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

The Auto Folding Scooter S21F is designed for indoor use for adults with mobility restrictions. It is classified as Class II medical device per US FDA 21 CFR 890.3800. It is compact, maneuverable and not necessarily able to overcome obstacles. The maximum load is 115 kg. The product is not intended for visually impaired people. The drivers need to be mentally and physically suitable to drive the scooters. The fingers need to work functionally. The driving distance will be reduced if the scooter is used frequently on slopes, rough ground or climbing curb. The scooter is not for use as a seat in motor vehicle. Auto Folding Scooter S21F is battery powered and configured with four solid wheels (03) (08), a seat (04), a handle bar to control the driving function (01), a cross bar (05), a main frame (06), a foot-rest (02), a back-rest (04), a set of 2 anti-tippers (09), referred to the components and parts diagrams of S21F below. S21F is driven by two solid rear wheels (08) as the drive wheel, two solid front castors (03) as the steering wheel, using the steering handles (01) to control the front frame assembly (02) to control the front wheels (03) as the power scooter steering direction mechanism. Steering handles (01) is able to control driving forward, driving backward, speed control. The main frame (06) is equipped with a rear bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. The maximum loading weight of S21F is 253 lbs. (115 kg), and its maximum speed is 3.75 mph (6 km/h). The dimensions of (Length * Width *Height) of the unfolded device are 33.0" x 18.1" x 30.3" (840 mm x 460 mm x 770 mm) and 28.7" x 17.3" x 16.5" (730 mm * 420 mm * 420 mm) for the folded device. The weight of the device is 51.8 lbs. (23.5 kg) with battery and 46.9 lbs. (21.3 kg) without battery. Seat belt is a standard accessory to S21F power scooter, and is not a 510(k)-clearance accessory. It can be installed onto the seat (as seen in the diagram below) by consulting with the local authorized dealer for seat belt installation.

This document describes the premarket notification for the "Auto Folding Scooter, S21F" and does not contain information about an AI/ML medical device. Therefore, a study proving a device meets acceptance criteria for such a device is not applicable. The information provided heavily focuses on the safety and performance of a physical medical device (a motorized scooter) as compared to a predicate device, based on engineering standards and physical testing, rather than a clinical study of an AI algorithm.

However, I can extract information related to product acceptance and testing mentioned for this physical device:

1. Table of acceptance criteria and reported device performance:

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

This document describes the testing of a physical medical device (a scooter), not an AI/ML algorithm. The "test set" here refers to the device itself being tested against engineering standards. The data provenance is from Taiwan, where the manufacturer (Heartway Medical Products Co., Ltd.) is located and where testing laboratories (e.g., Super Laboratory Co., Ltd., SGS Taiwan Ltd.) are likely based. The testing appears to be prospective as it's part of a premarket notification for a new device.

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

This is not applicable to the type of device and testing described. The "ground truth" for a physical device like a scooter is established by internationally recognized engineering and safety standards (e.g., ISO, RESNA, ANSI/AAMI), not by human experts creating a labeled dataset like for an AI algorithm. Compliance is determined by objective measurements and standardized test procedures in accredited laboratories.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like "2+1, 3+1" are used for resolving discrepancies in human expert labeling for AI/ML development. For a physical device, testing involves standardized procedures and measurements.

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 medical device.

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

Not applicable. This is not an AI/ML medical device.

7. The type of ground truth used:

The ground truth used for this physical device is compliance with established engineering and safety standards (e.g., ISO 7176 series, RESNA WC-2 series, ANSI/AAMI ES60601-1, ISO 10993 series for biocompatibility). Test results (e.g., "Passed") confirm the device meets these pre-defined, objective criteria.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML algorithm 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 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 sitting position.

The HEARTWAY Electrically Powered Wheelchair, Model P27 is battery powered and configured with 2 PU solid front castors and 2 pneumatic rear drive wheels, a width adjustable seat, a controller to control the lighting function and driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, a seat cushion, a pair of skirts, a set of anti-tippers.

