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For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The Trailrunner™ Guidewire is comprised of a PTFE coated stainless steel proximal core body and a Nitinol distal core body, joined by a Nitinol hypotube. The distal Nitinol core is inserted into the inside diameter of two adjacent, coaxial coils: a platinum coil (distal) and a stainless steel coil (proximal). A stainless steel flat wire (ribbon) is also inserted into the inside diameter of the coils. At the proximal extent of the stainless steel coil, a solder joint binds the coil to the Nitinol core and the flat wire. A second solder joint binds both coils at their junction; the core, and the SS ribbon together, A third solder joint at the distal tip of the device bonds the ribbon to the platinum coil. Depth markings using white PTFE are applied to the proximal end of the core. The distal tip of the guidewire is coated with hydrophilic coating. The 185cm version is designed to mate with the Lake Region extension wire cleared with other Lake Region Guidewires(Reference 510(k);s K970376, K041624)

The provided text describes a 510(k) submission for the TRAILRUNNER™ Guidewires, seeking substantial equivalence to a predicate device. This type of submission does not involve clinical trials with acceptance criteria for device performance in the same way a de novo or PMA submission might. Instead, substantial equivalence is demonstrated through non-clinical testing and comparison to a legally marketed predicate device.

Here's an analysis based on the information provided, specifically addressing the points in your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in terms of specific performance metrics with numerical values (e.g., sensitivity, specificity, accuracy) that would be common for AI/ML devices or diagnostics. Instead, the acceptance criterion for this 510(k) is substantial equivalence to the predicate device, the GUIDANT High Torque BMW Guidewire (K983033).

The "reported device performance" is described qualitatively as:

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a separate "test set" for performance evaluation in the context of clinical outcomes. The non-clinical testing involved "test pieces" for visual/tactile, dimensional, and mechanical attributes. The number of these test pieces is not quantified here.
• Data Provenance: Not applicable in the sense of patient data provenance (e.g., country of origin, retrospective/prospective). This is a physical medical device and the "data" would be from lab-based non-clinical tests.

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

• Number of Experts: Not applicable. For this type of 510(k) substantial equivalence submission, ground truth is established through engineering specifications, material properties, and physical performance testing against established standards or internal benchmarks, rather than expert clinical consensus on patient data.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Test results for physical and mechanical properties are typically objective measurements, not subject to expert adjudication of subjective interpretations.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices or AI-assisted diagnostic tools where human reader performance is a key metric. This submission is for a physical medical guide wire.

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

• Standalone Performance: Not applicable. This is not an AI/ML algorithm or a diagnostic device. The performance is intrinsically linked to its physical interaction during a medical procedure, but its evaluation for this submission is based on non-clinical engineering and material properties.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Engineering Specifications and Design Documents: The core "ground truth" for the device's design and materials.
  • Predicate Device Characteristics: The established design, materials, and (presumably) validated performance of the legally marketed predicate device served as the primary reference for comparison.
  • ISO Standards (e.g., ISO 10993 for biocompatibility): These provide the ground truth for safety aspects like biocompatibility.
  • Established Test Methods and Performance Requirements: For mechanical and functional tests, the ground truth is the expected performance based on relevant engineering principles and industry norms for such guidewires.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set.

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For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

These Freeway™ and Railrunner™ Guidewires are composed of two primary components: A PTFE coated stainless steel steerable core body, and a radiopaque platinum alloy distal coil. The coil is secured in its location by solder, which is attached to the core. The coil is attached to the core at the distal end, proximal end of the coil, and at a midpoint section (intermediate ioint). The product is offered with a shapeable straight tip or in a pre-shaped configuration. The Guidewires are optionally coated with MDX (silicone) over the distal tip and hydrophilic coating over portions of the distal tip of the Guidewire. The Guidewires are bound by the following parameters: Outside Diameter: .014", Lengths: 175cm - 300 cm, Tips: Straight or shaped, Flexibility: FREEWAY - 3 and 6 gm and RAILRUNNER - 9 and 12 gm distal loads.

No AI device assessment was conducted in the provided document. The submission is for Freeway™ and Railrunner™ Guidewires, which are physical medical devices (guidewires) and not an AI/ML software. Therefore, the requested information about acceptance criteria, study details, and AI performance metrics is not applicable based on the given text.

The document discusses non-clinical testing to demonstrate equivalence to predicate devices, biocompatibility testing, and conformance with design control procedures and quality systems, but these do not involve AI performance evaluation.

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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, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges of catheters, cannulas, and sphincterotomes.

