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The device is intended to be used to remove body fluids from a patient's airway or respiratory system. It is for use on the order of a physician only.

The EMG Suction Unit is a compact medical suctioning device which can be powered by AC current (115V 60Hz) through the wall electric outlet at home. The vacuum pressure of the EMG Suction Unit is to be produced through a built-in vacuum pump which is consisted of an AC motor, a cylinder, a piston connecting rod, a cup seal, an eccentric crank, an inlet valve, an outlet valve, etc. When turn on the suction unit, the motor starts to run, its shaft drive the eccentric crank which actuates the piston connecting rod moving up and down in the cylinder. When the piston is being in the down stroke, a vacuum pressure is produced in the cylinder, then air will be suctioned into the cylinder through a one-way inlet port, when the piston is being in the up stroke, it pressed out the suctioned air through another one-way outlet port to the atmosphere, these two one-way ports avoid air being suctioned from the atmosphere as well as air in cylinder being pressed back to the inlet port. When the motor keep running, a continuous vacuum pressure source through inlet port is produced. A set of plastic cover enclose the vacuum pump, wire harness, etc. to profect the user from electrical shock and mechanical hurt hazard. The operating interface includes: a power switch, a vacuum adjusting set, a vacuum meter and a device vacuum inlet port. The vacuum adjusting set is connected to the inlet port of the vacuum pump through inner tubing, the vacuum meter and the device vacuum inlet port are connected to the vacuum adjusting set through a three-way connector and inner tubing. Device's vacuum pressure can be adjusted by tuning the knob of the vacuum adjusting set, accuracy within +/-5%. The vacuum meter display the vacuum pressure data during operation, the device vacuum inlet port provides the vacuum pressure source. One end of a connection tubing is connected to a bacteria filter which is connected to the device vacuum inlet port, and the other end of the connection tubing is connected to a collection container. Furthermore, one end of a patient tubing is connected to the inlet port of the collection container, and the other end of the patient tubing is connected to an applied part (like suction catheter). Put the applied part to the adequate location of the patient body, then this device can start suctioning sputum or other body fluid.

The provided 510(k) summary describes the EMG Suction Unit, Model SUA01-AXX Series, and focuses on demonstrating substantial equivalence to a predicate device (Medi-Pump Aspirator, Model 1615). This type of submission generally relies on demonstrating compliance with recognized performance standards and comparing technical characteristics rather than extensive clinical studies with detailed acceptance criteria for diagnostic performance metrics like sensitivity, specificity, or AUC as seen in AI/ML medical devices.

Therefore, the requested information regarding diagnostic performance, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance is largely not applicable (N/A) in the context of this device and submission type. The "acceptance criteria" here are primarily compliance with engineering and safety standards.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For the operational specifications (vacuum range, flow rate, sound level, operational power consumption), the document only states that the differences from the predicate device "do not affect safety and effectiveness of the device or the application." Specific numerical acceptance criteria or performance values for these metrics are not explicitly presented. The core "acceptance criteria" are the compliance with the listed safety and performance standards.

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

N/A. This device is a hardware medical device (suction unit), not a diagnostic algorithm. The "test set" would refer to units of the device being tested under specified conditions according to the standards. The document doesn't specify a number of units tested, but rather refers to "non-clinical tests performed." The data provenance for such tests is typically from the manufacturer's testing or accredited laboratories.

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

N/A. Ground truth in the context of a diagnostic algorithm is not relevant for this device. Compliance with engineering standards does not involve expert adjudication of diagnostic outcomes.

4. Adjudication method for the test set

N/A. Not applicable as there is no diagnostic ground truth to adjudicate.

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

N/A. This is not an AI/ML device, and no MRMC study was performed.

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

N/A. This is a hardware device; the concept of "standalone algorithm performance" is not applicable.

7. The type of ground truth used

N/A. For a medical device like a suction unit, "ground truth" would relate to its physical performance and safety characteristics as measured against established engineering and safety standards.

8. The sample size for the training set

N/A. This is a hardware device, not an AI/ML device that requires a training set.

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

N/A. Not applicable.

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The device is a portable air compressor intended to provide compressed air for medical purposes. It is used with a pneumatic nebulizer to administer humidified air or medication to the patient. The device is intended for use on adult and pediatric patients in a home health care or institutional environment. It's not approved for use with ventilators.

