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The Future Mobility Healthcare Inc. Super Chair for Kids by Orion Wheelchair is intended to provide mobility to persons limited to a sitting position.

The ORIONII, Zippie TS and Super Chair for Kids by Orion tilt in space wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of mechanical steel frames for use by patients weighing up to 150 lbs.

The provided text describes a 510(k) premarket notification for a medical device, the "Super Chair for Kids by Orion Tilt in Space mechanical wheelchair." This is a mechanical wheelchair, not an AI/ML-driven diagnostic or medical device that typically requires extensive acceptance criteria, performance studies, or ground truth establishment in the way the prompt describes.

The 510(k) submission process for this type of device focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo performance metrics through clinical trials or complex diagnostic studies. Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this specific submission.

Here's an analysis based on the provided document and the nature of a mechanical wheelchair 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

For a mechanical wheelchair, "acceptance criteria" primarily relate to safety standards and functional equivalence to predicate devices, rather than diagnostic accuracy metrics.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. This is a mechanical device, not a diagnostic algorithm. The "testing" involved demonstrating compliance with international standards (ISO 7176) and technical equivalence to existing devices. This typically involves engineering testing and comparison of specifications, not a "test set" of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. The concept of "ground truth" as it applies to diagnostic accuracy from expert interpretation is not relevant for a mechanical wheelchair. Device functionality and safety are assessed against engineering standards and comparison with predicate devices.

4. Adjudication Method for the Test Set:

• Not Applicable. No human-interpreted "test set" in the diagnostic sense was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is a mechanical wheelchair, not an AI-driven diagnostic tool. No human readers or AI assistance are involved in its primary function.

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

• Not Applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used:

• For this type of device, the "ground truth" (or equivalent) is established by engineering standards compliance (ISO 7176) and the established safety and effectiveness of the legally marketed predicate devices. The claim of substantial equivalence is the "proof."

8. The Sample Size for the Training Set:

• Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As there is no training set, there is no ground truth to establish for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is fundamentally a technical comparison and demonstration of compliance with recognized standards.

• Nature of the "Study": This was not a clinical trial in the traditional sense, but rather a bench and engineering testing verification combined with a comparative analysis against predicate devices.
• Methodology:
  1. Technical Specification Comparison: The manufacturer compared the design, materials, intended use, and functional characteristics of the "Super Chair for Kids by Orion" to the predicate devices (Zippie TS and ORION II).
  2. Standards Compliance Testing: The device was developed and tested in accordance with ISO 7176 standards (parts 1, 5, 7, 8, 11, and 19). These standards cover various aspects of wheelchair performance, safety, and durability (e.g., dimensions, static strength, impact strength, fatigue strength, and securement in motor vehicles). The report explicitly states, "Future Mobility HealthCare Super Chair for Kids by Orion folding mechanical wheelchair was developed in accordance with ISO 7176, parts 1. 5. 7. 8. 11 and 19."
  3. Demonstration of Substantial Equivalence: The manufacturer argued that the device shared the same indications for use, similar key technical characteristics, similar operational modes (manual, self-propelled, attendant-propelled), similar construction (steel frames), equivalent weight capacity (up to 150 lbs), and met the same safety standards for motor vehicle transport tie-down systems (ANSI/RESNA WC/Vol.1 Annex A Section 19) as the predicate devices.
• Conclusion: Based on this comparison and compliance with international standards, it was concluded that the "Super Chair for Kids by Orion" is safe and effective and substantially equivalent to the identified predicate devices. The FDA's 510(k) clearance (K103073) formally acknowledges this determination of substantial equivalence.

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