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.

Device Description

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.

AI/ML Overview

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.

Summary

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13.0 510(k) SUMMARY OF SAFETY AND EFFICACY

Rebecca Andersen

6 1998 NO Submitter: Date:

K98 3520

Names of the devices:

QUICKIE SPECIALTY INPUT DEVICE

9/28/98

ModelNumber	Device Description	PerformanceFeatures	SwitchType	Function
139700	Breath Control	Same	Switched Input	Actuator
139900	Electronic Head Array	Same as the 3519, onlyclose proximity to sensorcauses activation	Switched Input	Actuator
139702	Tri Switch Head Array	Same	Switched Input	Actuator
139703	HD Switched Joystick	Same	Switched Input	Actuator
139923	CA - 5	Same	Switched Input	Actuator
139924	Penta	5 single switchespackaged in small disc.Single finger control.	Switched Input	Actuator
139925	Star Board Switch	5 single switchespackaged in "plus"arrangement. Smallhand control.	Switched Input	Actuator
139922	Wafer Board	5 single switches	Switched Input	Actuator
139706	Mini switched Joystick	Same	Switched Input	Actuator
139720	Treadle Switch	Same	Single Switch	Actuator
139721	Ribbon Switch	Same	Single Switch	Actuator
139722	Disc Switch	Same	Single Switch	Actuator
139920	Buddy Button	Same as Disc Switch	Single Switch	Actuator
139921	Micro Light	Very light touch singleswitch	Single Switch	Actuator
139926	Plate	Very light touch singleswitch	Single Switch	Actuator
139927	Grasp	Single switch activatedby grasping a tube	Single Switch	Actuator
139928	Soft	Foam covered singleswitch. Designed toprotect user from hardsurfaces.	Single Switch	Actuator
139910	Wobble Switch	Large activation area,used for gross motormovements	Single Switch	Actuator
ModelNumber	Device Description	PerformanceFeatures	SwitchType	Function
139909139907139908139906	Zero Touch	Proximity switch, willactivate when usercomes close to sensor	Single Switch	Actuator
139704	Proportional HeadControl	Same	Proportional Input	Actuator
139705	Proportional ChinControl / Mini Joystick	Same	Proportional Input	Actuator
3514	Head Rest Mount	Same	Mount	Mount
26102611	Swing Away Mount	Same	Mount	Mount
2615	Bib Mount	Same	Mount	Mount
3395347034202660	Arm Rest Mount	Mounts the USCM to thearmrest. Positionsdisplay	Mount	Mount
3205	Midline Mount	Positions joystick inmiddle of seat	Mount	Mount
34703420	Remote Mount	Same	Mount	Mount

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Identification of predicate devices:

PREDICATE	PREDICATE	PREDICATE
DEVICE	DEVICE	DEVICE
DUFCO	QUICKIE DUFCO	INVACARE

PredicateDevice Desc.In SubmissionK881463	PredicateModel #In SubmissionK881463	PredicateCurrentQuickie DufcoDescription	PredicateCurrentQuickie DufcoModel #	PredicateInvacareModel #	PredicateInvacareDeviceDescription
BreathActuator	2910	Breath Control	3365	SNPM4	Sip-N-Puff
N/A	N/A	Electronic HeadArray	3519	ASL105C	Electronic HeadArray Straightw/bracket
Tri-switchHead array	N/A	Tri SwitchHead array	3519
Joystickactuator	2656	HD SwitchedJoystick	2656	5020MSNP	Mini Joystickw/Pushw/SNP/DI
Four - To -One Adaptor	2355	CA-5JunctionBox		ASL502	5 SwitchAdapter
N/A	N/A	Penta
N/A	N/A	Star Board
JoystickActuator	2656-X	Mini-SwitchedJoystick	2656 -X	5020	Mini Joystickw/Push
Wafer SwitchActuator	2715	Wafer Board	2715	5018	Wafer Board
Treadle Switch	1474Passive	TreadleSwitch	1474Passive
Ribbon Switch	1475Passive	RibbonSwitch	1475Passive
N/A	N/A	Disc Switch	3265Passive
N/A	N/A	Buddy ButtonSwitch	Passive
N/A	N/A	Micro Light	Passive
N/A	N/A	Plate	Passive
N/A	N/A	Grasp	Passive
PredicateDevice Desc.In Sub-missionK881463	PredicateModel #In Sub-missionK881463	PredicateCurrentQuickie DufcoDescription	PredicateCurrentQuickie DufcoModel #	PredicateInvacareModel #	PredicateInvacareDeviceDescription
N/A	N/A	Soft	Passive	5830M4	Soft SwitchPackagew/SNP/DI/Display /Adapte
N/A	N/A	Wobble Switch	Passive
N/A	N/A	Zero Touch	Active
N/A	N/A	ProportionalHead Control	3500	1500M4	RIM HeadControl w/Adj.Slide tube
JoystickActuator(with chincupoption)	2651	Proportional chincontrol / Mini -Joystick	26513185	1558M4	CompactJoystick withDisplay
Actuator/Switched Output	2620	Switched OutputController	33293340335036303660
N/A	N/A	Head RestMountOr Swing AwayMount	3514 & 15	RIMHW	RIM HardwareFor 1500M4
Swing AwayMount	2610 & 11	Swing-away mount	2610 & 11
Breath TubeKit	2422	Breath ControlMount	2422	PKG32666	Sip-N-Puff, 16"Fixed
Bib Kit	2615	Bib Mount	26153390	PKG32669	Complete BibAssembly
ArmrestMount	2660	Armrest Mount	3395347034202660	1679	Arm AttachHdwr For1555M4
N/A	N/A	Mid-line mount	3205	JCMM4
N/A	N/A	Remote Mount orChair Back Clamp	34703420

