Search Results

The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures. These guide wires are not intended for Percutaneous Transluminal Coronary Angioplasty use or for use in the neurovasculature.

The Splashwire Hydrophilic guide wire consists of a nitinol core wire with a ground tapered distal section. A polyurethane jacket which contains tungsten for radiopacity is applied over the core wire and a hydrophilic coating is applied over the polyurethane jacket. The surface of the jacket is uniform with both the distal and proximal ends fully coated. The wire is placed inside a multiple loop flush dispenser, also referred to as a hoop. The dispenser has a flush port which facilitates solution flushing through the hoop to hydrate the guide wire. The wire is placed so that the distal end of the wire comes out of the outer portion of the hoop. A J-straightener is placed on the other end of the hoop to introduce the wire into the catheter. The wire is sold sterile and is a single use device. The subject Splashwire Hydrophilic Guide Wire Line Extensions and the predicate Splashwire Hydrophilic Guide Wire share the device characteristics described above, with the subject guide wire incorporating the following additional modifications:

J-Tip Guide Wires:
The J Tip devices incorporate a distal tip formed into a J shape. These guide wires are provided with a 1.5 mm J Tip.

Long Taper Guide Wires:
The Long Taper Guide Wires incorporate an extended core wire taper length providing enhanced flexibility.

The provided FDA 510(k) clearance letter and summary for the Splashwire Hydrophilic Guide Wire (K251181) outlines the regulatory approval process and demonstrates substantial equivalence to a predicate device (K201595). However, it does not contain the specific information required to address your request regarding acceptance criteria and the detailed study that proves the device meets those criteria, particularly for an AI-enabled medical device.

The document describes a traditional medical device (a guide wire) and the non-clinical bench testing performed to ensure its safety and performance. This typically involves physical and mechanical property tests. It does not refer to AI/ML software, algorithms, or any studies involving human readers or ground truth expert consensus in the way you've outlined.

Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI-enabled device, nor details on sample sizes, expert ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

Based on the provided document, the device is a physical medical device (a guide wire), not an AI-enabled one. The acceptance criteria and "study" described are standard bench tests for physical properties, not performance metrics for an AI algorithm.

Here's a breakdown of what can be inferred from the document regarding the device's performance, but it does not align with the parameters of an AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Testing was conducted on the subject Splashwire Hydrophilic Guide Wire in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." And "All test results were comparable to the predicate Splashwire Hydrophilic Guide Wire and the subject Splashwire Hydrophilic Guide Wire met the predetermined acceptance criteria."

While specific numerical acceptance criteria and performance data are not provided in this summary, the document indicates that the following categories of non-clinical bench tests were successfully completed and met their predetermined acceptance criteria:

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

This information is not available in the provided document. For a physical medical device, "test set" would refer to the number of units tested for each characteristic. The provenance of the data is not applicable in the context of clinical images or patient data; it would refer to the samples of the manufactured guide wire used for the bench tests. These are likely internal lab tests.

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

This information is not applicable to this type of device and study. "Ground truth" in this context would be derived from the physical properties of the device measured by laboratory instruments, not expert human interpretation of data.

4. Adjudication Method for the Test Set:

This information is not applicable as there are no human interpretations or adjudications involved in the physical bench tests.

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

This information is not applicable. MRMC studies are relevant for software that aids human interpretation (e.g., AI for radiology). This device is a physical guide wire.

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

This information is not applicable. This describes the performance of a physical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on measurements of its physical and mechanical properties according to established industry standards and FDA guidance for guide wires (e.g., ISO standards, FDA guidance on guidewire performance). It's not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

This information is not applicable. This device is not an AI/ML algorithm that requires a training set. The "design controls" mentioned refer to the engineering and manufacturing process, not data training.

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

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

In summary, the provided document details the 510(k) clearance for a physical medical device (Premarket Notification: K251181) and its substantial equivalence based on standard bench testing. It does not provide information relevant to the assessment of an AI-enabled medical device.

Ask a specific question about this device

The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures.

