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DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The DualView Catheter is a catheter consisting of two assemblies: the catheter sheath and the imaging core (consisting of lens and transducer). During imaging, the imaging core rotates inside the catheter sheath to obtain a 360°image of the surface layer of the vessel wall by irradiating with near-infrared light and ultrasound. By pulling back the imaging core inside the catheter sheath, an image in the long axis direction can be obtained.

This is a rapid exchange (RX) design (short monorail) catheter, which is used with a 0.014" (0.36 mm) guidewire. The catheter is 2.6 Fr (0.86 mm) in the imaging window section and 3.0 Fr (1.01 mm) in the shaft section with an effective length of 137 cm. The catheter has a 100 cm hydrophilic coating starting from the distal end, which becomes highly lubricious when wet. The catheter has a telescoping section, and the telescoping length is 155 mm. When connected to the OPUSWAVE, the imaging core can be pulled back 150 mm in the catheter sheath. There are two radiopaque markers. The distal radiopaque marker is located 7 mm from the distal end of the catheter sheath, and the sensor radiopaque marker is located where the near-infrared light and ultrasound are emitted. Those markers allow a user to confirm the positional relationship between the distal end of the catheter and the sensor position (imaging point). There are two depth markers, one at 90 cm and the other at 100 cm from the distal end of the catheter sheath, which serves as a guide for insertion.

The transducer has an IPX7 ingress rating in accordance with IEC 60529.

The catheter is stored in the holder tube and is secured to the catheter holder. The catheter comes with the Motor Drive Unit (MDU) Cover and accessories. The MDU Cover consists of an adapter and a plastic cover sheet to maintain the sterility of the catheter and clean field. The catheter accessories consist of a connection tube with a three-way stopcock, a priming syringe, and a reservoir syringe for priming the catheter lumen with heparinized saline solution.

The provided FDA 510(k) Clearance Letter concerns the DualView Catheter, a diagnostic intravascular catheter. This document is a Summary of a Traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing.

Therefore, the submission does not include a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, standalone algorithm performance, or extensive details on ground truth establishment involving human expert consensus for a clinical test set as would be typical for an AI/ML-based device. The clearance is based on direct device performance and safety, primarily through bench testing and animal studies, not a human reader study.

Here's an analysis of the provided information, specifically addressing the questions as much as possible given the nature of this particular 510(k) (a medical device clearance, not an AI/ML algorithm clearance):

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

Since this is a non-clinical device clearance, the "acceptance criteria" are the successful completion of the listed performance and safety tests, demonstrating the device meets its design specifications and is suitable for its intended use. The "reported device performance" is that it successfully met these criteria.

Detailed Study Information (Where Applicable for this Device Type):

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

   • Test Set (Non-Clinical): The document refers to various non-clinical tests (e.g., performance testing, software V&V, electrical safety, biocompatibility, sterilization). The "sample size" for these tests would correspond to the number of catheters or test articles subjected to each specific test. This specific number is not provided in the summary but is assumed to be sufficient for each test type according to relevant standards.
   • Animal Study: A "swine model" was used for both safety and performance animal studies. The specific number of animals is not provided in this summary.
   • Data Provenance: The document does not explicitly state the country of origin for the data (e.g., test labs, animal facilities). This is a traditional 510(k) submission, and the manufacturer is Terumo Corporation (Japan), with manufacturing in Japan. Animal studies were likely prospective.

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

   • Not Applicable in the context of this 510(k). This clearance is for a medical device (catheter), not an AI/ML algorithm that requires human expert consensus for image interpretation ground truth. The "ground truth" for this device's performance is established by direct physical measurements, engineering validations, and physiological outcomes in animal models against predefined specifications and safety standards.

3. Adjudication method for the test set:

   • Not Applicable. Since there's no human interpretation component needing adjudication for ground truth establishment. Test outcomes are determined by objective measurements against acceptance criteria.