P27 powered wheelchair is rear-wheel driven and operated by two pneumatic rear wheels as the drive wheels, two solid front wheels as the front casters and uses upper joystick to control the driving direction, driving speed, and lighting function. Main frame carries a width adjustable seat system and a set of anti-tipper to prevent a patient from tipping their wheelchairs backward. Main frame is equipped with the front & rear independent suspensions to enhance the stability. A width-adjustable seat system carries a set of back rest system, a seat cushion, a pair of arm-rest, a pair of foot-rest, and a pair of skirts to provide seat posture positioning functions. P27 power wheelchair maximum weight capacity is 265 lbs (120kg). Maximum speed is 3.75 mph (6 kph). The device can be disassembled for transport and is provided with an external battery charger.

This document describes a 510(k) premarket notification for the HEARTWAY Electrically Powered Wheelchair P27. The information provided focuses on demonstrating substantial equivalence to a predicate device (HEARTWAY Power Tilt Seating System Power Chair, P16RT) rather than presenting a study to prove a device meets specific acceptance criteria for diagnostic performance or treatment efficacy.

Therefore, many of the requested categories for acceptance criteria and study details (such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information) are not applicable to this type of regulatory submission. The "acceptance criteria" here are essentially the performance standards met to ensure safety and effectiveness in comparison to the predicate device.

Here's the breakdown of the available information:

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

The "acceptance criteria" in this context are the international standards (ISO 7176 series and ANSI/RESNA WC 2, Section 21 for EMC) that the device must pass to demonstrate safety and effectiveness. The reported device performance is that the subject device completed these performance tests. The document doesn't provide specific numerical results or thresholds for each test, but rather states that the device "function[s] safely and effectively" after completing them.

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

• Sample size: Not specified. This type of submission generally involves testing a single or a small number of devices against the listed standards. It is not a clinical study with a patient test set.
• Data provenance: The document indicates the manufacturer is HEARTWAY Medical Products Co., Ltd. located in Taichung City, Taiwan. The testing was conducted against international standards (ISO, ANSI/RESNA).

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 a performance testing submission against engineering and safety standards, not a clinical study requiring expert ground truth for diagnostic accuracy.

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

• Not applicable. No clinical adjudication process is described. The tests are defined by the referenced standards.

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/software device and no MRMC study was performed.

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

• Not applicable. This is a physical medical device (powered wheelchair), not an algorithm or AI.

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

• Not applicable. The "ground truth" for this device's performance is adherence to the specified international safety and performance standards (ISO 7176 series and ANSI/RESNA WC 2, Section 21).

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.

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

The HEARTWAY Electrically Powered Wheelchair, Model P19 is battery powered and configured with four solid wheels, a seat, a controller to control the driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, and a set of anti-tippers. Main frame carries a width foldable seat system and a set of rear anti-tipper to prevent a patient from tipping their wheelchairs backward. P19 maximum weight capacity is 250 lbs (113kg). Maximum speed is 3.75 mph (6 km per hour). The device can be folded for transport and is provided with an external battery charger.

This document is a 510(k) premarket notification for the HEARTWAY Electrically Powered Wheelchair, Model P19. It focuses on demonstrating substantial equivalence to a predicate device, not on proving general acceptance criteria for a novel device through a standalone study. Therefore, several aspects of your request (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, how ground truth was established) are not directly applicable or available in this type of submission.

However, I can extract the acceptance criteria (standards applied) and the reported device performance in relation to those standards from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: This document does not specify a "test set" in the context of a statistical study with a specific number of units. The testing refers to conformity with established international and national standards (ISO, ANSI/RESNA, CISPR, IEC) for medical devices like powered wheelchairs. Typically, such testing involves a limited number of physical units (prototypes or production samples) of the device being evaluated, not a large "test set" of data samples. The exact number of units tested is not provided.
• Data Provenance: The tests were performed according to international standards for wheelchair performance and safety. The location where these tests were conducted is not explicitly stated, but the manufacturer is based in Taiwan, R.O.C., so it is likely undertaken by a certified lab either in Taiwan or abroad. The nature of these tests is prospective (evaluation of the device itself) rather than retrospective data analysis.

