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The Dr. Amplatz Micro Plug is indicated for arterial embolization in the peripheral vasculature.

The Dr. Amplatz Micro Plug includes the Micro Plug Device which is a self-expanding braided Nitinol vascular occlusion implant that is supplied with components used for implantation.

The Micro Plug Device has been designed with a material, size, configuration and shape that allows introduction through a catheter for the occlusion of blood vessels in the peripheral vasculature. The Micro Plug Devices are provided in four different diameters (3 mm - 6 mm) to treat different sized blood vessels in the peripheral vasculature. The Micro Plug Device has radiopaque marker bands attached to each end and a screw attachment for connection to a Delivery Wire. The Micro Plug Device is packaged collapsed within a Loader and attached to a 180 cm Delivery Wire that is provided within a hoop dispenser.

The delivery system includes a 125 cm Delivery Catheter that is provided within a hoop dispenser for delivery and implantation of the Device; the Delivery Catheter contains a standard luer hub adapter at the proximal end and a single radiopaque marker band at the distal end. The Delivery Catheter is hydrophilic coated. Tuohy Borst Valves are provided for flushing; a Torque Device is provided for releasing the Device.

The Dr. Amplatz Micro Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature by physicians trained in vascular embolization.

The Dr. Amplatz Micro Plug is a vascular embolization device. The provided text outlines the performance data used to establish its substantial equivalence to a predicate device. However, the document does not contain a table of acceptance criteria and reported device performance values, nor does it describe a study involving human readers or a standalone AI algorithm. It focuses on non-clinical testing for equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• Not provided in the document. The document lists various performance evaluations conducted (Simulated Use, Tensile Strength, Radial Force, etc.) and states that "Test results demonstrated that all acceptance criteria were met," but it does not specify the numerical acceptance criteria for each test or the actual performance values obtained.

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

• Test Set Sample Size: Not explicitly stated for any individual test. The document refers to "evaluations" and "tests" but doesn't quantify the number of devices or samples used for each test (e.g., how many plugs were tested for tensile strength).
• Data Provenance: The studies were non-clinical (bench testing, material testing, and animal study).
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not applicable as these are laboratory and animal studies, not human data collection in the traditional sense.

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

• Not applicable. The "ground truth" for these tests would be established by the testing methodology and instruments, with interpretation by qualified engineers/scientists, rather than a panel of clinical experts determining "ground truth" on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not applicable. This concept typically relates to human-reviewed data where disagreements need resolution. For bench and animal testing, results are typically objective and follow pre-defined protocols and acceptance limits.

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

• No. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no MRMC study, human reader comparison, or AI assistance evaluation was performed or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This device is a physical medical implant, not a software algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is derived from:
  • Established Test Standards/Protocols: Performance against industry standards (e.g., for tensile strength, fatigue, corrosion, MRI compatibility).
  • Predicate Device Characteristics: Comparison against the known characteristics and performance of the predicate device (Amplatzer Vascular Plug).
  • Biocompatibility Standards: Performance against ISO standards for biological evaluation of medical devices.
  • Histopathological Analysis (for animal study): Tissue response and acute/chronic performance observed in the animal model.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, no training set was used.

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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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