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RADIFOCUS Torque Device is intended to facilitate guidewire manipulation during interventional procedures.

RADIFOCUS Torque Device is a supportive device intended to facilitate guide wire manipulation during interventional procedures. This product consists of a cap that screws onto the main body of the device (handle) to apply a clamping force on the guide wire. The cap is made of polypropylene and the handle is made of polyoxymethylene. The torque device can be used for the guide wires with diameters of 0.010" to 0.038". RADIFOCUS Torque Device is sterilized with ethylene oxide.

The provided text describes a 510(k) submission for the RADIFOCUS Torque Device, a medical device intended to facilitate guidewire manipulation. It specifically states that no clinical tests were performed or deemed necessary for this submission. The evaluation relies on non-clinical performance testing and comparison to a predicate device.

Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be fully provided in the context of a clinical study with human subjects, given that no such study was conducted or required.

However, based on the provided text, I can infer the "acceptance criteria" and "study" refers to the non-clinical performance testing conducted.

Here's the breakdown of what can be extracted from the provided text regarding the non-clinical performance testing:

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

The document states: "The RADIFOCUS Torque Device tested met the predetermined acceptance criteria." While the specific numerical or qualitative acceptance criteria for each test are not detailed, the results are uniformly positive.

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

• Sample size: Not specified. The document only mentions "Performance testing was conducted."
• Data provenance: Not specified. It's implied to be internal testing by the manufacturer (Terumo Medical Products (Hangzhou) Co., Ltd.) given the context of a 510(k) submission and the lack of external study details. The testing is retrospective in the sense that it was conducted before the submission.

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 there was no clinical study involving human subjects or expert assessment of clinical outcomes. The "ground truth" for the non-clinical performance tests would be the established engineering specifications and measurement standards.

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

• This is not applicable for non-clinical performance testing of a medical device. Adjudication methods are typically used in clinical studies for interpretation of imaging or clinical events.

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. The device is a physical torque device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.

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

• This is not applicable as the device is not an algorithm or AI. The performance testing was for the physical device.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" was established by predetermined specifications and engineering standards for mechanical performance (e.g., strength, dimensions, torque).

8. The sample size for the training set:

• This is not applicable as there was no AI/algorithm that required a training set. This is a physical medical device.

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

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

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The Roadrunner® PC Wire Guide is used for catheter positioning and exchange in diagnostic and interventional procedures, exclusive of the coronary arteries.

The Roadrunner® PC Wire Guides, subject of this submission, have been modified from the predicate device, Roadrunner Wire Guide (K920891), to include additional lengths ranging from 80, 145, 180, and 260 centimeters. The modifications to the Roadrunner® PC Wire Guides have been created to provide additional options for physicians in selecting the appropriate wire guide during diagnostic and interventional procedures. The Roadrunner® PC Wire Guides are packaged, sterile devices intended for single patient use. There are no prior submissions for the subject device.

The Roadrunner® PC Wire Guide is constructed with a nitinol mandril secured with a solder connection to platinum coils at the distal tip. The device has an outer polyurethane jacket that spans the entire device. The length of the device is coated with a hydrophilic coating except the proximal 6 centimeters of the device. The device is available with an angled or straight distal tip. The wire guide is available in a 0.035 inch or 0.038 inch diameter and lengths of 80, 145, 180, and 260 centimeters. The subject device will be provided sterile and intended for single patient use. An Olcott Torque Device and a Wire Guide Inserter are provided with each subject device configuration.

I am sorry, but the provided text does not contain information about acceptance criteria and study details for a device that meets those criteria. The document is a 510(k) premarket notification for a medical device (Roadrunner PC Wire Guide), primarily focusing on demonstrating substantial equivalence to a predicate device.

While it mentions that various tests were performed and all pre-determined acceptance criteria were met, it does not specify:

• The actual acceptance criteria themselves (e.g., specific thresholds for performance metrics).
• The reported device performance against those criteria.
• Any details about sample sizes, data provenance, expert ground truth adjudication, MRMC studies, standalone performance studies, or ground truth types for any of the mentioned tests.
• Training set details.

The text only lists the types of tests conducted (e.g., Biocompatibility Testing, Corrosion Testing, Simulated Use Testing) and states that acceptance criteria for these tests were met to support substantial equivalence.

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Distal Access torque devices are used to maneuver quide wires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature.