The Taxi® Endoscopic Guidewire is a dual colored, spiral patterned guidewire. The quidewire is composed of a Nitinol core with a dual colored PTFE jacket applied over the core to provide endoscopic visualization of wire movement. A polyurethane/lungsten loaded jacket encapsulates the distal end and ensures radiopacity. The distal tip of the guidewire is coated with hydrophilic coating.

The provided text is a 510(k) Summary for the Taxi® Endoscopic Guidewire (K081708). This document outlines the device's characteristics and its substantial equivalence to a predicate device, rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one would for an AI/ML-driven diagnostic device.

Therefore, many of the requested categories for defining acceptance criteria and study details are not applicable to the information provided. The document describes non-clinical tests to demonstrate safety and effectiveness for a medical device (guidewire), not a diagnostic algorithm.

Here's an attempt to extract relevant information where possible, and indicate where the requested information is not present in the provided text:

Acceptance Criteria and Device Performance (Limited Information available for a medical device, not a diagnostic algorithm):

Study Details (Not applicable for most items, as this is for a medical device's 510(k) submission, not an AI/ML diagnostic study):

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

   • Test Set Sample Size: Not specified in terms of specific number of guidewires tested, but "Test pieces" are mentioned.
   • Data Provenance: Not applicable. The testing was conducted by the manufacturer, Lake Region Manufacturing, Inc. (LRM).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to established engineering and material science standards for device performance, not expert labels for diagnostic images.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to resolving discrepancies in expert labeling for diagnostic studies.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a guidewire, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a guidewire, not an algorithm.

6. 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 requirements, material specifications (e.g., Nitinol core, PTFE jacket), and performance standards (e.g., ISO 10993 for biocompatibility). The document states, "Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."

7. The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML model.

8. How the ground truth for the training set was established: Not applicable. This device does not involve a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a series of non-clinical tests performed by Lake Region Manufacturing, Inc. (LRM). These tests assessed the device's functionality, performance characteristics, and biocompatibility.

• Non-Clinical Tests: "LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." The conclusion was that "The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the similar currently marketed devices."
• Biocompatibility Testing: "Biocompatibility testing per ISO 10993 series has been performed on the Taxi® Endoscopic Guidewire and has been found to be acceptable."

The overall conclusion states that the device is "substantially equivalent" to the predicate device (JAGWIRE™ RECANALIZATION GUIDEWIRE K922302) based on these non-clinical evaluations. This substantial equivalence determination by the FDA indicates that the device is considered safe and effective for its intended use without requiring a full clinical trial for approval.

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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Nitinol or Stainless Steel core with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetratlyoroethylene). Portions of the Guidewire can also be subsequently coated with silicone MDX4-4159 Fluid. The Guidewires are bound by the following parameters: Outside Diameter: .014" - .035" Lengths: Straight or shaped with various tip flexibilities. Tips: Coil Length: 2cm - 30 cm

The provided text describes a 510(k) premarket notification for Mandrel Guidewires (M-Wires), seeking substantial equivalence to existing predicate devices. However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

The document states that "Risk analysis was completed by means of a Failure Mode and Effect Analysis (FMEA) and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met." It also mentions "LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visualitactile, dimensional and mechanical attributes." And "Biocompatibility testing per ISO 10993 series has been performed on the Mandrel device and has been found to be acceptable."

However, it does not explicitly list the predetermined acceptance criteria themselves or the detailed results of the tests against these criteria in a quantitative manner. It only states that the results "demonstrated the functionality and performance characteristics of these Guidewires are comparable to the currently marketed devices" and "support the claim of substantial equivalence to the predicate devices."

Therefore, much of the requested information cannot be extracted from this specific filing.

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

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

Note: The document states that the predetermined acceptance criteria were met, but it does not specify the quantitative values for these criteria. The "Reported Device Performance" is a summary statement of comparability and acceptability, rather than specific performance metrics against defined thresholds.

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 for Test Set: Not specified in the provided text. The document only mentions "Test pieces were tested and inspected."
• Data Provenance: Not specified, but likely internal testing conducted by Lake Region Manufacturing, Inc. in Chaska, MN, USA. There is no mention of external data or patient data.
• Retrospective/Prospective: The testing described is prospective, in the sense that the new Mandrel Guidewire iterations were specifically tested to demonstrate equivalence.

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 information is not applicable and not provided. The "ground truth" for this type of device (guidewire) is typically established through engineering specifications, material science, and performance testing against established physical and biological standards, not through expert clinical consensus on images or patient outcomes in the context of a diagnostic AI.

