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The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.

The Hydrophilic Coating Guide Wire consists of a Nickel-Titanium alloy core wire; a polymer jacket (Polyurethane containing Tungsten for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The guide wire is provided sterile (EtO) and is intended for single use only.

This document is a 510(k) Premarket Notification from Suzhou Hengrui Disheng Medical Co., Ltd. for their "Hydrophilic Coating Guide Wire." It seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific performance criteria for an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, and sample sizes for training/test sets (as they pertain to AI/ML) is not available in this document.

This submission is for a medical device (a guide wire) and primarily focuses on its physical characteristics, materials, intended use, and non-clinical performance testing to show it's equivalent to existing devices. It does not involve any AI/ML component.

Consequently, I cannot fill in the table or answer the questions related to AI/ML performance. The document only reports on the substantial equivalence of the physical guide wire device to predicate devices.

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This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

The ASAHI Silverway consists of a one-piece core wire and a coil assembly that extends the entire length of the device. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. In addition, coatings are applied on the surface of the ASAHI Silverway. The distal and proximal sections are coated with silicone. The intermediate section is coated with hydrophilic coating. The ASAHI Silverway has a nominal outer diameter of 0.89mm (0.035in) and is available in various lengths from 150cm to 300cm and tip shapes.

This document describes the premarket notification (510(k)) for the ASAHI® Silverway® guidewire. The acceptance criteria and study details are focused on non-clinical performance given the type of device and the 510(k) pathway, which establishes substantial equivalence rather than independent safety and effectiveness.

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

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

The document states that the ASAHI Silverway "met all acceptance criteria" and "performed similarly to the predicate devices." While specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, maximum torque to twist in degrees) are not explicitly listed in the public summary, the general categories of tests performed indicate the areas for which acceptance criteria would have been established.

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

• Sample Size: The document does not explicitly state the specific number of units tested for each non-clinical test. It generally refers to "non-clinical laboratory testing."
• Data Provenance: The tests were "non-clinical laboratory testing" presumably conducted by or for ASAHI INTECC CO., LTD. Given the company's address (Japan), the testing was likely performed in Japan or by a qualified lab contracted by them. The studies are by nature prospective in that new guidewires were manufactured and then tested according to predefined protocols.

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

This section is not applicable to this type of regulatory submission. For a guidewire, "ground truth" is typically defined by engineering specifications, material properties, and performance benchmarks established through industry standards (e.g., ISO, ASTM) and comparison to predicate devices, rather than expert human interpretation of complex data (like medical images).

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

Not applicable. As this is non-clinical laboratory testing against pre-defined engineering and material standards, there is no need for expert adjudication in the way it might be applied to, for example, classifying medical images. Test results are objective measurements.

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 device is a medical guidewire, not an AI/imaging device. Therefore, no MRMC study or AI assistance evaluation would be relevant or expected.

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

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

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

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

• Engineering specifications and design requirements: Did the device meet its designed dimensions, material properties, and functional characteristics?
• International standards: Adherence to relevant ISO (e.g., ISO 11070 for catheter guidewires, ISO 10993 for biocompatibility) and ASTM standards.
• Performance of predicate devices: Substantial equivalence is demonstrated by performing "similarly to the predicate devices." The predicates themselves would have established a benchmark for acceptable performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense. The "training" in manufacturing comes from process validation and quality control, but not a data-driven model training.

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

Not applicable for the same reason as point 8.

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The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.

The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle. The distal tip of the MRWire is marked with discrete ring markers for MRI visibility and comes in different configurations such as straight and angled. Additionally, the Pebax® tip extrusion, contains BaSO4 for X-Ray visibility.

Guide wires are supplied sterile and non-pyrogenic. The MRWire's diameter is 0.035" (0.89 mm).

