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The AMPLATZER® Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.

The AMPLATZER Vascular Plug 4 (AVP4) is a self expanding, Nitinol mesh occlusion device. The device has a radiopaque marker band at each end and a micro screw attachment at one end for attaching to the delivery wire. The device is an extension of the previously approved AMPLATZER Vascular Plugs and has the identical indications for use: arterial and venous embolizations in the peripheral vasculature.

Included in the AVP4 device package are:
• Loader - consisting of two tubes, one inside the other with a stainless steel spring attached to extend the inner retractable tube
• Delivery Wire - comprised of a PTFE covered coil with core wire and attached end screw

The provided text describes a 510(k) summary for the AMPLATZER® Vascular Plug 4, a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or determining specific acceptance criteria for performance metrics in the same way an AI/ML device would. Therefore, the information requested in your prompt regarding acceptance criteria, specific device performance numbers, sample sizes for test and training sets, expert consensus, and comparative effectiveness studies (MRMC) for AI performance is largely not applicable or not present in this type of document for this device.

However, I can extract and restructure the information that is relevant to the performance data and the study performed to demonstrate substantial equivalence for this type of medical device submission.

Acceptance Criteria and Reported Device Performance

For medical devices like the AMPLATZER® Vascular Plug 4, acceptance criteria are typically related to meeting established standards for safety, biocompatibility, and functional performance that demonstrate equivalence to a predicate device, rather than specific numerical performance metrics for an AI algorithm. The device performance is reported as successful completion of these tests, indicating conformance to requirements for its intended use.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a comprehensive set of bench testing (in-vitro) and animal studies (in-vivo) designed to demonstrate substantial equivalence to predicate devices (AMPLATZER® Vascular Plug II and AMPLATZER® Vascular Plug II Extended Sizes). The document states: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."

The following points address the specific questions from your prompt, acknowledging that many are not directly applicable to a 510(k) submission for a non-AI/ML medical device like a vascular plug.

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

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

   • Test Set Sample Size: Not explicitly stated in terms of a "test set" for performance metrics like an AI model. For in-vivo studies, specific numbers of animals (canine and porcine) were used, but the exact count for each study is not provided in this summary document.
   • Data Provenance: The in-vivo studies were conducted using canine and porcine models. This is prospective animal study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., expert consensus on image interpretation) is not relevant for this device. The "ground truth" here is the physical and biological performance observed in laboratory and animal studies, assessed by engineers, scientists, and veterinarians against pre-defined safety and performance parameters.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for expert review in clinical trials or AI validation where subjective interpretation is involved. For this device, objective measurements and observations from animal studies and bench tests determine performance.

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 (vascular plug), not an AI/ML diagnostic or assistive tool for 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 (expert consensus, pathology, outcomes data, etc): For in-vitro tests, the ground truth is based on engineering specifications, material standards, and established physical/chemical properties. For in-vivo animal studies, the "ground truth" is derived from direct biological observations, histological analysis, and physiological measurements in the animal models, assessed against pre-defined safety and performance endpoints for embolization devices.

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model that requires a training set. The device's design is based on engineering principles and prior knowledge from the predicate devices.

9. How the ground truth for the training set was established: Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are validated through the specified bench and animal testing.

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The AMPLATZER TorqVue Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

The AMPLATZER® TorqVue® 2 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorqVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature. The AMPLATZER® TorqVue® 2 Delivery Sheath has a usable length of 120 cm and is available with a 5 Fr, 6 Fr, or 7 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight. The body of each sheath is radiopaque for visibility under fluoroscopy. The single-lumen sheath is constructed of two segments of different polyether block amide (Pebax®) materials to provide support for device advancement and tip flexibility for vessel engagement. The Pebax® encapsulates a stainless-steel braid support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

The provided text describes a 510(k) summary for the AMPLATZER® TorqVue® 2 Delivery Sheath, a medical device. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling typical "acceptance criteria" and "studies" in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested points related to AI software performance (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC studies, standalone performance, provenance of data) are not applicable to this type of device and submission.