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

• This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data where consensus is needed for ground truth. This filing discusses non-clinical engineering and 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, an MRMC comparative effectiveness study was not done. This is a medical device (guidewire), not a diagnostic AI algorithm that assists human readers.

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

• This is not applicable. The device is a physical medical guidewire, not an algorithm. The testing described is "standalone" in the sense that it evaluates the physical device's properties (visual/tactile, dimensional, mechanical attributes, biocompatibility).

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

• The ground truth for the non-clinical tests appears to be based on established engineering specifications, material standards, and performance requirements relevant to guidewires, as well as the ISO 10993 series for biocompatibility. This is considered objective, measurable physical properties and material safety standards rather than expert clinical consensus or pathology.

8. The sample size for the training set

• This is not applicable. The Mandrel Guidewires are physical medical devices, not an AI algorithm that requires a "training set."

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

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

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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The Pegasus 10 steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The wire employs a stainless steel proximal core shaft joined to a nitinol distal ground core portion. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire. The guidewires will be packaged in the standard Lake Region single pack packaging configuration (one wire in a dispenser, placed in a pouch, labeled and then placed in individual cartons). There will be no changes to the sterilization process for these guidewires.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Pegasus™ Guidewire.

Important Note: The provided document is a 510(k) Premarket Notification Summary for a medical device (guidewire). Such summaries primarily focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed clinical study proving strict acceptance criteria for a novel device. Therefore, the information you're requesting, particularly details on sample sizes, expert qualifications, and specific AI-related metrics, is largely not present in this type of document because it's not typically required for a 510(k) for a guidewire.

This document describes a non-clinical, benchtop comparison to a predicate device.

Acceptance Criteria and Study to Prove Device Performance:

Due to the nature of a 510(k) Premarket Notification for a guidewire, the "acceptance criteria" are primarily focused on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "study" referenced is a series of non-clinical, benchtop qualification tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of specific, quantitative acceptance criteria with corresponding performance metrics like a clinical trial report would. Instead, it states the following:

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

• Sample Size: Not specified quantitatively. The document states "Test pieces were tested," implying a defined number, but the exact count is not provided.
• Data Provenance: The testing was "Non-Clinical Tests" performed by LRM (Lake Region Manufacturing, Inc.) and Stereotaxis. This indicates laboratory/benchtop testing, not human subject data. The country of origin for the data is implicitly the USA, where Lake Region is located. The study is not retrospective or prospective in the clinical sense, as it's non-clinical bench testing.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

• Not Applicable: This type of non-clinical testing for a guidewire does not involve "experts" establishing a "ground truth" in the clinical diagnostic sense. The comparison is against established engineering specifications and the performance of a predicate device.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of clinical data (e.g., radiology images). This guidewire testing involves objective measurements and comparisons against engineering specifications and predicate device performance, not subjective human interpretation requiring adjudication.

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

• No: A MRMC study is not mentioned because this is a non-clinical submission for a guidewire. Such studies are typically conducted for diagnostic imaging devices or AI-powered clinical decision support tools where human readers are interpreting medical cases.
• Effect Size of Human Readers with/without AI Assistance: Not applicable, as no AI component for human assistance is described in this device or associated testing.

6. Standalone (Algorithm Only) Performance Study:

• Yes, in the context of non-clinical performance: The device itself (guidewire) is being tested for its standalone physical and mechanical performance characteristics (e.g., steerability, tip strength, lubricity, biocompatibility) without a human-in-the-loop performance metric being specifically detailed, beyond proving equivalence to the predicate. There is no "algorithm" in the AI sense for a guidewire.

7. Type of Ground Truth Used:

• Engineering Specifications and Predicate Device Performance: The "ground truth" for this submission are the established engineering design specifications for the device, and the known, acceptable performance characteristics of the legally marketed predicate device (Titan™ guidewire). Biocompatibility has its own 'ground truth' in the form of ISO 10993 standards.

8. Sample Size for the Training Set:

• Not Applicable: This device is a physical guidewire and does not involve AI algorithms that require a "training set" of data.

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

• Not Applicable: As there is no AI training set, this question is not relevant.

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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The Titan M steerable quidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.

