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The Phoenix Atherectomy System is in atherectomy of the peripheral vasculature. The system is not intended for use in the coronary, carotid, iliac, or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle.

The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle. The Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold the guidewire in a fixed position relative to the Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System.

There are multiple models of the Phoenix Catheter. The Phoenix Tracking Catheter models track directly over the guidewire with no tip deflection capability. The currently marketed models available for clinical use are 1.8mm, 2.2mm, and 2.4mm tip diameter sizes. The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle.

The subject 510(k) submission is proposed to introduce the following modifications:

(i) the predicate 2.2 mm X 130cm Phoenix Deflecting Catheter is being modified to add a new model with a 2.4mm distal cutter assembly to enable debulking to a larger lumen diameter. The 2.4 mm distal cutter assembly is equivalent in design to the currently marketed 2.4mm X 127cm Phoenix Deflecting Catheter.

(ii) the predicate 1.8 mm X 149cm Phoenix Tracking Catheter is being modified to add a 1.5mm tip diameter X 149cm Phoenix Tracking Catheter model to the Phoenix Catheter product family.

This document is a 510(k) premarket notification approval letter for the Phoenix Atherectomy System. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets them, particularly regarding the performance of an AI-based system.

The provided text describes a medical device for atherectomy, which is a mechanical procedure to remove plaque from peripheral arteries. The "Testing Summary" section lists various engineering and functional tests (e.g., dimensional inspection, simulated use, torque tests, embolic profile test), but these are related to the physical performance and safety of the atherectomy system itself, not to the performance of an AI system for diagnostics or image analysis.

Therefore, I cannot provide the requested information from this document, as it does not pertain to an AI-based device or a study structured with acceptance criteria, ground truth, and human reader performance data as typically seen in AI/ML medical device submissions.

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The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The QuickClear Mechanical Thrombectomy System is an aspiration thrombectomy system designed for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The QuickClear Mechanical Thrombectomy System removes thrombus from the peripheral vasculature using continuous vacuum aspiration, through a single lumen aspiration catheter. The system components are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The QuickClear Mechanical Thrombectomy System comprises the following devices and accessories:

• QuickClear Aspiration Pump
• A 60cc Syringe
• QuickClear Aspiration Catheters: Catheters are available in the following sizes: 6F straight tip, 8F straight tip, 8F shaped tip and 10F shaped tip.
• An Obturator is supplied with the 8F and 10F catheters.
• A Waste Collection Bag

This document is a 510(k) summary for the QuickClear Mechanical Thrombectomy System, seeking substantial equivalence to a predicate device. It primarily details the device's design, intended use, and a comparison to existing devices. It does not describe the acceptance criteria or a study proving the device meets performance criteria for a diagnostic tool (e.g., an AI-powered one).

Instead, this device is a mechanical thrombectomy system, meaning it physically removes thrombus (blood clots). The testing described is for the physical performance and safety of a medical device, not the diagnostic performance of an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications for ground truth, MRMC study, etc.) from this document. This document pertains to the regulatory clearance of a mechanical medical device, not a diagnostic AI system.

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The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle. The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle. The Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold a guidewire in a fixed position relative to the Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System.

The provided text is a 510(k) summary for a medical device called the Phoenix® Atherectomy System. It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information related to software performance, acceptance criteria for an AI/ML device, or any study involving human readers or expert consensus on image interpretation.

The document is about a mechanical atherectomy system used for clearing peripheral vasculature. The "testing summary" section lists various engineering and functional tests to demonstrate the device's performance and safety (e.g., dimensional inspection, simulated use, torque tests, temperature rise, trackability, etc.). These are typical for a physical medical device, not for a software-based AI/ML product.

Therefore, I cannot provide a response that directly answers your request using the provided text. The questions you posed are specifically designed for evaluating an AI/ML-based medical device, particularly one that involves image interpretation and human expert involvement in ground truth establishment.

If you have a different document describing an AI/ML medical device, please provide it, and I would be happy to analyze it according to your criteria.