The EMG TRITON-COMP. Is a compressor designed for continuous, high pressure performance, easy and practical for home and hospital use. It is capable of servicing nebulizers and humidifiers to produce particle aerosol mist. The EMG TRITON-COMP. Powered by AC current (115V 60Hz) through the wall electric outlet at home, Maximum constant working pressure at 50psi, delivering up to 22LPM of flow (at pressure 10psi) and does not need software to drive. The outlet compressed air pressure of EMG TRITON-COMP. is produced through a built-in compressor. The consist parts include motor, cylinder, piston connecting rod, cup seal, eccentric crank, inlet valve, outlet valve ----etc. When turns on the compressor, motor starts to run and its shaft drives the eccentric crank to actuate the piston connecting rod moving up and down in the cylinder. When the piston is being in the down strike, a vacuum pressure is produced in the cvlinder, then the air will be sucked into the cylinder through an one-way inlet port. When the piston is being in the up strike, it presses out the air through the other outlet port to the atmosphere, these two one-way ports avoid the air being sucked from the atmosphere as well as the air in cylinder being pressed back to the inlet port. When motor keeps running, then the compressed air through outlet port is produced. One set of iron cover with protective earth encloses the compressor and wire harness to protect user from electrical shock and mechanical hurt hazard. The operating interface includes: a power switch, a compressed air pressure regulator, pressure gauge and air outlet port. The pressure regulator connected to the air outlet tube of compressor. The pressure gauge and the compressed air outlet port are connected to the pressure regulator through a three way connector and inner tube. Device's compressed air pressure can be adjusted by tuning the knob of pressure regulator, accuracy within +/-5%. The pressure gauge display the pressure data during operation.

The provided document describes a 510(k) premarket notification for a medical device, the EMG TRITON-COMP. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with AI components. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission.

Here's the information that can be extracted or inferred:

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

The document doesn't explicitly state acceptance criteria in a quantitative table format with corresponding performance results in the way one would see for a novel device undergoing clinical trials. Instead, it relies on demonstrating compliance with safety standards and similarity to predicate devices. The "performance validation test" mentioned includes:

The core "acceptance criterion" for this 510(k) submission is substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, safety, and effectiveness. The reported performance is that it is the same as the predicate device for the listed validation tests, and it also meets specified safety standards.

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 document refers to "performance validation tests" but does not detail the methodology, sample sizes, or data provenance for these tests. This is typical for a 510(k) summary relying on engineering and bench testing rather than clinical study data.

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/not provided. The device is an air compressor, and its performance tests would involve measurements of physical parameters (pressure, flow rate, etc.) for which "ground truth" is established by calibrated instruments and engineering specifications, not expert human assessment in a clinical context.

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

This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments, typically in clinical studies or human-in-the-loop performance evaluations, which are not described for this device.

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

An MRMC study was not done. This device is a portable air compressor, not an AI diagnostic tool. Therefore, human reader improvement with or without AI assistance is not applicable.

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

This information is not applicable. The device is a physical air compressor, not an algorithm.

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

The "ground truth" for the device's technical specifications and performance tests would be based on engineering specifications, calibrated measurement systems, and established test protocols for mechanical and electrical devices. For example, pressure gauge accuracy is verified against a master calibrated gauge, and flow rates are measured using calibrated flowmeters. No expert consensus, pathology, or outcomes data are mentioned as ground truth.

8. The sample size for the training set

This information is not applicable/not provided. This device is a mechanical compressor, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.

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

This information is not applicable/not provided as there is no training set mentioned for this device.

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The device is a vacuum suction device. It is to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory. It is for use on the order of a physician only.

