The Escape Control Module is a non-contact, fully proportional, head movement commanded driving control intended to provide mobility to persons restricted to a seated position while operating a variety of powered wheelchairs.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for the "Escape Control Module" and its FDA clearance letter. It does not contain the kind of detailed information requested about acceptance criteria, study methodologies, or performance results that would typically be found in a clinical study report or a more comprehensive technical summary for an AI/CADx device.

This document describes a powered wheelchair control unit, a hardware device, not an AI or imaging diagnostic software. Therefore, many of the questions related to AI-specific testing (like MRMC studies, ground truth establishment for AI, data provenance for AI models) are not applicable.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not describe specific performance metrics or acceptance criteria for the device itself, beyond its intended function as a "non-contact, fully proportional, head movement commanded driving control intended to provide mobility to persons restricted to a seated position while operating a variety of powered wheelchairs." Performance data or acceptance criteria are not included in this type of summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. This information is not present. The document focuses on regulatory clearance based on substantial equivalence to existing predicate devices, not on a clinical trial with a defined test set.

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 / Cannot be provided. This refers to expert consensus for labelling data, typically for training or evaluating AI models against a 'ground truth'. As this is a hardware device (a wheelchair control module), such an approach to ground truth establishment is not relevant for its regulatory submission as described here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. Similar to point 3, adjudication methods are used in studies involving expert readers to resolve discrepancies in diagnoses or interpretations, particularly relevant for AI/imaging devices. This is not applicable to the "Escape Control Module."

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

No. An MRMC study is specifically designed for evaluating diagnostic devices, especially those involving human interpretation, and often to assess the impact of AI assistance. This type of study would not be performed for a power wheelchair control unit.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. "Standalone" performance is typically for algorithms that provide a direct output without human intervention, again primarily relevant for AI/software devices. The "Escape Control Module" is a control interface between a user and a wheelchair, inherently involving human-in-the-loop operation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. As a hardware medical device that provides control, the concept of "ground truth" as used in diagnostic AI is not relevant. Its performance would be evaluated based on functional testing (e.g., responsiveness, safety, durability, user control) rather than agreement with a diagnostic truth.

8. The sample size for the training set

Not applicable / Cannot be provided. This refers to data used to train an AI model. The "Escape Control Module" is a hardware device, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable / Cannot be provided. As there is no AI model or training set, this question is not relevant.

Summary based on the provided text:

The provided document is a 510(k) summary for the "Escape Control Module," a power wheelchair control unit. It primarily establishes substantial equivalence to predicate devices (Dynamic Systems PHC-2 and PHC-3, Adaptive Switch Laboratories Inc.'s ASL Head Array, Invacare's Sip and Puff head array, and Invacare's Remote Joystick) rather than presenting detailed performance studies against specific acceptance criteria.

The 510(k) clearance process fundamentally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not necessarily on proving performance against a set of predefined acceptance criteria through extensive clinical trials as might be required for novel, high-risk devices or AI/CADx software. Therefore, the specific types of studies and data requested, which are common for AI/CADx devices, are not found in this regulatory document for a hardware device clearing via the substantial equivalence pathway.

Summary

{0}------------------------------------------------

AUG 01 2002

K021995

510(k) Summary

Specialty Drive Technologies, Inc.'s Escape Control Module

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Specialty Control Technologies, Inc. 509 Pleasant Hill Church Rd. Winder, GA 30680 Phone: 770 363-7398 Fax: 770 586-0917

Contact Person: Scott Kersey

Date Prepared:June 17, 2002

Name of Device and Name/Address Of Sponsor

Escape Control Module Specialty Control Technologies, Inc. 509 Pleasant Hill Church Rd. Winder, GA 30680 Phone: 770 363-7398 770 586-0917 Fax:

Common or Usual Name

Escape Control Module

Classification Name

Power Wheelchair Control Unit

Predicate Devices

The Escape Control Module is substantially equivalent to Dynamic Systems PHC-2 and PHC-3, Adaptive Switch Laboratories Inc.'s ASL Head Array, Invacare's Sip and Puff head array and Invacare's Remote Joystick.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a cascading manner. The profiles are connected by flowing lines that resemble a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 01 2002

Specialty Drives Technologies, Inc. Scott Kersey 509 Pleasant Hill Church Road Winder. Georgia 30680

Re: K021995

Trade Name: Escape Control Module Regulation Number: 890.3860 Regulation Name: Wheelchair, powered (accessory) Regulatory Class: II Product Code: ITI Dated: June 17, 2002 Received: June 18, 2002

Dear Mr. Kersey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

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

{2}------------------------------------------------

Page 2 - Mr. Scott Kersey

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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 vours.

Sincerely yours,

Mark H. Milkman

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

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number: _ KO21995

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Device Name:

Indications for Use: The Escape Control Module is a non-contact, fully proportional, head movement commanded driving control intended to provide mobility to persons restricted to a seated position while operating a variety of powered wheelchairs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over-the-Counter Use ✓(Optional Format 1-2-96)
------------------------------------------	----	-----------------------------------------------------------------------------------------------------

for

(Division Sign-Off)	(Division Sign-Off)
Division of General, Restorativeand Neurological Devices	Division of General Restorative Devices
510(k) Number	510(k) Number
K021995

Mark N. Melleur

Regulation Number and Section

N/A