Search Results

The FATHOM -16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Fathom™-16 Steerable Guidewires are hydrophilic coated, steerable guidewires intended to facilitate the placement of balloon dilatation catheters, and/or other therapeutic devices during peripheral vascular procedures. They are not intended for use in the cerebral or coronary vasculatures. The devices provided are non-pyrogenic, sterile, and intended for one procedure only. The device shaft is coated with a thin hydrophilic coating over the distal section to provide lubricity, which aids in the navigation of distal, tortuous vasculature. Accessories include a torque device, guidewire introducer and torque device. They are not intended to enter the body and have no patient contact.

The provided document is a 510(k) summary for the Boston Scientific Fathom™-16 Steerable Guidewire. This type of submission is for medical devices, specifically guidewires, not for AI/ML-driven diagnostic or assistive software. Therefore, the document does not contain information related to acceptance criteria, ground truth, expert consensus, or study designs like MRMC or standalone performance evaluations as they would apply to an AI device.

The "Performance Data" section in the document indicates that the testing was conducted to demonstrate equivalence to a predicate device, focusing on physical and mechanical properties of the guidewire. The tests listed are:

• Total Length
• Particulate
• Tip Shape Retention
• Torsional Strength
• Pre-Shape Tips

The document states, "The Fathom™-16 Steerable Guidewires met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing." However, it does not provide the specific "acceptance criteria" values or the "reported device performance" values for these tests.

Therefore, I cannot populate the requested table or answer the questions related to AI/ML device study methodologies using the provided text. The information is simply not present in this type of regulatory submission for a physical medical device like a guidewire.

Ask a specific question about this device

The AGILITY® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

The NEUROSCOUT® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the neuro and peripheral vasculature.

The hydrophilically coated AGILITY® and NEUROSCOUT® Steerable Guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The basic principle of the guidewires is to act as a monorail that catheters can track over to reach a particular area of the neuro and peripheral vasculature. They have a nominal outside diameter range of 0.012 to 0.016 inches and overall length of up to 350 cm. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the guidewires.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:

This 510(k) summary describes a modification to existing AGILITY® and NEUROSCOUT® Steerable Guidewires, specifically material changes and related manufacturing process changes. The submission asserts substantial equivalence to predicate devices, meaning that clinical testing was not required. Therefore, the acceptance criteria and studies are focused on non-clinical (bench and biocompatibility) performance rather than clinical outcomes or human reader performance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes various tests conducted to verify the modified design. The acceptance criteria for these tests are generally implied to be meeting the performance of the predicate devices or established engineering specifications, but explicit numerical acceptance criteria are not provided in this summary. The reported device performance is stated as "performed according to their description, intended use and the established performance characteristics" and "meet all the same biocompatibility requirements as the predicate devices."

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

The document does not specify the exact sample sizes used for each individual bench test (e.g., number of guidewires tested for tensile strength, number of samples for coating adherence). It indicates "Design Verification testing" was conducted.

The data provenance is internal laboratory testing conducted by Codman & Shurtleff, Inc. "Bench testing data demonstrated..." and "Full biocompatibility testing... was conducted." This is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

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

Not applicable. This submission is for a medical device (guidewire) and relies on objective, quantifiable engineering and biological tests rather than expert interpretation of medical images or records. The "ground truth" for the bench tests is defined by the established test methods and specifications, often derived from industry standards (FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995 and ISO 11070:1998, ISO 10993-1). No human experts are involved in establishing ground truth for these types of device performance tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting data (e.g., medical images) to establish a consensus ground truth. For the bench and biocompatibility tests conducted here, the "adjudication" is inherent in the test method itself – a pass/fail criterion based on objective measurements or observations.

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 product is a physical medical device (guidewire), not an AI-powered diagnostic or assistive tool. Clinical studies involving human reader performance or AI assistance are not relevant to its regulatory pathway or the provided testing summary.

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

Not applicable. This product is a physical guidewire, not an algorithm or software. "Standalone performance" in this context refers to the device's inherent physical and biological properties. The bench and biocompatibility tests assess this standalone performance against predefined standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the bench tests, the "ground truth" refers to the established performance specifications (e.g., minimum tensile strength, acceptable coating integrity, specific torque response values) that the guidewire must meet. These specifications are derived from:

• FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995
• ISO 11070:1998 Sterile Single-Use Intravascular Catheter Introducers (though the device is a guidewire, this standard was cited, likely for relevant general requirements for intravascular devices)
• Internal engineering specifications designed to ensure the device performs as intended and is equivalent to the predicate.

For biocompatibility tests, the "ground truth" is defined by international standards and regulatory guidance:

• ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)
• General Program Memorandum #G95-1 on Biological Evaluation of Medical Devices

The device is deemed to meet these "ground truths" if it passes the tests within the defined acceptable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "training set" concept does not apply to the regulatory submission for this physical medical device.

