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The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts.

The SCIMED® Informer™ Pressure Wire System consists of the following components:

• · a guide wire,
• · a disposable transducer with attached cable, and
• · a permanent cable.
  The guide wire is a steerable coronary guide wire available in a nominal diameter of 0.014 inches, overall lengths of 185 and 300 centimeters, radiopaque tip lengths of 3 and 5 centimeters, straight and J-tip configurations and one tip flexibility that falls between the ChoICE Floppy and Intermediate models, similar to the ChoICE Extra Support. The guide wire is designed to monitor intravascular pressures and to facilitate the placement of balloon dilatation catheters.
  The disposable transducer with attached cable converts hemodynamic pressure signals from the guide wire into electrical signals. This transducer interfaces with standard physiologic monitors to display the electrical signals in phasic waveforms via the permanent cable.

The provided text describes a submission for a medical device called the SCIMED® Informer™ Pressure Wire System, seeking 510(k) clearance from the FDA. This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving they are met through a specific study with statistical performance metrics.

Therefore, the requested information (acceptance criteria, specific study, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) related to proving a device meets acceptance criteria is largely not applicable in the context of this 510(k) summary.

However, I can extract information related to the testing performed to demonstrate substantial equivalence, which serves a similar purpose in this regulatory pathway.

Here's a breakdown of the available information and what is not available based on the provided text:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria/Performance Metrics: Not explicitly stated as pass/fail criteria with numerical thresholds. The submission focuses on demonstrating "substantial equivalence" to predicate devices through various tests.
• Reported Device Performance: The "Non-Clinical Test Summary" section briefly mentions the types of tests conducted.

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

• Test Set Sample Size: Not specified in the provided text for any of the in-vitro or in-vivo tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The in-vivo testing suggests real-world data, but details are absent.

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

• Not applicable / Not provided. The safety and effectiveness summary for a 510(k) primarily relies on engineering performance tests and comparison to predicates, not expert-adjudicated ground truth in a clinical sense for a test set. The in-vivo tests would likely have involved medical professionals, but their role in establishing "ground truth" (e.g., for diagnostic accuracy) is not elaborated upon as this is not a diagnostic device.

4. Adjudication method for the test set:

• Not applicable / Not provided. This concept is usually relevant for studies involving human interpretation or subjective assessments, which are not detailed here for this device.

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

• Not applicable. This device is not an AI-powered diagnostic tool, and the concept of "human readers improve with AI vs without AI assistance" does not apply. The device's function is to directly measure pressure and facilitate catheter placement.

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

• Not applicable. This is a physical medical device (guide wire, transducer, cable system) that operates in conjunction with physiological monitors and human clinical procedures. It doesn't have a "standalone algorithm" in the sense of AI or image analysis. Its "performance" is its ability to accurately measure pressure and perform its mechanical functions. The in-vivo and in-vitro tests mentioned describe its standalone operational performance.

7. The type of ground truth used:

• For the in-vitro tests, the "ground truth" would be established by the physical standards and measurement techniques defined for each test (e.g., a calibrated pressure source for transducer accuracy, specified forces for tensile tests).
• For in-vivo tests, the comparison of "pressure reading capabilities" and "guide wire performance characteristics" implies a comparison against existing, accepted methods or devices within a clinical setting. The specific "ground truth" for accuracy (e.g., what pressure reading is considered correct) would be determined by the reference standard used in the comparison (e.g., simultaneous measurement with a gold-standard pressure measurement system).

8. The sample size for the training set:

• Not applicable / Not provided. This device is not an AI/machine learning device that requires a "training set" in the computational sense.

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

• Not applicable. As above, this device does not utilize a training set.

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SCIMED 6 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

The shaft of the 6 F Wiseguide guide catheter utilizes biocompatible materials and consists of the following three layers: 1) the inner layer that provides a low coefficient of friction and facilitates passage of medical devices such as stents, balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer that extends from the shaft to the tip to provide kink resistance and torque control; and 3) the outer layer which provides stiffness, backup support, curve retention and radiopacity.