Here's an analysis based on the information provided:

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

For this device, "acceptance criteria" are not reported as specific performance metrics in the same way an AI algorithm would have sensitivity/specificity thresholds. Instead, the acceptance criteria are implicitly that the device performs comparably to the predicate device across various functional and safety characteristics. The reported "performance" is that it met these criteria through bench testing.

Study Title: Not explicitly named, but referred to as "Bench testing" and "laboratory verification test."

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. Bench testing often involves a statistically determined number of units or replicates for each test, but the exact numbers are not detailed in this summary.
• Data Provenance: The testing appears to be internal "bench testing" and "laboratory verification tests" performed by the manufacturer, AGA Medical Corporation, in Plymouth, MN, USA.
• Retrospective/Prospective: As this is bench testing of physical properties, these terms are not applicable in the typical clinical study sense. The tests are designed and executed prospectively in a lab setting.

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: This is a physical medical device (delivery sheath), not an AI algorithm requiring expert interpretation for "ground truth" on images or clinical data. The "ground truth" for its performance is derived from standardized engineering tests measuring physical properties.

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

• Not Applicable: As above, this is bench testing of a physical device. There is no "adjudication method" involving experts for a test set in the context of clinical interpretation or diagnosis. Test results are objective measurements against predetermined 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 is a physical medical device, not an AI algorithm. Therefore, MRMC studies are not relevant.

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

• Not Applicable: As this is a physical medical device, not an algorithm, the concept of "standalone performance" for an algorithm is not relevant.

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

• Ground Truth Type: For a physical device, the "ground truth" is defined by engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, the "ground truth" for tensile strength would be a defined force threshold, or for kinking, a specific angle of bend without occlusion. These are objective, measurable physical properties.

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 machine learning or AI.

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

• Not Applicable: As there is no training set, the establishment of ground truth for it is not relevant.

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The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

The AMPLATZER® TorqVue® 3 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorgVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature.

The AMPLATZER® TorqVue® 3 Delivery Sheath has a usable length of 104 cm or 54 cm and is available with an 8 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight.

The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of polyether block amide (Pebax®) which encapsulates a stainless-steel coil support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

The provided text describes a 510(k) premarket notification for the AMPLATZER® TorqVue® 3 Delivery Sheath. This document primarily focuses on establishing substantial equivalence to a predicate device through bench testing rather than clinical study data involving human performance or specific acceptance criteria for a diagnostic AI device.

Therefore, the requested information, which is typically associated with AI/ML diagnostic device studies, cannot be fully extracted or is not applicable in this context.

Here's an attempt to answer based on the provided text, highlighting where the information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria or specific numerical performance metrics for a diagnostic device. Instead, it states that the functional characteristics were determined to be "substantially equivalent" to predicate devices. The bench tests are described generally.

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

• Sample Size: Not specified. The document refers to "bench testing" which typically involves a small, representative sample of devices for engineering tests, not a large clinical test set.
• Data Provenance: Not applicable. The data is from laboratory (bench) testing of the device itself, not from clinical data (e.g., patient records, images).

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

Not applicable. This device is a delivery sheath, not a diagnostic device requiring expert review for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or diagnostic decision-making involved in the bench testing described.

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 not an AI/ML diagnostic device, and no MRMC study was conducted or is relevant for this type of device.

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

Not applicable. This is not an AI/ML algorithm; it is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device's evaluation is based on engineering specifications, material properties, and functional performance benchmarks (e.g., resistance to kinking, tensile strength, leakage) as determined through bench testing. It's not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML 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. The "ground truth" for the device's design and manufacturing is established through engineering principles, material science, and prior regulatory approvals of similar predicate devices.

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The AMPLATZER TorqVue 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.

The AMPLATZER® TorqVue® 45°x45° Delivery Sheath is a sterile, singleuse, general-purpose sheath that is an extension of the TorqVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the chambers of the heart. The AMPLATZER® TorqVue® 45°x45° Delivery Sheath has a usable length of 100 cm and is available in 9 Fr, 10 Fr, 12 Fr, and 13 Fr sizes (inner diameter). A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are curved approximately 45° in two dimensions, resulting in a three-dimensional geometry. The 10 Fr, 12 Fr, and 13 Fr sizes also include a flush adapter that facilitates connection of accessories to the proximal end of the sheath. The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of two segments of different Pebax materials to provide support for device advancement and tip flexibility for vessel engagement. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

The provided text describes a 510(k) submission for the AMPLATZER® TorqVue® 45°x45° Delivery Sheath. My analysis will focus on extracting information related to acceptance criteria and the study that proves the device meets them, based on the provided document.