The guide wires may also 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 Command™ 14 ST Guide Wire (guide wire with short taper) and Hi-Torque Command™ 14 MT Guide Wire (guide wire with medium taper) have a maximum diameter of 0.0144" (0.366 mm) and are provided in 210 cm and 300 cm lengths. The distal tip of the guide wire is available as a straight tip or an angled tip, both of which are shapeable.

The provided FDA 510(k) clearance letter pertains to guide wires, which are physical medical devices, not AI/software systems. Therefore, the questions related to AI/software performance (e.g., ground truth establishment, MRMC studies, training/test sets, expert adjudication) are not applicable to this document.

For a physical device like a guide wire, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to non-clinical performance testing to demonstrate that the device performs as intended and is substantially equivalent to a predicate device, ensuring its safety and effectiveness.

Here's an analysis based on the provided document for the guide wires:

Analysis of Acceptance Criteria and Performance for Abbott Medical Guide Wires (K250552)

The substance of this 510(k) clearance is that the subject devices are identical to predicate devices, and the submission is primarily for a labeling change. This means extensive new performance testing demonstrating equivalence to a new set of criteria beyond what was already established for the predicate is not explicitly detailed as part of "new" acceptance criteria in this document. Instead, the testing listed serves to confirm that the labeling changes do not negatively impact the device's safe and effective use, and that the subject device remains substantially equivalent to its predicate.

Given that the device design, materials, and technological characteristics are identical between the subject and predicate devices, the "acceptance criteria" for this specific 510(k) are implicitly tied to confirming that the existing performance characteristics (established for the predicate) are maintained and that the labeling changes introduce no new risks or compromises to performance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a device identical to its predicate and addressing labeling changes, the "acceptance criteria" are implied to be meeting established performance standards for guide wires and demonstrating no negative impact from labeling updates. Actual numerical performance data is not typically a part of the publicly available 510(k) summary, but rather part of the internal design verification and validation report submitted to the FDA.

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

• Sample Size: The document does not specify the sample sizes used for each of the non-clinical tests (Friction, Kink resistance, etc.). These details are typically found in the full test reports submitted to the FDA, not in the 510(k) summary.
• Data Provenance: The document does not specify the country of origin of the data. For physical device performance testing, this often occurs in internal labs or contract research organizations. It is inherently prospective for the specific tests performed to support the 510(k) submission, as new data is generated to demonstrate compliance.

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

This question is not applicable. For physical device testing (mechanical, durability, etc.), "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert human interpretation like in medical imaging AI.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for subjective human interpretations of data, such as medical image readings, typically in AI/software performance studies. They are not used for objective physical device performance testing.

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

No, an MRMC study was not done. MRMC studies are specific to evaluating the diagnostic performance of software or imaging systems, often comparing human readers with and without AI assistance. This is a physical guide wire, so such a study is irrelevant.

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

This question is not applicable. "Standalone performance" refers to the performance of an algorithm or software system without human interaction. This document describes a physical medical device.

7. The Type of Ground Truth Used

For physical device testing, the "ground truth" is based on:

• Engineering Specifications: The design parameters and tolerances the device is intended to meet.
• Industry Standards: Recognized standards for guide wire performance (e.g., ISO, ASTM).
• Predicate Device Performance: The established, acceptable performance of the legally marketed predicate device.
  Data from the listed tests (Friction, Kink resistance, etc.) are measured and compared against these objective criteria.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train AI models. This document describes a physical medical device.

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

This question is not applicable for the same reason as above.

In summary, the provided 510(k) clearance letter is for a physical medical device (guide wires) that is stated to be identical in design, materials, and characteristics to a legally marketed predicate device, with the clearance primarily relating to labeling changes. Therefore, the "acceptance criteria" and "proof" focus on demonstrating that these labeling changes do not adversely affect the device's established safety and performance, and that the device remains substantially equivalent to its predicate through standard non-clinical performance testing. The concepts of AI/software-specific studies, ground truth establishment by experts, and training/test sets are not relevant to this type of device and clearance.