In addition, the outer primary catheter shaft is constructed of various material durometers providing transitional flexibility to the distal curve area of the catheter.

The catheter is radiopaque to allow visualization under fluoroscopy during a procedure.

The devices will be provided sterile and are intended for one procedure use only.

The provided text describes the 510(k) notification for the SCIMED® 6 French Wiseguide™ Guide Catheter. It outlines the device's description, intended use, and a summary of non-clinical testing. However, it does not contain the level of detail typically found in a study report proving acceptance criteria for an AI/ML medical device.

Based on the provided text, the device is a physical medical device (guide catheter), not an AI/ML-driven software device. Therefore, many of the requested criteria (e.g., sample sized for the test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable.

Here's the information that can be extracted and a clear indication of what is not present due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Verified": The document states: "Test results verified that the 6 F Wiseguide catheter is adequate for its intended use." Specific quantitative acceptance criteria (e.g., "pressure burst > X PSI") and the exact numerical results are not provided in this summary.

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

• Not applicable as this is a physical medical device. Testing involved physical device properties rather than a data-based test set.

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 medical device. Ground truth is based on engineering specifications and physical testing standards.

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

• Not applicable as 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:

• Not applicable. This device is a guide catheter and does not involve AI or human "readers."

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:

• The ground truth for this device's performance is based on engineering specifications and established functional performance standards for guide catheters, verified through non-clinical laboratory testing.

8. The sample size for the training set:

• Not applicable. This is a physical medical device; there is no training set in the context of AI/ML.

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

• Not applicable. This is a physical medical device; there is no training set in the context of AI/ML.

Summary of Non-Clinical Testing Section for Confirmation:

The document clearly states: "Functional testing consisted of pressure burst, tip bond tensile, shaft tensile, hub tensile, material adhesion, tip coefficient of friction, force transmitted by catheter tip, torque response and dye flow. Test results verified that the 6 F Wiseguide catheter is adequate for its intended use." This confirms the assessment that the acceptance criteria are related to the physical and mechanical properties of the catheter, not to AI/ML performance metrics. The device's equivalency was established by comparing its intended use, design, and in-vitro testing results to existing predicate devices.

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The SCIMED Quest Floppy and Moderate Support Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The Quest Floppy and Moderate Support Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The SCIMED Quest Floppy and Moderate Support Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and nominal lengths of 182 and 300 centimeters. The available tip flexibilities will be Floppy and Moderate Support. The distal two centimeters of both models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip.

Acceptance Criteria and Study for SCIMED® Quest™ Guide Wires

Based on the provided document, the "performance" of the device is assessed through "Non-Clinical Test Summary" which lists various physical and mechanical properties. The acceptance criteria are implicit in the successful completion of these tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the "Non-Clinical Test Summary." It mentions "testing and evaluation of the guide wires," which generally implies a sufficient number of samples were tested to demonstrate robust performance for each characteristic.

The data provenance is prospective as the testing was conducted on the physical device itself for the purpose of demonstrating its safety and effectiveness for a 510(k) submission. There is no information regarding the country of origin of the data, but it can be inferred that the testing was performed by the manufacturer, SCIMED Life Systems, Inc., which is based in Maple Grove, MN, USA.

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

This information is not applicable to this type of device and study. The "Non-Clinical Test Summary" describes physical and mechanical property testing, not subjective assessments by experts. The "ground truth" for these tests would be objective measurements against defined engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Since the testing involved objective physical and mechanical measurements, an adjudication method for different expert opinions would not be relevant.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The SCIMED Quest Guide Wires are interventional devices, and their performance is assessed through physical and mechanical testing, not by comparing human reader performance.

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

This information is not applicable. The SCIMED Quest Guide Wires are physical medical devices, not algorithms or AI. Therefore, the concept of "standalone performance" for an algorithm is irrelevant in this context.

