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

Cutie S17 power scooter is battery powered and configured with four pneumatic wheels, a swivel seat, a turning tiller column, an upper panel control, a main frame, a rear bumper, a front bumper, and an anti-tipper. S17 power scooter is operated by two pneumatic rear wheels as the drive wheels and two pneumatic front wheels as the steering wheels, using the upper panel control to control the turning tiller column mechanism to control the front wheel as the power scooter steering direction mechanism. Upper panel control is able to control driving forward, driving backward, speed control and lighting function. The main frame is equipped with a rear bumper and a front bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. Turning tiller column is equipped with the head light, back mirrors, a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward.

The provided text describes the HEARTWAY Power Mobility Scooter, Cutie S17, and its substantial equivalence to a predicate device. The information details performance testing against various ISO and ANSI/RESNA standards, but it does not contain acceptance criteria for an AI/ML powered device, nor does it describe a study specifically designed to prove a device meets such criteria.

The document is a 510(k) premarket notification for a physical medical device (a power mobility scooter), not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established is not applicable to this document.

The document focuses on demonstrating that the new scooter (Cutie S17) is substantially equivalent to a previously cleared scooter (S34) by comparing their specifications and performance against recognized device safety and performance standards.

Here's a breakdown of what the document does provide, in relation to device performance:

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

The document provides a comparison table between the subject device (Cutie S17) and the predicate device (S34), highlighting similarities and differences in specifications and performance attributes. It also lists various international standards that the subject device passed. While "acceptance criteria" for an AI/ML device are not present, the performance comparisons and the passing of these standards serve as the basis for the device's acceptable performance and safety.

The study that proves the device meets the acceptance criteria (Non-Clinical Performance Testing):

The document states that the subject device (HEARTWAY Power Mobility Scooter, Cutie S17) underwent and passed performance tests according to the following international standards:

• Electromagnetic Compatibility: ANSI/RESNA WC-2, Section 21:2009 (with exclusions)
• Static Stability: ISO 7176-1:1999 (with exclusions)
• Dynamic Stability: ISO 7176-2:2001 (with exclusions)
• Brakes: ISO 7176-3:2012 (with exclusions)
• Energy Consumption (Range): ISO 7176-4:2008
• Dimensions, Mass, Maneuvering Space: ISO 7176-5:2008
• Maximum Speed, Acceleration, Deceleration: ISO 7176-6:2001
• Seating Dimensions: ISO 7176-7:1998
• Static, Impact, and Fatigue Strength: ISO 7176-8:1998
• Climatic Tests: ISO 7176-9:2009
• Obstacle-Climbing Ability: ISO 7176-10:2008
• Test Dummies: ISO 7176-11:2012
• Coefficient of Friction of Test Surfaces: ISO 7176-13:1989
• Power and Control System: ISO 7176-14:2008
• Information Disclosure, Documentation, Labeling: ISO 7176-15:1996
• Resistance to Ignition (Upholstered parts): ISO 7176-16:2012

Additionally, for biocompatibility, patient-contacting materials (seat PVC, hand grip PVC, seat belt PVC) were tested for compliance to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

The conclusion states: "At last, subject devices pass the performance tests according to Safety standards of ISO 7176 series and the EMC test of ANSI / RESNA WC-2, Section 21:2009. The overall performances of the subject devices are ensured." and "The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed device identified in the submission."

Regarding the specific questions posed for AI/ML devices, the information is not present in this document because it is for a physical medical device:

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance testing is described as passing standards, not a statistical test set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Functional and safety standards are used, not expert-labeled ground truth for an algorithm.
4. Adjudication method: Not applicable. Standardized mechanical and electrical tests are performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context refers to the requirements set by the international performance and safety standards, which the physical device must meet.
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.