Ask a specific question about this device

Stedi Guidewire is intended for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR).

The Medtronic Stedi™ Extra Support Guidewire (herein after referred as Stedi Guidewire) is design for use to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement (TAVR) procedures.

The Stedi Guidewire has a 0.035" diameter and is 275cm in length and 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 and the ground core are joined in two locations: a proximal bond and a distal weld. The distal end of the Stedi Guidewire is comprised of a preformed 540° curved tip is available in 2 sizes (3cm and 4cm). The Stedi Guidewire has a polytetrafluoroethylene (PTFE) coating applied to the entire length of the device in order to aid in lubricity.

The Stedi Guidewire is sterilized using ethylene oxide, nonpyrogenic, disposable, and for single use only.

Based on the provided FDA 510(k) clearance letter for the Medtronic Stedi Extra Support Guidewire, here's a detailed breakdown of the acceptance criteria and the study information.

It's important to note that the provided document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. For medical devices like guidewires, the "studies" primarily consist of non-clinical (bench) performance testing to ensure the new device meets established safety and performance requirements, rather than clinical trials with human subjects in the way AI/software devices typically undergo. Therefore, many of the questions related to human readers, ground truth, and training sets are not applicable in this context.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Medtronic Stedi Extra Support Guidewire are demonstrated through various non-clinical (bench) performance tests. The FDA guidance "Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019)" was utilized to establish these tests. The conclusion states that the device "met all design input requirements based on the intended use."

Here's a table summarizing the types of tests conducted, which imply the acceptance criteria were met by the device's performance in these areas:

Study Details

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

   • Sample Size: The document does not specify exact sample sizes for each non-clinical test. However, it indicates "samples were analyzed according to predetermined acceptance criteria" for the various bench tests. In medical device bench testing, sample sizes are typically determined statistically to ensure sufficient power to detect differences or to demonstrate compliance with specifications.
   • Data Provenance: The data is generated from non-clinical bench testing performed by Medtronic Inc. This is not clinical data (i.e., no patient data is involved). It is prospective in the sense that the tests were designed and executed to evaluate the new device.

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

   • N/A. For this type of medical device (guidewire), ground truth is established through engineering specifications, material science standards (e.g., ISO standards), and performance benchmarks derived from predicate devices and historical data. It does not involve human expert consensus in the diagnostic sense. The "experts" are the engineers, material scientists, and testers who design and conduct the tests and interpret the results against predetermined specifications.

3. Adjudication method for the test set:

   • N/A. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies or studies involving human interpretation of data (e.g., image analysis). For bench testing of a guidewire, results are quantitative or qualitative against predetermined engineering specifications, and "adjudication" typically refers to the pass/fail criteria established for each test.

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:

   • No. This is a physical medical device (guidewire), not an AI/software device that assists human readers/clinicians, so an MRMC study is not applicable.

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

   • N/A. This is a physical medical device, not an algorithm. The "standalone" performance is the device's performance in the bench tests, independent of its use in a patient for the initial testing and FDA clearance.

6. The type of ground truth used:

   • The "ground truth" for each test is based on pre-established engineering specifications, material standards (e.g., ISO), and performance characteristics derived from the predicate device and FDA guidance documents. For example, the "ground truth" for tensile strength is a minimum force value, for biocompatibility it's compliance with ISO 10993, and for dimensions it's adherence to specified tolerances.

7. The sample size for the training set:

   • N/A. This is a physical medical device undergoing non-clinical testing, not a machine learning model, so there is no "training set."

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

   • N/A. As there is no training set for a physical device, this question is not applicable.

Ask a specific question about this device

PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not to be used in the neurovasculature.