7. The Type of Ground Truth Used

The ground truth used for the "Non-Clinical Test Summary" was based on objective engineering and material science specifications and established testing methodologies. For example:

• Physical measurements: For parameters like tip flexibility, torque response, etc.
• Mechanical strength standards: For tensile strength, torsion strength, shear strength.
• Material properties: For coating adherence and compatibility.
• Predicate device performance: The document explicitly states that the device "utilize the same materials and methods of construction as the currently marketed SCIMED Guide Wires (ChoICE, Luge and Sceptor Families of Guide Wires)," implying that the predicate devices set a benchmark for acceptable performance.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant to machine learning and AI, which are not involved in the development or testing of this physical medical device.

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

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

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The SCIMED 6 French IMPULSE™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

The 6 French SCIMED IMPULSE Angiographic Catheters are single lumen catheters which will be available in Selective, Pigtail and Multipurpose models. The shafts of all models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. 2) The middle layer provides torque control, kink resistance and support, and 3) The outer layer provides stiffness and curve retention. Radiopaque materials are utilized in the outer layer to allow visualization of the catheter during the procedure. A Pigtail Straightener is available to aid the physician in straightening the Pigtail curve while being introduced into the introducer sheath.

The medical device, SCIMED® 6 French IMPULSE™ Angiographic Catheters, did not provide acceptance criteria in a structured manner but rather demonstrated substantial equivalence to predicate devices through non-clinical functional testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

• Study Type: Non-clinical (in-vitro) functional testing and comparison study for substantial equivalence.
• Device: SCIMED® 6 French IMPULSE™ Angiographic Catheters.
• Predicate Devices: SCIMED® 6 French EXPO™ Angiographic Catheter and SCIMED 5 French IMPULSE™ Angiographic Catheter.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "functional testing" but does not quantify the number of catheters or tests performed for each criterion.
• Data Provenance: The study was non-clinical (in-vitro) and conducted by SCIMED Life Systems, Inc. The country of origin for the data is not specified beyond being generated by the submitter (SCIMED Life Systems, Inc. in Maple Grove, Minnesota, USA). The study is prospective in the sense that these tests were performed on the new device for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. This was a non-clinical, in-vitro functional testing study, not a study involving human interpretation or expert consensus for ground truth.

4. Adjudication Method: Not applicable. This was a non-clinical, in-vitro functional testing study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI algorithm or imaging device that would typically involve human readers interpreting cases.

6. Standalone Performance Study:
Yes, a standalone study was done in the sense that the device's functional performance was evaluated independently against engineering specifications and industry standards (implicitly, by demonstrating "adequacy for intended use" and "substantial equivalence"). The "algorithm only" context is not relevant here as it is a physical device.

7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was established by pre-defined engineering specifications, performance standards, and the demonstrated performance of predicate devices. For example, a catheter must withstand a certain pressure to pass the pressure burst test.

8. Sample Size for the Training Set: Not applicable. This is not an AI/machine learning study requiring a training set.

9. How Ground Truth for the Training Set was Established: Not applicable. This is not an AI/machine learning study requiring a training set.

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SCIMED 7 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

The shaft of the 7 F Wiseguide guide catheter utilizes common biocompatible materials and consists of the following three layers: 1) the inner layer that provides a low coefficient of friction and facilitates passage of medical devices such as stents, balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer that extends from the shaft to the tip to provide kink resistance and torque control; and 3) the outer layer which provides stiffness, backup support, curve retention and radiopacity.

In addition, the outer primary catheter shaft is constructed of various material durometers providing a distal curve area of the catheter with transitional flexibility.

The distal tip is radiopaque to allow visualization under fluoroscopy during a procedure.

The devices will be provided sterile and are intended for one procedure use only.

The medical device in question is the SCIMED® 7 French Wiseguide™ Guide Catheter, which is similar to Diagnostic Intravascular Catheters (21CFR Part 870.1200).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document describes non-clinical (in-vitro) testing. Therefore, there were no human patient test sets used. The document does not specify the exact sample sizes (number of units tested) for each functional test mentioned.

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

Not applicable. This was an in-vitro functional testing study of a medical device, not a study requiring human expert assessment for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which is not the case for this in-vitro functional testing.

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

No. The document only describes non-clinical (in-vitro) functional testing, not a comparative effectiveness study involving human readers or cases.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

The "ground truth" for this study was established through engineering specifications and performance standards for various physical and mechanical properties of the catheter. The functional tests (e.g., pressure burst, tensile strength, torque response) directly measured whether the device met these predefined engineering requirements.