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

Cutie Mini S16 is battery operated and configured with two rear pneumatic wheels as the drive wheels and two front pneumatic wheels as the steering wheels. The device uses the upper panel control to control the turning tiller column mechanism to control the front wheel as the steering directions. Upper panel control is able to control driving forward, driving backward, speed control and lighting function. The main frame is equipped with a rear bumper to allow the device to sustain an impact without damage to the power scooter safety system and with an independent suspension. Tuning tiller column is equipped with the head light, back mirrors, and a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward. Cutie Mini S16 maximum weight capacity is 300 lbs (135 kg), and the maximum speed is 3.6 mile/hr ( 6 km/hr). Owing to the feature of the body structure, the two rear wheels can always contact the surface, and the device can drive on the rough surface.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is a 510(k) premarket notification for a medical device (HEARTWAY Power Mobility Scooter, Cutie Mini S16). For devices like this, the "acceptance criteria" are generally demonstrating substantial equivalence to a predicate device by meeting recognized consensus standards for performance and safety. The document primarily focuses on comparing the new device to a predicate device (HEARTWAY Lightweight Power Mobility Scooter, S34) and showing that performance tests confirm its safety and effectiveness.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are usually aligned with international consensus standards for performance and safety. The reported device performance is indicated by its compliance with these standards and its specific design parameters.

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

The document details compliance with various ISO and ANSI/RESNA standards for performance testing. These standards typically involve specific test setups and a limited number of test units (e.g., one or a few devices) for physical and electrical performance evaluations rather than large "sample sizes" in the statistical sense (like patients in a clinical trial). The tests described are laboratory-based performance tests for the device itself.

• Sample Size: Not explicitly stated in terms of a "test set" sample size for statistical analysis (e.g., number of patients/cases). Instead, it refers to testing of the device(s) themselves. The implied sample size for each performance test is usually one or a few devices/components as per the specific test standard.
• Data Provenance: The tests are standard-based performance tests, likely conducted in a controlled laboratory environment by the manufacturer or a certified testing facility. The document refers to "Performance Testing" without specifying the location. Based on the manufacturer's location (Taiwan), it is likely conducted there or by an internationally recognized testing body.
  • Retrospective or Prospective: These are laboratory performance tests performed on the device model, not a retrospective or prospective study on users.

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

Not applicable. This is not a study involving expert assessment of images or clinical outcomes where a "ground truth" is established by human experts. The "ground truth" for these tests is defined by the objective measurement criteria and methodologies specified in the respective ISO and ANSI/RESNA standards. For example, static stability is measured by specific angles and forces, not by expert opinion.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described because there are no human-based assessments requiring reconciliation of opinions. The tests are objective measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a 510(k) for a physical medical device (mobility scooter), not an AI/CAD (Computer-Aided Diagnosis) software. Therefore, no MRMC study or AI assistance is relevant.

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

Not applicable. This device is not an algorithm or software requiring standalone performance testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is defined by the objective and measurable criteria set forth in the international consensus standards (ISO 7176 series, ANSI/RESNA WC-2, ISO 10993 series, etc.). For instance:

• Static Stability: Ground truth is specific angles (e.g., 6 degrees incline) at which the device must remain stable.
• Maximum Speed: Ground truth is the measurement of the device's actual maximum speed.
• Biocompatibility: Ground truth is the results of specific chemical and biological tests (e.g., cytotoxicity, irritation) as per ISO 10993.

These are objective, quantitative measurements, not subjective expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train machine learning models. This document is about a physical device and its performance testing against engineering standards, not AI.

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

Not applicable, for the same reason as point 8.

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

BRIO S19 power scooter is battery powered and configured with four solid wheels, a seat, a turning tiller column, a upper panel control, a main frame, a cross bar and an anti-tipper. BRIO S19 power scooter is operated by two rear wheels as the drive wheels and two front wheel as the steering wheel, using the upper panel control to control the turning tiller column mechanism to control the front wheel as the power scooter steering direction mechanism. Upper panel control is able to control driving forward, driving backward, speed control. The main frame is equipped with a rear bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. BRIO S19 power scooter maximum weight capacity is 220 lbs (100 kg), and BRIO S19 power scooter maximum speed is 5 mile/hr (8 km/hr).