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The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The system is not intended for use in the coronary, carotid, iliac, pulmonary, or renal vasculature.

Phoenix Atherectomy Plus System:

When used with the Phoenix Aspiration Pump as the vacuum source, the Phoenix 2.4mm Deflecting Atherectomy System is indicated for the removal of thrombus from vessels of the peripheral arterial vasculature.

The Phoenix 2.4mm Atherectomy Plus System comprises the currently cleared Phoenix 2.4mm Deflecting Atherectomy System (K172386) and a new Phoenix Aspiration Pump. which when used in conjunction with each other are designed for removal of thrombus from vessels of the peripheral arterial vasculature.

The Phoenix 2.4mm Deflecting Atherectomy System and the Phoenix Aspiration Pump are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The Phoenix 2.4mm Deflecting Atherectomy System comprises the Phoenix 2.4mm Deflecting Atherectomy Catheter and the Phoenix Atherectomy Handle with Wire Support Clip.

The Phoenix Catheter is an over-the-wire (OTW), multi-lumen Catheter with a cutter at the distal tip that continuously captures and clears debulked (excised) material proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectorny Catheter at its specified rotational speed, and is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold a guidewire in a fixed position relative to the Phoenix Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System. The Phoenix Catheter is compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires.

For the purpose of this 510(k), the design of the Phoenix 2.4mm Deflecting Atherectomy System remains unchanged.

The Phoenix Aspiration Pump connects to the disposal outlet of the Phoenix Catheter via the pump's aspiration tubing. The exit end of the aspiration tubing is connected to a waste disposal bag to collect aspirated material. A 60 ml syringe is provided as part of the Aspiration Pump Assembly to assist in priming the pump aspiration tubing and purging the aspiration system of air. The Aspiration Pump is battery-operated and is operated by an ON/OFF switch. It serves as a vacuum source for the Aspiration System for aspirating the thrombus from the target vessel out of the Phoenix Catheter via the pump aspiration tubing and into the disposal bag. The Aspiration Pump is non-patient contacting.

The provided text is a 510(k) summary for the Phoenix 2.4mm Atherectomy Plus System. It describes the device, its intended use, and a comparison to predicate and reference devices, as well as a summary of testing performed to demonstrate substantial equivalence. However, it does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm-driven device performance study.

The document describes the device as a mechanical atherectomy system with an aspiration pump for removing thrombus, which is a physical device, not an AI or algorithm. The "Testing Summary" section lists various engineering and preclinical tests (e.g., visual inspection, vacuum and leak test, flow rate test, system simulated use test, preclinical animal testing), which are typical for medical devices of this nature. There is no mention of an algorithm, AI, or any data-driven performance study comparing human readers with and without AI assistance, or standalone algorithm performance, or ground truth establishment based on expert consensus for image analysis.

Therefore, I cannot provide the requested information from the given text. The text does not detail an AI/algorithm-driven study with acceptance criteria.

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The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle.

The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle. The Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold a guidewire in a fixed position relative to the Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System.

There are multiple models of the Phoenix Catheter. The Phoenix Tracking Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8 mm and 2.2 mm tip diameter sizes; a 2.4 mm tip diameter size (identical in design to the currently marketed 2.4 mm Phoenix Deflecting Catheter) has been added under this 510(k). The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle.

This 510(k) includes modifications to the 1.8 mm and 2.2 mm tip diameter 149 cm Phoenix Tracking Catheter models to improve the overall catheter pushability and internal debris maceration of the longer length catheter models and (as just noted previously) to also add a 2.4 mm tip diameter 130 cm Phoenix Tracking Catheter to the Phoenix Catheter product family. Tables 9-1 and 9-2 summarize the subject modifications relative to the predicate devices.

The provided text describes a 510(k) premarket notification for the Phoenix Atherectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria from an AI/reader study perspective.

Therefore, many of the requested categories for AI/reader study evaluation cannot be fulfilled from this document.

