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JOVUS Eagle Eye™ F/X catheters are designed for use in the evaluation of vascular morphology blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

JOVUS Eagle Eye™ F/X ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The JOVUS Eagle Eye™ F/X catheters contain a catheter-tip ultrasound device that applies ultrasound energy dir ctly into the interior vessel wall of the patient to obtain an image of the vessel. This device is not currently indicated for use in cerebral vessels. The JOVUS Eagle Eye F/X catheter accommodates a 0.014" guide wire.

The JOVUS Eagle Eye™ F/X catheter utilizes an integral guide wire lumen in which the catheter tracks over the guide wire at the distal tip. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip.

The JOVUS Eagle Eye™ F/% catheter is introduced percutaneously or via surgical cutdown into the vascular sy:tem. A linear array ultrasonic transducer situated circumferentially near the tip of the catheter produces real time cross-sectional images of coronary and peripheral vessels.

The JOVUS Eagle Eye™ F/X 2.9F catheters may only be used with the In-Vision™ Imaging System. This catheter will not operate if connected to any other imaging system.

The provided document is a 510(k) summary for the JOVUS Eagle Eye™ F/X 2.9F Intravascular Ultrasound Imaging Catheter, seeking substantial equivalence to a predicate device. It's important to note that this type of submission typically focuses on comparison to a predicate device and does not involve the kind of detailed clinical study data often seen for novel devices that require extensive performance data to establish their safety and effectiveness.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the JOVUS Eagle Eye™ F/X 2.9F Intravascular Ultrasound Imaging Catheter in a table format. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and general performance.

The key statement regarding performance is:
"Applicable testing is being performed in accordance with the Master Design Verification Plan including a Risk Analysis addressing the impact of modifications to the device and components. The test results will be found to be comparable to those of the predicate device, Avanar™ F/X 2.9F Iritravascular Ultrasound Imaging Catheter. The new backing material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria."

Therefore, the implicit acceptance criterion for overall device performance is "comparable to the predicate device."

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

The document does not specify a sample size for a test set in the context of clinical performance evaluation directly. The evaluation focuses on engineering and biocompatibility testing. There is no mention of patient data (retrospective or prospective) or country of origin for such data.

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

This information is not applicable as the document does not describe a clinical study involving a test set that requires expert-established ground truth for image interpretation or diagnosis. The testing mentioned is primarily related to device performance, manufacturing, and biocompatibility.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. No clinical test set requiring adjudication is described.

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 and is not mentioned in the document. The submission focuses on device modifications and substantial equivalence, not a comparative clinical trial with human readers.

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. The device is an intravascular ultrasound catheter, which is a physical diagnostic tool operated by a human, not an AI algorithm.

7. The Type of Ground Truth Used

For the biocompatibility testing, the ground truth used was established by compliance with ISO 10993-1, a recognized international standard for biological evaluation of medical devices.

For the claim of "comparable" device performance, the ground truth is implicitly the performance of the predicate device, Avanar™ F/X 2.9F Intravascular Ultrasound Imaging Catheter, as measured through engineering and functional testing. No pathology, expert consensus, or outcomes data is mentioned as ground truth.

8. The Sample Size for the Training Set

This is not applicable. The document describes a medical device, not a machine learning or artificial intelligence system that requires a "training set."

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

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

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In-Vision™ Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also incicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vaculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The JOMED Inc. In-Vision™ Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intra'uminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the In-Vision™ Imaging Systems can be adjunct to interventional therapies, such as balloon angioplasty. With ChromoFloTM, a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing a ditional information for vessel analysis. The In-Line Digital™ option displays a two-dimensional, 360° rotations, and longitudinal view of the vessel.

Here's an analysis of the provided text regarding the In-Vision™ Imaging System's acceptance criteria and studies:

Based on the provided 510(k) summary, the document does not contain specific acceptance criteria tables or detailed performance study results in the manner requested. The submission is a "Special 510(k)" for a software modification (version upgrade to V4.1) of an existing device. For such submissions, the focus is often on demonstrating that the changes do not raise new questions of safety or efficacy, rather than presenting extensive de novo performance data.

Therefore, many of the requested fields cannot be filled directly from this document. However, I can extract the available information and highlight what is missing.

Acceptance Criteria and Device Performance

Not explicitly stated in the document. The document states: "Applicable testing was performed to evaluate the modifications to the In-Vision™ Imaging System. The test results were found to be acceptable as required by the respective test plans and protocols."

