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The intended use of the LIFTKAR PT™ is to transport a wheelchair user or a person needing assistance up or down stairs by means of a battery powered, mobile lifting device. LIFTKAR PT is operated by an attendant and is used in residential and public facilities indoors and outside.

The LIFTKAR PT™ Is a wheelchair, elevator commonly known as an easy method of transporting wheelchair users of uisabled persons, ap and as a mobile stair-climber. This is done with alitting - LIFT AD PT. LIFTKAR PT™ can be used on any stairs indoors or outside.

The LIFTKAR PT™ ADAPT is an attendant operated, battery powered lifting device that transports manual wheelchairs up or down stairs. The LIFTKAR PT is designed for indoor and outdoor use allowing mobility for the person needing assistance.

A portable stair-climber LIFTKAR PT can be dismantled into three parts, the climber unit, the battery pack and the handle. All parts are lightweight and easy to stow away.

Acceptance Criteria and Device Performance for SANO Transportgeraete GmbH LIFTKAR PT™ Elevator Wheelchair

This document outlines the acceptance criteria and reported device performance for the LIFTKAR PT™ ADAPT, an attendant-operated, battery-powered lifting device for transporting manual wheelchairs up or down stairs, as presented in the 510(k) Summary K110495.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LIFTKAR PT™ ADAPT are primarily based on conformity to established international standards for wheelchairs and stair-climbing devices, as well as demonstrating substantial equivalence to a predicate device. The performance data section indicates that the device meets specifications for performance criteria and intended functions, thereby satisfying the acceptance criteria.

The "Reported Device Performance" for the LIFTKAR PT™ ADAPT, as stated in the submission, is that it "conforms with the following standards" and that "The performance Data results of the testing confirm that the device meets specifications for the performance criteria and the functions it was intended for." This implies successful demonstration against the requirements within each standard.

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

• Sample Size: Not explicitly stated in the provided document. The testing reports are referenced as "BERLIN CERT Prui und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin, TEST Reports in Section: 11.7-32". These reports would contain the detailed sample sizes for the various tests carried out to confirm compliance with the listed ISO and EN standards.
• Data Provenance: The testing was performed by "BERLIN CERT Prui und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin". This indicates the testing was conducted in Germany (Berlin). The nature of the tests (compliance with standards for mechanical devices) suggests prospective testing specifically designed to evaluate the device against these criteria, rather than retrospective analysis of existing data.

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

This information is not provided in the document. For performance testing of a mechanical device against international standards, the "ground truth" is typically established by the specified test methods within the standards themselves and evaluated by qualified testing engineers at the certification body (BERLIN CERT). There is no indication of "experts" in the sense of clinical specialists establishing a "ground truth" for a diagnostic or interpretative task.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's disagreement among human readers/experts in diagnostic studies. For objective performance testing of a mechanical device against established engineering standards, an adjudication method for the "test set" as described is not applicable or typically used. The testing is based on objective measurements and predefined acceptance criteria outlined in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for medical imaging or diagnostic devices where human readers interpret results, and the study aims to assess the impact of AI assistance on their performance. The LIFTKAR PT™ is a mechanical mobility device; its evaluation focuses on engineering performance, safety, and substantial equivalence, not the interpretive accuracy of human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The concept of a "standalone" algorithm performance is not applicable to this device. The LIFTKAR PT™ is an attendant-operated mechanical device. Its performance is intrinsically linked to its mechanical function and its interaction with an attendant, not an independent algorithm making decisions or interpretations. The performance evaluation focuses on the mechanical and electrical integrity and functionality of the device itself.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation is based on objective engineering and safety standards (ISO and EN standards). This includes:

• Predefined thresholds and specifications: e.g., maximum load capacity, battery life (number of steps), static stability, dimensions.
• Standardized test methods: Procedures outlined in the ISO and EN standards for measuring these parameters.
• Substantial equivalence to a predicate device: Comparisons of design, components, and performance specifications to an already legally marketed device (Scalamobil K920105).

8. The Sample Size for the Training Set

This question is not applicable to the LIFTKAR PT™ ADAPT submission. "Training set" refers to data used to train machine learning algorithms. The LIFTKAR PT™ is a mechanical device, not an AI or machine learning product. Its development and approval process do not involve training sets for algorithms.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for an AI algorithm involved in the LIFTKAR PT™ ADAPT.

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