Here's an analysis based on the available information:

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

The document does not detail specific acceptance criteria with numerical targets. Instead, it states that the modified Phoenix Atherectomy System's performance and technological characteristics were evaluated by a series of tests to demonstrate equivalence to the predicate device. The general acceptance is that the device "meet pre-defined design requirements and that the modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System with the identical intended use."

The tests performed include:

• Dimensional and Visual Inspection
• Simulated Use
• Cutter Torque / Chain Torque-to-Failure Test
• Functional Outer Shaft Torque Test
• Knob to Shaft Testing
• Catheter Drive Train Stress Test
• Cutter Stall Test
• Temperature Rise of Catheter During Simulated Use
• Kink Bend Radius Test
• Catheter Trackability in Below-the-Knee Anatomy
• Sheath Flow Rate (2.4mm X 130 cm Phoenix Catheter only)
• Sheath Compatibility (2.4mm X 130 cm Phoenix Catheter only)

The document asserts that "The results from this testing demonstrate that the performance and technological characteristics of the modified Phoenix Atherectomy System meet pre-defined design requirements and that the modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System with the identical intended use."

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

This information is not provided in the document. The testing described appears to be bench testing and simulated use, not clinical or human-data-driven studies.

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

This information is not applicable as the document does not describe an AI/reader study or the establishment of ground truth by experts in that context. The "ground truth" here would relate to the engineering specifications and performance capabilities verified through the various tests.

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

Not applicable as this is not an AI/reader 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. No MRMC study or AI assistance is mentioned.

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

Not applicable. This device is a manual atherectomy system, not an AI algorithm.

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

The "ground truth" for this device's performance would be derived from engineering specifications, material properties, and the results of the described bench and simulated use tests. It is based on the device's physical and functional capabilities as measured against design requirements for safety and effectiveness, and comparison to the predicate device.

8. The sample size for the training set

Not applicable. There is no AI model or training set described.

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

Not applicable. There is no AI model or training set described.

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The Phoenix® Atherectomy System is in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle.

The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. An accessory, the Phoenix Wire Support Clip, is also supplied and can be used to clip a guidewire torque device in a fixed position relative to the Phoenix Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately as sterile, single-use components of the Phoenix Atherectomy System.

There are multiple models of the Phoenix Catheter. The smaller 1.8mm and 2.2mm Phoenix Catheter models are compatible with 5F and 6F sheaths, respectively, and track directly over the guidewire with no tip deflection capability. The larger 2.4mm Phoenix Catheter is 7F with the tip having deflection capability. All Phoenix Catheter models use the same Phoenix Handle and are compatible with specific commercially available 0.014" exchange length (260 cm or greater) guidewires listed in the product's instructions for use.

This 510(k) includes modifications to the 2.4mm tip diameter Phoenix Deflecting Catheter distal cutter assembly, as well as the Catheter and proximal chassis design to optimize the ease of use, tip deflection capabilities and manufacturability of the device. Table 9-1 summarizes the subject modifications relative to the predicate devices.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study proving a device meets them.

The document is a 510(k) premarket notification letter for the Phoenix Atherectomy System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of clinical study results or specific acceptance criteria with performance data.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• Acceptance Criteria and Reported Device Performance: While the document lists various types of testing performed (e.g., "Simulated Use", "Comparative Predicate Testing in Simulated Lesion"), it does not provide specific quantitative acceptance criteria for these tests nor the reported numerical performance of the device against those criteria. For example, it lists "Deflection span (Side-to-side) ≥ 6.0mm" as a characteristic of the modified device, implying this is a performance target, but it doesn't present a table showing the actual measured deflection span from a study.
• Sample Size and Data Provenance (Test Set): The document mentions "Comparative Predicate Testing in Simulated Lesion." However, it does not specify the sample size used for this or any other test. It also does not provide information about data provenance (e.g., country of origin, retrospective/prospective nature).
• Number and Qualifications of Experts for Ground Truth (Test Set): There is no mention of experts being used to establish a ground truth for any test sets. The testing appears to be primarily engineering and bench testing.
• Adjudication Method: Not applicable as no expert-based ground truth establishment is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not describe any MRMC studies or human-in-the-loop performance evaluations. The device is an atherectomy system, not an AI diagnostic tool that would typically involve such studies.
• Standalone (Algorithm Only) Performance: Not applicable for this type of medical device.
• Type of Ground Truth Used: The ground truth for the various engineering tests would be defined by the specified design requirements or physical measurements, not by expert consensus, pathology, or outcomes data in the traditional sense of AI/diagnostic device validation.
• Sample Size for Training Set: Not applicable as this is not an AI/machine learning device.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a regulatory submission for a medical device that details its technological characteristics and the types of non-clinical testing conducted to support its substantial equivalence to a predicate device. It does not contain the detailed clinical study data, acceptance criteria framework, or AI-specific validation information you are requesting.

