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The intended use of the 7000 Series Lightweight Wheelchair is to provide mobility to adult persons with limited mobility or adult persons limited to a seated position. The target population for the 7000 Series Lightweight Wheelchair is the United States adult population.

The 7000 Series Lightweight Wheelchair is mechanical wheelchair that is lightweight in design (weighs 31.5 lbs) and provides mobility to persons with limited mobility or persons limited to a sitting position. The 7000 Series Lightweight Wheelchair comes in 16", 18" and 20" seat widths and has component adjustments for optimum fitting. The 7000 Series Lightweight Wheelchair has dual crossbar support, flip back removable arms, flame retardant nylon upholstery, removable footrests with heel loops, dual axle positioning and wheel locks.

The Nova Ortho-Med, Inc. 7000 Series Lightweight Wheelchairs underwent non-clinical testing to demonstrate substantial equivalence to a predicate device (Invacare 9000 Series Wheelchair, K881951). The device is a mechanical wheelchair weighing 31.5 lbs, available in 16", 18", and 20" seat widths.

The acceptance criteria and reported device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

• Brakes Test passed
• Static Test passed
• Impact Test passed
• Strength Test passed | Passed all listed sub-tests. |
  | ISO 7176-11: Test Dummies | No specific acceptance criteria mentioned; likely refers to the standard's methodology for testing. | Implicitly Met (no failure reported). |
  | ISO 7176-13: Determination of Coefficient of Friction of Test Surfaces | No specific acceptance criteria mentioned; likely refers to the standard's methodology for testing. | Implicitly Met (no failure reported). |
  | ISO 7176: Determine of Effectiveness of Brakes | No specific acceptance criteria mentioned, but implies effective brake operation. | Implicitly Passed (On-Road Test explicitly passed brakes). |
  | ISO 7176-15: Requirements for information disclosure, documentation and labeling | Adherence to standard for labeling and documentation. | Implicitly Met (submission deemed compliant by FDA). |
  | ISO 7176-1: Determination of Static Stability | No specific acceptance criteria mentioned; implies stable operation. | Implicitly Met (Static Test explicitly passed). |
  | ISO WC: Determination of Overall Dimensions, Mass and Turning Space | Conformance to standard for measuring these parameters. | Implicitly Met (device description provides these details). |

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

The document does not specify a "test set" in the context of human subjects or a dataset. The testing performed was non-clinical, involving physical performance tests on the device itself.

• Sample Size: The document implies testing was performed on a sample of the 7000 Series Lightweight Wheelchair(s) to demonstrate compliance with the listed ISO standards and an "On Road Test for Durability." The exact number of units tested is not specified.
• Data Provenance: The testing was conducted by Nova Orthopedic and Rehabilitation Appliance Inc. (for the On-Road Test) and presumably by accredited labs for the ISO standards. The country of origin for the data is not explicitly stated, but Nova Ortho-Med, Inc. is based in the USA. The tests were prospective for the purpose of this submission (i.e., conducted specifically to demonstrate compliance).

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)

This question is not applicable to this submission. The "ground truth" for non-clinical performance testing typically refers to the objective results against established engineering and safety standards, not expert consensus on medical conditions. The tests were performed according to defined international standards (ISO) and the results were objectively measured.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert disagreement on complex interpretations (e.g., medical images) needs to be resolved to establish ground truth. For non-clinical performance testing, the results are typically determined by objective measurements and evaluation against predefined criteria within the respective standards.

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

This question is not applicable as this is a submission for a mechanical wheelchair, not an AI-powered diagnostic device or a device involving human readers for interpretation.

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

This question is not applicable as this is a mechanical device, not an algorithm or AI system.

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

The "ground truth" for the non-clinical testing was established by adherence to recognized international standards (ISO series) and the successful completion of specific physical performance tests (e.g., flammability, upholstery strength, durability). The criteria within these standards define what constitutes a "passing" result.

8. The sample size for the training set

This question is not applicable as this is a non-AI mechanical device. There is no "training set" in the context of machine learning.

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

This question is not applicable as there is no "training set" for this mechanical device.

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