SION blue PLUS is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 190cm and 300cm lengths. The guide wire is constructed from stainless-steel core wire with platinum-nickel and stainless-steel coils. The coils assembly consists of an inner coil and an outer coil, as well as a safety wire which is soldered to the inner and outer coils and the core wire. The distal end of the guide wire has a 3cm radiopaque tip to achieve visibility and is available in a straight, Pre-shape and J-shape to bend with the vessel curve. A silicone and hydrophilic coatings are applied to the distal portion of SION blue PLUS. The proximal sections of the SION blue PLUS are coated with PTFE. The extension wire is connected to the end of the guide wire outside of the body for 190cm model.

This FDA 510(k) clearance letter pertains to a conventional medical device (a guide wire), not an AI/ML-enabled device. Therefore, the information requested about acceptance criteria, study data, ground truth establishment, expert adjudication, and MRMC studies, which are typical for AI/ML device clearances, is not present in this document.

The document details non-clinical bench testing for the SION blue PLUS guide wire to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the available information based on your request, highlighting what is included and what is not applicable to this type of device submission:

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

The document states that "The in vitro bench tests demonstrated the SION blue PLUS met all acceptance criteria and performed similarly to the predicate/reference devices." However, it does not provide a specific table of acceptance criteria with corresponding performance data. It lists the types of tests performed:

• Dimensional Verification
• Visual Inspection
• Simulated Use/Human body Phantom
• Tensile Strength (including Tip Pull test)
• Torque Strength
• Torqueability
• Coating Integrity
• Particulate Evaluation
• Lubricity/Catheter Compatibility
• Corrosion Resistance
• Kink Resistance
• Tip Flexibility
• Radiopacity

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

• Sample Sizes: Not specified. For physical device bench testing, sample sizes are typically determined by engineering standards and statistical power analysis for the specific tests (e.g., n=3, n=5, n=10 per test) but are not typically detailed in 510(k) summaries as they are for clinical or AI/ML studies.
• Data Provenance: Not applicable in the sense of clinical study data provenance (country, retrospective/prospective). The data comes from in vitro bench testing conducted by the manufacturer, ASAHI INTECC CO., LTD. (Global Headquarters and R&D Center in Seto, Aichi, Japan).

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

• Not applicable. This information is relevant for AI/ML device evaluations where human experts establish ground truth for image interpretation or diagnosis. For a physical device like a guide wire, performance is measured against engineering specifications and industry standards, not against "expert ground truth" in a clinical diagnostic sense.

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

• Not applicable. Adjudication methods are typically used in clinical or AI/ML studies where multiple human readers might disagree on a diagnosis or interpretation, requiring a consensus mechanism. This is not relevant for bench testing of a physical medical 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

• Not applicable. An MRMC study is a type of clinical study used to evaluate the diagnostic performance of a device (often AI-enabled) by comparing multiple readers' interpretations across multiple cases, sometimes with and without AI assistance. This device is a physical catheter guide wire, not a diagnostic or AI-assisted device.

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

• Not applicable. This refers to the evaluation of an AI algorithm's performance independent of human interaction. Since SION blue PLUS is a physical guide wire, this concept does not apply.

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

• Not applicable in the clinical sense. For this device, "ground truth" equates to the pre-defined engineering specifications, performance standards, and material properties that the device must meet during bench testing. For example, a tensile strength test would have an acceptance criterion (e.g., withstand X Newtons of force), and the device's measured performance against this criterion is the "truth."

8. The sample size for the training set

• Not applicable. This concept pertains to AI/ML devices where a "training set" is used to develop the algorithm. This device is a physical instrument, not an AI.

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

• Not applicable. See point 8.

In summary, the provided 510(k) clearance letter is for a physical medical device. The types of detailed information requested regarding AI/ML study design, ground truth, expert adjudication, and sample sizes for training/test sets are not relevant to this specific device submission and therefore are not present in the document. The document focuses on demonstrating substantial equivalence through non-clinical bench testing of the device's physical and material properties.

Ask a specific question about this device

This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).

The CROSSLOOP is steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm) and available in various lengths of 200 cm, 235 cm and 300 cm. The CROSSLOOP consists of a stainless-steel (SUS) core wire with a Pt-Ni alloy coil, soldered with Au-Sn solder. The distal tip is loop-structured. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A silicone and hydrophilic coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text describes a 510(k) premarket notification for a medical device called "CROSSLOOP," a catheter guide wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).

