(346 days)
The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control.
The Explorer Mini includes a base to which the wheels and casters are attached. An adjustable height, vertical column is attached to the base. The driver control (joystick) is integrated at the top of the column and the seating system is attached to the column. The Explorer Mini speed and direction are controlled via a control system comprising a power module and joystick. The Explorer Mini has the appearance of a "ride on toy" and weighs between 60% and 90% less than typical power chairs available to this population today. Explorer Mini seat is configured with a permanent 360degree support assembly positioned around the upper torso for added user safety and stability. This assembly supports both sitting and standing. An adjustable-position saddle shaped seat is used for sitting. The saddle shape allows for 'straddle' standing or alternately the seat can be removed to open the area for full active standing. The 360degree support assembly adjusts to accommodate and support standing while driving. The Explorer Mini is powered by two 5 Amp. batteries providing an approximate driving range up to 4.6 miles. The base provides the propulsion which is derived from two (left and right) front mounted gear-motor wheel assemblies supported by two rear mounted 360degree swiveling casters. Also incorporated in the base are the batteries and control module. When the user activates the joystick, the controller receives a signal to move the device in the direction the joystick is pointed. Simultaneously, the controller directs the gear-motors to respond appropriately. When the user releases the joystick, the chair decelerates to a stop. The inherent gear ratio holds the device in place like a park brake.
Please note that the provided text is a 510(k) summary for a medical device (Explorer Mini, a pediatric powered wheelchair). It describes the device, its intended use, comparison to a predicate device, and the non-clinical and clinical testing performed to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT describe the acceptance criteria and study for an AI/ML-based medical device. It details the regulatory clearance process for a powered wheelchair, which involves proving its safety and effectiveness through engineering and human factors testing, not through AI performance metrics like sensitivity, specificity, or reader studies common for AI/ML devices.
Therefore, many of the requested points regarding AI/ML device testing (e.g., ground truth establishment, sample size for training data, MRMC studies, standalone performance) are not applicable to the information contained in this 510(k) summary.
However, I can extract the information relevant to the acceptance criteria and the studies that were performed for this specific device.
Here's a breakdown based on the provided document, addressing the applicable points and explaining why others are not relevant:
Acceptance Criteria and Device Performance (Based on "Non-Clinical Testing" Section)
The acceptance criteria for the Explorer Mini are primarily defined by successful passage of various ISO 7176 standards, which evaluate the physical and functional characteristics of wheelchairs.
| Acceptance Criteria (ISO Standard) | Reported Device Performance (Outcome) |
|---|---|
| ISO 7176-1:2014 - Determination of static stability | Pass |
| ISO 7176-2:2001 - Determination of dynamic stability of electric wheelchairs | Pass |
| ISO 7176-3:2012 - Determination of effectiveness of brakes | Pass |
| ISO 7176-4:2008 - Energy consumption for determination of theoretical distance range | Pass |
| ISO 7176-5:2008 - Determination of overall dimensions, mass and maneuvering space | Pass |
| ISO 7176-6:2001 - Determination of maximum speed, acceleration and deceleration | Pass |
| ISO 7176-7:1998 - Measurement of seating and wheel dimensions | Pass |
| ISO 7176-8:2014 - Requirements and test methods for static, impact and fatigue strengths | Partial conformance (alternative evidence provided) |
| ISO 7176-9:2009 - Climatic tests for electric wheelchairs | Pass |
| ISO 7176-10:2008 - Determination of obstacle-climbing ability of electrically powered wheelchairs | Pass |
| ISO 7176-14:2008 - Power and control systems for electrically powered wheelchairs and scooters | Pass |
| ISO 7176-15:1996 - Requirements for information disclosure, documentation and labeling | Pass |
| ISO 7176-16:2012 - Resistance to ignition of postural support devices | Pass |
| ISO 7176-21:2009 - Electromagnetic compatibility | Pass |
| ISO 7176-25:2013 - Batteries and chargers for powered wheelchairs | Partial conformance (alternative evidence provided) |
| RESNA WC-1:2009 Section 20 - Determination of the Performance of Stand-up Type Wheelchairs | Pass |
| ISO 10993-1 - Biological evaluation of medical devices | Pass |
Study Details:
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Sample size used for the test set and the data provenance:
- Non-Clinical Testing: The document refers to "the Explorer Mini" being tested according to the ISO standards. This implies testing of the device itself, likely multiple units for robustness, rather than a "test set" in the sense of patient data for an AI algorithm. The provenance is implied to be from the manufacturer's testing facilities based on compliance with international standards. Details like number of devices tested or specific test runs are not provided.
- Clinical Testing (Usability Study): 33 children with mobility impairments were included. This was a usability study, not a clinical trial to prove efficacy in the traditional sense, but focused on how users interact with the device.
- Clinical Testing (Label Comprehension Study): 15 physiotherapists/occupational therapists and 15 parents participated.
- Data Provenance: Not explicitly stated (e.g., country of origin for the usability study participants), but the studies were conducted by the manufacturer Permobil AB (Sweden). The studies appear to be
- Usability Study: Prospective, as it involved real children interacting with the device.
- Label Comprehension Study: Prospective, as it involved participants reviewing the user manual.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the traditional AI sense. For a physical device like a wheelchair, "ground truth" is established by direct measurement against engineering standards and specifications (e.g., speed, dimensions, stability tests). The experts involved would be engineers, technicians, and potentially clinical professionals ensuring the device meets the needs of pediatric users.
- For the Usability Study, the "ground truth" would be observed user behavior and feedback, assessed by human factors engineers/clinicians.
- For the Label Comprehension Study, the "ground truth" was whether participants could correctly understand the label, assessed by the study design and interpretation of responses from "physiotherapists/occupational therapists and parents." Their qualifications are stated by their profession.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is an AI/ML specific term for resolving discrepancies in expert labeling. For physical device performance tests (ISO standards), the results are typically objectively measured and don't require expert adjudication in the same way. For the usability/label comprehension studies, detailed adjudication methods are not provided, but such studies typically involve qualitative and quantitative analysis of user interactions and feedback.
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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 specific to AI/ML devices where AI assists human interpretation (e.g., radiologists reading images). This product is a physical mobility device and does not involve AI assistance for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As above, this is an AI/ML specific concept. The device's performance is inherently tied to its physical interaction with a user ("human-in-the-loop" is a given for a wheelchair).
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Non-Clinical Testing: Engineering specifications and standardized test methods (ISO 7176 series). The "ground truth" is adherence to these defined performance benchmarks.
- Clinical Testing (Usability/Label Comprehension): User behavior, performance, and understanding as observed and measured through structured studies.
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The sample size for the training set:
- Not Applicable. This device is a physical product, not an AI/ML algorithm that requires a training set of data.
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How the ground truth for the training set was established:
- Not Applicable. (See point 7).
In summary, the provided document outlines the process for clearance of a physical medical device (a pediatric powered wheelchair) by demonstrating its safety and effectiveness through compliance with recognized international standards for wheelchairs and human factors studies. It does not pertain to the development or validation of an AI/ML diagnostic or assistive algorithm.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).