8. Sample Size for the Training Set:

Not applicable. This document describes the functional testing of a specific medical device, not the development or training of a machine learning algorithm.

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

Not applicable, as there was no training set for an algorithm. The "ground truth" for the device's design and performance expectations would have been established during its development based on engineering principles, predicate device performance, and the intended clinical use.

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The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires).

Here's an analysis of the provided text regarding the SCIMED® Luge™ Guide Wire, focusing on the requested information.

It's important to note that the provided documents are a 510(k) summary and FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study reports with detailed performance metrics against pre-defined acceptance criteria. Therefore, some of the requested information, particularly regarding specific performance metrics, sample sizes for training/test sets, ground truth establishment for AI/ML models, and detailed adjudication methods, is not present in these documents. The device cleared is a guide wire, which is a medical device, not an AI/ML diagnostic tool, thus many of the AI/ML specific questions are not applicable.

Acceptance Criteria and Study for SCIMED® Luge™ Guide Wire

The SCIMED Luge Guide Wire's acceptance criteria and proven performance are based on its substantial equivalence to previously marketed SCIMED Guide Wires (ChoICE, Sceptor, and ChoICE PT Families). The study primarily involved non-clinical testing and comparison of design and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a clinical trial demonstrating new performance metrics. The comparison is based on the design, materials, manufacturing processes, and non-clinical testing results against existing predicate devices.
• Data Provenance: The data provenance is from non-clinical testing of the Luge Guide Wire and comparison with the design specifications and known performance characteristics of the predicate SCIMED Guide Wires. This is retrospective in the sense that it relies on established data and designs of existing products. The country of origin for the data is implied to be within the US, where SCIMED Life Systems, Inc. is located.

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

• Not Applicable. This device clearance is based on substantial equivalence to predicate devices through non-clinical testing and design comparison, not on establishing a "ground truth" for diagnostic accuracy by a panel of experts.

4. Adjudication Method for the Test Set

• Not Applicable. As there is no clinical "test set" requiring expert judgment for ground truth, no adjudication method is described. The review process is handled by the FDA based on the submitted non-clinical data and comparisons.

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

• No. An MRMC study is not mentioned as part of this 510(k) submission. These studies are typically for AI/ML diagnostic devices where the performance of human readers with and without AI assistance is evaluated. This device is a guide wire, not a diagnostic AI/ML system.

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

• Not Applicable. This device is a physical medical instrument (guide wire), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" here is the established safety and effectiveness profile of the predicate devices (ChoICE, Sceptor, and ChoICE PT Families of Guide Wires) in their intended use. The Luge Guide Wire's equivalence is demonstrated against this established standard through physical and engineering comparisons.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" in the conventional sense for model development. The design and manufacturing processes are likely informed by years of experience and testing with previous guide wire designs, but not in the format of a discrete "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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SCIMED guide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature

The shaft of the 8 F Wiseguide guide catheter utilizes common biocompatible materials and consists of the following three layers: 1) the inner polytetrafluoroethylene (PTFE) layer that provides a low coefficient of friction and facilitates easy passage of medical devices such as balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer which is made of braided stainless steel wire that extends from the shaft to the tip to provide kink resistance, torque control and support and 3) the outer layer, manufactured from Pebax® and a radiopaque filler, which provides stiffness, memory and radiopacity.

In addition, the distal 5.8 to 17.5 inches (depending on the curve style) of the outer primary catheter shaft is constructed of multiple sections of Pebax. These sections are composed of durometers of Pebax providing a distal curve area of the catheter with transitional flexibility. The catheter is assembled as components over a core mandrel. The catheter shaft is then heat fused, forming a composite catheter shaft. This process results in a continuous inner and middle layer and a seamless outer shaft layer.

The distal tip is made of Pebax and is radiopaque to allow visualization under fluoroscopy during a procedure.