The provided document is a 510(k) premarket notification for a medical device (Titan steerable guidewire). It does not describe a study involving an AI/ML device, nor does it present acceptance criteria or performance metrics in the way typically expected for such devices.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's why the document does not contain the requested information:

• Device Type: The document describes a physical medical device (guidewire), not an AI/ML system.
• Study Type: The "qualification testing" mentioned refers to non-clinical tests (visual/tactile, dimensional, mechanical attributes) to demonstrate equivalence to a predicate device, not a clinical study to assess the performance of an AI/ML algorithm.
• Ground Truth, Experts, Sample Sizes (for AI/ML): These concepts are not applicable to the type of device and testing described in the document.
• Acceptance Criteria/Performance Metrics (for AI/ML): The document states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met," but it does not specify what those criteria were in terms of performance metrics for an AI/ML system. It only generally refers to the device being comparable to currently marketed devices and supporting substantial equivalence.

If you have a document describing an AI/ML device and its associated studies, I would be able to extract the requested information.

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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

These steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 180 cm and 300 cm. The wire is configured with a radiopaque gold cup at the distal end and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.

This document describes a 510(k) premarket notification for a medical device, specifically the Titan™ Guidewire. Such submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with specific acceptance criteria and performance metrics for a new, innovative device's clinical efficacy. Therefore, a direct answer to your request, formatted as a table of acceptance criteria and reported device performance with all the specified details, is not fully extractable from the provided text.

The document states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met." However, it does not explicitly list these acceptance criteria or the specific quantitative results for the Titan™ Guidewire. Instead, it relies on demonstrating equivalence to predicate devices through "Qualification Testing" (Non-Clinical Tests and Biocompatibility Testing).

Here's what can be inferred and explicitly stated from the provided text based on your request, with significant limitations due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantified acceptance criteria and specific performance results for the Titan™ Guidewire itself are not provided in this 510(k) summary. The document focuses on demonstrating that the device is "substantially equivalent" to predicate devices, implying that its performance meets the established safety and effectiveness profiles of those predicates.

The text does state that:

• "Test pieces were Stereotaxis performed tooling to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."
• "The requirements for visual/tactile, functionality and performance results of these guidewires are comparable to the currently marketed devices."
• "All non-clinical test embedded magnet being assemmal equivalence to the predicate devices." (Likely a typo, meant to convey "all non-clinical tests re-affirmed substantial equivalence").

In lieu of a specific table, the "acceptance criteria" can be broadly interpreted as meeting the performance and safety profiles of the predicate devices. No specific numerical values for these criteria are given.

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

• Test Set Sample Size: Not specified. The document mentions "test pieces" for non-clinical testing but does not provide details on the number of units tested.
• Data Provenance: The testing described (visual/tactile, dimensional, mechanical attributes, biocompatibility) are non-clinical (bench) tests. The document does not refer to clinical test sets with patient data.

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

• Not applicable. The "ground truth" concept usually applies to clinical studies where experts evaluate outcomes. For these non-clinical tests, the "ground truth" would be established by the testing methodology and the specification requirements themselves, not by expert consensus in a clinical context.

4. Adjudication method for the test set

• Not applicable. This applies to clinical studies or assessments requiring human interpretation. The non-clinical tests would have pass/fail criteria based on 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

• No. This is a 510(k) submission for a guidewire, which is a physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

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

• For the non-clinical tests, the "ground truth" was based on engineering specifications and established test methods designed to ensure the device's physical attributes, functionality, and biocompatibility are comparable to predicate devices. There is no mention of clinical ground truth (e.g., pathology, outcomes data) for the Titan™ Guidewire itself in this submission document beyond relying on the predicate device's established safety and efficacy.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

• Not applicable. See point 8.

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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.

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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral 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, placed within the confines of the outer coil and over-wrapping the distal core section, provides radiopacity in the distal tip. The coils are secured in their location by solder, which is attached to the core. The proximal end of the outer coil is attached to the core with braze, and the distal end has a mid-point of the outer coil which is attached to the core with solder (applicable designs). The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are coated with MDX (silicone) or with hydrophilic coating. The guidewires are bound by the following parameters: Outside Diameter: .014", Lengths: 175cm - 300cm, Tips: Straight or shaped with various tip flexibilities, Flexibility: Floppy to Extra Support.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify an exact numerical sample size for the test set used in non-clinical tests. It refers to "Test pieces" being tested.
• Data Provenance: The data provenance is not explicitly stated. The testing was conducted by Lake Region Manufacturing, Inc. (LRM), based in Chaska, MN, USA. It is implied to be internal company testing and is retrospective to the submission date.