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, an MRMC study was NOT done. The document explicitly states: "This 510(k) does not include data from clinical tests." MRMC studies are typically used to assess the impact of AI algorithms on human reader performance, which is not relevant for this device's non-clinical clearance pathway.

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

   • No, not in the sense of an AI algorithm. This device does not appear to involve an AI algorithm whose performance would be assessed in a standalone manner for image interpretation or diagnosis. It is a diagnostic imaging catheter that generates images for human interpretation.

6. The type of ground truth used:

   • Engineering Specifications, Physical Measurements, and Physiological Outcomes (Animal Model):
     • For non-clinical performance tests (e.g., tensile strength, dimensions, imaging quality, etc.), the ground truth is the device's adherence to pre-defined engineering specifications and measurable performance characteristics.
     • For biocompatibility and sterilization, the ground truth is established by adherence to relevant ISO standards and successful completion of validated tests.
     • For animal studies, the "ground truth" relates to the physiological effects observed (e.g., absence of tissue injury, thrombus formation) and the successful performance of the device in a living system as intended by design, compared to predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set of data.

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

   • Not Applicable. As no training set for an AI/ML algorithm is involved.

Summary:

The DualView Catheter received 510(k) clearance based on demonstrating substantial equivalence to predicate devices primarily through rigorous non-clinical performance testing and animal studies. This type of submission relies on showing that the new device meets established safety and performance standards equivalent to existing legally marketed devices, rather than a clinical study evaluating an AI algorithm's interpretive accuracy and its impact on human readers. Therefore, many of the questions pertinent to AI/ML device clearances (e.g., human expert ground truth, MRMC studies) are not applicable to this traditional medical device submission.

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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.

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The Glidewire GT-R is intended 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, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are both operated through a manual process. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are the same design and construction except for Guide wire length. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are constructed from the same materials. The only material difference lies in the Individual Packaging.

This document is a 510(k) Pre-market Notification for a medical device called Glidewire GT-R. It focuses on demonstrating substantial equivalence to an existing predicate device rather than proving novel performance characteristics through a clinical trial or a deep-dive AI performance study.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets these criteria in the context of an AI/human-in-the-loop performance study.

Here's why and what the document does provide:

• Device Type: The Glidewire GT-R is a physical medical device (a catheter guide wire), not a software device or an AI algorithm.
• Purpose of 510(k): The 510(k) submission aims to show that the new device (Glidewire GT-R) is substantially equivalent to a legally marketed predicate device (Glidewire GT). This means it has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate.
• Testing Focus: The "performance testing" described (Section H, Table 3) is engineering performance testing (e.g., Tensile Strength, Torqueability, Lubricity, Kink Resistance, Radiopacity). These tests ensure the physical properties and functionality of the guidewire itself meet established physical and mechanical standards and are comparable to the predicate.
• No AI/Human Reader Study: Since this is a physical guidewire, there is no AI component, and thus no multi-reader multi-case (MRMC) study, human reader improvement, standalone algorithm performance, or ground truth establishment (expert consensus, pathology, outcomes data) as would be relevant for an AI diagnostic device.
• "Acceptance Criteria" in this context: The acceptance criteria here refer to the passing thresholds for the physical performance tests listed in Table 3 (e.g., a certain minimum tensile strength, a maximum friction coefficient for lubricity). The document states, "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide the specific numerical acceptance criteria for each test or detailed results beyond this summary statement.

To directly answer your request based on the provided text, while noting the different context:

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

   • Acceptance Criteria: Not explicitly detailed as numerical values in the document. The document states "Performance testing met the predetermined acceptance criteria."
   • Reported Device Performance: The document provides a summary statement that the device met these criteria, but no specific quantitative results for each test item listed in Table 3.

