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The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac are indoor/outdoor battery operated multifunctional wheelchairs. The intended use of these powered wheelchairs is to provide mobility to persons that have the capability of operating a powered wheelchair.

The Balder Finesse and Balder Junior powered wheelchairs are front-wheel driven power wheelchairs that have been designed and developed to be used in both indoor and outdoor environments. and to transport one (1) person at a time. The wheelchairs are outfitted with a seat lift, so that its user can reach objects on high shelves as well as slide their legs under the table when seated. The Balder Finesse and Balder Junior powered wheelchairs can also be purchased with a stand-up function option that allows the user to be placed in a stand-up position, thus allowing them to operate the wheelchair while standing. The Balder Finesse and Balder Junior powered wheelchairs operate using an electric, front-wheel drive motor that is driven by two (2) 12 Volt, 52 Amp dry cell batteries, and contains a D.C. permanent magnet type motor that uses graphite-copper brushes with integrated brakes (12/24V). The wheelchair frame is of welded steel construction and includes the rear castor wheels, front driving wheels with drive motor (i.e., motor, gear, brakes) and batteries. The motor controller, with joystick, can be mounted on either the left or right armrest depending on the user's needs. The motor controller, with joystick and software that is found in each wheelchair is manufactured by Dynamic Controls, a division of Invacare Corporation, and was previously cleared by the FDA on May 12, 1997 (see K970094).

The provided submission K072475 for the Balder Finesse and Balder Junior Powered Wheelchairs is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance metrics through a study.

Therefore, many of the requested items related to a clinical performance study (like sample size for test set, number of experts, adjudication methods, MRMC studies, specific ground truth types, and training set details) are not applicable or not provided in this type of submission.

The "acceptance criteria" here relate to compliance with recognized standards and substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance

Study Details (Generally Not Applicable for 510(k) Substantial Equivalence for this type of device)

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on engineering testing against consensus standards and a comparison to a predicate device, not a performance study with a clinical test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/diagnostic devices is not relevant here. Compliance with standards and substantial equivalence are the "ground truth."
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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-assisted diagnostic or assistive technology in that context.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is established through compliance with recognized consensus standards (ISO, EN, FDA Guidance) and the demonstrated equivalence to a legally marketed predicate device.
7. The sample size for the training set: Not applicable. This is not a machine learning/AI device that requires a training set in that sense.
8. How the ground truth for the training set was established: Not applicable.

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