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

Device: Heartway Power Mobility Scooter, BRIO S19
Predicate Device: Heartway Lightweight Power Mobility Scooter S34

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" as a separate, distinct list with numerical targets that the new device must meet independently for all parameters. Instead, the approach taken is a demonstration of substantial equivalence to a predicate device. The performance testing section lists the standards to which the device was tested, and the comparison tables highlight similarities and differences between the subject device (BRIO S19) and the predicate device (S34). The "acceptance criteria" are implied by the successful completion of these standards and the determination that any differences do not raise new questions of safety or effectiveness.

Therefore, the table below will combine the performance testing standards (which serve as the basis for acceptance) with the device characteristics and the conclusions drawn during the comparison.

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

This document describes premarket notification (510(k)) for a medical device. It relies heavily on performance testing conducted according to recognized international standards (ISO and ANSI/RESNA), along with a comparison to a predicate device.

• Sample Size: The document does not specify the number of individual units (scooters) subjected to these performance tests. Typically, in compliance testing for medical devices, a representative sample (often one or a few units) is tested to demonstrate adherence to the standard's requirements, as the standards themselves dictate the testing procedures. It's not a study involving a large "test set" of patient data in the way an AI algorithm might be evaluated.
• Data Provenance: The tests are performed by the manufacturer or accredited testing laboratories against international standards. The provenance is the manufacturer (Heartway Medical Products Co., Ltd., Taiwan) and the test reports generated by these compliance tests. This is a prospective assessment in the sense that the device was manufactured and then tested for compliance, rather than analyzing pre-existing patient data.

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

This type of device submission (510(k) for a physical product like a mobility scooter, relying on engineering performance standards) does not typically involve "experts establishing ground truth for a test set" in the way an AI/software medical device does for clinical data. The "ground truth" here is adherence to the recognized engineering and safety standards (e.g., whether the brake effectively stops the scooter, whether the frame can withstand certain forces). This "ground truth" is established by the standard's specifications and the objective measurements of testing laboratories, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth for diagnostic AI, where there are subjective interpretations involved. The performance testing for this scooter involves objective measurements against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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 (mobility scooter), not an AI/software device that assists human readers/clinicians.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" is defined by the requirements and methodologies specified in the international performance standards (ISO 7176 series, ANSI/RESNA WC-2, CISPR, IEC). For example, the ground truth for "static stability" is defined by the test procedures and quantitative acceptance criteria within ISO 7176-1. The ground truth for "biocompatibility" is defined by the pass/fail criteria of the specified ISO 10993 tests.

8. The Sample Size for the Training Set

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

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

Not applicable.

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

The HEARTWAY Power Mobility Scooter. S15 is an indoor / outdoor powered scooter that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the powered 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 external battery recharger.

The provided documents describe a 510(k) premarket notification for the HEARTWAY Power Mobility Scooter, S15. This is a submission for substantial equivalence to a predicate device, not a study performing a clinical trial to establish acceptance criteria for a new medical device technology. As such, the information typically requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, types of ground truth for a clinical study) are not present in these documents.

Instead, the documents demonstrate substantial equivalence by comparing the proposed device (S15) to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, S12, K092650) based on performance testing to recognized standards and direct comparison of specifications.

Here's a breakdown of the relevant information from the provided text:

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

The document doesn't present explicit "acceptance criteria" in the sense of predefined thresholds for a study. Instead, it relies on demonstrating compliance with recognized performance standards and direct specification comparison to a predicate device. The performance is "reported" through the completion of tests against these standards and the assertion of "same" or minor, justifiable differences in specifications.

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

• Sample Size for Test Set: Not applicable. This is a device comparison based on compliance with standards and specifications, not a clinical trial with a "test set" of patients or data. The testing mentioned refers to performance testing on the physical device itself.
• Data Provenance: The documents do not specify the provenance (e.g., country of origin, retrospective/prospective) of any clinical data because none appears to have been collected for this 510(k) submission. The performance testing was conducted according to international standards (ISO, ANSI/RESNA, CISPR, EN, IEC).

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

• Number of Experts/Qualifications: Not applicable. Ground truth for clinical data is not a concept applied in this 510(k) submission for a power mobility scooter. The "ground truth" here is compliance with engineering and safety standards.

