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Therapeutic effect:

• Provision of out-of-bed seating for disabled persons.
• Transportation of disabled persons from one location to another in a room or in a building or outdoors.
• Transportation of disabled persons in the device in motor vehicles.

Medical conditions for which the device is indicated:

• Post-operative weakness or debility.
• Age-related weakness or debility.
• Paralysis due to stroke, tumour, etc.
• Impairment of function due to MS, ALS, Polio.
• Impairment from physical trauma.
• Impairment from accidents at birth.

Designed to remedy perceived shortfalls in the design of standard wheelchairs, particularly in the category of user safety, the GOVAN+ device's distinctive appearance confirms that it is not meant to be a duplicate of the predicate device.

The provided text describes the GOVAN+ wheelchair and its substantial equivalence to a predicate device, focusing on safety improvements, particularly for transportation in vehicles.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of a number of wheelchairs or human subjects. The testing is described qualitatively (e.g., "crash-tested repeatedly") and by citing compliance with standards, rather than a specific number of units tested.
• Data Provenance:
  • Country of Origin: Not explicitly stated for all tests. Compliance with ANSI/RESNA and SAE standards are mentioned, which are US-based organizations, suggesting testing might have occurred in the US or Canada (company is based in Winnipeg, Manitoba, Canada).
  • Retrospective or Prospective: Not specified. Standard compliance testing is typically prospective, involving new products and controlled tests.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable or not specified. This document does not describe a study involving expert review for establishing ground truth as it would for, for instance, image analysis or diagnostic devices. The acceptance criteria are based on engineering and safety standards (ANSI/RESNA, SAE), which are objective and quantifiable, not subject to expert consensus in the same way clinical ground truth is.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since the 'ground truth' is defined by compliance with established engineering and safety standards, there's no need for an adjudication method involving multiple human readers. The results are based on objective measurements and calculations during standardized tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation is involved, and the AI's effect on human performance is being evaluated. The GOVAN+ is a physical medical device (wheelchair) and its performance is evaluated against engineering standards.
• Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: Yes, in a sense. The "standalone" performance is assessed by direct compliance with the ANSI/RESNA and SAE standards. The device itself (the GOVAN+ wheelchair) is the "algorithm" in this context, and its physical properties and crashworthiness are tested independently of a human operator, beyond the presence of an occupant for realistic testing conditions. The testing of the device and its docking accessory against these standards represents an evaluation of its intrinsic performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the GOVAN+ wheelchair's performance is established by engineering and safety standards. Specifically:
  • ANSI/RESNA WC VOL.1 Section 19 for dynamic crash testing of wheelchairs.
  • SAE J2249 for wheelchair docking/tie-down systems.
  • Observed physical characteristics (e.g., tipping angles).

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set of data. The "training" for the GOVAN+ device comes from its design and engineering principles rather than data.

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

• Ground Truth for Training Set: Not applicable. As there's no training set in the AI/ML sense, there's no ground truth established for it. The design and development of the GOVAN+ would have been guided by existing engineering principles, safety regulations, and potentially feedback from users or designers, but this is distinct from establishing a "ground truth" for a data-driven model.

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