The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.

To provide mobility for the disabled.

Device Description

The Dignity 100 functions like a standard mechanical wheelchair with the addition of a custom cushion. This 21 CFR Sec. 890.3920 wheelchair component is intended for medical o rurgoses and surface an integral part of the wheelchair, but will also be sold separately as a replacement part. The custom cushion is designed with a keyhole shaped drop down panel which is replacement by the patient when he or she wishes to use the toilet.

The Dignity 100 is constructed from 7/8 inch outside diameter (OD) round, mechanical steel tubing. The chair is of welded construction. The sewn components are secured to the frame using screws and bolts. This device is a rigid wheelchair that incorporates a seating surface. The Dignity 10 has removable footrests.

AI/ML Overview

The Dignity 100 is a manual wheelchair. The provided text, a 510(k) Premarket Notification summary, describes the device and its substantial equivalence to a predicate device, but does not contain acceptance criteria or a study proving that the device meets such criteria in the manner requested for AI/software devices.

This document is for a physical medical device, specifically a manual wheelchair, which falls under different regulatory requirements than AI/software as a medical device (SaMD). The performance data for this type of device typically involves demonstrating compliance with recognized safety and performance standards rather than metrics like sensitivity, specificity, or inter-reader agreement.

However, based on the information provided, here's a breakdown of what can be extracted and how it relates (or doesn't relate) to your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ANSI/RESNA parts 1, 3, 5, 7, 8 and 93 standards (safety and function for wheelchairs)	The Dignity 100 wheelchair passed all technical requirements identified in ANSI/RESNA parts 1, 3, 5, 7, 8 and 93.

Explanation: For a manual wheelchair, "acceptance criteria" are implied by the conformance to recognized industry standards for safety, durability, and functionality. The "reported device performance" is a statement of successful adherence to these standards.

The remaining information requested in your prompt (sample size, data provenance, expert consensus, MRMC studies, standalone performance, training set details) is not applicable or not provided in the context of this 510(k) submission for a manual wheelchair. This type of device does not involve algorithms, AI, or diagnostic interpretations that would require such detailed study designs.

Summary of missing/non-applicable information based on the prompt's focus on AI/software:

Sample sized used for the test set and the data provenance: Not applicable. Performance testing for wheelchairs typically involves physical product testing, not data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is relevant for diagnostic performance, not mechanical device performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used: Not applicable in the sense of diagnostic ground truth. The "ground truth" for a wheelchair would be its physical properties meeting engineering specifications.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K08 aa46

Dignity Medical Devices, Inc. Dignity 100

510(k) Premarket Notification

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1889 and 21 CFR 807.92.

510(k) Number ________________________________________________________________________________________________________________________________________________________________ Date Prepared: July 30, 2008

Submitter's Name, Address and Contact Person Dignity Medical Devices, Inc. 17500 29th Ave. North Minneapolis, Minnesota 55447

Contact Person: Charmaine Sutton

Trade Name: Dignity 100

Common Name: Manual Wheelchair

Classification Name: Wheelchair, mechanical

Predicate Device

The Dignity 100 wheelchair is substantially equivalent to the Sunrise Medical Quickie QX (K072153).

Intended Use

Device Description

Substantial Equivalence Comparison

The Dignity 100 is substantially equivalent to the Sunrise Medical/Quickie Design Model "Quickie QX Manual Folding Wheelchair" (K072153).

Performance Data

The Dignity 100 wheelchair passed all technical requirements identified in ANSV/RESNA parts 1, 3, 5, 7, 8 and 93.

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SEP 0 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dignity Medical Devices, Inc. %The Tamarack Group, Inc Ms. Charmaine Sutton 16917 73td Place North Maple Grove, Minnesota 55311

K082246 Trade/Device Name: Dignity 100 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair. Regulatory Class: Class I Product Code: IOR Dated: July 31, 2008 Received: August 08, 2008

Dear Ms. Sutton:

Re:

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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 – Ms. Charmaine Sutton

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Dignity Medical Devices, Inc. Dignity 100

510(k) Premarket Notification

· 510{k) Number (if known): __________________________________________________________________________________________________________________________________________________

Device Name: Dignity 100

Indications for Use:

To provide mobility for the disabled.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrent of CDRH, Office Of Device Evaluation (ODE)
(Posted November 13, 2003)

(Division Sign-Off)
Page
of

Division of General, Restorative,
and Neurological Devices

510(k) Number	K065246
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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).