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Description of the device:

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Warnings, cautions and contraindications are in the user's manual.

COMPARISON OF DEVICE CHARACTERISTICS TO PREDICATE(S):

Testing:

Pull Out Strength	Pass
Insertion Force	Pass
Pin Activity Compatibility	Pass

Safety:

An analysis of complaints against Quickie chairs was completed and charted. See Chart # 1 in This analysis was supported by a literature search which was conducted by a this section. third party to determine the number of complaints, MDR's and recalls that have been reported to the FDA concerning wheelchairs in general. This information was summarized, and presented in a Management Review report dated 2/20/97. The analysis demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share.

Efficacy

Articles are being provided on the use and efficacy of mechanical reclining wheelchairs. See Appendix D.

510(k) number:

Not assigned at the writing of this summary

Conclusion:

There are no new issues of safety or efficacy.

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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 6 1998

Ms. Rebecca Andersen Vice President, Quality and Regulatory Affairs Sunrise Medical, Inc. Mobility Products Division 7477A East Dry Creek Parkway Longmont, Colorado 80503

Re : K983520 Trade Names: Breath Control, Model # 139700 Head Array, Model # 139900 Tri-switch Head Array, Model # 139702 Heavy Duty Switched Joystick, Model # 139703 CA-5 Junction Box, Model # 139923 Penta Switch, Model # 139924 4 Zero Touch Switch without Lap Tray, Model # 139907 5 Zero Touch Switch without Lap Tray, Model # 139908 5 Zero Touch Switch with Lap Tray, Model # 139906 Mini-Switched Joystick, Model # 139706 Wafer Board, Model # 139922 Star Board, Model # 139925 Treadle Switch, Model # 139720 Ribbon Switch, Model # 139721 Disc Switch, Model # 139722 Buddy Button Switch, Model # 139920 Micro Light Switch, Model # 139921 Plate, Model # 139926 Grasp, Model # 139927 Soft, Model # 139928 Wobble Switch, Model # 139910 Zero Touch, Model # 139909 Proportional Head Control, Model # 139704 Proportional Chin Control/Mini Joystick, Model # 139705 Head Control Mount, Model # 3514 Swing-away mount, Model # 3514-x Bib Mount, Model # 2615 Armrest Mount, Model # 2660 Mid-line Mount, Model # 3205 Regulatory Class: II Product Code: ITI Dated: September 28, 1998 Received: October 8, 1998

Dear Ms. Andersen:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices

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marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to beqin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be

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Page 3 - Page 2 - Ms. Rebecca Andersen

obtained from the Division of Small Manufacturers Assistance obtained Trom the Division of 6.0.2.2041 or (301) 443-6597 or at at fes corr free namber (s://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

12.2 Indications for Use

510(k) number: Not assigned as of this time

Device name: Input Actuators and Mounts

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (per 21 CFR801.109)

[X] Over-the-counter use

bocollfo

Sign-Off f General Restorative Device 510(k) Number

Regulation Number and Section

§ 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).