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The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system.

The Medtronic® Zuma™ Guiding Catheters will be available in 5F 9F outer diameters. The 6F and 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:

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

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

The provided text does not specify the sample size used for the test set or the data provenance. The document indicates that tests were performed ("Test results verified"), but there are no details on the number of catheters or samples tested, nor where the testing was conducted or if it was 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 provided in the document. The document refers generally to "Test results" and "specifications" for a medical device (guiding catheter), which typically involve engineering and material science testing, rather than human expert interpretation of data like images. Therefore, the concept of "experts" establishing ground truth in this context (for mechanical and material properties) is not directly applicable in the same way it would be for AI-powered diagnostic devices.

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

This information is not provided and is not typically relevant for the type of device (guiding catheter) or the nature of the testing described (biocompatibility, performance specifications of physical attributes). Adjudication methods are more commonly associated with human interpretation tasks or clinical endpoints requiring consensus.

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

There is no indication of an MRMC comparative effectiveness study being conducted. This device is a guiding catheter, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

This question is not applicable as the device is a physical guiding catheter, not an algorithm or AI system.

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

For the performance criteria mentioned (biocompatibility, inner lumen diameter, stiffness), the "ground truth" would be established by standardized laboratory testing procedures, physical measurements, and adherence to predefined material science and engineering specifications. For example, biocompatibility testing would follow ISO standards, diameter measurements would use precision instruments, and stiffness testing would involve specific mechanical test setups.

8. The sample size for the training set

This information is not applicable. This document describes the 510(k) submission for a physical medical device (guiding catheter), not a machine learning model. There is no concept of a "training set" in this context.

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

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

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The Medtronic® Angiographic Catheter is designed to be used for delivering radiopaque media and making pressure measurements in selected coronary sites within the vascular system.

The Medtronic® Angiographic Catheters are 4F, 5F, 6F and 7F in diameter with a braided proximal shaft, non-braided distal segment and a variety of tip configurations.

This submission for the Medtronic® Angiographic Catheter (K980973) is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data or detailed performance studies that would typically be required for a novel device.

Therefore, the provided text does not contain the detailed acceptance criteria or a comprehensive study report as would be expected for a product with complex software or AI components. The information is limited to a general statement about meeting specifications and substantial equivalence.

Here's an analysis based on the provided text, while acknowledging the limitations for your specific request:

Acceptance Criteria and Device Performance

Study Information (Based on the provided text)

2. 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 submission refers to "Test results" generally, implying laboratory or engineering testing rather than a clinical human subject study with a "test set" as typically understood in AI/medical imaging contexts.

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)
* Not applicable/Not stated. This submission does not involve an AI device requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" for a physical device like a catheter would be its physical properties, dimensions, material integrity, and functionality, which are assessed through engineering and materials testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable/Not stated. This is relevant for studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need resolution. For a physical medical device, testing typically involves objective measurements against established engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
* No. This device is a diagnostic intravascular catheter, not an AI or imaging interpretation system. MRMC studies are not relevant for this type of product.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
* Not applicable. This device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not explicitly detailed, but implied to be engineering specifications and material standards. For a catheter, ground truth would relate to its physical dimensions, material strength, biocompatibility, flow rates, pressure measurement accuracy, and resistance to kinking, all measured against predetermined engineering and safety standards.

8. The sample size for the training set
* Not applicable. This is a physical device, not an AI model requiring a "training set."

9. How the ground truth for the training set was established
* Not applicable. This is a physical device, not an AI model.

Summary of Limitations for your Request:

This 510(k) submission for a physical medical device (catheter) precedes the era of widespread AI in medical devices and therefore does not provide the type of detailed information on AI algorithm performance, test set characteristics, expert involvement, or ground truth establishment that your questions are designed to elicit. The "study" mentioned is likely a series of laboratory and engineering tests to ensure the catheter meets its design specifications and is safe and effective for its stated indications for use, in comparison to existing predicate devices.

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The Medtronice ZumaTM Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system

The Medtronic® Zuma™ Guiding Catheters will be available in 6F, 7F and 8F outer diameters. The 6F catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 7F and 8F catheters are manufactured with a braided proximal and segmented shaft with an inner liner and a soft distal tip. The inner lumen of the 22ma™ catheter (6F-8F) has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft than its predicate devices.

The provided text refers to a 510(k) summary for a medical device called the Medtronic® Zuma™ Guiding Catheter, not a study evaluating an AI-powered device. Therefore, information regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, or training sets is not available in the provided document.

However, I can extract the general acceptance criteria for this medical device and how it was shown to meet them based on the provided text.