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

• Adjudication Method: Not applicable. This refers to consensus among human readers in a clinical study, which is not relevant to this submission.

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:

• MRMC Study/Effect Size: No. This type of study is relevant to AI-powered diagnostics or image analysis, not a power mobility scooter.

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

• Standalone Performance: No. This is not an AI/algorithm-based device.

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

• Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is established by adherence to international and national standards for medical devices and wheelchairs, such as the ISO 7176 series ("Wheelchairs") and ANSI/RESNA WC/Vol.2: 2009 (Electrically powered wheelchairs, scooters), as well as certifications for components (TUV, UL). These standards define performance requirements and test methods.

8. The sample size for the training set:

• Sample Size for 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:

• Ground Truth for Training Set: Not applicable.

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

The HEARTWAY Power Mobility Scooter. S11 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat. armrests. and a front basket. 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 documents describe a 510(k) premarket notification for the HEARTWAY Power Mobility Scooter, S11. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics in the way a novel medical device might.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details for an AI-powered device is largely not applicable to this 510(k) submission.

However, I can extract the relevant performance testing and equivalence information that is present:

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

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

• Not explicitly stated in terms of a "test set" for performance evaluation of a new algorithm. The performance testing refers to compliance with established international standards for wheelchairs, scooters, and their chargers. These are typically engineering and safety tests performed on representative units of the device.
• Data Provenance: The manufacturing company is HEARTWAY Medical Products Co., Ltd. in Taichung, Taiwan, R.O.C. The certifications are to international standards (ANSI / RESNA, CISPR, EN, IEC, UL).

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 submission does not involve expert-established ground truth for a diagnostic or AI-driven device. Compliance with engineering and safety standards is assessed through physical testing methods, not expert review of data.

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

• Not applicable. See point 3.

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 (mobility scooter), not an AI-assisted diagnostic or therapeutic tool.

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

• Not applicable. See point 5.

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

• Not applicable in the typical sense of "ground truth" for clinical data. The "ground truth" for this device's performance is adherence to established engineering, safety, and electrical standards as measured through predefined test protocols (e.g., strength tests, electrical compatibility tests, flammability tests).

8. The sample size for the training set

• Not applicable. This submission does not involve machine learning or a "training set."

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

• Not applicable. See point 8.

Summary of the Study (510(k) Submission for Substantial Equivalence):

The "study" described in these documents is essentially a demonstration of substantial equivalence for the HEARTWAY Power Mobility Scooter, S11, to a legally marketed predicate device, the HEARTWAY Power Mobility Scooter, PF6 (K072104).

The core of the submission focuses on demonstrating that all critical safety and performance aspects of the new device are either identical to the predicate device or meet relevant recognized consensus standards.

Key arguments for substantial equivalence include:

• Identical Intended Use: Both devices provide mobility to persons restricted to a seated position.
• Similar Materials: Mainframe materials are fixed and meet strength and fatigue tests; back upholstery uses the same fabric and passed ignition resistance.
• Similar Components/Design: Suspension, cross brace, footplates, incline degree, and armrest type are all the same.
• Identical & Certified Electronic Systems: The electronic systems (controller, batteries, switches, power supplies) are from the same suppliers and are UL certified, ensuring the same safety level.
• Compliance with Standards: The device underwent performance testing against EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, and IEC61000-3-3: 1995.

The differences noted (overall appearance, weight capabilities, maximum speed, and total weight) are argued not to affect the safety and effectiveness, and thus the devices are considered substantially equivalent. The new device also has an additional "free-wheel" manual feature, which is presented as an advantage rather than a safety concern.

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

The HEARTWAY Power Mobility Scooter, S12 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. 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 document is a 510(k) premarket notification for a medical device: the HEARTWAY Power Mobility Scooter, S12. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way typically associated with AI/ML-based medical devices or novel therapies.

Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not applicable to this document as it pertains to a mechanical mobility device and its comparison to an existing scooter.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative table format with corresponding performance results. Instead, it describes performance testing and then justifies "substantial equivalence" based on various device characteristics and safety standards. The "performance" in this context relates to meeting safety and functional standards, rather than clinical efficacy metrics.

