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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® 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.

• Handoff and advancement forces: Confirmed functional equivalence.
• Device deployment: Confirmed functional equivalence.
• Recapture and detachment verification: Confirmed functional equivalence.
• Overall strength determinations: Confirmed functional equivalence. |
  | Validation of product under simulated conditions of use | - Animal testing: Validated the product under simulated conditions of use. |
  | Maintain identical intended uses as predicate device | - The AMPLATZER® Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature, identical to the predicate device. |
  | Maintain same patient-contacting materials | - The AMPLATZER® Vascular Plug II has exactly the same patient-contacting materials as the predicate. |
  | Maintain same Nitinol Delivery Wire | - The AMPLATZER® Vascular Plug II has the same Nitinol Delivery Wire as the predicate. |
  | Maintain same operating principle | - Both devices operate on the principle of a self-expanding Nitinol mesh delivered through a catheter, expanding to occlude the vessel upon release. |
  | Device modifications (shape, braid layers, loader material) do not adversely affect performance and substantial equivalence. | - Verification and validation testing (radial force, deployment, etc.) confirms the functional characteristics are substantially equivalent despite these modifications. |

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

The AMPLATZER Vascular Plug is provided sterile and is intended for one-time use. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. The delivery system is comprised of a 135 cm long, stainless steel delivery cable and a PTFE loader. The AMPLATZER Vascular Plug is preloaded in a loader and delivered through currently available standard 5 or 6 French guiding catheters.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study for the AMPLATZER® Vascular Plug:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various tests performed on the AMPLATZER Vascular Plug and its delivery system, primarily focusing on mechanical performance, biocompatibility, and comparing its embolization efficacy to existing coil devices in an animal model. Unlike typical AI/software device submissions, this document focuses on a physical medical device. Therefore, the "acceptance criteria" are more about demonstrating safety and functional equivalence to predicate devices, rather than specific performance metrics like sensitivity, specificity, or AUC as seen in AI/ML applications.

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