   Test Item	Acceptance Criteria	Reported Device Performance
   Dimensional Verification	(Not specified, but assumed to be within manufacturing tolerances for guidewire dimensions.)	"met the predetermined acceptance criteria"
   Visual Inspection	(Not specified, e.g., no defects, smooth coating.)	"met the predetermined acceptance criteria"
   Simulated Use	(Not specified, e.g., successful navigation through a simulated vessel model without kinking or breaking.)	"met the predetermined acceptance criteria"
   Tensile Strength	(Not specified, but would be a minimum force required to break/yield.)	"met the predetermined acceptance criteria"
   Tip Pull	(Not specified, e.g., a minimum force to separate the tip.)	"met the predetermined acceptance criteria"
   Torque Strength	(Not specified, e.g., a minimum torque before a permanent twist.)	"met the predetermined acceptance criteria"
   Torqueability	(Not specified, e.g., the ability to transmit torque from the proximal to distal end smoothly.)	"met the predetermined acceptance criteria"
   Lubricity and Coating Integrity	(Not specified, e.g., a coefficient of friction, or visual assessment after use.)	"met the predetermined acceptance criteria"
   Particulate Evaluation	(Not specified, e.g., maximum number/size of particulates released.)	"met the predetermined acceptance criteria"
   Kink Resistance	(Not specified, e.g., ability to resist kinking at certain bend radii.)	"met the predetermined acceptance criteria"
   Tip Flexibility	(Not specified, e.g., ability to bend to a certain radius and return.)	"met the predetermined acceptance criteria"
   Radiopacity	(Not specified, e.g., visibility under fluoroscopy to a certain standard.)	"met the predetermined acceptance criteria"
   Shaping Test	(Not specified, for shapeable types, ability to hold a formed shape.)	"met the predetermined acceptance criteria"
   Shape Retention	(Not specified, for shapeable types, ability to retain shape after use.)	"met the predetermined acceptance criteria"
   Corrosion resistance	(Not specified, e.g., no signs of corrosion after exposure to specific solutions.)	"met the predetermined acceptance criteria"

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

   • The document does not specify the sample sizes (number of guidewires) used for each performance test.
   • Data Provenance: The tests were conducted internally by Terumo Corporation (Ashitaka Factory, Japan and Terumo Medical Corporation, NJ, USA) on their manufactured devices. The data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device, and the "ground truth" is determined by engineering measurements against pre-defined specifications, not by expert consensus on clinical images/data.

4. Adjudication method for the test set: Not applicable for engineering performance tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. 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: No, not applicable.

7. The type of ground truth used: For the physical performance tests, the "ground truth" is based on engineering specifications and recognized industry standards (e.g., ISO, internal company standards). The predicate device and reference devices informed the establishment of these acceptance criteria.

8. The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for infants aged two months (excluding low birth weight and/or preterm birth) to adults.

The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. This system consists of an Intradermal Injection Needle and an Immucise Syringe. The system is made of common materials used in needles and syringes. The Immucise Intradermal Injection Needle is comprised of a needle base. The Immucise Syringe is comprised of a barrel, a gasket and a plunger. The sterile Immucise Intradermal Injection Needle and Immucise Syringe are packed separately and assembled prior to use. The Immucise Intradermal Injection System is operated by a manual process.

Here's a breakdown of the acceptance criteria and study information for the Immucise Intradermal Injection System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K181369) for an expanded indication (including infants). Therefore, the "acceptance criteria" are largely implied by meeting the same performance standards as the predicate, or by achieving successful outcomes in functionality tests.

2. Sample Size and Data Provenance for Test Set:

• Bench Test: No specific sample sizes for "non-aged and aged samples" are provided in this document, but it refers to the prior submission K181369. Data provenance is not explicitly stated beyond "performed in K181369."
• Animal Test: No specific sample sizes for the animal study are provided in this document. The data provenance is Terumo (Japan). The study was conducted specifically to support the expanded indication, suggesting it was prospective for this submission, though the methodology was based on a previous study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Neither the bench tests nor the animal studies described in this document involved human experts establishing ground truth in the way a clinical study with image interpretation might.
• For the animal study, the "ground truth" (e.g., successful wheal formation, validated injection depth) would have been assessed by trained personnel through observation and potentially histological analysis. No specific number or qualifications of experts are mentioned.

