(29 days)
Alternate input devices are designed to provide those with sever physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit from a single actuating device.
Alternate actuators (input devices) are designed to provide those with severe physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit using a device other than the standard joystick. A variety of alternate input actuators are currently available on the market as many power wheelchair users require some form of input control other than a joystick.
In prior submissions, several alternate input devices (specialty controls) and their interface modules were employed in addition to the main wheelchair controller. These included the breath tube interface, which contained a pressure transducer, a single switch scanner module and a display. Other specialty control functions also required independent display boxes and / or displays. However Quickie's new controllers, that are intended to interface with specialty input devices, have incorporated these functions into the Controller/ USCM (Universal Specialty Control Module). This greatly simplifies the wheelchair's configuration as it eliminates the need for additional dedicated interface boxes and displays to be mounted on the chair.
As with the devices currently marketed by Quickie, the alternate actuator is used to signal both the speed and direction of the power chair, as well as the selection of various operating modes which are then controlled by the wheelchair controller/USCM. Examples of the various modes that can be controlled are: maximum speed, drive profile (e.g. indoor/outdoor), latched driving, powered seating systems and environmental controls systems.
The method of selection for both drive control and mode is dependent upon the type of alternate input actuator. Two basic types of input actuators exist: proportional and switched. Both types are compatible with Quickie's controller/USCM. When using alternate input actuators, the wheelchair controller will enter a sleep state if the actuator has not sent a signal for a specified period of time. This helps to extend the life of the chair batteries, and reduces the likelihood of unintentional movement.
The primary change being addressed is the modification of one of the standard connectors used to interface with the Quickie Controllers that have a Universal Specialty Control Unit (USCM). Two of the three connections that were made to the old Multi-mode remain the same. Some devices used a breath tube that activated a pressure transducer that translated the air pressure to electrical signals. This connection remains unchanged. Some devices used a single jack connector to transfer signal. This connection also remains unchanged. The third type of connector employed by the prior Multi-mode device was a DB15 connector. The Controller/ USCM, which replaces the Multi-mode, translates the same signals using a DB9 connector. The DB9 was selected for the Controller/USCM because it has developed across the specialty input device industry as the standard connector. The DB-9 is used by many companies making specialty input devices including Switch-it, Tash, and ASL.
Here's an analysis of the provided text regarding acceptance criteria and the study:
The provided document describes a 510(k) premarket notification for "QUICKIE SPECIALTY INPUT DEVICE" and its various models. However, it does not contain a formal study designed to prove the device meets specific acceptance criteria in the way one might expect for a typical medical device with measurable performance metrics (e.g., diagnostic accuracy, precision).
Instead, this submission is focused on demonstrating substantial equivalence to predicate devices. The "study" here is primarily a comparison to predicate devices and basic engineering testing, not a clinical trial or performance study against predefined targets.
Here's a breakdown based on your requested information, with explanations for what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices | "The indications for use are the same, the technological characteristics are the same, and the performance characteristics are the same for both the modified and predicate devices." |
| Mechanical Integrity (Connectors) | |
| Pull Out Strength | Pass |
| Insertion Force | Pass |
| Pin Activity Compatibility | Pass |
| Safety (General Wheelchair Safety) | Analysis of complaints against Quickie chairs completed and charted (Chart #1). Literature search conducted by third party on general wheelchair complaints, MDRs, and recalls. Demonstrated "common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share." |
| Efficacy (General Wheelchair Efficacy) | Articles provided on the use and efficacy of mechanical reclining wheelchairs (Appendix D). |
Explanation: The "acceptance criteria" are not explicitly stated with quantitative targets. Instead, the document argues for substantial equivalence by asserting that the device's characteristics and performance are "the same" as the predicate devices. The mechanical tests (pull out strength, insertion force, pin activity compatibility) are the only truly explicit performance tests mentioned, and their "acceptance criteria" appear to be simply "Pass."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable in the traditional sense of a clinical or performance study.
- For the mechanical tests (Pull Out Strength, Insertion Force, Pin Activity Compatibility), the sample size is not specified. It would typically be a small number of connectors tested in a lab setting.
- For the safety analysis, the "sample" was the complaints against Quickie chairs and a literature review of general wheelchair complaints/MDRs/recalls. The size of these datasets is not specified.
- Data Provenance: Not explicitly stated. Given it's a US 510(k) submission, it's likely primarily related to the US market, but this is not confirmed.
- Retrospective or Prospective:
- The mechanical tests would be prospective (conducted specifically for this submission).
- The safety analysis based on complaints/MDRs/recalls is inherently retrospective.
- The efficacy articles provided would be retrospective literature.
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 not a study that requires expert adjudication of ground truth for device output. The substantial equivalence argument relies on comparing the device's features to those of predicate devices and general knowledge of wheelchair safety and efficacy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication of a test set was 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 device is a physical input device for wheelchairs, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical input device, not an algorithm. Its function is to convert user input into signals for a wheelchair controller. Human-in-the-loop is fundamental to its operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This submission relies on:
- Engineering test results for mechanical properties ("Pass" indicates meeting an engineering specification).
- Comparison of features and intended use to legally marketed predicate devices.
- Analysis of existing safety data (complaints, MDRs, recalls) related to wheelchairs in general.
- Existing literature on wheelchair efficacy.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set. It's a hardware input device.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize a training set in the AI/ML sense.
§ 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).