The Distal Access Torque Device (Predict / Spinr Controller) is a single-use hand-held manually operated high-performance torque device / controller used to maneuver difficult-to-grasp devices including quidewires during interventional or diagnostic procedures. The Predict's design allows for predictable and controllable rotation of a device clockwise with counterclockwise return to its original orientation. Clockwise and counterclockwise rotations are manually controlled so the Predict rotates the same number of rotations in one direction as the other. Similar to the predicates, the user manually advances and retracts the Predict torque device forward and backward to introduce or remove the connected device from the body. Also, identical to the predicates, the Predict may be connected to a device already in the body. Same as the predicates, a device, including a guidewire, is loaded into the Predict 0.014 - 0.039" by inserting the proximal end of the device into the distal end of the Predict's cap. The Predict locks down on the device when the user rotates the collet cap clockwise, forcing the industry standard designed collet to grip onto the device is released when the user rotates the cap counterclockwise to loosen the collet's grip on the device. Once a device is connected, the Predictably rotates devices between 3 and 5 times clockwise and counterclockwise as per the labeled number of rotation is manually controlled by the user's finger, thumb and hand. Also, identical to predicates, the Predict does not use electrical power or software.

This document is primarily a 510(k) summary for the Distal Access Torque Device (Predict or Spinr). It details the device's description, indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document does not contain an acceptance criteria table or information typically found in an independent study report, such as specific performance metrics and their acceptance limits.

However, based on the provided text, I can infer some criteria and the general nature of the "study" (non-clinical testing) conducted.

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific numerical limits and corresponding performance results. Instead, it lists attributes evaluated and states: "The Predict subject device met all predetermined acceptance criteria identified in test protocols created to evaluate conformance with the relevant requirements of the above listed standards, guidance documents, and in-house protocols demonstrating that identified potential risks and hazards have been acceptably controlled and that the safety and/ or performance of the new device are equivalent to those of the cited predicate device(s)."

Here's a table based on the evaluated attributes and the general statement about meeting acceptance criteria:

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

The document mentions "Verification and validation tests" and "in-house protocols" for testing of the Predict device. However, it does not specify sample sizes for any of the tests conducted.

• Data Provenance: The data is from "in-house protocols" and "nonclinical tests" conducted by Distal Access, LLC. The country of origin is not explicitly stated, but the company address is in Park City, UT, USA. The data is retrospective in the sense that the tests were performed on finished devices to support the 510(k) submission, not as part of a prospective clinical trial.

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

This information is not provided in the document. The tests appear to be engineering and laboratory-based performance tests, not human-reader-based assessments where "ground truth" established by experts would typically be relevant.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical engineering and performance evaluations, not diagnostic assessments requiring adjudication of human interpretations.

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, an MRMC comparative effectiveness study was not done. This device is a manual torque device, not an AI-assisted diagnostic tool.
• The concept of human readers improving with AI vs without AI assistance is not applicable to this type of medical device.

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

• No, a standalone algorithm performance study was not done. This device is a mechanical tool operated by a human, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance and safety tests were established by engineering specifications, regulatory standards (e.g., ISO 10993, ANSI/AAMI/ISO 11135-1, ASTM F88, ASTM F1980-07), and internal design protocols. For instance, a test for "axial wire retention force" would have a defined minimum force that the device must withstand before the wire slips, and successfully meeting this force would be the "ground truth" for that attribute.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a mechanical tool, not an AI system that requires a "training set" of data.

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

This information is not applicable as there is no "training set" for this type of device.

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The Torque Device is used for guidewire manipulation during general intravascular procedures.

The Torque Device is an accessory device used to apply torsional and/or axial force to the guidewire to manipulate its distal end in the vasculature. It is designed to accommodate guidewires with diameters from 0.010 to 0.018 inches and is composed of three main components: 1.) a tubular collet contained within the body and cap assembly; 2.) a cap and 3.) a tubular body.

A guidewire is inserted through the Torque Device from the distal (cap) end. The Torque Device is positioned optimally on the guidewire at the desired location, and then secured by rotation of the cap. Once tightened, the torque device is used to apply torsional and axial force to the guidewire to manipulate its distal end in the vasculature.

The provided text in K123624 is a 510(k) summary and an FDA clearance letter for a medical device called "Torque Device." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that fits the rigorous criteria outlined in the request. Therefore, most of the requested information regarding acceptance criteria, specific study design, and performance metrics will not be available in this type of submission.

Here's a breakdown based on the provided text, highlighting the absence of certain information:

Acceptance Criteria and Reported Device Performance

The submission states that "Design verification was performed to verify the performance and usability of the Torque Device remains substantially equivalent to the predicate device." It then lists the following tests:

Note: The document does not provide specific quantitative acceptance criteria (e.g., "Torque Slip Force must be > X N-cm") or explicit numerical results for the device performance. The performance is broadly stated as "substantially equivalent" to the predicate.