Here's the information parsed from the provided text:

Acceptance Criteria and Device Performance for Medtronic® Zuma™ Guiding Catheter

Study Details (as inferable from a 510(k) submission for a non-AI device):

• Sample size for the test set and the data provenance: Not applicable in the context of an AI device. For this traditional medical device, testing would involve in-vitro (bench) testing, and potentially animal studies, to demonstrate performance and safety, but not human "test set" data in the AI sense. The provenance would be the laboratory where testing was conducted.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a guiding catheter, "ground truth" relates to physical and performance specifications verified through engineering and biocompatibility testing, not expert interpretation of data.
• Adjudication method for the test set: Not applicable. Performance is based on objective, quantifiable measurements against pre-defined specifications for physical properties, functionality, and biocompatibility.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" would be established by engineering specifications, material science standards (for biocompatibility), and established medical device performance criteria.
• The sample size for the training set: Not applicable. This is not an AI-powered device and therefore does not have a training set.
• How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

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The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

The Medtronic® Zuma™ Guiding Catheters will be available in a 6F outer diameter size. The catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The inner lumen of the catheter has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft.

The provided text is a 510(k) summary for the Medtronic® Zuma™ Guiding Catheter. It outlines the device's intended use, construction, and provides a statement of substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results, or the comprehensive information required to fill in all aspects of your request.

Here's a breakdown of what can be extracted and what is missing:

The document states:
"Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use."

This confirms that some testing was done to meet specifications, but it doesn't provide the specifications themselves (the acceptance criteria) or the detailed results.

Assuming a hypothetical scenario for a medical device cleared via 510(k) and drawing common practices from such submissions, the following table and explanations are constructed. Please note these are inferred or placeholders where the original text lacks details.

1. Table of Acceptance Criteria and Reported Device Performance

(The following sections will contain "Not mentioned in the provided text" for most points, as the 510(k) summary does not include this level of detail. Such information is typically found in the full 510(k) submission, not the public summary.)

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

• Sample Size: Not mentioned in the provided text. For physical properties, this would typically be a statistical sample of manufactured units (e.g., n=30 per test). For biocompatibility, it refers to the material samples tested.
• Data Provenance: Not mentioned in the provided text. Most likely laboratory testing (in-vitro) and animal studies (if required for certain biocompatibility or preclinical performance aspects), generally conducted in the country of manufacture or a certified lab. The summary implies the data is prospective, generated specifically for this submission.

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

• Not applicable/Not mentioned. This device is a guiding catheter, a physical medical device, not an AI diagnostic tool. Ground truth in this context refers to established engineering specifications and performance benchmarks, not expert consensus on interpretations. Physical tests are carried out by engineers and technicians according to established protocols.

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

• Not applicable/Not mentioned. Adjudication methods are relevant for subjective diagnostic tasks, not for objective physical performance testing of a catheter. Testing follows pre-defined pass/fail 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 is a physical medical device (guiding catheter), not an AI diagnostic system. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this submission.

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 (expert consensus, pathology, outcomes data, etc.)

• The ground truth for this type of device is established engineering specifications, mechanical test standards (e.g., ISO, ASTM), and clinical performance criteria derived from predicate devices and intended use. For biocompatibility, the ground truth is the pass/fail criteria of ISO 10993 tests.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for a physical device, this question is not relevant.

Summary of Device Clearance:

The Medtronic® Zuma™ Guiding Catheter was cleared through the 510(k) pathway by demonstrating substantial equivalence to existing legally marketed predicate devices (Medtronic® Vector™ X Guiding Catheter and Cordis® Brite Tip® Guiding Catheter). This means the FDA determined that the new device is as safe and effective as the predicate devices, based on its technological characteristics, intended use, and performance data. The review focuses on demonstrating that the new device does not raise different questions of safety and effectiveness compared to the predicate. The document confirms that "Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use." indicating successful performance testing, though the specifics of those tests and their acceptance criteria are not detailed in this public summary.

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The Mustang™ Steerable Guide Wire is indicated for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

The Medtronic® MUSTANG™ Steerable Guide Wire is a quide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).

The provided text describes a medical device, the Medtronic® MUSTANG™ Steerable Guide Wire, and its 510(k) submission for market clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm.

The document discusses the following:

• Device Description: The Medtronic® MUSTANG™ Steerable Guide Wire, its models, intended use (introducing and placing interventional catheters during PTCA and PTA), and physical characteristics.
• Performance Testing: It mentions "In vitro testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity and catheter compatibility. Testing was also performed to assess the biocompatibility of the device."
• Acceptance: "Test results verified that the MUSTANG™ meets all of the applicable specifications and is deemed adequate for the intended use."
• Substantial Equivalence: The primary basis for clearance is substantial equivalence to legally marketed predicate devices, not AI performance.

