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To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for PTCA use.

PTFE quidewire is designed to facilitate the placement of devices for diagnostic and interventional procedures. The guidewire is intended for single use.

The guidewire is: .032" diameter and is 200cm in length. The guidewire is composed of three primary components: PTFE coating, a coil and a core. The core and coil are made of 304 stainless steel (ASTM A313). The coil is coated with low-friction polytetrafluoroethylene (PTFE). The coil provides the outer shell while the core is fit inside the inner diameter of the coil. The core provides the stiffness to the guidewire body and flexibility in the J-tip. The core and coil are secured together using a weld on both the distal and proximal of the guidewire.

The guidewire is sterilized using ethylene oxide. The guidewire is loaded into a dispenser hoop and is provided with a J-straightener, which is used to aid the insertion of the delivery device. There are no accessories packaged with the guidewires.

The provided text is a 510(k) summary for a PTFE Guidewire. It details the device description, indications for use, comparison with a predicate device, and a summary of non-clinical (bench) performance testing.

However, the provided text describes the regulatory clearance process for a physical medical device (a PTFE Guidewire), not an AI/ML-driven device. As such, it does not contain the information requested in points 1-9, which are specific to the acceptance criteria and study design for software-as-a-medical-device (SaMD) or AI-enabled medical devices.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on engineering and material testing (e.g., torque strength, tip flexibility, biocompatibility, packaging integrity) to demonstrate substantial equivalence to a predicate guidewire, which is standard for hardware medical devices. It explicitly states:

• "Non-clinical (bench) performance testing was performed in order to demonstrate that the PTFE Guidewire met applicable design and performance requirements..." (Page 5, Section VII)
• It lists various physical and material tests, such as "Tip Flexibility," "Torque Strength," "Particulate Residue," "Corrosion Resistance," "Lubricity/Device Compatibility," "Radiopacity," etc., and confirms that "The predetermined acceptance criteria were met" for each.

The document does not describe any AI/ML components, image analysis, diagnostic capabilities, or human-in-the-loop studies that would necessitate the types of criteria and study designs outlined in your prompt.

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The Pre-Formed Blue guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.

The Pre-Formed Blue guidewire is designed to facilitate device placement during TAVR procedures and has a unique pre-shaped spiral distal tip to ensure placement within the heart. The guidewire is intended for single use. The guidewire has a 0.035" diameter and is 275cm in length. The guidewire composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The coil component is fitted over the distal end of the core and is a stainless-steel coiled wire coated with blue PTFE coating. The coil and core components are secured together using a weld on the distal end, forming the guidewire. The pre-shaped distal end of the guidewire is available in two sizes (extra-small and small). The Pre-Formed Blue guidewire is sterilized using ethylene oxide. There are no accessories packaged with the Pre-Formed Blue guidewire.

The provided text describes the regulatory clearance of a medical device, the "Pre-Formed Blue" guidewire, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the level of detail requested for a comprehensive acceptance criteria and study description for an AI device.

Specifically, the document pertains to a physical medical device (a guidewire), not an AI device. Therefore, many of the requested elements, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable and are not present in the provided text.

The closest information available related to "acceptance criteria" and "study" is the summary of non-clinical (bench) performance testing and an animal study comparing the new device to its predicate.

Here's an attempt to extract and present the information in the requested format, clearly indicating where information is not applicable (N/A) for a physical device or not provided in the text.

Device: Pre-Formed Blue Guidewire
Type of Device: Catheter Guide Wire (Physical Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for all listed tests, "The predetermined acceptance criteria were met." However, the specific quantitative acceptance criteria values for each test are not provided. The table below summarizes the tests conducted and the reported outcome.

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

• Sample Size for Test Set:
  • For non-clinical (bench) tests: Not explicitly stated how many units were tested for each specific bench test. The document refers to "samples were analyzed."
  • For the animal study: Not explicitly stated how many animals were used.
• Data Provenance:
  • For non-clinical (bench) tests: Data generated from internal laboratory testing according to established procedures and FDA guidance.
  • For the animal study: Conducted according to 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory studies. The geographic origin of the study is not specified. It is a prospective study in the context of device development and substantial equivalence demonstration.

