(161 days)
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.
| Feature/Test | Acceptance Criteria (Implied by Standards Met/Predicate Equivalence) | Reported Device Performance (BRIO S19) |
|---|---|---|
| Intended Use | To provide mobility to persons restricted to a sitting position (same as predicate). | Intended for medical purposes to provide mobility to persons restricted to a sitting position. |
| Weight Limit | 220 lbs (100 kg) (same as predicate). | 220 lbs (100 kg). |
| Electronic Controller | Penny & Giles S-Drive (same as predicate). | Penny & Giles S-Drive. |
| Motor Type | 3A 24V, 270W @1 (same as predicate). | 3A 24V, 270W @1. |
| Battery Quantity/Type | Two, 12Ah / 12VDC (same as predicate). | Two, 12Ah / 12VDC. |
| Biocompatibility | Compliance with ISO 10993-1, -5 (predicate's standard) and ideally ISO 10993-10 (enhanced safety for subject device). | Patient contacting materials (Seat PVC, Hand grip PVC, Seat belt PVC) tested to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. FDA Form 3654 provided. |
| EMC (Electromagnetic Compatibility) | Compliance with ANSI / RESNA WC-2:2009 (Section 21) and relevant CISPR/IEC standards. | Passed EMC Test: ANSI / RESNA WC-2:2009 (Section 21), CISPR 11:2009, IEC61000-4-2: 2008, IEC61000-4-3: 2006+A1:2008+A2:2010, IEC61000-4-4:2004, IEC61000-4-5:2005, IEC61000-4-6:2008, IEC61000-4-8:2009, IEC61000-4-11:2004, and ISO 7176-21:2009. |
| Static Stability | Compliance with ISO 7176-1. | Passed ISO 7176-1:1999. (Specifically mentioned that safety on maximum inclined slopes was ensured.) |
| Dynamic Stability | Compliance with ISO 7176-2. | Passed ISO 7176-2:2001. (Specifically mentioned that safety on maximum inclined slopes was ensured.) |
| Braking Effectiveness | Compliance with ISO 7176-3. | Passed ISO 7176-3:2012. |
| Energy Consumption/Range | Compliance with ISO 7176-4, demonstrating practical range. | Passed ISO 7176-4:2008. Reported range: 18 km / 11.25 miles (longer than predicate's 10-15 km). |
| Dimensions/Maneuvering Space | Compliance with ISO 7176-5, ensuring appropriate physical characteristics. | Passed ISO 7176-5:2008. Overall dimensions: 930 mm L / 485 mm W / 945 mm H (smaller than predicate); Turning Radius: 820 mm (smaller than predicate). |
| Maximum Speed/Acceleration/Deceleration | Compliance with ISO 7176-6. | Passed ISO 7176-6:2001. Reported max speed: 8.0 km/hr (5.0 mile/hr) (larger than predicate's 7.8 km/hr). |
| Seating Dimensions | Compliance with ISO 7176-7. | Passed ISO 7176-7:1998. Seat dimensions: 395 mm W / 350 mm H (smaller than predicate). |
| Static, Impact, Fatigue Strength | Compliance with ISO 7176-8 (for manual wheelchairs, but applied to frame material). | Passed ISO 7176-8:1998 (implied for frame materials: aluminum alloy for subject, carbon steel for predicate; both passed strength and fatigue tests). |
| Climatic Tests | Compliance with ISO 7176-9. | Passed ISO 7176-9:2009. |
| Obstacle-Climbing Ability | Compliance with ISO 7176-10. | Passed ISO 7176-10:2008. Curb climbing ability: 45 mm / 1.7" (smaller than predicate's 50 mm). Note: The recommended "avoid going up multiple steps" and "too steep incline over 6 degrees" are operational limitations rather than acceptance criteria. |
| Test Dummies | Compliance with ISO 7176-11 (related to testing methodology). | Passed ISO 7176-11:2012. |
| Coefficient of Friction of Test Surfaces | Compliance with ISO 7176-13 (related to testing methodology). | Passed ISO 7176-13:1989. |
| Power and Control System | Compliance with ISO 7176-14. | Passed ISO 7176-14:2008. Electronic systems are the same as predicate and passed UL certifications. |
| Information Disclosure, Documentation, Labeling | Compliance with ISO 7176-15. | Passed ISO 7176-15:1996. |
| Resistance to Ignition of Upholstered Parts | Compliance with ISO 7176-16. | Passed ISO 7176-16:2012 (Back upholstery fabric). |
| Incline Capacity | Demonstrates safe operation on stated incline capacity as per ISO standards. | 6 degrees (smaller than predicate's 10 degrees). Safety on the maximum inclined slope ensured by ISO 7176-1 and ISO 7176-2 tests. |
| Charger Safety | UL certification. | External (off-board) charger (4C24050A) with 24VDC output. Passed UL certification (UL E201162), similar to predicate's UL E241359. |
| Frame Material Strength | Strength and fatigue tests equivalent to predicate's carbon steel frame. | Aluminum alloy frame. Passed strength and fatigue tests (implied by the discussion stating "both carbon steel and aluminum alloy materials all passed the strength and fatigue tests"). |
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.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).