Acceptance Criteria and Device Performance

Note: The document explicitly states that "Bench testing of the AMPLATZER TorqVue® 45°x45° Delivery Sheath included verification of the distal curve dimensions after sterilization, distribution simulation, and six-month accelerated aging." While specific quantitative acceptance criteria values are not provided, the conclusion is that these tests demonstrated substantial equivalence, meaning the performance met the specified (though unquantified in this summary) criteria.

Study Information

1. 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 explicitly stated. The document refers to "Bench testing" without specifying the number of units tested for each criterion.
   • Data Provenance: Not specified. The testing described is "Bench testing," which typically occurs in a controlled laboratory environment. There is no information on human or animal data, country of origin, or whether it was retrospective or prospective.

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

   • Not applicable. The study involved "Bench testing" of physical device characteristics, not clinical assessment requiring expert interpretation for ground truth.

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

   • Not applicable. This type of adjudication is typically used for clinical interpretation or subjective assessments, not for objective bench testing of device characteristics.

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. The study performed was "Bench testing" of a medical device (delivery sheath), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and effect sizes for human reader improvement are not relevant.

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

   • Not applicable. This is not an algorithmic device; it is a physical medical device.

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

   • The ground truth for the "Bench testing" was derived from predefined engineering specifications and performance standards to establish substantial equivalence with the predicate device. These standards would dictate acceptable ranges for dimensions, stability after sterilization, and aging performance.

7. The sample size for the training set

   • Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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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The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.

The AMPLATZER TorqVue Exchange System is a sterile, single use device comprised of a delivery sheath, dilator, loader, hemostasis valve, delivery cable and vise. The system components are identical to the AMPLATZER TorqVue Delivery System, with the exception of the dilator, which incorporates an enlarged inner lumen for passage over a delivery cable. The Exchange System is available in two distal end curvatures: 180° and 45°.

The provided text describes a 510(k) summary for a medical device, the AMPLATZER TorqVue Exchange System. This is a submission for substantial equivalence to a predicate device, not a novel AI or diagnostic device. Therefore, many of the requested elements for an AI/diagnostic device study (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of regulatory submission.

The study described is a device verification study to demonstrate that the AMPLATZER TorqVue Exchange System meets established performance criteria and supports equivalency to a predicate device.

Here's the information that can be extracted or deduced from the provided text:

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)

• Sample Size: Not specified in the document.
• Data Provenance: Not specified, but typical for device verification is in-house testing by the manufacturer (AGA Medical Corporation, Plymouth, MN, USA). The study is prospective in nature, as it involves testing the device against specific criteria.

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

• This is not applicable as the study described is a device verification study for a delivery system, not a diagnostic or AI device requiring expert-established ground truth. The "ground truth" here is the established performance criteria for the device itself.

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

• Not applicable. The verification testing would involve standardized test methods and measurement, not expert adjudication in the context of diagnostic interpretation.

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 study is not relevant for this type of medical device (catheter delivery system). This device does not 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 not an algorithm. The "standalone" performance refers to the device's ability to meet its functional and safety requirements independently. The listed "visual, performance and compatibility testing" assesses this.

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

• Not applicable in the AI/diagnostic sense. The "ground truth" for this device's performance is the established performance criteria and specifications for a catheter delivery system, derived from engineering standards, regulatory requirements, and comparison to the predicate device.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm and does not have a "training set."

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

• Not applicable.

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The AMPLATZER® TorqVue® Low Profile Delivery System is indicated to provide a pathway through which devices are introduced into the peripheral vasculature.