Study Information Missing from the Provided Text:

The provided 510(k) summary explicitly states: "Clinical Evaluation was not required for this device." This means that the following information, which is typically associated with clinical or efficacy studies, is not present in this submission:

1. Sample size used for the test set and the data provenance: Not applicable as a clinical test set was not used. The design verification likely used physical samples of the device and guidewires.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth was established.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a non-AI medical device; MRMC studies are for evaluating AI's impact on human performance in diagnostic tasks.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the design verification tests (Torque Slip Force, Pull Slip Force, etc.), the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, against which the new device was compared.
7. The sample size for the training set: Not applicable. There is no AI model to train.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Design Verification):

The "study" described is a non-clinical design verification aimed at demonstrating substantial equivalence. It involved:

• Testing areas: Torque Slip Force, Pull Slip Force, Guidewire Deformation, Collet Release, and Biocompatibility.
• Methodology: The tests were performed to ensure that the Torque Device's performance and usability are "substantially equivalent" to two predicate devices: SCIMED® Sideliner™ Torque Device (K922706) and Encore 26 Advantage Kit (K120694).
• Ground Truth (implicit): The performance characteristics of the predicate devices.
• Conclusion: The results of these non-clinical tests, along with material and manufacturing process comparisons, supported the claim of substantial equivalence.

In essence, this 510(k) describes engineering and materials testing, not a clinical study involving human subjects or AI performance metrics.

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to facilitate manipulation of a guide wire during a vascular procedure

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Coeur, Inc. Disposable Torque Device." It's a regulatory approval document and does not contain the information requested in your prompt.

The prompt asks for details about a study proving a device meets acceptance criteria, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This FDA letter simply states that the device is "substantially equivalent" to legally marketed predicate devices and is approved for marketing. It does not provide any of the study design, acceptance criteria, or performance data that would be found in a clinical or validation study report.

Therefore, I cannot extract the requested information from the provided text.

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The Haskal™ Torque Device is intended to facilitate steering of guidewires during interventional procedures.

The Haskal™ Torque Device is a one-piece molded unit with rows of interlocking "teeth". When the sides of the device are squeezed, the "teeth" line up and a groove is exposed in the center. The device is then positioned with the guidewire in the groove. When the sides are released, the device "teeth" close onto the guidewire to secure it firmly. The Haskal™ accommodates guidewires with diameters between 0.010 inches to 0.038 inches.

The Haskal™ is designed to be mounted onto the guidewire from the side with one hand, eliminating the need for threading along the wire starting from the distal end. It can also be released from the guide wire or repositioned as the guide wire advances by squeezing it on both sides to release the wire.

The Haskal™ is a sterile, non-pyrogenic single use device. It is manufactured in several colors.

The provided text describes the Haskal™ Torque Device, a medical device intended to facilitate steering of guidewires during interventional procedures. The text primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval (510(k) K100425).

Here’s an analysis of the acceptance criteria and the study information based on the provided text, while explicitly noting what information is not available:

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

The document does not explicitly present specific numerical acceptance criteria (e.g., minimum torque force, maximum operational force thresholds) or corresponding reported performance values in a table. It states that "Results of nonclinical testing demonstrated that the device is as safe, as effective, and performs as well as the legally marketed devices identified in paragraph 5 of this section," implying that the device met internal or regulatory expectations for each test.

The studies performed are listed as:

• Packaging Environmental Endurance
• Dimensions Verification
• Device and Guidewire Axial Force
• Torque Force
• Device Operational Force
• Performance During Exposure to Fluids
• Usability
• Sterility Integrity and Shelf life
• Biocompatibility (Cytotoxicity, Systemic toxicity, Sensitization, Irritation, Subchronic toxicity, Genotoxicity, Haemocompatibility- Hemolysis)

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

• Sample size for test set: Not specified. The document repeatedly refers to "in-vitro/bench studies," which typically involve a certain number of units or measurements, but these numbers are not provided.
• Data provenance: Not specified, other than being "in-vitro/bench studies." It does not mention country of origin, nor whether the studies were retrospective or prospective.

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

This information is not applicable to the type of studies described. The "Haskal™ Torque Device" is a mechanical tool used to manipulate guidewires. Its performance is evaluated through bench testing (e.g., force measurements, usability assessment), not by interpretation of images or patient data requiring expert clinical judgment as "ground truth." Therefore, there were no experts establishing ground truth in the sense of clinical diagnoses or interpretations.

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

Not applicable. Adjudication methods are typically used in studies where human readers or experts are disagreeing on interpretations (e.g., image readings). Since this device underwent bench testing, not a reader study, no adjudication method was relevant or performed.