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

Not applicable. As explained above, there is no training set for this device.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The NEUROSCOUTTM Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

The hydrophilically coated NEUROSCOUT 0.014 guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The basic principle of the guidewires is to act as a monorail that catheters can track over to reach a particular area of the neuro and peripheral vasculature. They have a nominal outside diameter of 0.014 inch and nominal overall length of up to 300 cm.

The provided text describes the 510(k) summary for the NEUROSCOUT™ Steerable Guidewire. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria in the typical sense of AI/ML performance evaluation (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" here refer to meeting engineering performance standards and demonstrating safety and effectiveness comparable to existing devices. The "study" refers to a series of preclinical tests validating these physical and functional properties.

Here's an analysis based on the provided text, addressing your questions where applicable and indicating when information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the conformance to FDA Guidance and the performance of the predicate devices. The reported device performance is that it met these criteria through preclinical testing.

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

This document does not describe an "AI/ML test set" in the conventional sense. The "test set" here refers to the guidewire samples used for various preclinical tests.

• Sample Size for Test Set: Not specified in the document. The tests like tensile, torque, lubricity, etc., would have involved a sufficient number of device samples per test to generate statistically sound data, but the exact numbers are not provided.
• Data Provenance: The preclinical testing was conducted by Codman & Shurtleff, Inc. This is prospective testing of the device itself, not data from patients or a specific country. Animal studies were also conducted, implying live subject data (animals), but specific information on the type of animal or location is not given.

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 and not provided. The "ground truth" for this medical device submission involves objective physical and mechanical measurements, and direct observation of performance in simulated and animal use. It does not rely on expert interpretation of data like images for AI/ML models.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for resolving discrepancies in expert interpretations (e.g., radiologists reading images). The preclinical tests described here yield objective measurements or observations of physical performance.

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 and not provided. An MRMC study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The NEUROSCOUT Steerable Guidewire is a physical medical device, not an AI/ML product designed to assist human interpretation.

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

This information is not applicable and not provided. This device is a physical guidewire, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation refers to:

• Engineering Specifications/Standards: Performance measured against predefined acceptable ranges derived from regulatory guidance (FDA Guidance for Coronary and Cerebrovascular Guidewires, 1995) and the performance characteristics of the predicate devices.
• Objective Measurements: Results from tests for tensile strength, torque strength, flexibility, kink radius, lubricity, coating integrity.
• Observed Functional Performance: During simulated use and in animal studies to ensure user needs are met.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no mention of a "training set" as this is not an AI/ML device. The device itself is manufactured based on design specifications; it is not "trained" on data.

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

This question is not applicable and not provided for the same reason as point 8.

Ask a specific question about this device

The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.

The Sequitor™ Steerable Guidewire (.014" or .018") is a stainless steel guidewire with a polymer distal tip and a radiopaque distal tip that is shapeable. The distal 50 cm is coated with a hydrophilic coating. The guidewire length is depicted on the product label.

The provided text is a 510(k) summary for the BioSphere Medical, Inc. Sequitor™ Steerable Guidewire. It describes the device, its intended use, predicate devices, and a general statement about performance testing. However, it does not include detailed information regarding specific acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, or ground truth establishment.

Therefore, most of the requested information cannot be extracted directly from the provided document.

Here's a breakdown of what can and cannot be provided based on the input:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document states, "In-vitro and in-vivo design verification and validation testing demonstrates that the Sequitor™ Steerable Guidewire fulfills design and performance specifications." However, it does not specify what those specifications are (i.e., the acceptance criteria) or what the quantitative performance results were against those criteria.

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

• Cannot be provided. The document mentions "in-vitro and in-vivo design verification and validation testing" but does not provide any details about the sample sizes used in these tests or the provenance of any data (e.g., country of origin, retrospective/prospective).

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

• Cannot be provided. This information is typically relevant for studies involving human interpretation (e.g., imaging devices with AI assistance). This document describes a guidewire, which is a physical device, and its testing would likely involve engineering and clinical performance evaluations, not expert-established ground truth in the context of diagnostic interpretation.

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

• Cannot be provided. Similar to point 3, adjudication methods are usually for resolving discrepancies in expert interpretations, which is not applicable to the type of device and testing described here.

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:

• Cannot be provided. An MRMC study is relevant for AI-assisted diagnostic tools. The Sequitor™ Steerable Guidewire is a physical medical device (a guidewire), not an AI diagnostic tool. Therefore, this type of study is not applicable.

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

• Cannot be provided. This question is also relevant for AI algorithms. The device described is a physical guidewire, so the concept of an "algorithm only" performance doesn't apply.