The AMPLATZER TorqVue Low Profile Delivery System is a sterile, single-use device designed to facilitate the introduction of devices to a location within the peripheral vasculature. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 4 and 5 French. The catheters will be provided in 60 cm and 80 cm usable lengths. The system includes the following components:
• Delivery Catheter - used to deliver transvenous devices
• Loader- used to help introduce the selected implantable device into the delivery catheter
• Delivery Wire (optional) – attaches to the implantable device and facilitates advancement through the catheter, placement and, if desired, recapture of the specified implantable device. [If this surgical accessory (Product Code = DWS) is included, the labeling will specify compatibility with the appropriate implantable devices.]
• Plastic Vise (included with delivery wire) – a handle that is attached to the Delivery Wire by means of a set screw
• Hemostasis Valve- used on the proximal end of the Loader to minimize bleeding from the Delivery Catheter and for flushing air from the system

Here's an analysis of the provided text regarding the acceptance criteria and study for the AMPLATZER® TorqVue® Low Profile Delivery System:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states that "Verification and validation testing confirms that the functional characteristics of the AMPLATZER® TorqVue® Low Profile Delivery Systems are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices." The specific numerical acceptance criteria (e.g., "kink resistance must withstand X N of force") and the exact performance values (e.g., "kink resistance withstood Y N") are not provided in this summary. The evaluation is made against a predicate device, seeking "substantial equivalence."

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "Verification and validation testing" and "laboratory verification tests and in vitro performance information."

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 studies described are primarily laboratory and in vitro performance tests, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided as the described tests are laboratory and in vitro performance assessments, not studies requiring human expert adjudication of results.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant to this device. This device is a medical delivery system, not an AI-powered diagnostic or assistive tool for human readers.

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

A standalone performance evaluation in the context of an algorithm or AI was not performed or described. This is a medical device, not a software algorithm. The "standalone" performance here refers to the device's functional characteristics tested in a lab setting, which were indeed conducted without human operator variables, beyond basic operation.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests was established through objective laboratory measurements and in vitro performance evaluations against pre-defined engineering and performance specifications, likely derived from the predicate device's characteristics or internal design requirements. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. A training set typically refers to data used to train machine learning models, which is not relevant here.

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

This information is not provided and is not applicable as there is no mention of a training set or machine learning in the context of this device.

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The AMPLATZER® TorqVue® Delivery System is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

The AMPLATZER® TorqVue® Catheter Delivery System is a sterile, single-use device designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 5-12 French (2.5-4.8 mm). The catheters currently come in 60 cm and 80 cm usable lengths. The system includes the following components: Delivery Catheter, Dilator, Loader, Delivery Wire (optional), Plastic Vise, Hemostasis Valve.

The provided text describes a 510(k) premarket notification for the AMPLATZER® TorqVue® Delivery System. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Test Data" section.

Here's a breakdown of the requested information:

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

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

The document does not explicitly state the sample size used for the test set (i.e., the specific number of devices or trials for each verification and validation test).

The data provenance is from laboratory verification and validation testing. There is no mention of country of origin for the data or whether it was retrospective or prospective, as this was a pre-market submission for a physical medical device, not a data-driven AI model.

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

This information is not applicable as the document describes validation for a physical medical device, not an AI or diagnostic imaging device where expert ground truth establishment for a test set would typically be required. The "ground truth" for this device's performance is based on direct physical testing against established functional requirements and comparison to a predicate device.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for AI-powered diagnostic tools assisting human readers, which is not the case for this delivery system.

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

This information is not applicable as the submission is for a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The type of ground truth used

The "ground truth" for this device's performance was established through laboratory verification and validation testing against functional requirements and by demonstrating substantial equivalence to a predicate device (Medtronic® SelectSite™ Deflectable Catheter Delivery System). This involves engineering and performance metrics rather than medical pathology, outcomes, or expert consensus in the diagnostic sense.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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 AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.

The AMPLATZER® Vascular Plug II is a sterile, single-use, triple-lobed, self-expanding Nitinol mesh occlusion device, with a screwattachment for a Delivery Wire and radiopaque marker bands at both ends. The Plug is attached to a 135 cm Delivery Wire with a stainless steel screw. The AMPLATZER® Vascular Plug II is provided contained within a Loader Device that facilitates loading into a delivery catheter. The Delivery Wire comes coiled in a hoop dispenser. The AMPLATZER® Vascular Plug II is available in fully-expanded diameters of: 3 mm to 22 mm.