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

N/A. This information is relevant for AI devices where experts establish ground truth for image interpretation or diagnosis. For a physical guidewire, "ground truth" is established by direct measurement and performance against engineering specifications and accepted standards. The document does not refer to experts establishing ground truth in this sense.

4. Adjudication method for the test set

N/A. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements in expert interpretations, typically for AI model ground truth establishment. This is not applicable to the bench and animal testing of a physical guidewire.

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

N/A. This is a physical guidewire, not an AI device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

N/A. This is a physical guidewire, not an AI device.

7. The type of ground truth used

• For non-clinical (bench) tests: Ground truth is based on predetermined acceptance criteria derived from engineering specifications, industry standards (e.g., ASTM, ISO, EN ISO), and FDA guidance for guidewire performance.
• For the animal study: Ground truth is based on safety and performance objectives and Customer Requirement Specifications as measured by post-procedure feedback forms, with comparison to the predicate device.

8. The sample size for the training set

N/A. This is a physical medical device, not an AI model that requires a training set.

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

N/A. This is a physical medical device, not an AI model that requires a training set.

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Pre-Formed Extra Support guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.

The Pre-Formed Guidewire Extra Support guidewire is designed to facilitate device placement during TAVR procedures and has a unique pre-shaped spiral distal tip to ensure placement within the heart. The guidewire is intended for single use.

The guidewire has a 0.035" diameter and is 275cm in length. The guidewire composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The proximal end of the core wire is coated with grev polytetrafluoroethylene (PTFE) coating. The coil component is fitted over the distal end of the core and is a stainless-steel coiled with green PTFE coating. The coil and core components are secured together using a weld on the distal and a glue joint at the proximal end of the coil, forming the guidewire. The pre-shaped distal end of the guidewire is available in three sizes (extra-small, small and large).

The Pre-Formed Extra Support guidewire is sterilized using ethylene oxide. There are no accessories packaged with the Pre-Formed Extra Support guidewire.

The provided text is a 510(k) summary for a medical device (a guidewire) and not a summary of an AI/ML device study. Therefore, most of the requested information regarding AI/ML device acceptance criteria, study details, and data provenance cannot be extracted or inferred from this document.

The document discusses the substantial equivalence of a new guidewire to a predicate device based on bench testing and animal performance data, not AI/ML performance.

However, I can extract the acceptance criteria and the (non-AI/ML) "device performance" as reported for this specific guidewire:

1. Table of Acceptance Criteria and Reported Device Performance (for a Guidewire):

Missing (as the document is not about an AI/ML device):

• Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. The document refers to samples for bench testing and a porcine model but does not specify "test sets" in the AI/ML sense.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is typically established by human experts or pathology, which is not relevant for this guidewire's non-clinical and animal testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 is a study type for AI-assisted human performance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI device. For this guidewire, "ground truth" equates to established engineering standards, material properties, and biological responses in animal models.
• The sample size for the training set: Not applicable (no AI model).
• How the ground truth for the training set was established: Not applicable (no AI model).

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Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Hi-Torque Vektor Guide Wire is a 0.014" (0.36 mm) diameter steerable guide wire available in several lengths and has a shapeable distal tip. Refer to the product label for product specifications (e.g. wire length, diameter and length of tip radiopacity).

The Hi-Torque Vektor Guide Wires have a modified proximal end that permits the attachment of the DOC Guide Wire Extension. Refer to the product label for Guide Wire Extension system compatibility. Joining the guide wire extension to the guide wire facilitates the exchange of one interventional device for another, while maintaining guide wire position in the anatomy. After the interventional device exchange has been completed, the extension can be detached and the guide wire can be used in its original capacity.

Brachial and femoral markers located on the proximal segment of the 0.014" (0.36 mm) Hi-Torque Vektor guide wire aid in gauging guide wire position relative to the guiding catheter tip when using bare wire technique. These Hi-Torque Vektor guide wires are compatible with guiding catheters that are at least 90 cm (brachial) or 100 cm (femoral) long.