The study proving the device meets the acceptance criteria is detailed in the "Performance Testing" and "Summary for substantial equivalence comparison" sections. The key aspects are:

1. Nature of the "Study": This is not a clinical study but rather an engineering and regulatory comparison against a predicate device and relevant industry standards.
2. Comparison to Predicate Device: The HEARTWAY Power Mobility Scooter, S12 (new device) was compared to the HEARTWAY Power Mobility Scooter, PT7 (K073044) (predicate device).

Specific Information Requests:

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

   • N/A. This is a physical device, and the "testing" refers to meeting engineering standards and direct comparison of specifications and components between the new device and the predicate device. There is no "test set" of clinical data. Data provenance would refer to the location of manufacturing and testing, which is Taichung, Taiwan, ROC.

2. 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):

   • N/A. "Ground truth" in the context of clinical expert consensus is not relevant here. The "ground truth" is established by adherence to recognized engineering standards (e.g., ANSI/RESNA, CISPR, EN, IEC) and the specifications of the predicate device. Expertise would be in engineering and regulatory compliance.

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

   • N/A. No adjudication method for clinical data is described or applicable. The "adjudication" is essentially the manufacturer demonstrating compliance to FDA regulators.

4. 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 device is a power mobility scooter, not an AI/ML diagnostic or assistive device for human readers.

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

   • N/A. This is a mechanical device, not an algorithm. Considerations of human-in-the-loop performance are related to the user operating the scooter safely and effectively, which is addressed by design and user manual instructions, not algorithmic performance.

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

   • Engineering Standards and Predicate Device Specifications: The "ground truth" used for demonstrating safety and effectiveness relies on established engineering and safety standards (e.g., EMC, strength, fatigue, ignition resistance, UL certifications) and the proven safety and performance characteristics of the legally marketed predicate device (HEARTWAY Power Mobility Scooter, PT7).

7. The sample size for the training set:

   • N/A. This is not an AI/ML device with a training set. The "training" for the device would be its design and manufacturing process, optimized through engineering iterations, but not in the sense of an algorithmic training set.

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

   • N/A. As above, no algorithmic training set is involved.

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

The HEARTWAY Power Mobility Scooter, S9 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. 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.

This appears to be a 510(k) premarket notification for a medical device, specifically a power mobility scooter. The document describes a comparison to a predicate device to establish substantial equivalence, rather than a study with a defined set of acceptance criteria for a novel device's performance.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.

This document focuses on demonstrating that the new device (HEARTWAY Power Mobility Scooter, S9) is substantially equivalent to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, PF6 (K072104)).

Here's an breakdown of the relevant information provided in the document:

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

This document does not provide a table of acceptance criteria and reported device performance in the way a clinical trial or performance study report for a novel medical algorithm might. Instead, it compares the new device to a predicate device on various design and performance aspects to establish substantial equivalence.

The document states:

• "According to the above table that the intended use between the two devices is the same."
• "Mainframes materials of the two devices are fixed, and all meet the strength and fatigue tests and they use the same material aspects."
• "Moreover, the weight limit, maximum speed, cruising range, suspension of cross brace, footplates, and armrest type are all the same."
• "The back upholstery material is also the same fabric and passed the resistance ignition test."
• "Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, battery charge, and the competent switches and switching power supplies."
• "The maximum slope for the two devices is difference. This means the new device is 12°, the predicate device is 10°." (This is a difference, not an 'acceptance criterion' being met, but the document argues it's still substantially equivalent, stating "For the real life use, the two devices are substantially equivalent.")
• "The main differences for the two devices are overall appearance, wheels size, weights, and the warranty are difference between the two devices. The safety levels of the two devices are the same and the overall appearance differences are not safety aspect."

Summary Table (based on substantial equivalence comparison, not specific acceptance criteria):

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

• Sample Size: Not applicable. This is not a study involving a test set of data like an AI/ML algorithm. It's a comparison of device specifications.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth for a test set is not relevant here as this is a device specification comparison.

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. This is not an AI/ML device requiring an MRMC study.

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

• Not applicable.