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

• MRMC study: No. The document describes laboratory bench testing and mechanical performance evaluation for a physical medical device (a torque device), not an AI algorithm or an imaging diagnostic tool. Therefore, an MRMC study was not conducted.
• Effect size of human reader improvement: Not applicable, as no MRMC study was performed.

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

• Standalone performance: Not applicable. The Haskal™ Torque Device is a physical, hand-operated tool. It is not an algorithm, and it always functions with human interaction to "steer guidewires." The "performance" described refers to the mechanical and physical characteristics of the device itself (e.g., torque force, operational force, biocompatibility), which are inherently "standalone" in the sense that they are properties of the device, not an algorithm's output.

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

The concept of "ground truth" as clinical diagnosis or outcomes data is not applicable to this device's evaluation. For mechanical device testing, the "ground truth" would be established by:

• Reference standards for dimensions and material properties.
• Calibrated instruments for measuring forces (axial, torque, operational).
• Standardized protocols for evaluating usability.
• Laboratory tests (e.g., ISO standards) for biocompatibility and sterility.
  Essentially, the ground truth is derived from objective, quantifiable measurements against established engineering and safety standards.

8. The sample size for the training set

Not applicable. The Haskal™ Torque Device is a physical medical device. It does not involve any artificial intelligence or machine learning component, therefore there are no "training sets" in the context of an algorithm.

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

Not applicable, as there is no training set for this device.

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The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.

The VSI Torque Device is a two-part oblong-shaped, medical grade plastic device designed to be used with guidewires ranging in size from 0.014" - 0.038". The two halves of the torque device snap together and the device is then placed onto a guidewire. One half of the device is rotated to lock it onto the guidewire. The VSI Torque Device provides additional control of the movement of the guidewire.

The provided text describes the VSI Torque Device and states that its design has been qualified through "tensile and torque testing, dimensional verification, and visual inspection to verify the performance of the device." However, the text does not include specific acceptance criteria or detailed results of these tests such as numerical targets or reported performance values. It only states that "The results of the verification testing and biomaterial assessment did not raise new safety or performance questions."

Therefore, I cannot populate a table with acceptance criteria and reported device performance.

Here's what can be extracted from the provided text:

• Study Title: Not explicitly named, but the studies relate to "tensile and torque testing, dimensional verification, and visual inspection" of the VSI Torque Device.
• Purpose of Study: To verify the performance of the device and ensure substantial equivalence to predicate devices.

Here's a breakdown of the other 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 (e.g., country of origin, retrospective or prospective).

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

• Not applicable/Not mentioned. The studies described are engineering verification tests, not clinical studies requiring expert ground truth establishment in the traditional sense for medical imaging or diagnostic devices.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. This is typically relevant for studies involving human interpretation or subjective assessments.

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. The studies mentioned are engineering verification tests.

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

• Yes, the described "tensile and torque testing, dimensional verification, and visual inspection" are standalone engineering tests of the device itself. There is no algorithm involved here; it's a physical device.

7. The type of ground truth used:

• For "tensile and torque testing, dimensional verification, and visual inspection," the ground truth would typically be established specifications, engineering drawings, and material properties. For example, a specified tensile strength, a precise dimension from a blueprint, or a visual standard for acceptable finish. The document does not detail these specific ground truths.

8. The sample size for the training set:

• Not applicable. This is an engineering device, not a machine learning model, so there is no training set.

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

• Not applicable. (See #8)

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The Guide Wire Torque Device is intended to facilitate guide wire manipulation during interventional procedures.

The Guide Wire Torque Device is a guide wire accessory developed to assist in the manipulation and placement of hydrophilic and other typical guide wires during interventional procedures. It accomodates guide wires from .018 to .038 inches and is composed of three components: 1. An ABS plastic body; 2. A polypropylene "core" which grips the guide wire; and 3. A stainless steel spring which supplies the force to grip the guide wire.

The design of the Guide Wire Torque device allows single-handed operation. The wire gripping actuator is depressed while the guide wire is threaded through the device's lumen. When the Guide Wire Torque Device is located on the guide wire in the appropriate location, the actuator is released allallowing the device to grip the guide wire.

The provided text describes a medical device, the Guide Wire Torque Device, which is an accessory to assist in manipulating guide wires during interventional procedures. However, it does not contain any information regarding specific acceptance criteria, performance studies, or test results (such as accuracy, sensitivity, or specificity metrics) that would typically be found in a study proving a device meets acceptance criteria.