The EMG AC/DC Suction unit is a compact medical suctioning device which can be powered by the AC current through a attached AC Adapter unit connecting to the wall electric outlet at home or DC power source through a set of built-in rechargeable battery or automobile DC 14V electric power through power cord connecting to the receptacle during transportation. The vacuum pressure of EMG AC/DC Suction unit is to be produced through a built-in vacuum pump which is consisted of DC motor, cylinder, piston connecting rod, cup seal, eccentric crank, inlet valve, outlet valve---etc parts. When turn on the suction unit, motor start to run, its shaft drive the eccentric crank which actuate the piston connecting rod moving up and down in the cylinder. When the piston is being in the down stroke, a vacuum pressure is produced in the cylinder, then air will be suctioned into the cylinder through an one way inlet port, when the piston is being in the up stroke, it pressed out these suctioned air through another one way outlet port to the atmosphere, these two one way port avoid air being suctioned from the atmosphere as well as air in cylinder being pressed back to the inlet port. When motor keep running, then a continuous vacuum pressure source through inlet port is produced. One set of plastic cover enclose the vacuum pump, control p. c. board, battery and wire harness to protect user from electrical shock and mechanical hurt hazard. Following components on the cover are to be the operating interface to the use: a power switch, a receptacle, a vacuum adjusting set, vacuum meter and device vacuum inlet port. The vacuum adjusting set through inner tubing connecting to the inlet port of vacuum pump, the vacuum meter and the device vacuum inlet port are connecting to the vacuum adjusting set through a three way connector and inner tubing. Device's vacuum pressure can be adjusted by tuning the knob of vacuum adjusting set, accuracy within +/-5%. The vacuum meter display the vacuum pressure data during operation, the device vacuum inlet port provide the vacuum pressure source. Connect the device vacuum inlet port, bacteria filter (Bacteria filter pore size: 0.2microns,Model:3928) and collection container with two PVC tubing respectively. then connect one end of a biocompatible patient tubing (comply with ISO10993 / material: PVC compound, Type: 3MSA060p3X) to the collection container inlet port, the other end of the patient tubing connected to the applied part (like drainage tubing). Put the applied part to the adequate location of patient body, then this device can start to carry out the suctioning sputum and other body liquid's operation.

The provided text describes a 510(k) premarket notification for the "EMG AC/DC Suction Unit, Model SUF01-XXX Series." This document primarily focuses on demonstrating substantial equivalence to a predicate device (DeVilbiss Suction Unit, Model 7305P-I) rather than presenting a detailed clinical study with numerical acceptance criteria and performance data in the format requested.

Here's a breakdown of the information that can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device is "designed and manufactured to comply with UL60601-1, CSA C22.2 No.601.1-M90 and IEC60601-1-2 EMC safety standards and meet the performance standard per ISO10079-1:1991." It also mentions that "Device's vacuum pressure can be adjusted by tuning the knob of vacuum adjusting set, accuracy within +/-5%."

However, specific numerical acceptance criteria (e.g., minimum flow rates, maximum vacuum levels, noise levels, battery life) and corresponding reported device performance values as typically presented in a summary table from a detailed performance study are not explicitly provided in this 510(k) summary. The document relies on compliance with established standards rather than detailing specific performance outcomes from a dedicated study.

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

The document describes non-clinical tests to establish substantial equivalence. It does not mention a "test set" in the context of human subjects or patient data. The tests performed are stated as "Compliance to the applicable voluntary standards include ISO10079-1, IEC60601-1-1 and IEC60601-1-2 requirements."

Therefore, information regarding:

• Sample size for a test set (human subjects/patient data): Not applicable or not provided. The evaluations mentioned are against engineering and safety standards.
• Data provenance (country of origin, retrospective/prospective): Not applicable or not provided. The tests described are compliance-based, likely performed in a lab setting by the manufacturer or a testing facility.

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

As the document focuses on non-clinical compliance testing against standards, there is no mention of "experts" establishing a ground truth for a patient-based test set, as would be common in clinical studies for diagnostic or therapeutic efficacy.

4. Adjudication method for the test set:

Not applicable, as there is no patient-based clinical test set requiring adjudication in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study is not mentioned. The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and compliance with standards, not on human reader performance with or without AI assistance.

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

Not applicable. This device is a physical suction unit, not an algorithm or AI system.

7. The type of ground truth used:

For the compliance testing mentioned:

• The "ground truth" would be the requirements and specifications outlined in the referenced international standards (ISO10079-1, UL60601-1, CSA C22.2 No.601.1-M90, IEC60601-1-2). The device performance is measured against these established engineering and safety benchmarks.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

In summary:

The provided 510(k) summary is a regulatory filing focused on establishing substantial equivalence for a physical medical device (an AC/DC suction unit). It demonstrates compliance with recognized safety and performance standards rather than presenting results from a clinical trial or AI evaluation. Therefore, many of the requested elements pertaining to clinical studies, human performance, and AI algorithms are not present in this type of document.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The Middle Wheel Drive Power Chair, CWD01 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided text describes a 510(k) premarket notification for a powered wheelchair, the Middle Wheel Drive Power Chair, CWD01. The submission focuses on demonstrating substantial equivalence to a predicate device (EPW POWERED WHEELCHAIR GP-201, K023148) rather than presenting a study to prove the device meets specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not present in this document, as they are typically associated with performance studies for novel devices or when demonstrating clinical superiority/non-inferiority.

Based on the provided information, here's what can be extracted and what cannot:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study. Instead, it compares the subject device's specifications to those of a predicate device to demonstrate substantial equivalence. The "performance testing" mentioned refers to compliance with safety and electrical standards, not specific clinical performance metrics.