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

• Not applicable in the context of "ground truth" for a dataset. The "truth" here is the documented specifications and performance of the predicate device (K072104) and the measured specifications and performance of the new device (S9), which are then compared.

8. The sample size for the training set:

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

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

• Not applicable.

In summary: This document is a 510(k) submission focused on demonstrating substantial equivalence between a new power mobility scooter and a previously cleared predicate device based on design, materials, components, and performance specifications. It is not a performance study for an AI/ML device that would include acceptance criteria, test/training sets, or expert ground truth as typically defined for such a submission.

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

The HEARTWAY Power Mobility Scooter, S8 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. 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 is a 510(k) summary for the HEARTWAY Power Mobility Scooter, S8. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way a medical AI/software device submission would.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (HEARTWAY Power Mobility Scooter, PT7 (K073044)) rather than proving performance against predefined clinical or analytical acceptance criteria with a dedicated study.

Based on the provided text, I cannot complete most of your requested information as it is not present in this type of submission. The content provided is typical for a medical device (hardware) 510(k) submission, not a medical AI/software device.

Here's an analysis of what can be extracted and what is missing:

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

The document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity for a diagnostic device, or a specific functional outcome for a therapeutic device). Instead, it relies on demonstrating that the new device (S8) is similar enough to a predicate device (PT7) by having comparable characteristics and meeting certain general safety standards.

The performance testing section mentions:

• EMC Report ANSI / RESNA WC/Vol.2-1998
• CISPR 11: 1990
• EN61000-3-2: 1995
• IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)

These are standards that the device meets, not acceptance criteria in the sense of a clinical benchmark. The "reported device performance" is essentially that it complies with these standards and is comparable to the predicate device in terms of:

• Intended use
• Mainframe materials (strength and fatigue)
• Maximum speed
• Suspension of cross brace
• Footplates
• Armrest type
• Overall dimensions
• Back upholstery material (passed resistance ignition test)
• Electronic systems (same suppliers, UL certificated - electronic controller, batteries, recharger, switches, switching power supplies), assuring the "same safety level."

Differences noted (weight capabilities, maximum slope, weights, cruising range, warranty) are deemed "not safety aspect" and do not prevent 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 not a study involving a test set of data samples for an algorithm. It's a submission for a physical medical device.

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's no ground truth establishment in the context of an AI/software device.

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. This is not an AI-assisted device.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary:

The provided document is a 510(k) submission for a physical power mobility scooter. Its purpose is to demonstrate that the new device, HEARTWAY Power Mobility Scooter, S8, is "substantially equivalent" to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, PT7). This type of submission relies on comparing specifications, materials, and compliance with general safety and performance standards (like EMC and RESNA) rather than clinical studies with explicit acceptance criteria for algorithmic performance, ground truth, or human reader effectiveness, as would be expected for an AI/software as a medical device (SaMD).

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

The HEARTWAY Power Mobility Scooter, PF7 is an indoor / outdoor clectric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. 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 document (K080242) is a 510(k) premarket notification for a medical device, specifically the HEARTWAY Power Mobility Scooter, PF7. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with strict acceptance criteria and clinical endpoints for standalone device performance.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as typically associated with performance studies for novel AI/medical imaging devices, is not present in this document.

Instead, the document details the comparison to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, PT6 - K073044) to establish substantial equivalence. The "performance testing" mentioned is related to safety standards (EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown of what is available in the document, framed against your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the "acceptance criteria" for substantial equivalence are met when the new device (PF7) demonstrates that its intended use, materials, safety aspects (like electronic systems meeting UL certification), and key physical/performance characteristics (e.g., maximum speed, range per charge) are equivalent to the predicate device (PT6), and that differences (like the number of wheels) do not raise new questions of safety or effectiveness.
• Reported Device Performance:

  Aspect	Predicate Device (PT6)	New Device (PF7)	Substantial Equivalence Claim
  Intended Use	Same	Same	Same
  Mainframes materials	Fixed, strength/fatigue tests met	Fixed, strength/fatigue tests met	Same
  Maximum Speed	Same	Same	Same
  Suspension of cross brace	Same	Same	Same
  Footplates	Same	Same	Same
  Armrest type	Same	Same	Same
  Warranty	Same	Same	Same
  Overall dimensions	Same	Same	Same
  Back upholstery material	Same fabric, passed ignition test	Same fabric, passed ignition test	Same
  Electronic Controller	Same supplier, UL certified	Same supplier, UL certified	Same
  Batteries	Same supplier, UL certified	Same supplier, UL certified	Same
  Recharger	Same supplier, UL certified	Same supplier, UL certified	Same
  Range per charge	32 miles	32 miles	Same
  Number of Wheels	Three	Four	Different, but not a safety aspect
  Overall Weight	Not explicitly stated	Different (due to wheels), but not a safety aspect	Differences not safety-critical
  Performance Testing (Safety)	(Implied) EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3	EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3	All passed

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

• Not applicable. This submission relies on comparisons of device specifications and adherence to safety standards, not a clinical "test set" of patient 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 in the context of clinical endpoints or diagnostic accuracy is not addressed. The "ground truth" here is adherence to engineering and safety standards, and equivalence to a legally marketed device.

4. Adjudication method for the test set

• Not applicable. There is no "test set" in the clinical or diagnostic sense described here. The evaluation relies on engineering tests and comparison by the manufacturer and subsequently reviewed by the FDA.

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 motorized scooter, not an AI-powered diagnostic or imaging device. There are no "human readers" or AI assistance involved.

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

• Not applicable. This device is a mechanical/electrical product, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this submission is regulatory compliance and engineering specifications. It includes:
  • Predicate Device Specifications: The established characteristics and performance of the legally marketed HEARTWAY Power Mobility Scooter, PT6 (K073044).
  • Industry Standards: Adherence to standards like ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods).
  • Component Certifications: For example, UL certification for electronic systems (controller, batteries, recharger).
  • Material Testing: Strength and fatigue tests for mainframes, resistance ignition test for upholstery.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, no training set. The "ground truth" for demonstrating substantial equivalence is based on established engineering and safety standards and the characteristics of the predicate device.

Ask a specific question about this device

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

The HEARTWAY Power Mobility Scooter, PF7 is an indoor / outdoor electric scooter that is battery operated. It has a base with three-wheeled with a seat, armrests, and a front basket. 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) submission for the HEARTWAY Power Mobility Scooter, PF7. This is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a novel AI/software medical device would.

Therefore, many of the requested elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable to this type of device and submission. The document primarily details performance testing related to safety and engineering standards, and comparison to an existing device to establish equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like power mobility scooters, acceptance criteria are typically met through compliance with recognized standards for safety, performance, and electrical compatibility. The "reported device performance" is framed as meeting these standards and demonstrating equivalence to a predicate device in key functional areas.

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

• Test Set Sample Size: Not applicable in the context of clinical or AI performance. The "test set" here refers to the physical device undergoing engineering and safety tests. It's typically one device or a representative sample for these types of compliance tests.
• Data Provenance: The testing was conducted by or for HEARTWAY Medical Products Co., Ltd. in Taiwan, R.O.C. The reports (e.g., EMC Report) would be generated from this physical testing. This is a design validation/verification process, not a clinical data collection.

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

• Not applicable. The "ground truth" for a power mobility scooter's performance is objective measurements against established engineering and safety standards, not expert consensus on medical images or clinical outcomes. Certification bodies (like UL, those associated with ISO/IEC/EN standards) provide the "ground truth" by defining the tests and acceptable limits.

4. Adjudication Method for the Test Set

• Not applicable. Performance against engineering standards is typically binary (pass/fail) based on objective measurements, not a consensus or adjudication process.

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 power mobility scooter, not an AI or diagnostic imaging device.

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

• Not applicable. This device is electro-mechanical, not an algorithm.

7. The Type of Ground Truth Used

• Engineering and Safety Standards: The "ground truth" is defined by internationally recognized engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, UL certifications). Compliance with these standards serves as the ground truth for safety and basic performance.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As there's no training set, there's no ground truth to be established for it.

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