The provided document is a 510(k) summary for the MRWire Guide Wire. It details the device, its intended use, and a comparison with a predicate device to demonstrate substantial equivalence. However, it does not describe a study involving an AI algorithm or human readers for diagnostic performance. Therefore, many of the requested fields, particularly those related to AI model evaluation, ground truth establishment, expert consensus, and MRMC studies, cannot be directly addressed from this document.

Here's an analysis of the provided text in relation to your request:

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

The document lists performance tests, implying certain acceptance criteria were met for each, but it does not quantitatively define these criteria or provide specific numerical results for each test. Instead, it offers a qualitative statement of substantial equivalence.

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

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

The provided text refers to a medical device, the "Merit Hydrophilic Guide Wire," and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, study design, and ground truth for an AI/ML model are not applicable.

However, I can extract information related to the device's performance testing and how it met acceptance criteria for substantial equivalence to predicate devices.

Summary of Acceptance Criteria and Device Performance (for the Merit Hydrophilic Guide Wire):

Study Information (Based on Substantial Equivalence Evaluation):

1. Sample sizes used for the test set and data provenance:
   This information is not provided in a way that is applicable to an AI/ML model. The "test set" in this context refers to a series of physical tests performed on the guide wire samples. The document does not specify the number of guide wires tested for each attribute or their provenance. The "data provenance" mentioned in your request (country of origin of data, retrospective/prospective) is relevant for clinical data, not for material property testing of a medical device.

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 would typically refer to expert consensus on clinical diagnoses for AI/ML. For a physical device, testing against defined engineering specifications serves as the "ground truth." The document states "protocols based on requirements outlined in guidance's and industry standards," implying established engineering and scientific methods rather than expert clinical consensus on individual test results.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies, particularly for AI/ML evaluation. This document describes laboratory testing against established standards.

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, as this is not an AI/ML device.

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

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For this medical device, the "ground truth" for the performance tests was established by industry standards (e.g., ISO 11070:1998, ISO 11135-1:2007, ASTM F1980-07, ISO 10993-1:2009) and FDA guidance (Coronary and Cerebrovascular Guide Wire Guidance January 1995, FDA Modified ISO 10993 Test Profile FDA Memo G95-1). The device's performance was compared to a "predicate device" (Terumo Radiofocus® Glidewire® K863138) for various attributes.

7. The sample size for the training set:
   Not applicable, as this is not an AI/ML device, and therefore no "training set" in that sense was used. The device underwent physical and chemical testing.

8. How the ground truth for the training set was established:
   Not applicable, as this is not an AI/ML device.

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

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

The provided text does not describe a study involving an AI/algorithmic device. The document is a 510(k) premarket notification for a Merit Hydrophilic Guide Wire, which is a physical medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics is not applicable in this context.

The document discusses the substantial equivalence of the subject guide wire to predicate devices based on various performance attributes and safety tests.

Here's a breakdown of what is provided, as it relates to the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of specific acceptance criteria values and corresponding device performance data for each test. Instead, it states that:

Tests Performed (implied acceptance criteria for each):

• Tensile Strength
• Torque Strength
• Torquability
• Tip Flexibility
• Coating Adherence/Integrity (including Evaluation using Anatomical Model)
• Catheter Compatibility (Durability)
• Surface
• Fracture Test
• Flex test
• Size Designation/Dimensions
• Radiopacity

The acceptance criteria for these tests were based on:

• FDA guidance: Coronary and Cerebrovascular Guide Wire Guidance January 1995.
• ISO 11070: 1998, Sterile Single-Use Intravascular Catheter Introducers.
• ISO 11135-1: 2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
• ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
• ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.

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

Not applicable for an AI device. For the physical guide wire, the sample sizes for each specific test (e.g., tensile strength, flex test) are not explicitly stated in this summary. The tests were likely conducted on a sufficient number of samples to statistically demonstrate compliance with the acceptance criteria, as is standard practice for medical device testing. The provenance of the "data" (i.e., the physical test results) would be from in-house laboratory testing conducted by Merit Medical Systems, Inc. in Ireland.

