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The Caterpillar and Caterpillar Micro Arterial Embolization Devices are indicated for arterial embolization in the peripheral vasculature. The Caterpillar Micro Arterial Embolization Devices are contraindicated for use in vessels subject to cyclic bending, such as highly locomotive joints or muscle beds.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices are self-expanding arterial occlusion plugs. The devices consist of the following components and are intended to be a permanent implant: cobalt-chrome stem, nickel-titanium fibers, platinum-iridium radiopaque marker bands, and a polyurethane and polyethylene occlusion membrane.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device Systems are packaged as a single unit with the implant, loader, dispenser hoop, detachable delivery wire, and torque tool. The Caterpillar™M Micro delivery wire is coated with a hydrophilic coating. While the Caterpillar™ delivery wire has a PTFE hydrophobic coating. The system is provided sterile and non-pyrogenic and is intended for single use only.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device is designed for a specific arterial diameter range. The artery diameter range and required delivery catheter (ID)) for deployment are provided in the table below.

| Product Name | Product
Reference | Target Artery
Diameter (mm) | Delivery Catheter
Compatibility: Inner
Diameter (in/mm) | Marker to
Marker
Length
(mm)1 | Maximum
Deployed
Length
(mm)2 | Delivery
Wire
Length
(cm) |
|-----------------------|----------------------|--------------------------------|---------------------------------------------------------------|----------------------------------------|----------------------------------------|------------------------------------|
| Caterpillar™
Micro | 027 | 1.5 - 4 | 0.027 / 0.686 | 7 | 16 | 170 |
| Caterpillar™ | 038 | 3 - 6 | 0.038 / 0.965 | 17 | 26 | 155 |
| Caterpillar™ | 056 | 5 - 7 | 0.056/ 1.422 | 18 | 37 | 155 |

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices). This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy through a clinical trial with specific performance metrics against a defined acceptance criterion. The "acceptance criteria" referred to in the document are primarily related to general design verification and safety testing, not specific clinical performance endpoints in the way you might find for an AI algorithm.

Therefore, the answers below will reflect the nature of this type of regulatory submission. There is no information provided in this document regarding AI algorithms, human-in-the-loop performance, or AI-specific ground truth methodologies.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table of specific numerical acceptance criteria with corresponding performance values for clinical efficacy. Instead, it lists types of tests performed and states that the device "met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs." The animal study concluded that "the study device performance was equivalent or superior to control devices across each of the evaluated endpoints."

Here's an interpretation based on the provided information, focusing on categories of testing:

• Chronic ovine study also addressed subchronic toxicity, implantation, chronic toxicity, and in vivo thrombogenicity.
• Chemical characterization testing and toxicological assessment evaluated genotoxicity, chronic toxicity, and carcinogenicity. |
  | In Vivo Performance (Animal Study): | A chronic ovine study found that "the study device performance was equivalent or superior to control devices across each of the evaluated endpoints," which included:
• Migration resistance
• Ease of delivery
• Occlusion efficiency
• Recanalization
• Deliverability
• Hemostasis after procedure
• Thrombogenicity
• Device safety
• Freedom from complications |

Regarding aspects typically related to AI performance, the document does not contain information on the following:

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

• No "test set" in the context of an AI algorithm. Performance data was generated through various bench tests and one pre-clinical animal study.
• Animal Study Sample Size: Not explicitly stated, but implies multiple animals to evaluate chronic effects and comparisons.
• Data Provenance: Non-clinical (bench) and pre-clinical (animal) studies. No human data (clinical data) is mentioned as a "test set" for performance evaluation in this 510(k) summary.

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 for this type of device submission. "Ground truth" in the context of an AI algorithm is not relevant here. For the animal study, evaluations would typically be done by veterinary specialists, pathologists, and dedicated study personnel according to a protocol.

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

• Not applicable for this type of device submission. This is relevant for AI image review. For the animal study, endpoints would be assessed according to pre-defined criteria, likely by the study investigators and possibly independently reviewed by a pathologist for tissue samples.

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 MRMC study was done, as this is not an AI device. This section is entirely irrelevant to the provided document.

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

• Not applicable, as this is not an AI device.

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

• Not applicable for an AI device. For the non-clinical and pre-clinical animal studies, "ground truth" would be established by:
  • Bench Testing: Engineering measurements, adherence to specifications, validated test methods.
  • Animal Study: Direct observation by study personnel, pathology findings following necropsy, physiological measurements, imaging results, and histological analysis.

8. The sample size for the training set

• Not applicable, as this is not an AI device. No training set exists.

