The intended use of the STREET powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Description

Street Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair PM100Amp controller. The user interface is a joystick. The Street is powered by two 12VDC 73Ah, Group 24 batteries, approximate driving range on fully charged batteries is up to 35 km (22 miles), depending on use and the terrain the chair is driven on. The chair frame is of welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

AI/ML Overview

The provided text describes a 510(k) submission for a powered wheelchair named "STREET" (K032765). This is a traditional medical device submission, focusing on establishing substantial equivalence to a predicate device, rather than proving the performance of a novel AI/ML-driven device through a study with acceptance criteria.

Therefore, many of the requested categories (such as acceptance criteria, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission.

The document primarily focuses on demonstrating that the STREET wheelchair is safe and effective by showing its substantial equivalence to a previously cleared predicate device, the Quantum Blast (K011993).

Here's a breakdown of the information that is available in the provided text, and an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) submission for this powered wheelchair does not detail specific acceptance criteria or performance metrics in a way that would be typical for an AI/ML device. Instead, it relies on demonstrating that its technological characteristics and intended use are substantially equivalent to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This is a hardware device (powered wheelchair). There is no "test set" in the context of an AI/ML algorithm. The performance is assessed through non-clinical testing and comparison to the predicate device. The information provided does not specify any particular sample size or data provenance related to a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. There is no "ground truth" establishment in the context of an AI/ML algorithm for this powered wheelchair submission. Safety and effectiveness are demonstrated via engineering design, compliance with relevant standards (not explicitly detailed in this summary but implied by the 510(k) process), and substantial equivalence to a predicate.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

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 is not an AI/ML device, and therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a powered wheelchair; it does not have a standalone algorithm in the sense of an AI/ML device.

7. The Type of Ground Truth Used

Not Applicable. There is no "ground truth" as it would be understood for an AI/ML algorithm. The safety and effectiveness are established through engineering principles, adherence to manufacturing practices, and comparison to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware device; there is no "training set" in the context of an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See point 8.

Summary of Relevant Information from the Provided Text:

Device Name: STREET Powered Wheelchair
Predicate Device: Quantum Blast (K011993) manufactured by Pride Mobility.
Intended Use: To provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Safety and Effectiveness Justification: "The STREET has in substantially the same intended use and similar technological characteristics as the Quantum Blast. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in technological characteristics do not raise any new questions of safety or effectiveness. Thus, the STREET device is substantially equivalent to the predicate device."

Conclusion:

The provided document describes a traditional 510(k) submission for a physical medical device (a powered wheelchair). The framework for acceptance criteria and study design requested in the prompt is specific to AI/ML-driven devices, which this product is not. The "study" described is the process of comparing the STREET wheelchair to its predicate device, the Quantum Blast, through non-clinical testing and characterization of its technological features to demonstrate substantial equivalence.

Summary

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K032765

ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: STREET

JAN : 0 2004

Attachment 12

510(k) Summary

Submitter	Permobil ABBox 120Årvältsvägen 10S-861 23 TimråSweden
Phone:	+46 60 595900
Facsimile:	+46 60 575250
Contact Person:	Bengt Persson
e-mail address:	bengt.persson@permobil.se
Date Prepared:	September 1, 2003
Device name:	STREET
Classification Name:	Powered wheelchair
Predicate Devices:	Quantum Blast (K011993) manufactured by Pride Mobility.
Intended use:	The intended use of the STREET powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Description of device:	Street Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair PM100Amp controller. The user interface is a joystick. The Street is powered by two 12VDC 73Ah, Group 24 batteries, approximate driving range on fully charged batteries is up to 35 km (22 miles), depending on use and the terrain the chair is driven on. The chair frame is of welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2004

Mr. Bengt Persson Director, Quality and Environment Permobil AB Box 120 Årvältsvägen 10 S-861 23 Timrå Sweden

Re: K032765

Trade/Device Name: STREET Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: December 2, 2003 Received: December 2, 2003

Dear Mr. Persson:

We have reviewed your Scction 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 Fedcral 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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 I'DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 – Mr. Bengt Persson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis leter with and in you vo or substantial equivalence of your device to a legally premativer notification." The 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 if you desire specific as no as a moliance at (301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millikan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: STREET

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Attachment 13

Indication for Use Statement

Substantial Equivalence

The product, which is substantially equivalent to this device, is Pride Mobility's Quantum Blast Rear Wheel Drive Power Wheclchair (K011993 July 13, 2000).

Safety and effectiveness

The STREET has in substantially the same intended usc and similar technological characteristics as the Quantum Blast. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in technological characteristics do not raise any new questions of safety or effectiveness. Thus, the STREET device is substantially equivalent to the predicate device.

Indication for Use

The intended use is to provide indoor and outdoor mobility to persons restricted to a sitting position.

510(k) number

Not assigned at the writing of this submission

Device name

STREET

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (per 21 CFR 801.109) □

Over the counter use

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(SID)
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I Devices

KO32

(Division Sign-Off) Division of General Restorative Devices

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).