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The Stryker Sorano Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.

The Stryker Sorano Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position.

The product consists of a titanium frame (also available in chrome-moly steel), large rear wheels with handrims for propelling the chair, and smaller front pivoting casters for stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair.

The Stryker Sorano offers a suspension system made of a fibre glass composite. The two suspension elements are part of the frame construction as they connect the main frame to the rear wheel axle. As it is part of the frame, the suspension is a standard feature.

The Stryker Sorano offers an additional propulsion method to conventional handrims. A lever drive option may be added that provides two forward gear ratios an incorporates a disc braking system. Handrim use is still possible as handrims are standard on all units. The key benefits to the drive system are that it eliminates the need to grip the handrim, provides mechanical advantage and provides an enhanced braking system.

The Stryker Sorano also offers modularity and adjustability features. The seat height, angle, rear seat-to-floor height, and front seat-to-floor height may be adjusted by the end user. The footrest module with caster wheels may be adjusted forward and backward, and the footrest height may be adjusted. The backrest angle and height may also be adjusted. In addition, the footrest module is removable and may be replaced with optional sports or other special purpose footrests. The seat/backrest module and the footrest module may be removed by the user, allowing the entire wheelchair to be packed in a compact space for travel. The optional folding backrest enhances this feature.

The provided text describes the Stryker Sorano Wheelchair, a manual wheelchair, and its FDA 510(k) submission. However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert ground truth).

Instead, the "Performance Data" section states that the device will meet applicable performance standards specified in ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs." This indicates a reliance on an established industry standard for wheelchair performance, rather than a specific, custom-designed study with unique acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is an attempt to address the request based on the available information, with clear indications of what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the device will meet these standards, implying a commitment or expectation, rather than reporting specific test results from a study. Actual quantitative performance metrics against these standards are not provided.

Regarding the study proving the device meets acceptance criteria, the document states:

"The Stryker Sorano Wheelchair will meet the applicable performance standards specified in Rehabilitation Engineering Sociey of North American (RESNA) Standard ANSI/ RESNA WC/Vol. 1-1998 'Requirements and Test Methods for Wheelchairs.'"

This indicates that the device's performance is gauged by its adherence to this established industry standard. The document does not describe a specific, custom study conducted by Stryker with unique acceptance criteria and reporting on that study's outcomes. Instead, it leverages existing standards recognized for wheelchair safety and effectiveness.

The following information is NOT available in the provided text:

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
  • No specific test set or data provenance is mentioned beyond the general reference to the RESNA standard.
• 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 is not applicable as no specific test set requiring expert ground truth is described. The performance is assessed against an engineering standard.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
  • This is not applicable for the same reason as above.
• 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 is not applicable. The device is a mechanical wheelchair, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
  • This is not applicable. The device is a mechanical wheelchair.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
  • The "ground truth" or standard of performance is defined by the ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs." These are engineering and performance specifications, not medical ground truth in the diagnostic sense.
• 8. The sample size for the training set
  • This is not applicable. The device is a mechanical wheelchair, not a machine learning model requiring a training set.
• 9. How the ground truth for the training set was established
  • This is not applicable for the same reason as above.

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