(66 days)
The RTD Arm permits persons with severe disabilities to manipulate objects in their personal environment and thus to establish a greater measure of functional independence. The client population for this device includes individuals with
- very limited or complete absence of bilateral upper extremity function.
- lower extremity impairment requiring the use of a power wheelchair, and
- intact cognitive and visual perceptual ability.
The medical diagnoses of the target user populations include high-level quadriplegia, neuromuscular disabilities, cerebral palsy, and other congenital disabilities such as spina bifida, or arthrogryposis.
In addition, individuals with other types of disabilities resulting in permanent or temporary impairment to upper extremity function may also benefit from use of the RTD Arm as an aid in performing manipulation of objects. These disabilities include paraplegia, stroke, severe head injury, multiple broken bones, and severe rheumatoid arthritis, among others.
The RTD Arm may be purchased as an over-the-counter device.
The RTD Arm is a wheelchair-mountable powered electromechanical arm which permits persons with severe disabilities to manipulate objects in their personal environment. The RTD Arm is controlled through standard switch-based input devices and can be mounted on either side of most powered wheelchairs. At full reach (48 inches), the RTD Arm can lift four pounds and, as the arm is retracted, the lifting capacity becomes proportionally greater. The arm has 4 degrees of freedom to enable the arm to access an obiect, which is augmented by the two planar degrees of freedom of the wheelchair.
Using the RTD Arm input control device, the operator retrieves an object by quiding the arm one ioint at a time until it is in the correct position. The operator then activates the gripper to grasp the object and directs the arm to the desired end point. The arm can be operated by the user's existing chair switch mechanism (e.g. joystick, head pad sensor, or sip and puff), with wiring modifications, or with the 8 Position Joystick or Keypad provided with the arm. The arm includes four 24V motors controlled by a solid state motor controller powered by the wheelchair battery. Wheelchair installation is performed using a mounting bracket, which secures the unit to the chair frame directly behind the front caster.
The RTD Arm includes the following primary safety features:
Gripper strength limit. Iimited to 5 pounds per square inch.
Slip clutches. All joints include an in-line, maintenance-free slip clutch at each motor which begin to slip when 5 pounds per square inch is exerted by the arm.
Low center of gravity. The center of gravity of the arm is kept very low on the wheelchair by mounting it under the seat behind the front wheels. In most cases, the center of gravity of the overall chair and arm is lower than without the arm.
The provided text does not contain detailed information about specific acceptance criteria for the "RTD Arm" device, nor does it describe a study that explicitly proves the device meets such criteria. The document is a 510(k) summary for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.
However, based on the information provided, we can infer some aspects and acknowledge the absence of others:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Lifting Capacity | 4 pounds at full reach (48 inches); proportionally greater when arm is retracted. |
| Degrees of Freedom | 4 degrees of freedom (augmented by 2 planar degrees of freedom of the wheelchair). |
| Gripper Strength Limit | Limited to 5 pounds per square inch. |
| Slip Clutch Functionality | Slip clutches activate when 5 pounds per square inch is exerted by the arm. |
| Low Center of Gravity | Mounted under the seat behind the front wheels, typically resulting in a lower overall center of gravity for the chair and arm than without the arm. |
| Control Mechanism | Controlled through standard switch-based input devices (joystick, head pad sensor, sip and puff) or 8 Position Joystick/Keypad provided. |
| Mounting Compatibility | Mountable on either side of most powered wheelchairs. |
| Power Source | Powered by the wheelchair battery (four 24V motors). |
| Target User Manipulation | Enables manipulation of objects in a personal environment for individuals with severe disabilities. |
| Safety Features | Gripper strength limit, slip clutches, low center of gravity. |
Absence of Information Regarding Acceptance Criteria-Specific Studies: The document does not describe specific tests or studies conducted to quantify and prove that the device consistently meets these performance metrics with predefined thresholds. For example, it states the lifting capacity but doesn't detail a study where the arm was tested to ensure it consistently lifts 4 lbs in various conditions.
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective study) related to demonstrating the device's technical performance. The focus is on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- The document does not describe any ground truth establishment for a test set that would involve experts. This type of information is typically found in clinical trials or performance validation studies, which are not detailed here.
4. Adjudication Method for the Test Set:
- As there is no description of a test set requiring ground truth establishment by experts, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The document does not describe an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The RTD Arm is an electromechanical assistive device, not an AI-based diagnostic or assistive reading tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- The RTD Arm is a physical, electromechanical device that requires human operation ("human-in-the-loop"). Therefore, a "standalone algorithm only" study, as conceptualized for AI software, is not applicable and not mentioned. The document describes the device's functional capabilities.
7. Type of Ground Truth Used:
- The concept of "ground truth" as typically applied to performance studies (e.g., expert consensus, pathology, outcomes data) is not directly relevant or discussed in this 510(k) summary regarding the performance of the RTD Arm. The information provided describes the device's design, intended use, and safety features.