The provided document is a 510(k) summary for the AMPLATZER® Vascular Plug II, which describes a medical device, not an AI/ML device. Therefore, the typical acceptance criteria and study design elements requested in the prompt, such as test sets, ground truth definitions, expert qualifications, and MRMC studies, are not applicable here.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is the standard for 510(k) clearances.

However, I can extract the relevant information from the provided text to demonstrate the device's performance against its stated equivalence.

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

The "acceptance criteria" for a medical device in a 510(k) submission are typically related to demonstrating that the modified device performs as intended and is as safe and effective as the predicate device. These are generally not quantitative metrics like precision or recall, but rather tests confirming functional equivalence.

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

The document does not specify a "test set" in the context of an AI/ML device. For this medical device, the "test data" refers to the studies performed to validate its functional characteristics and in vivo performance.

• Sample Size: Not explicitly quantified. For bench testing (radial force, handoff, etc.), it would depend on the specific test protocols. For animal testing, the number of animals or procedures is not disclosed in the summary.
• Data Provenance: Not specified within the provided summary. Typical for such a submission, bench testing would be conducted in a laboratory setting, and animal testing would be conducted under appropriate ethical and regulatory guidelines, likely within the US or a country with comparable standards.

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 concept is not applicable as the submission is for a medical device, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for a test set. The validation relies on engineering and biological tests demonstrating physical and functional attributes.

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

Not applicable. There is no "test set" requiring expert adjudication as would be found in an AI/ML study.

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 not an AI-assisted device, and thus no MRMC study would be performed for human reader improvement.

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)

For the verification and validation (V&V) of this device, the "ground truth" is established by:

• Engineering specifications and standards: For bench tests like radial force, deployment, and strength. The "ground truth" is adherence to predefined engineering requirements.
• Physiological and anatomical suitability: For animal testing, the "ground truth" would be successful embolization and lack of adverse events in a simulated biological environment, demonstrating the device performs its intended function in vivo without unforeseen complications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML 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."

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The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.

The AMPLATZER® Vascular Plug II is a sterile, single-use, triple-lobed. self-expanding Nitinol mesh occlusion device, with a screwattachment for a Delivery Wire and radiopaque marker bands at both ends. The Plug is attached to a 135 cm Delivery Wire with a stainless steel screw. The AMPLATZER® Vascular Plug II is provided contained within a Loader Device that facilitates loading into a delivery catheter. The Delivery Wire is coiled and packaged in a hoop dispenser.

The AMPLATZER® Vascular Pluq II is available in fully-expanded diameters of: 4mm, 6mm, 10mm, 12mm, 14mm and 16 mm.

The provided 510(k) summary for the AMPLATZER® Vascular Plug II does not contain the level of detail regarding acceptance criteria and performance studies typically associated with AI/ML device submissions. This document describes a medical device, an embolization plug, which is a physical device, not a software algorithm. Therefore, many of the requested categories related to software performance, AI/ML models, and clinical study design (like ground truth, expert consensus, MRMC studies, large training/test sets, etc.) are not applicable or detailed in this type of submission for a physical device.

However, I will extract and synthesize the relevant information presented in the document to address as many of your points as possible, adapting the interpretation to fit the context of a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format typically seen with software performance metrics (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance criteria" for this physical device are implicitly tied to demonstrating "substantial equivalence" to the predicate device through various verification and validation tests. The "reported device performance" refers to the successful completion of these tests, confirming functional equivalence.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of cases or patients. The testing described (radial force, handoff, deployment, etc.) likely involved a number of device units or components, and animal testing would have involved a certain number of animals. However, these specific numbers are not provided.
• Data Provenance:
  • Country of Origin: Not specified. Standard practice for such tests often involves in-house labs or contract research organizations, but the geographical location is not mentioned.
  • Retrospective or Prospective: The testing described (radial force, deployment, animal testing) is inherently prospective. These are laboratory and in-vivo tests conducted specifically for the purpose of demonstrating device performance and safety for the 510(k) submission. They are not analyses of pre-existing clinical data.

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

This concept is not applicable to this type of device submission. "Ground truth" established by experts (e.g., radiologists interpreting images) is a concept relevant to AI/ML or diagnostic devices where human interpretation is being benchmarked or assisted. For a physical embolization device, the "ground truth" is determined by direct physical measurements (e.g., radial force, deployment success) and direct observation of physiological effects in animal models. No human experts are described as establishing a "ground truth" in the diagnostic sense for these tests.