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

Not applicable. This is a 510(k) submission based on substantial equivalence to a predicate device, not a performance study involving a patient test set. The "performance testing" refers to engineering and safety standard compliance, not clinical data from patients.

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. There was no clinical test set for which ground truth needed to be established by experts.

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

Not applicable. There was no clinical test set requiring adjudication.

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 device is a powered wheelchair and does not involve AI or human readers for interpretation.

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

Not applicable. This device is a powered wheelchair, not an algorithm.

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

Not applicable. There was no clinical test set requiring ground truth. The "ground truth" here is compliance with established engineering and safety standards for powered wheelchairs.

8. The sample size for the training set

Not applicable. There was no training set for an algorithm.

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

Not applicable. There was no training set. The "ground truth" for the device's design and manufacturing is adherence to regulatory and industry standards for safety and performance of powered wheelchairs.

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The Handle Nebulizer is a disposable device, which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with Nebulizers.

The Handle Nebulizer is a disposable device, which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with Nebulizers.

The provided text is a 510(k) premarket notification letter from the FDA regarding a nebulizer. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.

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The EMG CTX01-XXX Series Oxygen Concentrator is designed to provide 1 to 5 liters per minute oxygen for the patient who has been prescribed oxygen therapy by a physician. This device is used in home type environments, nursing homes, patient care facilities, etc.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding an oxygen concentrator (EMG CTX01-XXX Series Oxygen Concentrator). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.

The request asks for specific details about a study proving the device meets acceptance criteria, including:

1. Table of acceptance criteria and reported device performance: This information is not present.
2. Sample size, test set, and data provenance: Not mentioned.
3. Number of experts and qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: Not mentioned.
6. Standalone performance study: Not mentioned.
7. Type of ground truth: Not mentioned.
8. Training set sample size: Not mentioned.
9. Ground truth for training set: Not mentioned.

The document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device, as opposed to a detailed performance study with specific acceptance criteria that might be found in a clinical trial report or a more technical submission for a novel device or AI/ML-based device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a regulatory clearance letter, not a technical performance report.

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The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer used as prescribed by a physician for medication in the home or health care facility.

The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer.

This document is a 510(k) premarket notification letter from the FDA to EMG Technology Company Limited regarding their EMG NBA02-XXX Compressor Nebulizer. It states that the device has been found substantially equivalent to legally marketed predicate devices and can be marketed.

This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a regulatory approval document, not a scientific study or performance report. Therefore, I cannot extract the requested information from the provided text.

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The Model SUA01 Suction unit is intended for professional use to remove infectious materials from wounds or fluids from a patients airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, or device performance metrics for the "Model SUA01 Suction Unit". The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device and allows the device to be marketed. It states the indications for use but does not contain a study report or technical specifications with performance data.

Therefore, I cannot provide the requested table and study details.

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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

EPW Foldable Power Wheelchair, EPW-03

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a powered wheelchair, indicating that the device is substantially equivalent to a legally marketed predicate device. It does not include details on performance metrics, study designs, sample sizes, or ground truth establishment.

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The device is intended for medical purposes to provide mobility to persons restrict to a seated position.

The ESG 4-WHEEL SCOOTER, ESG-03 is an indoor / outdoor electric scooter tl is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided text describes a 510(k) premarket notification for the "ESG 4-WHEEL SCOOTER, ESG-03". This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device meets specific acceptance criteria through clinical trials or detailed performance metrics.

Therefore, many of the requested sections regarding acceptance criteria, study design, ground truth, and expert evaluation cannot be extracted from this document, as they are not applicable to this type of regulatory submission for a simple mobility device.

However, I can extract information related to the device description and the comparison to the predicate device.

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

The document does not specify quantitative acceptance criteria or detailed performance reports in a clinical or analytical study context. Instead, it relies on regulatory standards for performance testing to demonstrate safety and substantial equivalence.

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

Not applicable. This is a 510(k) submission for a mobility device, not a study involving a test set of data. Performance testing appears to be on a device prototype/model and adherence to 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)

Not applicable. Ground truth for a test set is not relevant for this type of device and submission.

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

Not applicable.

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. The device is an electrical scooter and does not involve AI or human "readers".

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

Not applicable. The device is an electrical scooter.

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

Not applicable. The "ground truth" here is compliance with established electrical and performance standards for wheelchairs/scooters and demonstrating substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/algorithm-based product.

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

Not applicable.

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