The catheters utilize a one piece Pebax hub/strain relief that is molded to the proximal end of the guide catheter shaft. The 8 F Wiseguide Guide Catheters have a 0.086" ID. The catheters will be available in lengths ranging from 40 to 125 cm, with optional side holes. The devices will be provided sterile and are intended for one procedure use only.

The provided text describes a medical device, the SCIMED® 8 French Wiseguide™ Guide Catheter, and its clearance process, but it does not present specific acceptance criteria or a dedicated study proving the device meets those criteria in the way a diagnostic AI/ML device submission would.

Instead, this document (K970823) is a 510(k) premarket notification for a predicate device. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet pre-defined performance acceptance criteria with a formal study as you might find for a novel diagnostic device.

However, I can extract the relevant information and present it in the requested format, interpreting "acceptance criteria" based on the functional testing mentioned to demonstrate substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a physical medical device, not a diagnostic AI/ML system, "acceptance criteria" are not explicitly stated in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, acceptance is demonstrated by successfully passing functional tests and showing substantial equivalence to predicate devices. The "reported device performance" refers to the verification that these tests were passed.

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

The document does not specify a "test set" in the context of diagnostic data. The evaluation was primarily through non-clinical functional testing of the physical device. The sample size for these specific engineering/functional tests (e.g., number of catheters tested for pressure burst) is not reported in the provided text.

• Data Provenance: Not applicable in the context of patient data. The tests are in-vitro (bench testing).

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

• Not applicable. The "ground truth" for functional testing of a physical device is typically established by engineering specifications and objective measurements, not expert consensus on diagnostic images or pathology.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication method" in the sense of reconciling expert opinions for a ground truth dataset, as the testing involves objective physical 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

• No. This is a physical medical device (coronary guide catheter), not an AI/ML diagnostic device. Therefore, an MRMC study and AI assistance are not relevant to this submission.

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

• No. This is a physical medical device. No algorithm or standalone performance study was conducted.

7. The Type of Ground Truth Used

• For the functional tests, the "ground truth" would be engineering specifications and established test methods (e.g., a certain pressure must be withstood, a certain tensile strength achieved, a specific coefficient of friction measured).

8. The Sample Size for the Training Set

• Not applicable. This being a physical device, there is no "training set" in the context of an AI/ML model. Device development involves design iterations and manufacturing process refinement, not algorithmic training.

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

• Not applicable. No training set as per AI/ML context.

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

The "study" described in the document is a non-clinical test summary focusing on the physical and material properties of the SCIMED® 8 French Wiseguide™ Guide Catheter. This testing was conducted to demonstrate its substantial equivalence to already marketed predicate devices (SCIMED® 8 French Cyber™ Guide Catheters and Cordis® Corporation, 8 French Vista Brite Tip™ Guide Catheters).

The tests performed included:

• Pressure burst
• Tip bond tensile
• Shaft tensile
• Hub tensile
• Tip coefficient of friction
• Force transmitted by the catheter tip
• Torque testing
• Biocompatibility
• Shelf life testing

The results of these in-vitro tests "verified that the 8 F Wiseguide catheter is adequate for its intended use." The conclusion drawn from these tests, along with a comparison of the device's intended use and design, was that the new catheter is substantially equivalent to the predicate devices. This finding of substantial equivalence by the FDA (as indicated in the clearance letter K970823) allows the device to be marketed. There is no mention of a formal clinical trial or a diagnostic performance study as would be required for an imaging or AI/ML device.

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The SCIMED ChoICE Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Guide Wire family is not intended for use in the cerebral vasculature.

The ChoICE Super Support and Super Support II Guide Wire models are steerable guide wires available in a nominal diameter of 0.014" and two tip configurations, straight shapeable and pre-formed J-Tip. A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating. The available lengths for the Super Support and Super Support II Guide Wire will be: ChoICE -190 cm, ChoICE Plus-182 cm, and ChoICE Exchange-300 centimeters.

The provided document is a 510(k) premarket notification for a medical device, specifically PTCA Guide Wires. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study with detailed statistical analysis.