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

• This information is not applicable to this type of submission. "Ground truth" in this context is established by the well-defined and quantitative metrics and methodologies specified within the cited international engineering and safety standards (e.g., ISO 7176 series). Expertise is embedded in the standards themselves and the accreditation of the testing facility, rather than a panel of clinical experts establishing ground truth for individual cases.

4. Adjudication method for the test set

• Not applicable. Performance against engineering and safety standards is typically determined by objective measurements and pass/fail criteria defined within the standards, not through adjudication by multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging AI devices, where human readers (e.g., radiologists) interpret images with and without AI assistance. The HEARTWAY Electrically Powered Wheelchair is a physical medical device for mobility, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

• Not applicable. The device is a physical powered wheelchair, not an algorithm. Its performance is evaluated through physical and electrical testing against established standards, not as a standalone algorithm.

7. The type of ground truth used

• The "ground truth" for the device's performance is defined by adherence to the objective, measurable parameters and criteria set forth in the international engineering, safety, and electromagnetic compatibility standards (e.g., ISO 7176 series, ANSI/RESNA WC/Vol.2, CISPR, IEC for EMC, ISO 10993 for biocompatibility, UL for chargers). These standards represent an industry consensus on acceptable performance and safety for such devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device. There is no 'training set' in the context of algorithm development.

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

• Not applicable, as there is no training set mentioned in this context.

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

The HEARTWAY Power Wheelchair, P25 is an indoor / outdoor power chair that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the power chair 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 charger.

The HEARTWAY Power Wheelchair, P25 (K132856) is a powered wheelchair intended to provide mobility to persons restricted to a seated position. The device's performance was evaluated against a series of ISO 7176 standards related to wheelchairs and other relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for performance testing of the device itself (P25). It does mention various ISO and other standards that the device complies with, implying that testing was conducted according to the methodologies defined by these standards. The data provenance is Taiwan, R.O.C., where the manufacturer is located. The nature of these tests (e.g., laboratory simulations, physical trials) is characteristic of prospective performance evaluations during product development and regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information (number and qualifications of experts) is not typically detailed for performance testing of a medical device like a powered wheelchair, as the ground truth is established by objective measurements and adherence to engineering standards. The compliance with ISO and other recognized standards serves as the basis for "ground truth" concerning the device's physical and electrical performance.

4. Adjudication Method for the Test Set:
Not applicable for this type of performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where subjective interpretation is involved. For this device, compliance is determined by objective measurements against established standard criteria.

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 diagnostic or interpretive device, but rather a mobility device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, and its performance is evaluated through standardized physical and electrical tests.

7. The Type of Ground Truth Used:
The ground truth is established by adherence to internationally recognized engineering and safety standards (e.g., ISO 7176 series, CISPR, EN, IEC, ANSI/RESNA WC/Vol.2) and UL certifications. These standards define objective performance criteria and test methods for powered wheelchairs.

8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI-driven device that requires a training set.

9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason as above.

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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 Lightweight Power Mobility Scooter, S34 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 does not contain information about acceptance criteria for a device's performance that would typically be described in a study, such as diagnostic accuracy metrics (sensitivity, specificity, AUC). Instead, it describes a medical device called the "HEARTWAY Lightweight Power Mobility Scooter, S34" and its substantial equivalence to a predicate device.

The "Performance Testing" section refers to compliance with established safety and engineering standards for electrically powered wheelchairs and scooters, rather than specific performance metrics for a diagnostic or AI device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This information is not present in the provided document.

The document primarily focuses on:

• Device Description: A lightweight electric mobility scooter.
• Intended Use: To provide mobility to persons restricted to a seated position.
• Substantial Equivalence: Comparison to a predicate device (HEARTWAY Lightweight Power Mobility Scooter, S33 (K071007)) based on materials, strength, fatigue, suspension, back upholstery, electronic systems (which passed UL certification), and safety levels.
• Differences noted: 4-wheels vs. 3-wheels, "free-wheel" manual feature, cruising range, overall appearance, weight capabilities, and maximum speed. These differences were deemed not to affect safety significantly.
• Performance Testing Mentioned:
  • 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 compliance standards, not performance metrics related to diagnostic accuracy or AI.

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