Therefore, I cannot provide the requested information for an AI/ML device, as this document pertains to a traditional medical device (a guidewire) and its premarket notification (510(k)) based on substantial equivalence and in-vitro performance testing, not an AI/ML algorithm.

If you have a document describing an AI/ML device and its validation study, please provide that.

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The Medtronic® MUSTANG™ Steerable Guide Wire is for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

The Medtronic® MUSTANG™ Steerable Guide Wire is a guide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).

The provided text describes a medical device, the Medtronio® MUSTANG™ Steerable Guide Wire, and its verification through in vitro testing. However, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostic tools.

This 510(k) summary is for a physical medical device (a guide wire), and the verification methods are standard for such devices, focusing on physical properties and biocompatibility. The prompt's questions are tailored towards the evaluation of algorithms, AI models, or diagnostic software, which require different types of performance metrics and study designs.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: The text mentions "applicable specifications" but does not detail them or provide quantitative performance metrics against these specifications. It focuses on the type of tests performed rather than the specific results or targets.
• Sample size used for the test set and the data provenance: Not applicable to this type of in vitro testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The closest information available is:

1. Acceptance Criteria and Reported Device Performance (Partial, Qualitative Only):

Study Details:

• Study Type: In vitro testing and biocompatibility assessment.
• Conclusion: "Test results verified that the MUSTANG™ meets all of the applicable specifications and is deemed adequate for the intended use."

The document focuses on demonstrating substantial equivalence to existing devices based on these physical and biological tests, not on diagnostic performance or algorithmic output.

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The Indications for the Medtronic® Everest™ 30 Inflation Device / Survival Kit are identical to those for commercially available inflation devices. The devices are used for the inflation / deflation of balloon dilatation catheters. These devices are intended for single use.

The Medtronic® Everest™ 30 Inflation Device is a sterilized, single use device intended as an accessory to balloon dilatation catheters. The Everest™ 30 Inflation Device will be used to inflate and deflate balloon dilatation catheters during angioplasty procedures. The device contains an analog pressure gauge which will read the inflation pressure of the balloon catheter. The pressure gauge is isolated from the syringe fluid with use of a bouron tube and is graduated in 0.5 atmosphere / bar increments to a 30 atmosphere / bar maximum. The device has a twenty (20) cubic centimeter syringe to hold a contrast medium for balloon inflation. The device has a plunger engaging mechanism. When engaged, the plunger, which applies contrast medium to the syringe, is rotated in a clockwise direction by the user to slowly increase the syringe pressure or in a counter clockwise direction to slowly decrease the syringe pressure. When disengaged, the plunger can be manually retracted to rapidly apply vacuum and advanced to rapidly apply syringe pressure. The inflation device is connected to the balloon catheter manifold via a high pressure connecting tube which terminates into a male luer fitting. The inflation device also contains an accessory three way stopcock for preparation procedures.

The inflation device may also be provided as a Survival Kit. The Survival Kit includes one (1) Y -Adapter with Hemostasis Valve, one (1) Guide Wire Introducer and one (1) Guide Wire Torque Handle.

Here's a breakdown of the acceptance criteria and study information for the Medtronic® Everest™ 30 Inflation Device / Survival Kit, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The provided text does not specify the exact number of devices tested for each test (Pressure Gauge Accuracy, Leak Test, Pressure Test). It states "All samples were previously EtO sterilized" for the Pressure Gauge Accuracy Test and "Each device was filled with water" for the Leak and Pressure Tests, implying multiple devices were tested, but precise numbers are not given.
   • Data Provenance: This was a retrospective, in-house laboratory study conducted by Medtronic, focusing on the physical performance of the device.

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

   • This type of device (inflation device) does not typically involve expert interpretation of results for its functional performance tests. The ground truth (accurate pressure readings, absence of leaks, achievement of pressure) is established by calibrated instruments.
   • Therefore, no human experts (e.g., radiologists) were used to establish the ground truth for these engineering performance tests.

3. Adjudication method for the test set:

   • Not applicable. The tests involve direct measurement and observation against predefined physical criteria using calibrated equipment. There is no subjective human interpretation requiring adjudication.

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. This is a medical device (an inflation device), not an AI-powered diagnostic tool or imaging system. Therefore, an MRMC study and assessment of AI assistance for human readers is not applicable.

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

   • Not applicable. This device is a physical tool, not an algorithm. Its performance is inherent to its design and manufacturing, not an independent algorithm.

6. The type of ground truth used:

   • The ground truth for these tests was established by calibrated instruments (e.g., calibrated pressure gauges) and direct observation against engineering specifications (e.g., visual inspection for leaks).

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the computational sense. The design and manufacturing processes are refined through engineering principles and quality control, not data-driven training.

8. 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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