Therefore, the input does not contain the kind of information requested for many of your points, such as:

• A table of acceptance criteria and reported device performance (in a quantifiable, statistically analyzed sense).
• Sample sizes for test sets, data provenance, or number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies with effect sizes.
• Standalone algorithm performance.
• Training set information.

Instead, the document describes non-clinical (in vitro) testing for the guide wires and states that the results verified that the device met minimum requirements for its intended use. It does not provide specific numerical acceptance criteria or performance metrics.

Here's an analysis based on the information available in the document, and an explanation for what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states, "Test results verified that the ChoICE Super Support and Super Support II Guide Wire models met all of the minimum requirements and are adequate for their intended use." However, the specific numerical values for these "minimum requirements" (acceptance criteria) and the actual numerical results of the tests are not provided in this summary.

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

• Sample Size for Test Set: Not specified. The document only mentions "Testing and evaluation of the guide wires included" the listed tests, but does not detail the number of units tested.
• Data Provenance: The tests conducted were "Non-Clinical Test Summary" and "in vitro testing and evaluation." This implies laboratory/bench testing, not data from human subjects or clinical settings. Therefore, country of origin is not applicable in the usual sense (it's manufactured in Maple Grove, MN, USA, as per the submitter's address). The study is non-clinical/in-vitro.

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

• Not applicable. This was a non-clinical/in-vitro engineering performance test. "Ground truth" in the context of expert review for medical imaging or clinical outcomes is not relevant here. The "ground truth" (or standard) for these tests would be established by engineering specifications and test methodologies.

4. Adjudication method for the test set:

• Not applicable. As this was non-clinical/in-vitro testing, there's no "adjudication" in the sense of reconciling human expert opinions. The results would be objectively measured against predefined engineering specifications.

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

• Not applicable. This device is a PTCA guide wire, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

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

7. The type of ground truth used:

• Ground Truth: For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards for guide wires, which dictate the "minimum requirements" mentioned in the results. This is established through materials science, biomechanical engineering principles, and regulatory requirements for medical devices.

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. (See #8)

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The SCIMED ChoICE Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The ChoICE Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and two tip configurations, straight shapeable and pre-formed J-Tip. The available tip flexibilities are

• · Floppy,
• · Intermediate,
• · Extra Support,
• · Standard,
• · Super Support, and
• · Super Support II
  A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating.

The available lengths for the guide wires are
• ChoICE-190 cm,
• ChoICE Plus-182 cm, and
• ChoICE Exchange-300 centimeters.

The provided document is a 510(k) Notification for medical devices (PTCA Guide Wires). It focuses on regulatory approval based on equivalence to predicate devices and describes the device's characteristics and intended use. However, it does not contain information about clinical studies with acceptance criteria or device performance data in the way typically found for algorithms or AI-driven devices.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies as these are not present in the provided text.

The document primarily states:

• The device (SCIMED ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires) is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures.
• It refers to Non-Clinical Test Summary stating that Additional testing of the modified ChoICE Extra Support Guide Wires was not performed since the identical core wire dimension is present on the ChoICE PT Extra Support Guide Wires. And Testing presented in K960657, ChoICE PT Extra Support on the first support diameter is directly applicable to the ChoICE Extra Support because of the identical design in this section of the wire. This indicates reliance on previous testing of a similar predicate device, rather than new, detailed performance studies for this specific submission.

In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria, device performance, study methodology, or ground truth establishment for a clinical study.

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The SCIMED ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The proximal section of the guide wire consists of a differential magnetic (Hiperco®) core wire encased in a FEP or PTFE coated stainless steel hypotube. The Hiperco® core wire/hypotube assembly is attached to the distal stainless steel core wire assembly by means of a weld and an adhesive bond. There are no other changes being made to the proximal section of the guide wires.

The provided document is a "Summary of Safety and Effectiveness" for a medical device (PTCA Guide Wire) seeking 510(k) clearance. It describes the device, its intended use, and a comparison to existing devices to establish substantial equivalence. The document does not describe acceptance criteria for an AI/ML device, nor does it detail a study proving such a device meets acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the input document does not contain this type of information. It specifically focuses on a physical medical device (catheter guide wire) and its mechanical testing, not an AI/ML system.

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