4. Adjudication Method for Test Set:

• This type of information (e.g., 2+1, 3+1) is typically relevant for studies involving subjective human interpretation, such as radiology reads.
• For bench and animal studies (focused on objective measurements and physiological responses), such adjudication methods are not applicable. The assessment would be based on predefined protocols and measurements.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• This device is a physical medical device (intradermal injection system), not an AI-powered diagnostic tool that human readers would use in conjunction with. The comparative effectiveness focused on technical performance against a reference device, not human reader improvement with AI.

6. Standalone (Algorithm Only) Performance:

• No, standalone performance was not done.
• Again, this is a physical medical device. The concept of "algorithm only" performance is not applicable here as there is no AI algorithm involved in its direct function. The device's performance is its physical function.

7. Type of Ground Truth Used:

• Bench Test: Physical and functional measurements against predefined specifications (e.g., durability, material properties, dimensional accuracy).
• Animal Test: Direct physiological observations (wheal formation) and histological evaluation for injection depth, based on in-house standards designed to confirm intended physiological effects of intradermal injection.

8. Sample Size for Training Set:

• This concept is not applicable for this device. This is a physical medical device, not a machine learning model that requires a training set. The "training" in the context of device development would refer to design iterations and engineering testing, not data used to train an algorithm.

9. How Ground Truth for Training Set Was Established:

• Not applicable, as there is no training set in the context of machine learning. The "ground truth" for the device's design and engineering would be established through established engineering principles, material science, and regulatory standards.

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The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for adults.

The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. The system consists of a needle and syringe that are packed separately and assembled prior to use. The Immucise Intradermal Injection Needle consists of a needle tube and needle base, and the Immucise Syringe consists of a barrel, gasket and plunger.

The Immucise Intradermal Injection System, intended for intradermal injections of FDA approved drugs in the deltoid region for adults, did not undergo a comparative effectiveness study with human readers assisted by AI, nor a standalone AI algorithm performance study, as it is a medical device (needle and syringe system) rather than an AI-powered diagnostic or therapeutic tool. Therefore, sections pertaining to MRMC effect size, standalone AI performance, sample sizes for test/training sets, data provenance, number and qualifications of experts, and adjudication methods for AI performance are not applicable.

The device's performance was evaluated through a series of non-clinical tests (bench, animal, human factors, biocompatibility, sterilization, and packaging) to demonstrate substantial equivalence to predicate devices and ensure it met predetermined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the samples of the device used for the various non-clinical performance evaluations. The provenance of these samples would be the manufacturer's production line in Japan (Kofu Factory of Terumo Corporation). All testing was conducted prospectively as part of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to the evaluation of the medical device's physical and functional properties against established engineering and biological standards, not diagnostic or interpretive tasks requiring expert ground truth in the context of AI studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for establishing ground truth, typically in image interpretation or diagnostic performance studies. The performance of this device was assessed against objective, measurable criteria defined by international standards (ISO, USP) and in-house standards.

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. The Immucise Intradermal Injection System is a medical device (needle and syringe system), not an AI-powered diagnostic or therapeutic tool for which such studies would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Immucise Intradermal Injection System is a medical device, not an AI algorithm. Its performance is inherent to its physical design and manufacturing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance was established by:
* Bench Testing: Adherence to international standards (ISO, USP) and in-house established specifications.
* Animal Study: Direct observation of wheal formation and histopathological evaluation of injection depth.
* Human Factors and Usability Engineering Study: Observation of user interaction to identify potential use-errors that could cause serious harm, as per FDA guidance.
* Biocompatibility: Results of standardized biological tests (e.g., cytotoxicity, sensitization) evaluated against ISO 10993-1 criteria.
* Sterilization: Demonstrated Sterility Assurance Level (SAL) of 10-6 per ISO 11137 standards.
* Packaging: Verification of package integrity against ISTA 3A standards.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. As the device is not an AI algorithm, there is no training set or associated ground truth.

