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The Future Mobility HealthCare Inc. Orion II Wheelchair is intended to provide mobility to persons limited to a sitting position.

The Future Mobility HealthCare Orion II wheelchair is a compact tilt-in-space wheelchair offering 45° of tilt, 30° of recline and adjustable seat-to-floor heights of 12 3/4' to 19". It consists of rigid, mechanical, steel frame and upholstery that meets the California Technical Bulletin CAL 117 standard for flame retardant. It has two rear wheels (12", 20", 22" or 24" in diameter) and two front casters (4", 5", 7" or 8" in diameter) for turning and maneuverability.

This submission for the Future Mobility HealthCare Inc. Orion II Wheelchair is a 510(k) premarket notification. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of detailed study data you're asking for in points 2-9.

Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is not applicable to this type of regulatory submission for this device. The document provided does not contain a study of the type you describe.

Here's an analysis based on the information provided, fitting it to your requested structure where possible, and noting where the information is absent or not applicable due to the nature of a 510(k) for a mechanical wheelchair:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) of a mechanical wheelchair, "acceptance criteria" are generally tied to demonstrating equivalence in design, materials, and intended use as compared to a predicate device. Performance is assessed through compliance with recognized standards.

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

• Not applicable / Not provided. This 510(k) summary does not describe a clinical performance study with a test set of patients or data in the way you might find for an AI/diagnostic device. The "test" for a mechanical wheelchair 510(k) involves demonstrating mechanical equivalence and adherence to engineering standards (like ANSI/RESNA, ISO 7176).

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)

• Not applicable / Not provided. As there is no clinical performance study with "ground truth" to establish for a mechanical wheelchair 510(k). Ground truth in this context would typically relate to a diagnostic outcome, which is not relevant here.

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

• Not applicable / Not provided. See point 3.

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

• Not applicable. MRMC studies are relevant for diagnostic/AI devices. This is a mechanical wheelchair.

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

• Not applicable. This is a mechanical wheelchair, not an algorithm.

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

• Not applicable / Not provided in this context. The "ground truth" for a mechanical device's safety and effectiveness relies on engineering standards, material specifications, and mechanical testing to ensure the components perform as intended (e.g., tilt mechanism holds weight, frame doesn't fail). These tests are typically outlined in the full 510(k) submission but are not detailed in this summary.

8. The sample size for the training set

• Not applicable / Not provided. As there is no "training set" for a mechanical wheelchair undergoing a 510(k) for substantial equivalence.

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

• Not applicable / Not provided. See point 8.

Summary of the Basis for Substantial Equivalence (as reported in the document):

The Orion II Wheelchair's substantial equivalence to the Invacare Concept 45 Wheelchair is based on:

• Same Indications for Use: Both provide mobility to persons limited to a sitting position.
• Similar Key Design Technical Characteristics: Both are mechanical wheelchairs with tilt (45°) and recline (30°) capabilities, adjustable back angles, and similar seat depth and widths.
• Similar Size, Weight, and Performance: A general claim of similarity.
• Similar Materials: Both use resistance-ignitability fabric meeting California Technical Bulletin CAL 117 for flame retardant standards.
• Compliance with Standards: The Orion II was developed based on ANSI/RESNA Wheelchair Vol.1, which involves ISO 7176 standards.

The FDA's decision to clear the device (K061010) confirms their agreement that the provided information demonstrates substantial equivalence to the predicate device, allowing it to be marketed.

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