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

• Not applicable, as this is not an AI device. No training set exists.

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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 EMBA Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.

The EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.

This document describes the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED). The information provided focuses on the device's substantial equivalence to predicate devices rather than a detailed study proving it meets specific quantitative acceptance criteria for performance metrics in a clinical setting.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria for performance metrics (e.g., specific thresholds for occlusion rates, migration rates, etc.) that the device was evaluated against in a clinical study. Instead, it lists various comparative performance tests conducted to demonstrate substantial equivalence to predicate devices. These tests focused on design and functional characteristics to show that technological differences do not raise new safety or effectiveness concerns.

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

• Sample Size: Human Use Clinical Testing was conducted on n=51.
• Data Provenance: The document does not specify the country of origin. The study appears to be a prospective human use clinical study, although full details are not provided in this summary.

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

• The document does not mention the number of experts used to establish ground truth for the clinical test set or their specific qualifications. It only states that human use clinical testing was conducted to evaluate "safety and effectiveness endpoints," implying clinical assessment by medical professionals.

4. Adjudication Method for the Test Set:

• The document does not specify the adjudication method used for the clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, this was not an MRMC comparative effectiveness study. The text discusses comparative performance testing against predicate devices, but this refers to bench testing and animal testing, and for the human use study, it was to evaluate safety and effectiveness endpoints of the EMBA device itself, not to compare human readers with and without AI assistance. The device is a physical medical implant, not an AI diagnostic tool.

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

• This question is not applicable as the EMBA™ HOURGLASS™ Peripheral Embolization Device is a physical medical device, not a software algorithm. Its "standalone" performance would typically refer to its mechanical and functional performance in in-vitro or animal models, which was indeed performed as "comparative performance testing."

7. The Type of Ground Truth Used:

• For the human use clinical testing, the "ground truth" would implicitly be clinical outcomes data assessed by medical professionals, related to the safety and effectiveness of the device's embolization. For the non-clinical performance tests (Kink Radius, Trackability, Migration Resistance, Occlusion Effectiveness, etc.), the "ground truth" was established by engineering and scientific measurements against predefined specifications or comparison with predicate device performance.

8. The Sample Size for the Training Set:

• This question is not applicable as the device is a physical medical implant, not an AI algorithm that requires a "training set" in the context of machine learning.

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 AMPLATZER™ TorqVue™ LP Catheter is intended 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 Low Profile Delivery Catheter (TVLPC) is an extension of the AMPLATZER TorqVue Low Profile Delivery System (TVLP) product line. The TVLPC is identical to the TVLP with the exception of a delivery wire, which is omitted on the TVLPC catheter only product. The TorqVue LP Catheter includes a catheter, loader, Tuohy-Borst hemostasis valve, and a self-sealing hemostasis valve. The TorqVue LP Catheter is intended for use with AMPLATZER devices packaged with a delivery wire. Figure 1 illustrates the delivery system and identifies the following essential components: Catheter – Single-lumen catheter that is used to deliver the device after it has . been positioned by the physician. The body of the catheter is radiopaque to increase visibility when using fluoroscopy. The distal end of the catheter is curved approximately 90°. Tuohy-Borst hemostasis valve – An adapter designed to control back-bleeding ● from the Delivery Catheter. . Loader - catheter short tube with luer fittings that aids in placing the desired devices into the Delivery Catheter. ● Self-sealing hemostasis valve - An adapter designed to control back-bleeding from the Delivery Catheter. The self-sealing valve provides additional sealing capabilities for use with delivery wires of smaller diameters.

The provided text is a 510(k) Summary for a medical device (AMPLATZER TorqVue Low Profile Delivery Catheter). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not include information about acceptance criteria for a study, nor does it detail a study that proves the device meets specific performance criteria in the way an AI/ML device would be evaluated.

The document is a submission to the FDA for market clearance, not a study report. It focuses on demonstrating equivalence to existing devices rather than proving novel performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as the document does not contain this type of data.

To directly answer your numbered points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes functional and safety testing as being performed and provided in cleared applications for predicate devices, implying that the current device leverages those existing approvals for its components.
2. Sample sized used for the test set and the data provenance: Not applicable. The document refers to "Design Verification and Design Validation testing" performed on predicate devices, but doesn't specify test set sizes or data provenance for the current device's performance claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of information is not relevant for the kind of device and submission described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study involving human assessment of outcomes for a test set.
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/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of device performance in a clinical setting for this type of device. The "ground truth" would be engineering specifications and safety standards for the functional components.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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