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

• Cannot be provided. As a physical guidewire, its performance would be assessed against engineering specifications (e.g., flexibility, torque transmission, coating integrity, tensile strength) and possibly clinical outcomes related to its safe and effective use (e.g., successful catheter placement, lack of vessel damage). The document only vaguely refers to "design and performance specifications" without detailing them or the ground truth against which they were measured.

8. The sample size for the training set:

• Cannot be provided. This concept is specific to machine learning/AI models. The guidewire is a physical device and doesn't involve a "training set."

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

• Cannot be provided. As explained in point 8, this is not applicable to the described device.

Ask a specific question about this device

Lake Region's steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature, including the renal vasculature. The steerability feature allows the guidewire to be torqued to facilitate navigation through the vasculature.

This device is a guidewire with a PTFE coated stainless steel core that has been ground at the distal end to provide the appropriate tip flexibility. The coils are joined to the core at the ground end and a distal tip coil is soldered to the core. The proximal PTFE coated portion of the core has two sections of the PTFE removed to aid in estimating guidewire positioning. The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are optionally coated with MDX (silicone). The guidewires are bound by the following parameters: Outside Diameter: .014" - .018", Lengths: 130cm - 300cm, Tips: Straight or shaped with various tip flexibilities.

Here's an analysis of the provided text regarding the acceptance criteria and study for the medical device (guidewire):

Important Note: The provided document is a 510(k) summary, which is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on showing that a new device is as safe and effective as an existing one, rather than proving efficacy from scratch with extensive clinical trials. Therefore, much of the information typically sought for a study proving device performance (like detailed sample sizes, expert qualifications, MRMC studies, or standalone performance) is often not present in these documents.

Acceptance Criteria and Reported Device Performance

The core of this 510(k) submission is that the proposed device is substantially equivalent to a predicate device. This means the acceptance criteria are implicitly met by demonstrating that the new device performs comparably to the predicate and that any differences do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a numerical sample size for a "test set" in the traditional sense of a clinical study or even a detailed verification/validation study. The testing described is primarily bench testing for "Qualification Testing," focusing on visual/tactile, dimensional, and mechanical attributes.

• Sample Size: Not specified. It refers to "Test pieces" which are likely units of the guidewire product.
• Data Provenance: The testing was performed in-house by Lake Region Manufacturing, Inc. (LRM). It is retrospective in the sense that it evaluates a modified device against established requirements and a predicate's performance. The country of origin of the data would be the USA (where LRM is located).

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

This information is not provided in the 510(k) summary. Given that it's primarily bench testing for substantial equivalence, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, or industry standards, rather than expert-established ground truth on clinical cases.

4. Adjudication Method for the Test Set:

This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic evaluations where human interpretation of complex data is involved. This document describes physical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. MRMC studies are typically used for diagnostic or screening devices to evaluate reader performance. This device is an interventional tool (guidewire) subject to performance testing against engineering specifications and comparison to a predicate.

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

This question is not applicable to a guidewire. "Standalone performance" usually refers to the performance of an AI algorithm without human involvement. The guidewire is a physical medical device that inherently requires human-in-the-loop operation. The "device performance" is its physical and mechanical characteristics as measured in bench tests.

7. The Type of Ground Truth Used:

The ground truth used for verifying the new device's performance against its own design and against the predicate device is:

• Engineering specifications: The device must meet predefined dimensional, mechanical, and material specifications.
• Predicate device characteristics: The proposed device's performance (visual, tactile, dimensional, mechanical) must be "comparable" to the currently marketed predicate device.
• Established requirements/industry standards: The testing was performed against "established requirements."

8. The Sample Size for the Training Set:

This question is not applicable to this type of device. "Training set" refers to data used to train an algorithm (e.g., in AI/ML). This guidewire is a physical medical device, not a software algorithm, so there is no training set.

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

This question is not applicable for the same reason as #8.

Ask a specific question about this device

Lake Region's steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature, including the renal vasculature. The steerability feature allows the guidewire to be torqued to facilitate navigation through the vasculature.

Utilizing a proprietary process, LRM produces a PTFE coated stainless steel steerable core. The proximal portion of the core wire is coated with PTFE to provide lubricity and improve wire handling. A platinum alloy coil provides radiopacity in the distal tip. The coil is secured in its location by solder, which is attached to the core. The proximal end of the coil is attached to the core with solder. Additionally, two sections of PTFE are removed from the proximal end of the core to aid in estimating guidewire positioning. The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are optionally coated with MDX (silicone). The guidewires are bound by the following parameters: Outside Diameter: .018", Lengths: 130cm - 300cm, Tips: Straight or shaped with various tip flexibilities, Flexibility: Floppy to Support.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a guidewire, and the submission emphasizes its substantial equivalence to previously cleared predicate devices (K970376 and K011968), rather than detailing specific numerical performance metrics for acceptance criteria and results. The "performance" is primarily demonstrated through meeting established requirements and the absence of adverse effects due to minor modifications.

