FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

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.

ITEM	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Capella/Capella 45)
Indications for Use	Providing mobility to persons limited to a sitting position.	Providing mobility to persons limited to a sitting position.
Product Description	Dynamic tilt-in-space mechanical wheelchair, rigid aluminum frame, anti-tippers, tilt and manual recline, gas spring(s) for tilt operation controlled by caregiver levers. Accommodates different size occupants.	Dynamic tilt-in-space mechanical wheelchair, rigid aluminum frame, anti-tippers, tilt and manual recline, gas spring(s) for tilt operation controlled by caregiver levers. Accommodates different size occupants. Capella uses two gas springs, Capella 45 uses one.
Intended surface for operation	All surfaces except rough surfaces.	All surfaces except rough surfaces.
Safety Characteristics	Spring return push-to-lock wheel lock, anti-tippers, rigid body frame for resistance to fatigue, shear, and impact forces.	Spring return push-to-lock wheel lock, anti-tippers, rigid body frame for resistance to fatigue, shear, and impact forces. Designed and tested according to ANSI/RESNA WC/Vol.1, with satisfactory results.
Overall Function & Physical Characs.	Rigid, aluminum frame, anti-tippers, tilt and manual recline. Capacity: 250 lbs.	Rigid, aluminum frame, anti-tippers, tilt and manual recline. Capacity: 350 lbs (Capella), 250 lbs (Capella 45).
Tilt	20 degrees.	17 degrees (Capella), 44 degrees (Capella 45). (Static stability test performed to ensure no stability problems).
Fixed Recline	0 to 30 degrees.	-7 to +21 degrees (28 degrees). (Standard chair resting state is +7 deg recline).
Seat Width	13-20 inches.	16-24 inches. (Test results satisfactory, no impact on safety/effectiveness).
Seat Depth	15-20 inches.	15-20 inches. (Test results satisfactory, no impact on safety).
Seat-to-floor height	13-20 inches (front).	13-19 inches (front). (Comparable, no bearing on safety/effectiveness).
Adjustable arm heights	10-14 inches.	9.5-14 inches. (No impact on effectiveness/safety).
Front Riggings	70 and 90 degrees.	60, 70, 80, 90 degrees. (No impact on safety/effectiveness).
Back Post Heights	20 and 25 inches.	19 and 24 inches. (No impact on safety/effectiveness).
Rear Wheel Sizes	12, 16, 20, 22, 24 inches.	16, 20, 22, 24 inches. (Each size evaluated for stability and strength with satisfactory results).
Caster Sizes	5, 6, or 8 inches.	5, 6, 7, or 8 inches. (Each size evaluated by Future Mobility, no impact on safety).
Chair Width	For 12 and 16" rear wheels: seat width is +9.5"; for 20, 22, 24" rear wheels: seat width is +10.75".	Seat width +10.75 inches. (Safety evaluated to be satisfactory, no impact to effectiveness).
Chair Length (no riggings)	28 inches.	31 inches. (No impact on safety/effectiveness).
Overall Length	42 inches.	45 inches. (No impact on safety/effectiveness).
Maximum Human Support Weight	250 lbs.	350 lbs (Capella), 250 lbs (Capella 45). (All chairs passed safety, stability, fatigue, and strength tests).
Flammability Standards (Materials)	Meets California Technical Bulletin CAL177 standard for flame retardant.	Meets California Technical Bulletin CAL 177 standard for flame retardant for backrests and seat cushions. (No impact on safety and effectiveness).
Prescription use or over-the-counter	Over the counter.	Over the counter. (No impact to safety and effectiveness).
Gas Spring Configuration	Single center-positioned locking gas spring.	Capella: Two locking gas springs in tandem parallel configuration. Capella 45: Single center-positioned locking gas spring. (No impact to safety and effectiveness).
Compliance with Standards (Overall)	Implied compliance to relevant medical device standards for mechanical wheelchairs (as K063736 was cleared).	Developed in accordance with ISO 7176, parts 1, 5, 7, 8, 11, 13, and 15. All results are satisfactory and meet the standards indicated from ANSI/RESNA WC/Vol.1. Passed safety, stability, fatigue, and strength tests.

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.

Summary

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).