8. Sample Size for the Training Set:
- The RTD Arm is an electromechanical device, not a machine learning model. Therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Given that this is an electromechanical device and not an AI/ML system, this question is not applicable.
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DEC 17 1999
Image /page/0/Picture/1 description: The image shows the logo for Rehabilitation Technologies Applied Resources Corp. The logo features a stylized letter "R" in black on the left side of the image. To the right of the "R" are the words "Rehabilitation Technologies" in bold, with the words "Applied Resources Corp." underneath.
Rehabilitation Technologies Division
October 6, 1999
1052
510(k) Summary RE:
Submitter's Name, Address, Phone number:
Rehabilitation Technologies Division 1275 Bloomfield Avenue Fairfield, New Jersey 07004 973-575-0650, fax: 973-575-0704
Contact Person:
Richard M. Mahoney Director of Business Development
Date Prepared:
October 6, 1999
Common Names:
Rehabilitation Robot
- Wheelchair Robot
- Assistive Robot
- Telethesis
- Robotic Aid
- Powered Arm
- Electric Reacher
Proprietary/Trade Name:
RTD Arm
Classification Name:
Prosthesis
{1}------------------------------------------------
200
Predicate Devices:
| Device Name | Company | 510(k) |
|---|---|---|
| Helping Hand | Kinetic Rehabilitation Instruments | K954427 |
| Prehensile Hand | Therapeutic Recreation Systems | K791931 |
Description:
The RTD Arm is a wheelchair-mountable powered electromechanical arm which permits persons with severe disabilities to manipulate objects in their personal environment. The RTD Arm is controlled through standard switch-based input devices and can be mounted on either side of most powered wheelchairs. At full reach (48 inches), the RTD Arm can lift four pounds and, as the arm is retracted, the lifting capacity becomes proportionally greater. The arm has 4 degrees of freedom to enable the arm to access an obiect, which is augmented by the two planar degrees of freedom of the wheelchair.
Using the RTD Arm input control device, the operator retrieves an object by quiding the arm one ioint at a time until it is in the correct position. The operator then activates the gripper to grasp the object and directs the arm to the desired end point. The arm can be operated by the user's existing chair switch mechanism (e.g. joystick, head pad sensor, or sip and puff), with wiring modifications, or with the 8 Position Joystick or Keypad provided with the arm. The arm includes four 24V motors controlled by a solid state motor controller powered by the wheelchair battery. Wheelchair installation is performed using a mounting bracket, which secures the unit to the chair frame directly behind the front caster.
The RTD Arm includes the following primary safety features:
Gripper strength limit. Iimited to 5 pounds per square inch.
Slip clutches. All joints include an in-line, maintenance-free slip clutch at each motor which begin to slip when 5 pounds per square inch is exerted by the arm.
Low center of gravity. The center of gravity of the arm is kept very low on the wheelchair by mounting it under the seat behind the front wheels. In most cases, the center of gravity of the overall chair and arm is lower than without the arm.
Intended Uses:
The RTD Arm is designed to be mounted on a powered wheelchair, and used to carry out simple manipulation tasks.
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Image /page/2/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 eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 1999
Mr. Richard M. Mahoney Director of Business Development Rehabilitation Technologies Division 1275 Bloomfield Avenue Fairfield, New Jersey 07004
Re: K993443
Trade Name: RTD Arm Assistive Robotic Device Regulatory Class: II Product Code: ITI Dated: October 7, 1999 Received: October 12, 1999
Dear Mr. Mahoney:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 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 action. In addition, FDA may publish further announcements concerning your device 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.
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Page 2 - Mr. Richard M. Mahoney
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Nil R.P. Ogden
James E. Dillard III
James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
510(k) NUMBER (IF KNOWN): K993443 RTD ARM ASSISTIVE ROBOTIC DEVICE DEVICE NAME: INDICATIONS FOR USE:
The RTD Arm permits persons with severe disabilities to manipulate objects in their personal environment and thus to establish a greater measure of functional independence. The client population for this device includes individuals with
- very limited or complete absence of bilateral upper extremity ● function.
- lower extremity impairment requiring the use of a power . wheelchair, and
- intact cognitive and visual perceptual ability. .
The medical diagnoses of the target user populations include high-level quadriplegia, neuromuscular disabilities, cerebral palsy, and other congenital disabilities such as spina bifida, or arthrogryposis.
In addition, individuals with other types of disabilities resulting in permanent or temporary impairment to upper extremity function may also benefit from use of the RTD Arm as an aid in performing manipulation of objects. These disabilities include paraplegia, stroke, severe head injury, multiple broken bones, and severe rheumatoid arthritis, among others.
The RTD Arm may be purchased as an over-the-counter device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | PRO for |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K993443 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter-Use(Optional Format 1-2-96) |
|---|---|---|
| X |
N/A