM Hydrophilic Guidewire), not for an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets them in the context of AI/ML performance metrics (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) is not applicable here.

This document describes the substantial equivalence of the TXM Hydrophilic Guidewire to a predicate device (Hydrophilic Coated Guidewire, K133155). The acceptance criteria and "study" are in the context of demonstrating this substantial equivalence through bench testing, biocompatibility testing, and sterilization testing.

Here's an analysis of the provided text based on the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list numerical "acceptance criteria" for each test. Instead, it states that "The TXM Hydrophilic Guidewire met the predetermined acceptance criteria." and then reports "Pass" for each test, indicating conformity. The applicable standards or internal test methods implicitly define the acceptance criteria.

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

• Sample Size: The document does not specify the exact number of devices tested for each bench test or biocompatibility test. It only indicates that tests were performed on "non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)." This implies at least two groups of samples for most tests.
• Data Provenance: Not applicable in the context of an AI/ML device. For physical device testing, the data is generated internally by the manufacturer (Texas Medical Technologies, Inc.) through their testing processes. There's no mention of country of origin for test data, as it's product performance data. The tests are prospective, as they are performed on newly manufactured devices for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. For a physical medical device, "ground truth" is established by direct measurement and observation against engineering and biological standards, not by expert consensus in the way it is for AI/ML image interpretation. The "experts" would be the engineers, technicians, and biologists performing and interpreting the standardized tests, but their specific number and qualifications are not detailed in this type of submission.

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

Not applicable. Adjudication methods are relevant for human interpretation tasks, especially in AI/ML performance evaluation where human experts might disagree. For device bench testing, the results are objectively measured against predefined criteria.

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

Not applicable, as this is a physical medical device, not an AI-powered diagnostic or interpretive tool. MRMC studies are used to evaluate AI performance with human readers.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

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

For this device, the "ground truth" is defined by established engineering and biological standards (e.g., ISO, ASTM, FDA Guidance documents, USP). Deviations from these standards constitute a "failure." For example:

• Bench Testing: Mechanical properties (e.g., tensile strength, flexibility, lubricity) are measured directly and compared against predefined ranges or thresholds specified in the applicable standards.
• Biocompatibility Testing: Biological responses (e.g., cytotoxicity, irritation, sensitization) are assessed using standardized in-vitro and in-vivo assays, and the absence of unacceptable biological reactions indicates compliance.
• Sterilization Testing: Sterility Assurance Level (SAL) of 10^-6 is the standard ground truth for terminal sterilization.

8. The sample size for the training set:

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

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

Not applicable. As there is no AI/ML algorithm, there is no "training set" or ground truth establishment for it. The design specifications of the device are based on engineering principles and regulatory requirements, not learned from data.

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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 Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight, angled, standard and stiff configurations, in various lengths.

The provided text describes a 510(k) premarket notification for a medical device, the "Merit Hydrophilic Guide Wire." The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving novel effectiveness. Therefore, the study described is a comparative performance study against predicate devices, not an effectiveness study in the typical sense of a human-in-the-loop clinical trial or a standalone AI algorithm performance study.

Here's an analysis of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results for each criterion. It broadly states that a "battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence."

The tests performed and their general outcomes are listed:

The general acceptance criterion is that the new Merit Hydrophilic Guide Wire performs substantially equivalently to the predicate devices in these physical and biological tests. The document declares that the device met these criteria, indicating successful performance in all listed tests.

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

• Sample Size: The document specifies that performance testing was performed on the 0.018" and 0.038" diameter wires only. These represent the "minimum and maximum wire diameters within the cleared device range." The manufacturer believes this is sufficient to demonstrate equivalence for intermediate diameters. The exact number of units or samples tested for each specific test (e.g., number of wires for flex test, number of samples for biocompatibility) is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the applicant is Merit Medical Systems, Inc. (South Jordan, UT, USA) with a correspondent in Ireland, suggesting that the testing could be internal to the company or contracted out to labs in various locations. Given the nature of a 510(k) submission, this testing is typically controlled in a laboratory setting for regulatory purposes. It is retrospective data in the sense that the tests were conducted prior to submission for regulatory clearance.

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

This question is not applicable in the context of this device and study. The "ground truth" for a guidewire's performance is objective measurements against established engineering and biocompatibility standards, not expert evaluation of medical images or clinical outcomes. The tests evaluate physical properties, material compatibility, and biological safety, which are quantifiable against predefined acceptance limits or comparative performance with predicate devices.

4. Adjudication Method for the Test Set

This question is not applicable. The performance tests for a guidewire (e.g., fracture test, flex test, coating adherence) involve objective measurements and comparisons to engineering specifications or predicate device performance, not subjective human 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 question is not applicable. This is a 510(k) submission for a physical medical device (guidewire), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.

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

This question is not applicable, as the device is a physical guidewire and not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's evaluation is based on:

• Engineering specifications and performance standards: These are derived from industry standards (e.g., ISO 11070:1998, ASTM F1980-07) and FDA guidance documents (e.g., Coronary and Cerebrovascular Guide Wire Guidance January 1995).
• Biocompatibility standards: Primarily ISO 10993-1:2009 and FDA Modified ISO 10993 Test Profile FDA Memo G95-1.
• Comparative performance against predicate devices: The objective of the submission is to demonstrate "substantial equivalence" to existing, legally marketed guidewires. Therefore, the performance of the new device is compared to the established performance of the predicate devices in the listed tests.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this guidewire's regulatory submission, as it is a physical device and not an AI or machine learning model.