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The NaviCross 0.018" is intended to guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The NaviCross 0.018" is a single use, ethylene oxide sterilized device that is intended to guide and support a guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

NaviCross 0.018" features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyamide and an inner layer of polytetrafluoroethylene. It has a distal tip that is comprised of a polyamide. It also has a hydrophilic coating over the distal 40 cm of the catheter.

The device is offered in effective lengths of 65, 90, 135 and 150 cm.

The provided text describes a 510(k) submission for the NaviCross 0.018" catheter. It details the device's technical specifications, comparison to predicate and reference devices, and non-clinical performance testing. However, it explicitly states that no clinical tests were performed or included in this 510(k) submission.

Therefore, I cannot provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text, as these typically pertain to clinical studies.

The document focuses on demonstrating substantial equivalence through non-clinical performance testing and biocompatibility testing.

Here's a breakdown of what is available in the document regarding non-clinical performance:

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

The document lists various performance tests conducted. While it states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life," the specific numerical acceptance criteria and the exact reported performance values for each test are not detailed in the provided text. The table (Table 5.4) only lists the Test Items.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test. It states that tests were performed on "non-aged and accelerated aged samples."
• Data Provenance: The device manufacturer and sterilization facility are the Ashitaka Factory of Terumo Corporation in Japan (Fujinomiya, Shizuoka 418-0015, Japan). The testing was conducted as part of their 510(k) submission for the US market. The testing is pre-market, laboratory-based performance and biocompatibility testing, not human data.

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

This is not applicable as the testing described is non-clinical performance and biocompatibility testing, not clinical data requiring expert ground truth or interpretation of images/patient outcomes.

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

Not applicable for non-clinical performance 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. No clinical studies, especially MRMC studies comparing human performance with and without AI assistance, were performed or referenced in this document.

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

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

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

For the non-clinical tests, the "ground truth" or reference for acceptance is established by predefined engineering and material science standards (e.g., ISO standards, internal specifications for dimensions, strength, leakage, etc.). It's based on physical and chemical measurements rather than clinical ground truth types.

8. The sample size for the training set:

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

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

Not applicable. No training set for an algorithm is mentioned.

In summary, the provided document details non-clinical performance and biocompatibility testing for a medical device (catheter) to establish substantial equivalence. It explicitly states that no clinical tests were included in this 510(k) submission. Therefore, most of the questions relating to clinical study design, expert involvement, and AI performance are not applicable to the information given.

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The Glidewire® GT 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 Glidewire® GT is a guide wire which is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. The Glidewire® GT consists of a core wire of a Nickel Titanium superelastic alloy and has a flexible radiopaque gold coil around the distal tip of the core wire. The Glidewire® GT is offered with two distal tip types: Shapeable and Preshaped. The wire distal segment comes in angled or straight configurations. Physicians choose the guide wire types depending upon their personal preference and the type of interventional procedure being performed. Other considerations may include: anatomy, difficulty of access, and the interventional device used for procedure. The device is packaged in a plastic holder that is contained within an individual package. A guide wire inserter, torque device and mandrel (Shapeable type only) are contained within the individual package to assist with the manipulation of the guide wire. Following the guide wire insertion, the guide wire inserter is removed from the proximal portion of guide wire.

The provided document is a 510(k) summary for the Glidewire GT and describes non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets an acceptance criterion for an AI/ML device.

Here's an analysis based on the structure of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests. It states that "All samples tested met the applicable acceptance criteria, and no new issues of safety and effectiveness were raised by the testing performed." However, it does not explicitly list the specific quantitative acceptance criteria alongside the reported performance for each test. Instead, it refers to ISO standards, FDA guidance documents, and in-house standards.