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The Phoenix® Atherectomy System is in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle.

The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. An optional Wire Support Clip can also be used to clip a guidewire torque device in a fixed position relative to the Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately as sterile, single-use components of the Phoenix Atherectomy System.

There are multiple models of the Phoenix Catheter. The smaller Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8 mm and 2.2 mm tip diameter sizes. The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle.

This 510(k) includes modifications to the 1.8 mm and 2.2 mm tip diameter Phoenix Catheter models to increase the overall working length from 130 cm to 149 cm and thereby create two new longer-length models within the Phoenix Catheter product family.

The provided document is a 510(k) premarket notification for a medical device (Phoenix® Atherectomy System). These notifications primarily aim to demonstrate substantial equivalence to a predicate device, rather than providing extensive details on novel acceptance criteria and study designs typically found in regulatory submissions for new devices or software.

Based on the provided text, the device is an updated version of an existing device (the only change being an increased working length of the catheter). Therefore, the "acceptance criteria" discussed relate to demonstrating that the modified device performs equivalently to the predicate device, not to establishing new performance benchmarks for a novel device or AI algorithm. The study described is a series of engineering and performance tests rather than a clinical trial or a study assessing human reader performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the traditional sense, nor does it provide quantitative performance metrics for each. Instead, it states that the testing "demonstrate[s] that the performance and technological characteristics of the modified Phoenix Atherectomy System meet defined design requirements and that the modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System."

The technological characteristics of the modified device are compared to the predicate device in Table 9-1. The "acceptance" is implied by the "Identical" assessment for most characteristics, and the successful completion of the listed tests.

The "study" that proves the device meets these criteria consists of the following tests:

• Dimensional and Visual Inspection
• Simulated Use
• Cutter Torque Chain Torque-to-Failure Test
• Functional Outer Shaft Torque Test
• Knob to Shaft Testing
• Catheter Drive Train Stress Test
• Cutter Stall Test
• Temperature Rise of Catheter During Simulated Use
• Kink Bend Radius Test
• Guidewire Compatibility
• Catheter Trackability in Below-the-Knee Anatomy

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

The document does not specify a "test set" in the context of clinical data or patient outcomes. The testing described is bench testing and simulated use. Therefore, there is no information on a sample size of patients or data provenance (country of origin, retrospective/prospective). The "samples" would be the catheters themselves used in the engineering tests.

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 not a study involving expert review of medical images or patient data to establish ground truth. The "ground truth" for these engineering tests would be the established design specifications and performance characteristics of the predicate device.

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

Not applicable, as this is not a study requiring expert adjudication of clinical outcomes or interpretations.

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 premarket notification for a mechanical atherectomy system, not an AI software device.

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

Not applicable. This is a premarket notification for a mechanical atherectomy system, not an AI software device.

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

The "ground truth" for the equivalence demonstration is the established performance and specifications of the legally marketed predicate device (K140944 Phoenix Atherectomy System). The objective of the testing was to show that the modified device's performance, despite an increased length, did not deviate in a way that would alter its safety or effectiveness compared to the predicate.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would involve a "training set."

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

Not applicable. This is not a machine learning or AI device that would involve a "training set."

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