This indicates that internal acceptance criteria and protocols were used, but the specific metrics and performance values are not disclosed in this 510(k) summary.

Study Details (Based on Available Information)

Since detailed performance data is not provided, many of these sections will indicate "Not specified in document."

Summary of Information from the Document:

• Device Name: In-Vision™ Imaging System
• Purpose of Submission: Software modification (version upgrade to V4.1) to an existing intravascular ultrasound imaging system.
• Comparison: Claims substantial equivalence to predicate devices based on fundamental scientific technology, intended use, and clinical applications.
• Performance Data Statement: "Applicable testing was performed to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols." This indicates internal testing was done and met predefined criteria, but the specifics are not public in this summary.
• Conclusion: The software modification "raises no new questions about safety and efficacy."

This 510(k) summary focuses on demonstrating that a software update to an already cleared device does not alter its fundamental safety or effectiveness profile, rather than providing a detailed performance study as might be expected for a novel device or an AI/ML product today.

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To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Neo's Guide Wires are not to be used in the cerebral blood vessel.

The JoWire Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from stainless steel core wire with varying core lengths and diameters for each design. The core wire and core are soldered. The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic or silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

The provided text describes a 510(k) premarket notification for the JoWire Asahi PTCA Guide Wires, which aims to demonstrate substantial equivalence to a predicate device. The document states that performance data was collected through bench and biocompatibility testing.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: Not specified.
• Data provenance: Not specified, but based on the nature of bench and biocompatibility testing, it would be in vitro (bench testing) and potentially in vivo (biocompatibility, if animal studies were performed, though not explicitly stated for this 510(k)). There is no indication of human clinical data or geographical origin.

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

• Not applicable as the testing described is bench and biocompatibility, not expert-adjudicated clinical data.

4. Adjudication method for the test set:

• Not applicable for bench and biocompatibility testing. Performance is assessed against pre-defined engineering and biological criteria.

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-assisted diagnostic tool.

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

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

7. The type of ground truth used:

• For bench testing: Engineering specifications, performance standards, and comparisons to predicate device characteristics.
• For biocompatibility testing: Established biological safety standards and guidelines.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable.

Summary from the provided text:

The submission highlights that bench and biocompatibility testing were conducted. The crucial statement is: "Bench and biocompatibility testing were conducted according to the recommendations from relevant guidances to demonstrate that the JoWire Asahi PTCA Guide Wires met the acceptance criteria and performed similarly to the predicate devices." This indicates that the study performed was the bench and biocompatibility testing, and its outcome was that the device successfully met the predefined acceptance criteria and showed performance comparable to the predicate device. However, the specific details of these criteria (e.g., tensile strength, lubricity targets, specific biological response limits) and the quantitative results are not provided in the summary.

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To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Neo's Guide Wires are not to be used in the cerebral blood vessel.

The JoWire Neo's PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 180 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire with varying core lengths and diameters for each design. The core wire and coil are soldered. The distal end of the wire guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic or silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

The provided text is a 510(k) summary for the JoWire Neo's PTCA Guide Wires, submitted by JOMED Inc. in August 2002. This document describes a medical device and its intended use, but it does not contain the detailed information required to fill out the table and answer the specific questions about acceptance criteria, study design, and ground truth for an AI/algorithm-based device.

Instead, the document states:

• "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the JoWire Neo's Guide Wires met the acceptance criteria and performed similarly to the predicate devices."
• "No new safety or effectiveness issues were raised during the testing."

This indicates that standard device performance and safety testing (bench testing, biocompatibility) was performed, which is typical for physical medical devices like guide wires. It does not refer to the kind of "acceptance criteria" or "study" (like an MRMC study or standalone algorithm performance) that would be relevant for an AI or algorithm-based device.

Therefore, I cannot provide answers to your specific questions based on the input text. The questions you've asked are designed for the evaluation of AI/ML-driven medical devices, for which this 510(k) document is not applicable.

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The SmartWire/SmartMap Pressure System is intended for use in the coronary and peripheral arteries to measure blood pressure during diagnostic and/or interventional procedures. The SmartWire can also be used in replacement of an angioplasty guide wire to facilitate the placement of a balloon dilation catheter, as well as other interventional devices. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The SmartWire/SmartMap Pressure System is indicated for use in all blood vessels, I he Sinal White Smarthup Fressure Byoss to measures blood pressure during diagnostic angiography and/or interventional procedures.