Therefore, the information you're asking for, such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not directly applicable or available in this document.

This 510(k) summary focuses on non-clinical testing/performance data and biocompatibility to demonstrate that the device is substantially equivalent to existing cleared devices, not that it independently proves clinical efficacy or diagnostic accuracy (as would be the case for an AI-powered diagnostic device, for example).

Here's how to address your points based on the provided text:

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

The document states: "The in vitro bench tests demonstrated the CROSSLOOP met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide a table specifying the precise acceptance criteria or quantitative performance results for each test. It only lists the types of non-clinical tests performed:

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are "in vitro bench tests" and "biocompatibility" tests. The manufacturer is ASAHI INTECC CO., LTD. whose global headquarters and R&D center are in Japan. The specific country where the testing was performed is not explicitly stated, but it's likely linked to the manufacturer's R&D facilities. These are laboratory tests, not clinical data, so terms like "retrospective" or "prospective" don't apply in the common clinical sense.

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 to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for AI/ML-powered diagnostic tools or clinical studies, neither of which are described here. The "ground truth" for the non-clinical tests would be the established engineering and materials science standards and specifications.

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

This is not applicable. Adjudication methods are typically used in clinical trials involving human observation or interpretation, especially with imaging reads. For bench testing, results are typically quantitative measurements compared against predefined engineering specifications.

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

This is not applicable. An MRMC study is designed for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. The "CROSSLOOP" is a physical medical device (catheter guide wire), not an AI/ML software tool.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The CROSSLOOP is a physical medical device.

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

For a physical device like a guide wire, the "ground truth" for non-clinical testing refers to pre-defined engineering specifications, material properties, and performance standards (e.g., tensile strength required to withstand certain forces, flexibility within a specified range, biocompatibility per ISO standards). This is not derived from expert consensus on clinical cases, pathology, or outcomes data, but rather from material science and mechanical engineering principles.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train AI/ML models. This device is not an AI/ML product.

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

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

Ask a specific question about this device

This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels) during diagnostic or interventional procedures.

The CROSSLEAD 0.018inch is steerable guide wire with a maximum diameter of 0.46mm (0.018inches) and available in various lengths of 100 cm, 200 cm, 235 cm and 300 cm. The quide wire consists of a hybrid nitinol (Ni-Ti) and stainlesssteel (SUS) core wire with a stainless steel inner coil, a stainless steel and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A hydrophilic and polyurethane coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text is a 510(k) Premarket Notification from the FDA regarding the "CROSSLEAD 0.018inch" guide wire. This document primarily focuses on establishing substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments. It does not contain information about a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or a multi-reader multi-case (MRMC) comparative effectiveness study, which are typically associated with the evaluation of artificial intelligence (AI) or software-based medical devices.

Therefore, I cannot fulfill your request for information related to:

• A table of acceptance criteria and reported device performance in the context of an AI/software study. The document lists non-clinical tests and states they met acceptance criteria, but these are for the physical device, not an AI.
• Sample size used for a test set (in the context of an AI study).
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses the physical characteristics and performance of a medical guide wire, not a software or AI device that would require such studies. The "non-clinical testing/performance data" section refers to bench tests for the physical guide wire's properties (e.g., tensile strength, torqueability, coating integrity, biocompatibility), not an algorithm's performance on a dataset.

In summary, the provided text does not describe the kind of study you are asking about, which typically pertains to the evaluation of AI/software in medical devices.

Ask a specific question about this device

This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD 0.014inch is steerable guide wire with a maximum diameter of 0.014inch (0.36mm) and available in various lengths of 100cm, 200cm, 235cm and 300cm. This quide wire consists of a hybrid nitinol (Ni-Ti) and stainless-steel (SUS) core wire with a stainless-steel inner coil and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction and materials of the CROSSLEAD 0.014inch are similar to those of previously described in the predicate ASAHI Gladius (K150445/K163426) and references; CROSSLEAD Penetration (K230377), MINAMO (K190176) and Astato XS40 (K153443/K163426).