General Summary of Performance Testing:

Biocompatibility: The device is classified as Externally Communicating Devices, Circulating blood, Limited Contact (<24 hrs). It's deemed biocompatible based on substantial equivalence to predicate devices with the same classification, intended use, body contact, and contact duration, and demonstrated histories of safe and effective clinical use.

Sterilization: Validated in accordance with ISO 11135: 2014 to provide a Sterility Assurance Level (SAL) of 10-6.

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

The document states, "All samples tested met the applicable acceptance criteria," indicating that a test set was used for each performance test. However, the specific sample sizes for each test are not provided.

Data Provenance: The data comes from non-clinical (bench) performance testing and biocompatibility evaluation based on predicate devices. There is no mention of country of origin as it's not clinical data, nor is it retrospective or prospective in the sense of patient data.

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

This information is not applicable as the document describes a 510(k) submission for a medical device (guide wire) based on non-clinical performance and biocompatibility. It does not involve AI/ML, image analysis, or expert-established ground truth on a test set in the context of an AI/ML device. The "ground truth" for the performance tests would be the established scientific and engineering principles and standards against which the functional performance of the guide wire is measured.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review of data/images to establish ground truth for AI/ML performance evaluation.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not described in this document.

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

No, a standalone (algorithm only) performance study was not done. This document pertains to a physical medical device (a guide wire), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance and biocompatibility studies is derived from:

• Recognized consensus ISO standards (e.g., ISO 11070: 2014, ISO 11135: 2014, ISO 10993-1: 2009)
• FDA guidance documents (e.g., Coronary and Cerebrovascular Guidewire Guidance, Class II Special Controls Guidance Document for Certain PTCA Catheters)
• In-house standards of Terumo Medical Corporation
• Biocompatibility data and clinical histories of legally marketed predicate devices

8. The Sample Size for the Training Set

This information is not applicable as the document describes a physical medical device (guide wire) and not an AI/ML device that requires a training set.

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

This information is not applicable for the same reasons as #8.

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The Capiox® RX05 Hollow Fiber Oxygenator/Reservoir device is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.

The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedures). The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal.

The Capiox® RX05 Oxygenator/Reservoir can be used in procedures lasting up to 6 hours.

The Capiox® RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5L/min.

The modified Capiox® RX05 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.

The modified Capiox® RX05 device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.

The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir. The reservoir component remains identical to the design of the original reservoir that was cleared by FDA with K022115 - except that a positive pressure relief valve will be included on the lid of the reservoir. The intent of the relief valve is to eliminate excessive pressure that could accumulate in a reservoir during bypass procedures.

The materials that are used in the construction of the Capiox® RX05 Hollow Fiber Oxygenator/Hardshell Reservoir includes, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyester, polyester, polyester, polyethylene terephthalate, stainless, polyethylere and X CastingTN polyethylene and X-Coating™.

This document is a 510(k) Summary for a modified medical device, the Capiox® RX05 Oxygenator/Reservoir. It describes a modification to an existing, cleared device, specifically the addition of a positive pressure relief valve to the hardshell reservoir. The submission focuses on demonstrating substantial equivalence to the predicate device (Terumo's Capiox® RX05 Oxygenator/Reservoir - K022115).

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

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

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results. Instead, it lists performance evaluations conducted to demonstrate substantial equivalence, implying that the acceptance criteria are met if these evaluations show performance equivalent to the predicate device or demonstrate the proper functioning of the new feature.

Based on the "Performance Evaluations" section and "Comparison of Performance," here's an inferred table:

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

The document mentions several "in-vitro performance evaluations" but does not specify the sample sizes used for any of the tests. It also does not provide details on the data provenance in terms of country of origin or whether studies were retrospective or prospective. All studies described are in-vitro (laboratory) tests, not human or animal studies.

