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The Future Mobility Healthcare Inc. Capella wheelchair is intended to provide mobility to persons limited to a sitting position.

Dynamic tilt in space mechanical wheelchair which offers adjustability to redistribute the body weight for optimal positioning. The tilting is operated by the care-giver in the back handles of the chair. The Capella/Capella 45 can accommodate different size occupants. The seat width and depth can be ordered in several sizes. The Capella/Capella 45 is constructed of a rigid, aluminum frame with anti-tippers and the ability to tilt and manual recline. Depending on the seat depths, it has a capacity to support a human weight of 350lbs (250lbs Capella45). One gas spring is used to lift an ddecline the seat and back to the tilting positions in the Capella 45. And the Capella uses two gas springs. The gas spring(s) are connected by cables to levers on the push bar so that they can be locked and unlocked by the caregiver.

The provided text is a 510(k) summary for a mechanical wheelchair, not a medical imaging or AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set) are not applicable to this type of device submission.

The acceptance criteria for this device, a mechanical wheelchair, are primarily based on ensuring its safety and effectiveness through compliance with recognized standards and comparison to a predicate device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device (Future Mobility Healthcare Inc. Capella/Capella 45) demonstrates substantial equivalence to the predicate device (PDG Inc. Fuze T20) by meeting or exceeding similar performance characteristics and conforming to relevant safety standards.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is an engineering and performance testing study conducted against harmonized standards. The submission states:

• "The Capella/Capella45 has been designed and tested according to the ANSI/RESNA WC/Vol.1. All results are satisfactory and meet the standards indicated from ANSI/RESNA WC/Vol.1"
• "All chairs passed safety, stability, fatigue and strength tests."
• "Each wheel size has been evaluated by Future Mobility for stability and strength with satisfactory results."
• "Each caster size has been evaluated by Future Mobility."
• The conclusion explicitly states: "Future Mobility Healtheare Capella Dynamic Tilt mechanical wheelchair was developed in accordance with ISO 7176, parts 1, 5, 7, 8, 11, 13, and 15. It is the conclusion that the Future Mobility HealthCare Capella wheelchair is safe and effective, as well as substantially equivalent to the legally marketed device identified as the predicate devices."

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated as a number of devices. It refers to "All chairs" and "Each wheel size" and "Each caster size," implying that representative samples of the manufactured devices and their components were tested. For a mechanical device of this nature, testing protocols usually involve a predefined number of units or components to demonstrate reliability and meet engineering standards.
• Data Provenance: Not explicitly stated, but the testing would have been conducted by Future Mobility Healthcare Inc. or a contracted testing facility, likely in the country of origin (Canada, based on the submitter's address). This is a prospective evaluation of the newly designed device's performance against established physical standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. "Ground truth" in the context of mechanical device testing typically refers to the objective physical measurements and performance metrics defined by the specific engineering standards (ANSI/RESNA WC/Vol.1, ISO 7176 parts). Experts are involved in setting these standards and designing the tests, but not in establishing "ground truth" for individual test results in the same way as in a diagnostic study.

4. Adjudication method for the test set

• Not applicable. Performance is measured against objective, quantitative engineering specifications, not subjective interpretation requiring adjudication.

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. This is not an AI or diagnostic device.

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

• Not applicable. This is not an AI or diagnostic device. Performance is inherently "standalone" in that the wheelchair's mechanical properties are tested independently of a human user, though it's designed for human interaction.

7. The type of ground truth used

• Engineering Standards / Objective Performance Metrics: The "ground truth" is defined by the objective pass/fail criteria and quantitative limits set forth in the referenced international and national standards: ANSI/RESNA WC/Vol.1 and ISO 7176 (parts 1, 5, 7, 8, 11, 13, and 15). These standards cover aspects like static stability, strength, fatigue, dimensions, and material properties.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI model requiring a training set. The "design and development" process would involve iterative prototyping and testing, but not in the sense of a machine learning training set.

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

• Not applicable. No training set is used for this type of device.

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Capella is designed to test cochlear function of both infants and adults in a hospital, nursery, ENT clinic or audiology office. It allows the operator to get information about a person's hearing without through or requiring any response from the individual being tested.

Capella Cochlear Emissions Analyzer

The provided text is a 510(k) premarket notification letter from the FDA to Madsen Electronics, Inc. regarding their Capella Cochlear Emissions Analyzer. It states that the device is substantially equivalent to legally marketed predicate devices.

The information needed to describe acceptance criteria and the study that proves the device meets those criteria is not present in the provided document. This document is an FDA clearance letter, which confirms substantial equivalence but does not detail the specific performance studies, acceptance criteria, or their results.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device