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

Not applicable. Ground truth as typically defined for AI models (e.g., expert consensus on medical images) does not apply to the performance testing of a physical guide wire. The "ground truth" for these tests would be the established engineering and biological standards and guidances mentioned above.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1, 3+1" are used for resolving disagreements among multiple human readers in image interpretation, which is not relevant to this physical 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

No. This is irrelevant to a physical medical device.

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

No. This is irrelevant to a physical medical device.

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

For the physical device, the "ground truth" refers to the established scientific and engineering principles, material properties, and biological safety standards (e.g., biocompatibility standards like ISO 10993) against which the device's performance was measured. There's no "ground truth" in the AI sense.

8. The sample size for the training set

No. This is irrelevant to a physical medical device.

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

No. This is irrelevant to a physical medical device.

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The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

The Glidesheath is comprised of an introducer sheath and a dilator.

The Glidesheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the Glidesheath. The mini guide wire is available in a stainless steel or a nickel-titanium alloy polyurethane coated configuration. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.

The A kit also contains a Surflo IV catheter, 2.5ml syringe, and scalpel for use in priming the system and gaining initial access to the vessel. Once access is obtained, the Mini Guide Wire is inserted through the cannula which was placed in the patient's blood vessel. The Glidesheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Ditator maintains the integrity of the Sheath and dilates the blood vessel while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.

The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

The provided text describes a 510(k) summary for the Glidesheath, a medical device, and its substantial equivalence to a predicate device. It indicates performance testing was conducted to demonstrate this equivalence. However, the document does not describe acceptance criteria, the specific study design to prove acceptance criteria, or the detailed results of such a study in terms of quantitative performance metrics. Instead, it lists the types of verification tests performed and states that "None of the data raises any new issues of safety and effectiveness."

Therefore, based solely on the provided text, I cannot complete the requested tables and information as it is not present in the document. The general nature of the performance section, which focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific, quantified acceptance criteria for a novel functionality, means this level of detail is absent.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (since this is a device modification, likely internal laboratory testing, but not explicitly stated).
• Retrospective or Prospective: Not specified.

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):

• Number of Experts: Not applicable. This is a physical medical device, not an AI or diagnostic imaging device that requires expert ground truth establishment in the traditional sense. The "ground truth" would be the engineering specifications and performance of the device itself.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This is 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:

• MRMC Study: No, this is not an AI or diagnostic imaging device.

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

• Standalone Performance: Not applicable. This is a physical medical device.

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

• Type of Ground Truth: For the "verification tests" performed (Leakage/clogging, Tensile strength of connections, etc.), the "ground truth" would be established engineering standards, material specifications, and physical measurement against those standards. It's an internal verification process, not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Ground truth for training set: Not applicable.

Summary of available information:

The document focuses on demonstrating substantial equivalence of a modified Glidesheath device to a predicate device (Glidesheath K033681). This is done through a series of "verification tests" on the physical properties of the device components. The tests listed are:

• Leakage/clogging
• Tensile strength of connections
• Separation force of dilator and sheath
• Internal sliding resistance
• External sliding resistance
• Penetration force

The conclusion from these tests and a risk analysis is that "None of the data raises any new issues of safety and effectiveness," thus supporting substantial equivalence. The document does not provide specific numerical acceptance criteria or quantitative results for these tests.

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The CanaliZer Hydrophilic Guide Wire is designed for use in the peripheral vasculature with medical devices requiring a 0.035" or 0.038" outer diameter guidewire. The CanaliZer is not intended for use in the coronary arteries.

The guidewires are constructed from a Nitinol core coated with Tecoflex EG85-A polyurethane to provide a wire with a maximum OD of 0.035" or 0.038". The polyurethane formulation contains BaSO4 for radiopacity. A hydrophilic coating is applied to the distal portion of the guidewire to facilitate wire movement within 0.035" or 0.038" diameter devices. The guidewires are available in lengths of 150, 180 and 260 cm. Two tip shapes are also available, straight and angled. Both tip shapes are provided on wires of standard stiffness, and a stiffer design. The family of guidewires has a CE mark and is in commercial distribution in Europe.