When wet, a hydrophilic coating increases the lubricity of the Hi-Torque Vektor guide wire surface. This coating contains highly purified hyaluronic acid (HA).

Principles of Operation: The Hi-Torque Vektor guidewire is operated manually by a manual process.

The provided document describes the predicate device comparison and performance testing for the "Hi-Torque Vektor Guidewire Family" to demonstrate substantial equivalence to its predicate devices, rather than a study proving the device meets general acceptance criteria in the context of AI/ML performance evaluation. The document is for a traditional medical device (a guidewire) and not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML performance (e.g., sample size for test set, expert qualifications for ground truth, MRMC study, effect size of AI assistance, standalone performance, training set size) are not applicable or extractable from this document.

However, I can extract information related to the acceptance criteria and performance of the device based on the provided text, focusing on the bench testing conducted to demonstrate equivalence.

Here's a summary of the applicable information:

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

The document states that "The results from these performance evaluations demonstrated that the Hi-Torque Vektor Guidewire range met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s)."

The acceptance criteria themselves (e.g., specific values for tensile strength, torque strength) are not explicitly detailed in the provided text. Instead, the performance is reported in relation to the predicate devices and internal product specifications. The table below outlines the tested parameters and the reported performance relative to the predicate devices.

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

The document describes in vitro bench tests. No specific sample sizes for each test are provided, nor is information on data provenance in terms of country of origin or retrospective/prospective nature, as these are not relevant for bench testing of a physical device.

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

This question is not applicable. Ground truth for these physical performance tests (e.g., tensile strength, lubricity) is established by standardized test methods and instrumentation, not by expert consensus or clinical assessment.

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

This question is not applicable, as ground truth is based on objective physical measurements and established test methods, not subjective 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. The device is a guidewire, a physical medical device, not an AI/ML-powered diagnostic or assistive tool. "Human readers" and "AI assistance" are not relevant to this submission.

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 guidewire and does not involve algorithms or AI.

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

The ground truth for the performance evaluations (bench tests) is based on the results generated by standardized in vitro test methods and comparison to predefined product specifications and the performance of "legally marketed predicate devices."

8. The sample size for the training set

This question is not applicable, as the device does not involve machine learning or a training set.

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

This question is not applicable, as the device does not involve machine learning or a training set.

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The ENROUTE 0.014" Guidewire is intended for use in the peripheral vasculature.

The ENROUTE .014” guidewire is a disposable medical device designed for single use only. It consists of a 95cm PTFE coated 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over approximately 9.5cm in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product an area of reduced stiffness. The very distal tip section is flattened to further reduce stiffness and enable the tip to be shaped.

The distal section is covered with a 5cm platinum tungsten spring coil. This provides for greater visibility on x-ray equipment (radiopacity). A hydrophilic coating is applied to the distal section to enhance lubricity. The product is available in straight configuration

This document describes the 510(k) premarket notification for the ENROUTE 0.014" Guidewire, which is intended for use in the peripheral vasculature. The device demonstrates substantial equivalence to predicate devices (Brivant Guidewire K060551 and Nitrex Nitinol Guidewire K040345) based on technological characteristics, performance testing, and intended use.

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

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

The document does not explicitly state numerical "acceptance criteria" in a table format for each test. Instead, it states that "The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed ENROUTE 0.014" Guidewire device were met. The ENROUTE 0.014" Guidewire device test data supports the claims of substantial equivalence to the predicate devices." This implies that the device's performance results were within acceptable ranges to demonstrate substantial equivalence to the predicate devices. The types of tests performed are listed, and for some, the new device had specific data generated ("X") or leveraged data from a predicate ("X").

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 mentions "in vitro bench tests" but does not specify the sample sizes used for each test. The data provenance (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from "Lake Region Medical" in "Galway, Ireland."

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 a medical device submission, not an AI/software claim. Therefore, the concept of "ground truth established by experts" as typically understood in AI studies (e.g., radiologists labeling images) does not apply here. The "acceptance criteria" and "performance" are based on engineering specifications and bench testing, not expert consensus on diagnostic interpretations.