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

• This information is not applicable to this submission. The "acceptance criteria" and "ground truth" discussed here refer to objective engineering and material performance tests for a medical device (guidewire), not a diagnostic or AI-driven interpretative device that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods are relevant for subjective assessments, typically found in clinical trials or diagnostic studies where multiple experts interpret data. The tests described are objective non-clinical performance and material tests.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not the scope of this guidewire submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone algorithm performance study was not done. This submission is for a physical medical device (guidewire), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for the test set was based on established specific inspection criteria requirements for visual/tactile, dimensional, and mechanical attributes, as well as criteria established for the hydrophilic properties of the guidewire. For biocompatibility, it was based on biocompatibility testing performed on material components and a market history of proven biocompatibility. For design control and risk analysis, it was based on conformance with 21 CFR 820.30 and results of FMEA verification and validation activities. For material/product/process qualification, it was based on achieving equivalence to predicate products and ensuring no adverse effect on safe and effective use.

8. The Sample Size for the Training Set

• This information is not applicable. This submission describes the testing of a physical medical device (guidewire) to demonstrate substantial equivalence, not the development or training of an AI algorithm.

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

• This information is not applicable. As stated above, this is not an AI/algorithm submission.

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The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.

The Lake Region Hydrophilic Guidewire consists of a flexible, tapered core wire that decreases in outer diameter from the proximal to the distal end. The hydrophilic coating reduces friction during use. The radiopaque distal coil facilitates fluoroscopic visualization. The Lake Region Hydrophilic Guidewire will be available in two configuration, with either an outer diameter of 0.010" or 0.014" and 180cm long.

The provided text describes a 510(k) premarket notification for a medical device, specifically the Lake Region Hydrophilic Guidewire. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (K003084), not to prove that the device meets specific acceptance criteria through new clinical or performance studies.

Therefore, many of the requested sections related to acceptance criteria, device performance, sample sizes, ground truth, and expert adjudication are not applicable to this document as it is a substantial equivalence submission, not a de novo submission or a PMA (Premarket Approval) where new performance data would typically be generated and presented against acceptance criteria.

However, I can extract information related to the device itself and the basis for its substantial equivalence.

Here's a breakdown based on the provided document:

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

This information is not applicable as this submission is for substantial equivalence to a predicate device, and no new performance acceptance criteria or testing were conducted for the proposed device itself. The document explicitly states: "As there were no changes to the device itself and Lake Region conducted the original design verification testing used to establish safety and effectiveness under Concentric Medical Hydrophilic Guidewire K003084, no further testing has been required."

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

This information is not applicable. No new test set data was generated for the proposed device. The submission relies on the data that established the predicate device's safety and effectiveness.

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 information is not applicable. No new ground truth establishment was reported for the proposed device.

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

This information is not applicable. No new test set data or adjudication method was reported for the proposed device.

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. This is a medical device for intravascular use (a guidewire), not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

This information is not applicable. As in point 5, this is not an AI/algorithm-based device.

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

This information is not applicable for the proposed device directly. The "ground truth" for its safety and effectiveness was established through design verification testing conducted for the predicate device (K003084), which involved laboratory and engineering tests to ensure physical and performance specifications were met. This would typically involve objective measurements against predefined specifications, rather than expert consensus on diagnostic outcomes.

8. The sample size for the training set

This information 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 information is not applicable. As in point 8, this is not an AI/machine learning device.

Summary of the Device and Substantial Equivalence Claim (as per the document):

The document aims to demonstrate that the Lake Region Hydrophilic Guidewire is substantially equivalent to a predicate device cleared under 510(k) K003084. The basis for this claim is that the proposed device is identical to the predicate device, which Lake Region Manufacturing (LRM) previously manufactured for Concentric Medical. LRM also conducted the original design validation testing for that predicate device.

Key points from the document supporting substantial equivalence:

• Proposed Device is the same as the Predicate Device: "The proposed device is the same device as the predicate device."
• No Changes to Core Device Attributes: The comparison table explicitly states "No change" for Raw Materials, Assembly Process, Physical Characteristics, Intended Use, Anatomical Sites, Target Population, Performance Testing, Safety Characteristics, and Biocompatibility.
• Minimal Labeling Change: "The only change to the IFU will be to the manufacturer information and the omission of the optional introducer information."
• Original Testing Suffices: "As there were no changes to the device itself and Lake Region conducted the original design verification testing used to establish safety and effectiveness under Concentric Medical Hydrophilic Guidewire K003084, no further testing has been required."
• Design Control and Validation: LRM is in conformance with 21 CFR 820.30 and states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria could be met" for the original design.
• Biocompatibility: "The materials for the proposed device are identical to the predicate device cleared under K003084 and are identically processed and sterilized. Therefore, biocompatibility testing for the proposed device is not required."

In essence, the "study" proving the device meets acceptance criteria is the original design verification and validation testing performed for the predicate device K003084, which the current device is identical to.

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