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 section is not applicable to this submission. The device is a medical oxygenator/reservoir, and the evaluations are engineering/performance tests, not image-based diagnostics requiring expert interpretation to establish ground truth. The "ground truth" here is the physical and functional performance of the device against predefined engineering specifications or equivalence to the predicate.

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

This section is not applicable. The evaluations are described as objective performance tests (e.g., pressure measurements, sterility tests, physical integrity tests), which typically do not involve human adjudication in the sense of consensus reading or conflict resolution. The results are likely binary (pass/fail) or quantitative measurements against a standard.

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 section is not applicable. The device is a physical medical device (an oxygenator/reservoir), not an AI-powered diagnostic tool, and the submission does not involve human readers or AI assistance.

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

This section is not applicable. The 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 the performance evaluations described consists of:

• Engineering specifications/standards: For parameters like pressure relief, flow rates, and physical integrity.
• Predicate device performance data: For demonstrating substantial equivalence in performance where applicable.
• Validated sterilization protocols: To achieve the specified SAL.
• International standards (ISO 10993): For biocompatibility assessment.

This is primarily performance-based and regulatory standard-based ground truth, not clinical or diagnostic ground truth.

8. The sample size for the training set

This section is not applicable. The submission describes a device modification and performance testing, not the development or training of an algorithm or AI model.

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

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

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The Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant oxygenator intended for use in procedures up to a maximum flow of 1.5 L/min. The patient weight and BSA should be considered upon use.

The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures.

The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.

The modified Capiox FX05 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.

The modified Capiox FX05 device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.

With respect to the filtration of arterial blood, the modified Capiox FX05 Oxygenator/Arterial Filter relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.

The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir. The design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with K071572 - except that a positive pressure relief valve will be included on the lid of the reservoir.

The materials that are used in the construction of the Capiox FX05 Hollow Fiber Oxygenator/Hardshell Reservoir includes, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.

This document is a 510(k) summary for a modified Capiox FX05 Oxygenator/Reservoir. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets predefined acceptance criteria through clinical studies. Therefore, many of the requested categories (such as sample size for test sets, number of experts for ground truth, MRMC studies, etc.) are not applicable to this kind of regulatory submission.

Here's the information that is available based on the provided text, primarily falling under the "Performance Evaluations" section and the "Substantial Equivalence Comparison":

1. Table of Acceptance Criteria and the Reported Device Performance

As this is a 510(k) submission demonstrating substantial equivalence rather than a de novo clinical trial with explicit acceptance criteria for efficacy, specific numerical acceptance criteria (e.g., "accuracy > 90%") are not defined in the way you might expect for an AI/diagnostic device. Instead, the "acceptance criteria" are implicitly that the modified device performs equivalently to the predicate device for various evaluated aspects.

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

This submission does not detail specific "test sets" in the context of clinical trials or large-scale data analysis. The performance evaluations were in-vitro tests (laboratory-based) to demonstrate the functional equivalence of the modified device to the predicate. Therefore, sample sizes for patient data or data provenance are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the evaluations were in-vitro engineering tests, not dependent on expert clinical interpretation or ground truth establishment in a clinical sense.

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

This is not applicable as the evaluations were in-vitro engineering tests.

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

This is not applicable. This device is a medical device (oxygenator/reservoir), not an AI diagnostic or assistance tool that would involve human "readers" or AI-assisted interpretation.

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

This is not applicable as this device is not an algorithm or AI system.

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

For the in-vitro performance evaluations, the "ground truth" would be engineering specifications, established physical principles, and validated test methodologies to determine if the device performed as expected and equivalently to the predicate. For example:

• For pressure relief valve performance: The ground truth would be the expected pressure-relief characteristics and the predicate device's measured performance.
• For sterilization: The ground truth is the established SAL of 10⁻⁶ and acceptable residue limits.
• For biocompatibility: The ground truth is compliance with ISO 10993 standards and established toxicological profiles.

