(25 days)
The intended use of the Freedom Sciences Version 1.5 Motion Control Module is to allow for remote motion control of a powered wheelchair that uses the Invacare MK6 Electronics while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM Version 1.5 is compatible with powered wheelchairs that use Invacare MK6 Electronics.
The Freedom Sciences Version 1.5 Motion Control Module for powered wheelchairs is a wireless, remote control product designed for use with powered wheelchairs which use the Invacare MK6 Electronics . Its intended function and use is to allow for remote motion control of the powered wheelchair only while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM v1.5 allows for remote motion control using high level motion control commands. It interfaces to the power wheelchair using the host wheelchair attendant control interface on the motor controller. This method of interfacing with the powered wheelchair retains all configured safety interlocks inherent to the host motor controller itself and is the standard means for integrating auxiliary input devices.
The provided text describes a Special 510(k) Premarket Notification for the "Freedom Sciences LLC Version 1.5 Motion Control Module (MCM)". This device is intended for remote motion control of unoccupied powered wheelchairs that use Invacare MK6 Electronics.
However, the document is a premarket notification for a medical device and not a study report. It does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and performance studies in the requested format for an AI/device performance study.
Here's an attempt to answer the questions based on the limited information provided in the document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance: |
- Ability to provide remote motion control of a powered wheelchair.
- Compatibility with Invacare MK6 Electronics.
- Retention of host motor controller's safety interlocks.
- Operation only when the wheelchair is unoccupied. | The MCM v1.5 allows for remote motion control using high-level motion control commands.
It interfaces to the power wheelchair using the host wheelchair attendant control interface on the motor controller.
This method of interfacing with the powered wheelchair retains all configured safety interlocks inherent to the host motor controller itself and is the standard means for integrating auxiliary input devices.
"The Freedom Sciences MCM v1.5 met the applicable required performance criteria and functioned as intended."
"It is not intended for use when a person is seated in the wheelchair." |
| Safety: - Adherence to safety standards.
- Prevention of use when a person is seated. | The device's interface method retains all configured safety interlocks inherent to the host motor controller.
Its intended use explicitly states, "It is not intended for use when a person is seated in the wheelchair."
The study mentioned was "as required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles"". This guidance would implicitly cover safety aspects. |
| Substantial Equivalence: - Equivalence to a predicate device (Freedom Sciences Motion Control Module for Powered Wheelchairs, K073330). | The Freedom Sciences MCM v1.5 Motion Control Module is "substantially equivalent to the Freedom Sciences Motion Control Module (MCM) for powered wheelchairs (K073330)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" sample size or data provenance in the context of an AI/algorithm performance study. The testing refers to the "MCM v1.5 was tested as required by FDA's July 26, 1995, draft publication entitled 'Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles'". This guidance would relate to engineering and functional testing of the physical device, not an AI model requiring a test dataset.
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)
This information is not applicable and not provided. The device is a motion control module for a wheelchair, not an AI diagnostic or analytical tool that requires expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not provided.
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 and not provided. This device is not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device itself is a "standalone" system in the sense that it operates independently to control the wheelchair remotely. However, it's not an "algorithm only" in the context of typical AI performance studies. Its performance is about the module's ability to transmit commands and the wheelchair's response, which is a functional test. The document states it allows for "remote motion control using high level motion control commands," implying the module's algorithms are responsible for interpreting and executing these commands. The testing "met the applicable required performance criteria and functioned as intended." This confirms its standalone functional performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be objective measurements of its functional capabilities (e.g., successful remote control of movement, adherence to safety interlocks, reliability of communication) against engineering specifications and regulatory guidance for powered wheelchairs. It is not based on expert consensus on diagnoses, pathology, or outcomes data.
8. The sample size for the training set
Not applicable and not provided. This is not an AI model that undergoes "training" with a dataset in the conventional sense. The "training" would be more akin to software development and hardware testing.
9. How the ground truth for the training set was established
Not applicable and not provided.
§ 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).