The Proactive Comfort Pure Tilt™ wheelchair is an indoor / outdoor manual wheelchair composed of two (2) main components (assemblies): a lower frame assembly and a tilting seat assembly. The lower frame contains two rear wheels, two front casters, two anti-tippers, one pair of brakes and two armrest assemblies. The Seat assembly contains four sub-assemblies; a tilting seat, a leg rest, a backrest and a headrest. The Proactive Comfort Pure Tilt™ possesses the following features:

A tilting seat with adjusting capability up to 45°;
User-operated seat tilt adjusting mechanism, which is assisted by a mechanical spring piston;
Hinged, non-detachable armrests that swing upward and toward the back to facilitate transfer of a subject into or out of the wheelchair;
Built-in housing for compatible transfer board;
Mechanical armrest locks that secure the armrests to be used safely as handles for lifting the wheelchair with the user in it;
Two 21" diameter rear wheels with aluminum hand-rims for self-propelling;
Two 6" diameter front casters that swivel for easy maneuvering;
Adjustable seat-to-floor height (2 Settings: 19" and 17");
Angle-adjustable leg-rest assembly with the following features:
Foot platform that swings upward to facilitate stowage .
Telescoping adjustable height .
User-operated mechanism to adjust leg-position angle, which is assisted by mechanical spring piston;
Backrest that has adjustable vertical position and that folds 90° forward to facilitate storage and transport; and
Headrest with adjustable vertical position.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for a mechanical wheelchair, not an AI/ML medical device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and studies for such devices.

The document describes the Pure Tilt™ wheelchair and seeks to prove its substantial equivalence to a predicate device (BRODA – 587 Manual Wheelchair, K032133). The studies conducted are non-clinical performance tests for mechanical devices, not AI/ML algorithm performance.

Here's why the requested information cannot be extracted from this document:

AI/ML Specifics: The prompt asks for details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set sample size, and ground truth establishment for AI/ML models. None of these are relevant or present in a 510(k) for a mechanical wheelchair.
Acceptance Criteria & Device Performance (Mechanical Context): The acceptance criteria for a mechanical wheelchair revolve around safety, stability, durability, and ergonomic measurements as defined by standards like ISO and RESNA. The "reported device performance" are the "Passed" results for these tests.

Therefore, I cannot fulfill the request as the input document does not pertain to an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2016

Proactive Comfort, LLC % EJ Smith President Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K152021

Trade/Device Name: Pure Tilt Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: February 29, 2016 Received: March 1, 2016

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152021

Device Name Pure Tilt™ wheelchair

Indications for Use (Describe) The Pure Tilt™ wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

SPONSOR

Company Name:	Proactive Comfort, LLC
Company Address:	3901 Centerview Drive, Suite LChantilly, VA 20151USA
Telephone:	703-995-7104
Fax:	703-834-0039
Contact Person:	Tracy Augustine

Summary Preparation Date: February 23, 2016

DEVICE NAME

Trade Name:	Pure Tilt™
Common/Usual Name:	Mechanical Wheelchair
Classification Name:	Physical Medicine
Regulation Number:	890.3850
Product Code:	IOR
Device Class:	Class I

PREDICATE DEVICE

Legally Marketed Equivalent Device
Company	Product	510(k) #
BRODA	587 Manual Wheelchair	K032133

DEVICE DESCRIPTION

A tilting seat with adjusting capability up to 45°; ●
User-operated seat tilt adjusting mechanism, which is assisted by a mechanical spring ● piston;
Hinged, non-detachable armrests that swing upward and toward the back to facilitate ● transfer of a subject into or out of the wheelchair;
Built-in housing for compatible transfer board;
Mechanical armrest locks that secure the armrests to be used safely as handles for lifting ● the wheelchair with the user in it;
Two 21" diameter rear wheels with aluminum hand-rims for self-propelling;
Two 6" diameter front casters that swivel for easy maneuvering;
Adjustable seat-to-floor height (2 Settings: 19" and 17"); ●
Angle-adjustable leg-rest assembly with the following features:
Foot platform that swings upward to facilitate stowage .
Telescoping adjustable height .

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User-operated mechanism to adjust leg-position angle, which is assisted by mechanical . spring piston;
. Backrest that has adjustable vertical position and that folds 90° forward to facilitate storage and transport; and
. Headrest with adjustable vertical position.

DEVICE INDICATIONS FOR USE

The Pure Tilt™ wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.