8. The sample size for the training set

This is not applicable. This is a hardware medical device, not an AI model that requires a training set.

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

This is not applicable as a training set is not relevant for this device.

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The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shaft cover and tip shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The 18 to 22 gauge catheters are suitable for use with power injectors rated for a maximum of 325 psi.

The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin and catheter hub), needle assembly (needle, needle housing, transparent flash chamber with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, junction cylinder). The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. Whole length cannula including the sharp end of the inner needle is covered by the needle shielding mechanism as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries. The grooved cannula which allows the clinician to visualize flashback detection through the groove indicating that there is confirmation of vessel entry is the same as the TERUMO® Surshield®-PUR Safety I.V. Catheter (K100282) and TERUMO® SURFLASH™ I.V. Catheter (K991406).

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

A non-clinical performance testing study was conducted to demonstrate the safety and effectiveness of the SURFLASH® Safety I.V. Catheter, its conformity to applicable ISO standards, and substantial equivalence to predicate devices. This study included:

• Compliance to ISO Standards: Tests were performed to confirm conformance with relevant parts of ISO 10555-1, ISO 10555-5, and ISO 23908, as detailed in the table above.
• Testing by Internal Standard: Additional performance tests, not covered directly by the listed ISO standards, were conducted against internal standards.
• Simulated Use Study: This study was conducted in accordance with FDA's Guidance For Industry and Staff, Medical Devices with Sharps Injury Prevention Features (August 9, 2005).

Detailed Information on the Study:

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

• Test Set Sample Size: Not explicitly stated for each individual test. However, the document mentions "study participants" for the simulated use study but does not quantify them. For other physical and material tests, a specific sample size is not provided, but it is implied that a sufficient number were tested to demonstrate compliance with standards.
• Data Provenance: The tests were conducted internally by Terumo Medical Corporation and its Kofu Factory in Japan. The data is retrospective in the sense that it reflects tests completed for the premarket submission.

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):

• Simulated Use Study: Healthcare workers (implied to be experts or trained professionals in I.V. catheter use) were the "participants" in the simulated use study. The number of participants and their specific qualifications (e.g., years of experience) are not explicitly stated, but the intent was to verify proper activation by those who use such devices.
• Physical/Material Tests: These tests rely on standardized methods and equipment, not expert consensus on individual cases. The "ground truth" for these tests is the quantitative measurement against defined ISO or internal standard thresholds.

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

• For the simulated use study, the "adjudication" was based on direct observation of whether "All safety features activated effectively and there were no de-activations after discarding" and if "All participants were able to read and activate the catheter safety feature without further explanation or training." This implies direct observation and evaluation against predefined criteria, not a specific 2+1 or 3+1 expert consensus method.
• For the physical and material tests, adjudication is based on whether the measured performance falls within the specified limits of the ISO standard or internal standard.

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 MRMC study mentioning AI was performed or reported. This device is a manual medical device (intravascular catheter with a passive safety feature), not an AI-assisted diagnostic or interpretative system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. This device does not involve an algorithm or AI. It is a physical medical device.

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

• Physical/Material Tests: The ground truth is the objective measurement of physical properties and performance characteristics against established technical standards (ISO) and the manufacturer's internal specifications.
• Simulated Use Study: The ground truth was based on the observable successful activation of the safety feature and the user's ability to follow instructions and operate the device effectively in a simulated environment. This represents a form of performance outcome directly observed.
• Biocompatibility Tests: The ground truth for biocompatibility is whether the materials meet predefined safety criteria as per ISO 10993 and FDA G95-1, assessed through specific biological tests (e.g., cytotoxicity, sensitization, systemic toxicity).

8. The sample size for the training set:

• Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. Performance is based on engineering design, material properties, and physical testing.

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

• Not applicable. See point 8.

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