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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:

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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