The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data against predefined acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not mentioned.
• Adjudication method: Not mentioned.
• Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable for this type of mechanical device.
• The type of ground truth used: Not applicable for this type of mechanical device.
• The sample size for the training set: Not mentioned (and not applicable for this mechanical device).
• How the ground truth for the training set was established: Not mentioned (and not applicable).

The document states:
"Merit believes that the prior use of the component materials of the Guide Wire Torque Device in legally marketed devices, the performance data provided, and the biocompatibility data provided demonstrate that the Guide Wire Torque Device is substantially equivalent to the predicate device."

This indicates that some performance data was submitted, likely focusing on mechanical functionality, material safety (biocompatibility), and design similarity to the predicate device, rather than clinical performance metrics in the way you'd expect for an AI/software device. The summary itself does not elaborate on what that "performance data" entailed.

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The ASAHI Tornus support catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.

The ASAHI Tornus support catheter is a device that is intended to provide additional support to a steerable guidewire when accessing discrete regions of the coronary and peripheral vasculature. The Tornus Catheter contains a full metal spiral shaft that provides enhanced pushability when attempting to cross difficult lesions. The full metal shaft provides the user with a device that has excllent torqability and pushability during intravascular procedures.

The Tornus support catheter is being supplied with a torque assistance device. The torque device is a plastic device that is attached to the connector of the Tornus Support Catheter to assist in catheter manipulation and directional control. In addition to assisting in Tornus catheter manipulation the torque device contains a function mechanism that limits the rotational force exerted upon the catheter during manipulation.

Here's an analysis of the provided text regarding the Kobo745 device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of Implied Criteria: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable acceptance criteria in the same way a clinical trial might. The criteria are implied by what the manufacturer states they tested and what they concluded about the device's performance relative to its predicate.

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

• Sample Size: The document does not specify a numerical sample size for the "mechanical and functional bench testing." It refers to "bench testing" generally.
• Data Provenance: The study was "bench testing," meaning it was conducted in a laboratory or simulated environment, not on human patients. The country of origin of the data is not explicitly stated beyond the applicant being from Japan and the US contact being in California. Given it's pre-market notification, it's a prospective study in the sense of being conducted specifically to support this submission.

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

• Not Applicable. As this was bench testing, there were no human patient cases requiring expert interpretation or establishment of ground truth in the clinical sense. The "ground truth" for bench testing would typically be engineering specifications, material properties, and functional performance metrics established by design engineers and verified through laboratory measurements.

4. Adjudication Method for the Test Set:

• Not Applicable. There was no human-based assessment requiring adjudication for this bench testing.

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

• No, an MRMC study was not done. The submission focuses solely on bench testing, not clinical performance or comparative effectiveness with human readers.

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

• Not Applicable. This device is a physical medical device (catheter and torque device), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" doesn't apply.

7. The Type of Ground Truth Used:

• Engineering Specifications and Functional Performance Metrics. For bench testing of a physical device, the "ground truth" is typically defined by:
  • Design Specifications: How the device should perform according to its engineering design.
  • Material Standards: Compliance with established material properties and biocompatibility.
  • Functional Metrics: Measurable outcomes from bench tests (e.g., torquability, pushability, dimensional accuracy, compatibility with guidewires) compared against predefined thresholds or predicate device performance.

8. The Sample Size for the Training Set:

• Not Applicable. This device is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative development and testing, but not a "training set" for an algorithm.

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

• Not Applicable. As there is no training set for an algorithm, this question is not relevant to this submission. For physical devices, "ground truth" during development is established through engineering principles, material science, and iterative testing against design requirements and safety standards.

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This device is intended for use as a torque device for guidewires with a diameter of 0.014 --0.038" to facilitate twisting and advancing the guidewire during a procedure.

The JS Vascular Guide Wire Vise™ is a sterile single-use wire vise/torque device consisting of a dual pin vise clamp construction. Guidance and tracking of a guidewire through the coronary or peripheral vasculature is accomplished by manual manipulation of the vise.

The provided document is a 510(k) summary for the JS Vascular Guide Wire Vise™. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information on acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) or clinical trial might.

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

1. A table of acceptance criteria and the reported device performance: This is not present.
2. Sample size used for the test set and the data provenance: No test set or study data is described.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as no test set is detailed.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone performance study (algorithm only without human-in-the-loop performance): Not applicable as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states that "performance testing results provided in this pre-market notification" were used to demonstrate substantial equivalence, but these results are not detailed in the provided text. For 510(k) submissions of devices like this torque device, performance testing usually involves bench testing to ensure the device performs its intended mechanical function safely and effectively (e.g., proper gripping of guidewires, durability, biocompatibility if applicable). However, the specific details of such tests, their acceptance criteria, and results are not included in this summary.

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