(652 days)
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
The proposed device, Electric wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The electric wheelchair consists of two foldable armrests, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.
The provided text is a 510(k) Premarket Notification for an Electric Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than describing acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/medical imaging device. As such, it does not contain the specific information required to answer the prompt comprehensively for an AI-based device.
However, I can extract information related to how this specific device (an electric wheelchair) demonstrates its safety and effectiveness, which serves a similar purpose to "acceptance criteria" and "proving it meets them." The "study" here is non-clinical testing against established engineering standards.
Here's an attempt to answer the prompt based on the provided document, acknowledging that it's for a physical device, not an AI:
Acceptance Criteria and Study for the Electric Wheelchair (Models: JRWD6010 and JRWD6012)
The "acceptance criteria" for this electric wheelchair are primarily defined by adherence to a comprehensive set of ISO standards specific to wheelchairs and related electrical and material safety. The "study" demonstrating the device meets these criteria is a series of non-clinical tests conducted against these standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document defines acceptance relative to a predicate device and extensive non-clinical testing against ISO standards. The table below summarizes key performance characteristics and their reported values, demonstrating compliance or acceptable differences compared to the predicate device and relevant standards. The "remark" column often serves as the "acceptance" or justification for differences.
| Acceptance Criteria (Defined by ISO Standard Compliance & Predicate Equivalence) | Reported Device Performance (JRWD6010 / JRWD6012) | Rationale/Compliance/Remark (Implicit Acceptance) |
|---|---|---|
| Static Stability (ISO 7176-1:2014) | Forward: 21.8° Rearward: 19° Sideways: 19.2° | Evaluated according to ISO 7176-1:2014. Differences from predicate (which is "Not publicly available" for specific values) are acceptable if standards are met. |
| Dynamic Stability (ISO 7176-2:2017) | Tested | Complies with ISO 7176-2:2017. |
| Brake Effectiveness (ISO 7176-3:2012) | Minimum braking distance: 1m (for both models) | Complies with ISO 7176-3:2012. |
| Energy Consumption/Range (ISO 7176-4:2008) | Cruising Range: 20 km (JRWD6012) | Larger cruising range due to less weight is not a safety concern. Complies with ISO 7176-4:2008. |
| Overall Dimensions, Mass & Maneuvering (ISO 7176-5:2008) | Dimensions: Varied (e.g., 38.1"x24.0"x37.0" for JRWD6010) Weight: Varied (e.g., 58.4 lbs for JRWD6010) Min. Turning radius: 1820mm (JRWD6010) / 833mm (JRWD6012) | Minor differences in dimensions/weight/turning radius do not impact safety and effectiveness. Complies with ISO 7176-5:2008. |
| Max Speed, Acceleration/Deceleration (ISO 7176-6:2018) | Max. Speed Forwards: 3.75 mph (6 km/h) Max. Speed Backward: 2.80 mph (4.5 km/h) (JRWD6010); 1.86 mph (3.0 km/h) (JRWD6012) | Differences in backward speed do not impact safety/effectiveness. Complies with ISO 7176-6:2018. |
| Obstacle-Climbing Ability (ISO 7176-10:2008) | JRWD6010: 1.97" (50mm) JRWD6012: 1.36" (34.5 mm) | Larger height in obstacle climbing (JRWD6010) will not impact safety/effectiveness. Complies with ISO 7176-10:2008. |
| Maximum Safe Operational Incline | JRWD6010: 10 degrees JRWD6012: 8 degrees | Larger safe operational incline (JRWD6010) offers more convenience. Complies with ISO 7176-2:2001 (presumably, as 7176-10 also relates to inclines). |
| Electromagnetic Compatibility (EMC) (ISO 7176-21:2009, IEC 60601-1-2:2015) | Tested | Complies with relevant EMC standards. |
| Biocompatibility of Patient-Contacting Parts (ISO 10993-1, -5, -10) | Materials like joystick knob (Santoprene 101-80), gaiter (Silicone), enclosure (ABS/PC), keypad (Silicone); Armrest (PU), Backrest/Seat (Oxford cloth). Tested for Cytotoxicity, Irritation/Skin Sensitization. | Materials are identical to a cleared predicate (K202482) or assessment carried out according to ISO standards. No new safety concerns. |
| Maximum Loading Capacity | JRWD6010: 220lbs (100kg) JRWD6012: 264lbs (120kg) | Predicate device "Less loading weight means more convenient for the transportation" - this appears to be a favorable difference for the subject device. |
| Flame Retardancy (ISO 7176-16:2012) | Tested for seat cushion/back cushion and armrest. | Assured to be under the same safety level as the predicate. |
| Software Validation | Performed for control systems. | No new safety and effectiveness concerns due to different controllers. |
Note: The document states "Not publicly available" for some predicate device values, and "Same" for others. Where specific numbers for the predicate are missing, the comparison is qualitative or based on standard compliance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of devices tested. It refers to extensive non-clinical tests conducted on the proposed device models (JRWD6010 and JRWD6012). For physical device testing against engineering standards, typically a representative number of units (often a small number, e.g., 1-3) are tested to demonstrate compliance of the design.
- Data Provenance: The testing was non-clinical (laboratory/benchtop) and conducted by the manufacturer, Jerry Medical Instrument (Shanghai) Co., Ltd. The document does not explicitly state the country of origin of the test data (beyond the manufacturer's location) or whether it was retrospective or prospective, but it implies a prospective testing approach conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as this document describes non-clinical testing of a physical medical device (electric wheelchair), not an AI/imaging device. The "ground truth" for a physical device is established through calibrated measurement instruments and adherence to internationally recognized engineering standards (ISO). There's no mention of experts in the context of "ground truth" for the performance metrics.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of human readers or subjective assessments requiring adjudication. The tests described are objective, quantitative measurements against predefined criteria in engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This is not applicable. No MRMC study was performed or is relevant for this type of device. The document explicitly states "No clinical study implemented for the electric wheelchair."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes a physical electric wheelchair, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the electric wheelchair's performance is based on:
- Adherence to international engineering standards (e.g., ISO 7176 series for wheelchairs, IEC 60601-1-2 for EMC, ISO 10993 for biocompatibility). These standards define test methods and acceptable performance limits.
- Comparison to a legally marketed predicate device, demonstrating that any differences in specifications do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is a physical device, not an AI/machine learning model.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this physical device.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).