All sizes are available with a straight and a pre-shaped design.

This document is a 510(k) Premarket Notification for a medical device (CROSSLEAD 0.014inch guide wire) and does not describe a study involving an AI/Machine Learning enabled device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and performance studies for such devices, including details on test sets, expert ground truth, MRMC studies, or training sets.

The document discusses non-clinical bench testing to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not an AI algorithm.

Therefore, I cannot fulfill the request as the provided text does not contain information related to AI/ML device testing and acceptance criteria.

Ask a specific question about this device

The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures.
The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.

The Prelude® Small O.D. Introducer Guide Wire is composed of a stainless-steel core wire inside a stainless-steel coil. The guide wire is welded at the distal and proximal tips and has a polished weld finish. The stainless-steel construction provides radiopacity and visibility to the user under X-ray. The wires are available in outer diameters 0.018", 0.021" and 0.025", lengths from 45 cm to 80 cm, straight and double-ended J 3mm / straight tip shapes, Standard and Firm body wire stiffness profiles, with a flexible atraumatic tip.

The provided text is a 510(k) summary for a medical device called the "Prelude Small O.D. Introducer Guide Wire." It details the device's characteristics, intended use, and a comparison to a predicate device, along with a list of non-clinical performance and biocompatibility tests conducted.

However, the request asks for specific information regarding acceptance criteria and a study that proves the device meets the acceptance criteria, particularly in the context of an AI-powered device or a study involving human readers and AI assistance.

The provided document does not describe an AI-powered device, a study involving human readers, a test set with expert ground truth, or an MRMC comparative effectiveness study. The tests listed are for a physical medical guide wire, focusing on its mechanical properties, material integrity, and biocompatibility.

Therefore, I cannot fulfill the request for information on acceptance criteria and study proving device meets the criteria for an AI device or a study involving human readers and AI assistance, as the provided text pertains to a traditional, non-AI medical device.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: While the document states "The subject Prelude Small O.D. Introducer Guide Wire met the predetermined acceptance criteria," it does not list the specific numerical or qualitative acceptance criteria for each test (e.g., "Tensile strength must be >X Newtons"). It also does not report the exact performance results (e.g., "Tensile strength was Y Newtons"). It only confirms that the criteria were met.
• 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical guide wires tested, not a dataset of images or clinical cases. Sample sizes for each mechanical and biocompatibility test are not provided. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of device testing.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as typically defined for AI/imaging studies (e.g., expert radiological reads) is not relevant for the physical testing of a guide wire.
• 4. Adjudication method for the test set: Not applicable. There's no "adjudication" for mechanical and biocompatibility tests in the way there would be for expert interpretations of medical images.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable. This type of study involves human readers interpreting medical images, usually with and without AI assistance. The device in question is a physical guide wire, not an AI algorithm for imaging.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is not an algorithm.
• 7. The type of ground truth used: Not applicable. Ground truth in the context of AI/imaging studies (expert consensus, pathology, outcomes data) is not relevant here. The "ground truth" for this device's performance is derived from standardized physical and chemical tests (e.g., measuring tensile strength against a specification).
• 8. The sample size for the training set: Not applicable. This device does not involve a training set as it's not an AI model.
• 9. How the ground truth for the training set was established: Not applicable, as there's no training set.

In summary, the provided document is for a conventional medical device (a guide wire) and does not contain the information requested regarding AI device performance studies.

Ask a specific question about this device

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.

Ask a specific question about this device

The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process. The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction. Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.

The provided text is a 510(k) summary for a medical device (guide wire) and does not contain any information about an AI/ML-driven device or study results related to acceptance criteria for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-driven device meets those criteria based on this document. The document describes traditional performance and biocompatibility testing for a physical medical device.

Ask a specific question about this device