The Jometrics SmartWire/SmartMap Pressure System consists of the SmartWire and the SmartMap. Additionally, the SmartWire can be used with the existing WaveMap with the inclusion of the Patient Cable Model 8000.

The SmartWire is a steerable pressure monitoring guide wire used to obtain intracoronary pressure measurements before, during, and after interventional procedures. There are two lengths. 189 cm and 300 cm and the outside diameter is .014". The screw tip, core wire, proximal coil and hypotube are manufactured from stainless steel. The tip coil is composed of a platinum, iridium alloy and coated to provide lubricity. The hypotube and proximal coil are also coated to provide lubricity.

The SmartMap is designed to interface a SmartWire Pressure Wire to the auxiliary input of hemodynamic (Physio Monitor) systems. The SmartMap's power is derived from the hemodynamic system and provides in return an industry standard (AAMI BP22-2-1994) 5uV/V/mmHg output back to the hemodynamic system.

The instrument is intended to measure pressure from a pressure sensor on a guide wire in the coronary and peripheral vasculature during diagnostic and/or interventional procedures.

The Patient Cable Model 8000 is a preamplifier/signal condition unit designed to interface the SmartWire family of wires to an existing WaveMap Instrument. It uses intelligence to set up the circuitry designed to process the SmartWire as done in the SmartMap so that SmartWires may be used with either the SmartMap or the WaveMap.

The provided document is a 510(k) summary for the Jomed SmartWire/SmartMap Pressure System, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials. As such, the document does not contain details about specific acceptance criteria, a standalone study proving those criteria, or information typically found in studies for AI/software devices (like sample sizes for test/training sets, ground truth establishment, or expert involvement).

Here's a breakdown of why many of your requested items cannot be found in this document:

• Device Type: This is a physical medical device (a guide wire and pressure system) from 2002, not a software or AI-based device. Therefore, the types of studies mentioned in your request (MRMC, standalone algorithm performance, AI vs. human assistance) are not applicable or typical for this kind of device at that time.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device. This often involves bench testing, material characterization, and comparison of technological characteristics, rather than extensive clinical trials that establish acceptance criteria and then prove them with a dedicated study against a "ground truth" as you've outlined.

Given these limitations of the source document, here's the information that can be extracted or inferred, alongside explanations for what cannot be provided:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criterion for this 510(k) submission was substantial equivalence to the predicate device, the WaveWire/WaveMap Pressure System (K965140). This means the device's technological characteristics and performance had to be "comparable" to the predicate.

Study Details and Explanation for Missing Information

The provided document describes a 510(k) submission for a physical medical device (catheter guide wire and pressure system) in 2002. This regulatory pathway focuses on demonstrating "substantial equivalence" to a previously cleared predicate device, rather than proving de novo safety and effectiveness through extensive, detailed clinical trials with the specific types of studies you've requested for AI/software. Therefore, much of the requested information is not present or applicable to this document.

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

   • Not explicitly stated. The document refers to "Applicable testing" but does not detail the nature, sample size, or specific methodologies of these tests beyond stating they were found "comparable" to the predicate. Device testing for 510(k)s often includes bench testing (e.g., pressure accuracy, fatigue, burst strength), and potentially animal or limited human use data, but the specifics are not in this summary.

2. 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):

   • Not applicable/Not stated. "Ground truth" in the context of clinical expert consensus (as often used for AI diagnostics) is not a concept typically applied to the performance evaluation of a physical pressure wire system for a 510(k). Performance comparision would likely involve engineering and clinical validation against established standards or the predicate device's measured performance.

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

   • Not applicable/Not stated. This concept is relevant for expert review in clinical studies for diagnostic accuracy, which is not the primary focus of this 510(k) summary.

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 is not relevant here. This device is a physical pressure sensing system used by clinicians, not a diagnostic imaging or AI system that assists human readers.

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

   • Not applicable. This device is a physical instrument for measuring pressure, not an algorithm. Its function inherently involves human operators and interaction with existing hemodynamic systems.

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

   • Not applicable/Not stated in the context of AI ground truth. The "ground truth" for a pressure system would be established by validated reference pressure measurement devices or methods. The document states "Applicable testing was performed," implying comparison against established benchmarks or the predicate.

7. The sample size for the training set:

   • Not applicable. This device is hardware, not an AI algorithm that requires a training set.

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

   • Not applicable. As above, no training set or AI algorithm is involved.

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