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

Not applicable as this is a medical device bench testing study, not an expert-driven AI study.

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 medical device bench testing study, not an AI comparative effectiveness study.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device is based on engineering specifications, FDA guidance documents (e.g., "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995"), and established performance characteristics of the predicate devices. For biocompatibility, the ground truth is adherence to internationally recognized standards like ISO 10993-1:2009.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device, not an AI model.

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The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.

The 0.035" diameter, 260-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are manufactured from Stainless Steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE), The coil and the core components are welded together on the distal and proximal ends, forming the guidewire. The distal ends are shaped into a double-curve.

The provided text describes a 510(k) submission for a "Pre-Formed Guidewire." This is a medical device, and the information pertains to proving its substantial equivalence to a legally marketed predicate device, rather than a study on an AI/ML powered device.

Therefore, many of the requested categories (such as human-in-the-loop performance, expert ground truth for AI, typical AI study design elements) are not applicable to this type of traditional medical device submission.

Here's an analysis based on the information provided, highlighting the applicable parts and noting the non-applicable ones:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in the way one might expect for a quantitative AI performance evaluation. Instead, it lists the types of bench tests performed to demonstrate compliance with design input and substantial equivalence. The "reported device performance" is summarized as "the devices comply with the design input summary" and "resulted in the ability to demonstrate that the predetermined acceptance criteria were met."

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

• Test Set Sample Size: Not explicitly stated for each bench test. The document mentions "Test devices were manufactured and inspected."
• Data Provenance: The bench testing and animal study were conducted by Lake Region Medical, the manufacturer based in Chaska, Minnesota, USA. This is a prospective study in the sense that the tests were performed specifically for this 510(k) submission on newly manufactured devices.

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

• This is not applicable as the tests are for a physical medical device, not an AI/ML algorithm requiring expert ground truth for interpretation. Performance is measured objectively through physical and mechanical tests.

4. Adjudication method for the test set

• Not applicable for this type of physical device testing. Results are typically based on objective measurements against pre-defined 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. This is not an AI/ML powered device or an AI assistance study.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• For the bench tests, the "ground truth" or reference is the "design input summary" and "predetermined acceptance criteria" derived from engineering specifications and applicable standards (e.g., FDA, ISO standards).
• For the animal study, the "ground truth" for comparison was the performance of the currently marketed predicate device.

8. The sample size for the training set

• Not applicable. There is no AI/ML training set mentioned.

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

• Not applicable. There is no AI/ML training set mentioned.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device's safety and effectiveness (and thus meeting acceptance criteria) were demonstrated through a combination of bench testing and an animal study.

• Bench Testing: Several physical and mechanical tests were conducted on manufactured test devices. These included Dimensional, FDA Tensile Strength, FDA Tip Flexibility, FDA Catheter Compatibility, Packaging Study, Tip Shape Retention, Particulate, ISO Visual, ISO Fracture, ISO Flex, ISO Corrosion Resistance, and Linear Stiffness tests. The manufacturer states that these tests demonstrated "compliance with the design input summary" and "resulted in the ability to demonstrate that the predetermined acceptance criteria were met."
• Biocompatibility Testing: No new biocompatibility tests were performed because there were no changes to the materials used from the predicate device.
• Animal Study: A GLP (Good Laboratory Practice) animal study was conducted. This study's purpose was to evaluate the safety and performance of the new guidewire compared to the currently marketed predicate device. The conclusion was that "the guidewires are substantially equivalent to the legally marketed device."

The overall conclusion is that "the conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary which shows the device is at least as safe and effective as the current legally marketed device." The changes made to the device (additional tip shape, distal core grind diameter minimum made larger) did not alter its intended use or fundamental scientific technology, supporting the claim of substantial equivalence.

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Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, poplited anteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

The Hi-Torque Connect guidewire range are disposable medical devices designed for single use only. They consist of a PTFE coated 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support. Each of these 3 levels of support are provided in 3 different length options (145cm - 300cm)

The provided text is related to a 510(k) premarket notification for a medical device called "Hi Torque Connect Guidewire." This document focuses on demonstrating the substantial equivalence of a modified device to a previously cleared predicate device, rather than presenting a study of an AI algorithm's performance or a diagnostic device.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific ground truth types) are not applicable to this type of regulatory submission, as it deals with a physical medical device and its mechanical/material properties.