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

This question is not applicable for the reasons stated above (no training set for a physical device).

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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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The SilverSpeed™, Mirage™, X-celerator™ Exchange , and X-pedion™ Hydrophilic Guidewires are indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated on the distal portion. For the Xcelerator ™ Hydrophilic Guidewire labeled as an "Exchange" quidewire, the proximal portion is coated with polytetrafluoroethylene (PTFE). The Exchange guidewire facilitates the exchange of one interventional device for another, while maintaining guidewire position in the anatomy.

The following modifications have been made to the device:

• Change in the degree of polymerization with the base coat . material.
• . Elimination of Brown Oxide pigment from base coat material.

The provided text describes a 510(k) premarket notification for a Hydrophilic Guidewire and its substantial equivalence determination. It does not include details of a clinical study or acceptance criteria with associated performance metrics for a device to meet specific performance targets. Instead, it focuses on non-clinical (bench and biocompatibility) testing to support changes to an existing device, and then a determination of substantial equivalence to predicate devices.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided.

However, I can extract the information related to the non-clinical performance and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission primarily relying on substantial equivalence and non-clinical testing for minor device modifications, the "acceptance criteria" are implied by successful completion of standard evaluations and demonstration of comparable performance to predicate devices. Specific quantitative targets for each test are not explicitly detailed in the provided text.

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

• Sample Size (Test Set): Not specified for any of the non-clinical tests. The text indicates "no clinical or animal testing was performed" beyond the specified biocompatibility and bench tests. The dog study (thromboresistance) is an animal study, but its sample size is not mentioned.
• Data Provenance: The tests are standard laboratory/bench tests and an animal study. No human clinical data from any country is presented. The testing would have been conducted by the manufacturer or contracted labs.

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

• Not applicable. The "ground truth" here is determined by objective physical and chemical testing standards and biological responses in laboratory settings, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

• Not applicable. As above, this pertains to clinical data interpretation, not objective non-clinical testing.

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

• No, a MRMC comparative effectiveness study was not done. The submission explicitly states "no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device," except for the listed biocompatibility and bench tests.

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

• Not applicable. This device is a physical medical device (guidewire), not a software algorithm.

7. The Type of Ground Truth Used

• For biocompatibility: Established ISO and ASTM standards, and direct biological responses (e.g., cytotoxicity, sensitization, hemolysis, pyrogenicity, in-vivo thromboresistance in dogs).
• For bench testing: Engineering specifications, performance characteristics comparable to predicate devices, and internal quality control standards.
• For shelf-life: Stability and performance measurements over time, extrapolated from accelerated aging data.

8. The Sample Size for the Training Set

• Not applicable. This is for a physical device, not an AI/ML model that requires a training set. The "training" for this device's development would be engineering design, material science, and manufacturing process development.

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

• Not applicable. See point 8.

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The endoscopic guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, pancreatic, cystic, right and left hepatic ducts. The endoscopic guidewire is designed to be used during endoscopic pancreatic -biliary procedures for catheter introduction and exchanges of catheters, cannulas and sphicterotomes.

Utilizing proprietary processes, these guides are constructed from a steerable, metallic core (Witinol) with a polymer jacket (polyurethane) coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Guidewires are available in 260cm length and in diameters 0.018", 0.025" depending on specific design requirements. Guidewires may have a straight or a pre-shaped distal tip and are available in different tip flexibilities, which are dependent on the grind configuration of the core.

The provided text describes a 510(k) submission for the NaviPro™ Guidewire. The acceptance criteria and the study proving the device meets these criteria are related to non-clinical performance testing and biocompatibility, as this is a medical device approval. The document states that the device is "substantially equivalent" to predicate devices, meaning it does not claim superiority, but rather equivalent safety and effectiveness based on similar design and performance.

Here's an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results. Instead, it broadly states that testing was performed to establish requirements and demonstrate functionality.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Test pieces were tested and inspected," but does not quantify how many pieces were in the test set.
• Data Provenance: The studies are described as "non-clinical" and "biocompatibility testing," suggesting laboratory-based testing rather than human subject data. The manufacturer is Lake Region Medical, located in Chaska, MN, USA, implying the testing was conducted or overseen by them. No mention of retrospective or prospective data in a clinical sense, as it refers to device performance testing.

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for a medical device like a guidewire is established through engineering and material science testing against predefined specifications and industry standards (e.g., ISO standards like 10993, 11070, 15223, EN 980, ISO 594, which the device is stated to comply with). It doesn't involve expert consensus on medical images or patient outcomes in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies where human interpretation is involved. For non-clinical device performance testing, the "adjudication" is based on meeting engineering specifications and test methodologies.

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

No. There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of how much human readers improve with AI vs. without AI assistance. This type of study is relevant for AI-powered diagnostic devices, not for basic medical devices like guidewires.

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

Not applicable. This device is a guidewire, a physical medical instrument, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, industry standards (e.g., ISO), and comparison to functionally equivalent predicate devices. The non-clinical testing "demonstrate[d] the device is as safe, as effective and performs as safely and effectively as the legally marketed device."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the machine learning sense. The development process would involve iterative design, prototyping, and testing, but not machine learning training.

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

Not applicable, as there is no "training set" for this physical medical device.

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