ITEMS	PROACTIVEWHEELCHAIR	PREDICATE DEVICE
BRAND NAME	Pure Tilt™	Valentine
K number		K130017
Product Code	IOR	IOR
MANUFACTURER	Proactive Comfort, LLC129 N. West Street,Easton, MD 21601	Valentine International Ltd
MODEL	Proactive - Pure Tilt™	Steel Wheelchair model 1000
510K NO.		K130017
Indications for Use	The device is intended toprovide mobility to persons thatare unable to ambulate safely orare restricted to a sittingposition.	The device is intended for medicalpurposes to provide mobility topersons restricted to a sittingposition.
OPERATING	To be used on a level surfaceIndoor or Outdoor	Indoor/Outdoor Wheelchair
TECHNOLOGICALCHARACTERISTICS	According to ANSI/RESNAseries standards (Sections 1, 3,5,7,8 and 15)	According to ISO 7176-1/-3/-5/-7/-8/-1 1/-13/ - 15/-16 series standards
FRAME
Primary Material	Tubular Aluminum
Overall Height	35" (889mm)
Overall Width	30" (762mm)
Seat Width	16.9" (430mm)	18"
Seat Depth	17.4" (442mm)
Seat Height	Max: 19" (482mm) Min:17" (431mm)	20"
Seat Angle	Up to 45°
Cross Brace	Built-in	Yes
Backrest Height	17.6" (447mm)	Un-adjustable / Fixed
Backrest Width	15.4" (391mm)
Reclining Backrest	13.2° - 52.7°	Fixed
Seat Sling	Padded cushion system	Padded nylon
Frame Colors	Black	Blue
ARMREST
Arm Pad	Padded	Padded
Flip Back	Yes, detachable padding	Yes, detachable
Height Adjustable	No	No
HANGERS
Swing-Away	Yes	Yes
Elevating Leg Rest	Yes	Yes
Articulating Leg Rest	Yes	Yes
Footplate Style	Flat, Non-Padded	Padded
Heel Loop	No	No
Footrest Angle	18.9° - 90°	10~15°
REAR AXLE
Offset Axle	Yes	Yes
Quick Release Axle	No	Yes
Whorl	No	No
REAR WHEEL
Size	21" (533mm) x 1" (25.4mm)	24"
Tire Type	PU Solid Material	PU Solid Material
Handrim Material	Aluminum	Steel Composite
CASTERS
Size	6" (152mm)	8"
Tire Type	Non-Marking Rubber Tires	PU Solid Material
WHEEL LOCK	Push-to-Lock / Manual	Pull-to-Lock / Manual
UPHOLSTERY MATERIAL	Vinyl
WEIGHT CAPACITY	275 lbs / 125 kgs	250 lbs / 113.5 kgs
WEIGHT OF CHAIR	59.8 lbs (31.7 kgs) w/ocushions 69.8 lbs (31.7 kgs)including all cushions	40 lbs / 18.2 kgs
WARRANTY	12 Months from date ofshipment	12 Months for Main Parts (Thechair side frames are guaranteedfor 5 years from the date ofpurchase)
ACCESSORIES
Anti-tipper	Yes	No
Rear Stepper	No	Yes
Fold Down Push Handle	No	Yes
Safety Belt	No	Optional

COMPARISON OF TECHNICAL CHARACTERISTICS

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NONCLINICAL PERFORMANCE DATA

Standard	Test Description	Results
ISO 8191-1:1987Attachment 18.1	Assessment of Ignitability of Upholstered Furniture - Smoldering Cigarette	Passed
ISO 8191-2: 1988Attachment 18.2	Assessment of Ignitability of Upholstered Furniture – Match-Flame Equivalent	Passed
Resna standards: 2009 VersionAttachment 18.3	Section 1: Determination of Static Stability Section 3: Determination of Effectiveness of Brakes Section 5: Determination of Dimensions, Mass, and Maneuvering Space	Passed

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•	Section 7: Method of Measurement ofSeating and Wheel Dimensions
•	Section 8: Requirements and Test Methodsfor Static, Impact and Fatigue Strengths
•	Section 15: Requirements for InformationDisclosure, Documentation and Labeling

CONCLUSION

The data submitted in this 5 10(K) Premarket Notification supports the finding that this device (Proactive - Pure Tilt™) is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed Predicate Device (BRODA – 587 Manual Wheelchair). Therefore, we believe that this device meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(K) guidelines.

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).