However, I can extract the acceptance criteria and performance data related to the device's physical properties.

Here's an analysis based on the information provided:

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

The document states that a design change involved a new PTFE coating for the guidewire. The performance testing was conducted to demonstrate the equivalence of the modified design to the existing design and to ensure the new coating does not adversely affect performance.

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 sample sizes (number of guidewires or test repetitions) for each bench test. It generally refers to "bench tests" being carried out.
• Data Provenance: The tests were "In vitro bench tests." The company, Lake Region Medical Limited, is located in Ireland. Therefore, the testing was likely conducted in Ireland or by designated testing facilities on behalf of the Irish manufacturer. The data is prospective as it was generated specifically for this 510(k) submission.

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

This is not applicable. The "ground truth" here is the performance of the guidewire against established engineering and material specifications, and comparison to the predicate device. This is determined by quantitative bench testing, not expert interpretation.

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

This is not applicable as the tests are quantitative bench tests, not qualitative assessments 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 is not applicable. This is a physical medical device (guidewire), not an AI algorithm for diagnostic imaging or similar application.

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

This is not applicable. This is a physical medical device.

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

The "ground truth" for this medical device's performance is based on established engineering and material specifications, as well as the performance characteristics of the previously cleared predicate device (K112381, cleared Nov 3, 2011). The tests also referenced the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995". This is a combination of:
* Engineering Specifications: Defined product specifications for the guidewire's physical and mechanical properties.
* Predicate Device Performance: Performance data from a legally marketed device used as a benchmark for substantial equivalence.
* Regulatory Guidance: Adherence to recognized testing methods and performance expectations outlined in FDA guidance.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device that requires a training set.

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

This is not applicable.

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PREDICATE™ III GUIDEWIRE are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

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 provided document describes a 510(k) premarket notification for the Predicate III Guidewire, a Class II medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than a standalone study proving novel performance against specific acceptance criteria. Therefore, most of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or AI-based devices, is not directly applicable or available in this submission.

However, I can extract information related to the device's qualification testing which serves to ensure it meets its design inputs and performs comparably to the predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met," and "The conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary." However, it does not provide a specific table listing quantitative acceptance criteria and the corresponding reported performance values for the Predicate III Guidewire. Instead, it lists the types of tests performed to ensure compliance.

Specific Qualification Tests Performed (acting as evidence for meeting implied acceptance criteria):

• Dimensional
• Guidewire Pull Test
• Camber Resistance
• Visual Inspection
• Wire Fracture Test
• Corrosion
• Wire Flex Test
• ISO Strength of Union
• Particulate Residue Test
• Cytotoxicity (Biocompatibility)
• Hemolysis (Biocompatibility)
• Chemical Characterization (Biocompatibility)

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 sample sizes used for each of the bench tests or biocompatibility tests. It generally refers to "Test devices."
• Data Provenance: Not applicable. The data is from in-house bench and lab testing of the manufactured guidewires by Lake Region Medical. The country of origin of the data is not explicitly stated but would presumably be the United States, given the company's location (Chaska, MN). The data is generated prospectively as part of product development and verification.

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. This is a medical device (guidewire) cleared based on substantial equivalence, not a diagnostic or AI device requiring expert-established ground truth from patient data. The "ground truth" for guidewire performance is established through engineering design specifications and material science.

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

• Not applicable for this type of device submission. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads).

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 is not an AI-assisted device.

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

• Not applicable. This is not an algorithm or software device. Bench testing constitutes a "standalone" evaluation of the physical device's characteristics against its design specifications.

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

• The "ground truth" for this device is based on engineering design specifications, material properties, and established medical device performance standards (e.g., ISO standards for guidewires and biocompatibility). Compliance with these predefined technical and safety requirements serves as the "truth" that the device must meet.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI 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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