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

• Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial or large-scale performance study. It mentions "Test pieces were tested and inspected" (Section 2.5.4) and "testing was done to ensure the changes to the device met the predetermined performance criteria" (Section 2.5.1), but without a number. This submission relies heavily on a "substantial equivalence" argument, meaning much of the "proof" comes from the established performance of the predicate devices combined with verification of the minor changes.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be primarily non-clinical bench testing and in-house verification against established standards and internal protocols. There's no mention of patient data.

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

This information is not provided in the document. The "ground truth" for guidewire performance in this context would likely be defined by the established engineering specifications and performance standards (FDA guidance, ISO 11070, internal protocols) rather than expert consensus on individual cases. The document refers to "established specific inspection criteria requirements" (Section 2.5.4) which would have been defined by qualified engineers and regulatory specialists during the design control process.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth from clinical data. Since the testing described is primarily non-clinical bench testing and verification against standards, such a method wouldn't typically be used.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images with and without AI assistance. This submission pertains to a physical medical device (guidewire), not an AI algorithm. Therefore, there is no mention of human readers, AI assistance, or effect sizes in this context.

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

No. This is a submission for a physical medical device (guidewire), not a standalone AI algorithm. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering Specifications: Conformance to the design and performance criteria set for guidewires, identical to the predicate device.
• Regulatory Standards: Compliance with requirements of the FDA guidance document "Coronary and Cerebrovascular Guidewire Guidance, issued January 1995," and ISO 11070 "Sterile Single-use Intravascular Catheter Introducers."
• Internal Protocol Requirements: Verification against LRM's own internal test protocols, especially for verifying use in peripheral and renal vasculature.
• Visual/Tactile, Dimensional, and Mechanical Attributes: Established specific inspection criteria for these physical properties. (Section 2.5.4)

Essentially, the ground truth is a combination of validated engineering requirements and compliance with recognized industry and regulatory standards.

8. The Sample Size for the Training Set

This information is not applicable/provided. The concept of a "training set" is relevant for machine learning or AI algorithms. This submission is for a physical medical device (guidewire), which does not involve a training set in this context. The "training" for the device's design would be the extensive R&D and manufacturing experience of LRM that led to the predicate devices.

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

This information is not applicable/provided for the reasons stated in point 8.

Ask a specific question about this device

The Back-Up Meier Steerable Guidewire facilitates catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures.

The proposed Back-Up Meier Steerable Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures including AAA endovascular graft procedures. The Back-Up Meier Steerable Guidewires are sterile, single-use wirres and are available in different tip shapes with overall wire lengths of 185cm - 300cm. The distal segment of the wire is radiopaque to aid in visualization of the device under fluoroscopy.

The provided text describes a medical device, the "Back-Up Meier Steerable Guidewire," and its 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device and does not involve a study with acceptance criteria and device performance as typically understood for AI/ML-based medical devices.

Therefore, many of the requested categories are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "criteria" for this 510(k) submission are related to demonstrating substantial equivalence through bench testing and biocompatibility.

• Reported Device Performance: The document states: "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen."

  This is a qualitative statement about the outcomes of the tests, not specific performance metrics (e.g., accuracy, sensitivity, specificity) against predefined numerical acceptance criteria.

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

• Sample Size: Not applicable. The submission refers to "bench testing" and "biocompatibility testing," which typically involve a set number of devices or material samples for physical, mechanical, and biological evaluations, not a "test set" of patient data as implied by the question.
• Data Provenance: Not applicable, as there is no patient data involved in this type of submission for this device.

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

• Not applicable. There is no "ground truth" derived from expert consensus on patient data presented in this submission. The evaluation is based on engineering and biological test standards.

4. Adjudication Method for the Test Set:

• Not applicable for the reasons stated above.

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

• No. This type of study is not relevant for a guidewire device and its 510(k) submission.

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

• No. This is not an AI/ML algorithm or software device.

7. The Type of Ground Truth Used:

• Not applicable. The "ground truth" for the performance of a guidewire is compliance with established engineering and biocompatibility standards, not clinical outcomes data in the context of an AI/ML algorithm.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI/ML model being trained.

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

• Not applicable for the reasons stated above.

Conclusion based on the provided text:

The submission for the Back-Up Meier Steerable Guidewire is a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The "study" referenced refers to bench testing and biocompatibility testing to show the device meets requirements for its intended use. This is a much different type of evaluation than what is typically performed for AI/ML devices, and therefore, many of the requested details about acceptance criteria, data sets, and expert evaluations are not present in this document. The FDA's letter (K020283) confirms that the device was found substantially equivalent to the predicate device based on the information provided, which included these tests.

Ask a specific question about this device

Ask a specific question about this device