4. Adjudication Method for the Test Set

This is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in human interpretations or expert opinions when establishing ground truth for diagnostic accuracy studies. For physical device performance tests (e.g., radial force, deployment), results are typically objective measurements or observations, rather than subjective interpretations requiring adjudication.

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

• Done?: No, an MRMC comparative effectiveness study was not done or reported.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: This question is not applicable. An MRMC study with AI assistance is specifically designed for AI/ML diagnostic or assistive devices to measure the impact of AI on human reader performance. The AMPLATZER® Vascular Plug II is a therapeutic embolization device, not an AI-powered diagnostic tool.

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

This is not applicable. The AMPLATZER® Vascular Plug II is a physical embolization device, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was based on:

• Engineering and Biomechanical Measurements: Objective measurements of physical properties (e.g., radial force, handoff force, deployment success, recapture, detachment, strength).
• In Vivo Observation: Direct observation of the device's performance and physiological interaction in animal models under simulated conditions of use. Essentially, the "truth" was whether the device performed as expected and intended in a controlled physical/biological environment.

8. Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train an AI/ML model. This device is a physical product, not an AI/ML system.

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

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

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The AMPLATZER® Reliant™ Catheter Delivery System is intended to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart.

The AMPLATZER® Reliant™ Catheter Delivery System is a sterile. single-use device designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart. The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 6-12 French (2.0-4.0 mm). The catheters currently come in 60 cm and 80 cm usable lengths. The system includes the following components: Delivery Catheter, Dilator, Loader, Delivery Wire, Vise, Hemostasis Valve.

The provided text describes a 510(k) premarket notification for the AMPLATZER® Reliant™ Catheter Delivery System. This is a medical device submission, and the "study" referred to here is the set of verification and validation tests conducted to demonstrate substantial equivalence to a predicate device, rather than a clinical study with human patients and outcomes data in the typical sense for a diagnostic AI device.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Verification and validation testing confirms that the functional characteristics of the AMPLATZER® Reliant™ Catheter Delivery System are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices."

Specific numerical acceptance criteria and performance values are not provided in this summary. The 510(k) summary typically provides a high-level overview, with detailed test reports available to the FDA reviewer.

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

• Sample Size: The document does not specify the sample sizes for each of the "verification and validation testing" categories (catheter integrity, kink resistance, etc.). These would typically be detailed in the full test reports.
• Data Provenance: The tests are described as in vitro performance information and laboratory verification tests. This indicates the testing was conducted in a controlled lab setting, not on patient data. Therefore, there is no country of origin for patient data, nor is it retrospective or prospective in the clinical sense.

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

This concept is not applicable here. Ground truth, in the context of diagnostic AI, refers to the definitive determination of a condition (e.g., presence of disease) that the AI is trying to detect. For a physical medical device like a catheter delivery system, the "ground truth" for its performance is established through standard engineering and materials testing, adhering to recognized industry standards. The performance is measured against established physical and mechanical specifications, not expert interpretation of images or patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among expert interpretations of complex data (e.g., medical images) to establish a consensus ground truth. Since the "test set" here refers to physical products undergoing engineering tests, this methodology is not relevant.

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. MRMC studies are used for evaluating the impact of diagnostic aids (like AI) on human reader performance for tasks such as image interpretation. This device is a catheter delivery system, a physical tool for introducing other devices, not a diagnostic aid that enhances human reading of cases.

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

Not applicable. This device is a physical catheter delivery system, not a software algorithm.

7. The Type of Ground Truth Used:

As explained in point 3, the concept of "ground truth" in the diagnostic AI sense doesn't apply directly here. The "truth" for this device's performance is derived from:

• Engineering specifications and standards: The device is tested against predefined physical and mechanical properties and performance criteria (e.g., minimum tensile strength, maximum leak rate, resistance to kinking).
• Predicate device performance: The primary goal of a 510(k) is to demonstrate substantial equivalence. Therefore, the "truth" is often relative to the established performance characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable, for the same reasons as point 8.

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