The provided text refers to a premarket notification for a medical device called the "InterV® brand CanaliZer Hydrophilic Guide Wire." This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, the requested information regarding acceptance criteria, a study proving performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not available in the provided text.

The document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This process typically relies on comparing the technological characteristics of the new device to a predicate device, and often includes bench testing to confirm compliance with recognized standards or demonstrate equivalence, but not necessarily a full clinical study with acceptance criteria and reported performance in the way a new drug or a novel high-risk device might.

The relevant sections provided are:

• Premarket Notification [510(K)] Summary: This section describes the device, its intended use, and technological characteristics, and identifies predicate devices.
• FDA Review Letter: This letter from the FDA confirms that they have reviewed the 510(k) and found the device substantially equivalent to predicate devices for its stated indications for use.
• Indications for Use: This section reiterates the intended use of the device.

In summary, the provided content is for a 510(k) submission, which does not typically include the detailed study information as requested.

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The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil are used to facilitate the placement of ballon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

The RADIFOCUS Glidewires for coronary use with platinum (or gold) coil have a core of titanium nickel alloy coated with polyurethane which is second coated with a hydrogel. The wires are 180cm and 300cm in length and come in 0.014", 0.016" and 0.018" diameters respectively. The platinum coil wire, 300cm length, is used exclusively for exchange purposes. The wires also possess a radiopaque marker at the tip of the wire. This coil is made of an amalgam of platinum and iridium or gold. The coil is entirely coated with polyurethane with tungsten. The distal portion of the wire is gradually tapered from 10 to 30 cm in length providing increasing flexibility at the distal portion of the wire.

The provided document describes a submission for substantial equivalence for a medical device, the RADIFOCUS® Glidewire® for coronary use. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for an AI/ML device is not applicable to this document.

However, I can extract information related to the device's performance testing demonstrating substantial equivalence to a predicate device.

Here's a summary of the performance information provided:

Device: RADIFOCUS® Glidewire® for coronary use with platinum (or gold) coil

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

Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" against numerical targets like those for a novel device. Instead, the performance tests demonstrated equivalence to a predicate device (K953533). The document states:

"The Terumo PTCA guide wires (represented in this submission) tested are substantially equivalent to the cleared Terumo RADIFOCUS® Glidewires® for coronary use with platinum (or gold) coil K953533."

"For all other physical characteristics the Terumo PTCA guide wires represented in this submission were found to be equivalent to the cleared Terumo RADIFOCUS Glidewires for coronary use with platinum (or gold) coil K953533."

"The Terumo PTCA guide wires represented in this submission exhibit a higher pushing resistance that can be associated with the higher crossability." (This is noted as a difference that does not raise new safety/effectiveness concerns).

*Note: Coating Adherence and Coating Flake tests were not performed for this submission as "none of the coating features of the Terumo PTCA guide wires represented in this submission are different from the cleared Terumo PTCA guide wires K953533."

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

• Sample Size: Not specified. The document only states "The Terumo PTCA guide wires (represented in this submission) tested...".
• Data Provenance: Not specified. The tests are physical performance tests of the device itself, not clinical data from patients.

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

• Not Applicable. This is a physical device performance study, not a study requiring expert clinical review or interpretation for ground truth.

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

• Not Applicable. No adjudication was explicitly mentioned for mechanical device 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:

• Not Applicable. This is not an AI/ML device, and no MRMC study was conducted.

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

• Not Applicable. This is not an AI/ML algorithm.

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

• For the physical tests (Tensile Strength, Torque Transmission, etc.), the "ground truth" is the measured physical properties of the device relative to the predicate device. There is no biological or clinical "ground truth" as described in the prompt.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device; there is no training set mentioned.

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

• Not Applicable. As there is no training set.

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