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The LIFTKAR PT™-S Is a method of transporting disabled persons, up and downstairs while seated on the stairclimber, and not in a wheelchair. This is done with a lifting mechanism. It is a battery on the bailed in the been and on a certified attendant and can be used on any stairs indoors or outside.

The LIFTKAR PT™ S is an attendant operated, battery powered lifting device that transports a disabled person in an integrated chair up or down stairs, not in a wheelchair. The LIFTKAR PT-S is designed for indoor and outdoor use allowing mobility for the person needing assistance.

Here's an analysis of the provided text regarding the LIFTKAR PT™-S device, focusing on acceptance criteria and study details:

This submission is for a K111858, a 510(k) premarket notification. In a 510(k), manufacturers demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that their new device is as safe and effective as the predicate device, often through performance testing and comparison of technical specifications. It's important to understand that a 510(k) does not usually involve extensive clinical trials like a PMA (Premarket Approval) application, nor does it typically detail acceptance criteria in the same way one might for a novel, high-risk device. The "acceptance criteria" here are largely implied by demonstrating compliance with recognized standards and equivalence to the predicate.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LIFTKAR PT™-S are not explicitly stated in a quantitative table with pass/fail thresholds. Instead, acceptance is demonstrated by conforming to relevant international standards and showing substantial equivalence in performance to its predicate device, the C-Max-U2 (K103122).

The following table summarizes the device performance of the LIFTKAR PT™-S and its comparison to the predicate, which implies the performance criteria were met if the LIFTKAR PT™-S's performance is similar to or better than the predicate and complies with the standards.

The "acceptance criteria" are intrinsically tied to demonstrating that the LIFTKAR PT™-S meets the requirements of the listed international standards (ISO 7176-23:2002 and DIN EN ISO 10993-5) and performs comparably to or better than the predicate device in key functional areas.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a "sample size" in terms of number of devices tested for performance. It states that "The LIFTKAR PT™-S was tested by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin." This implies that the device (likely one or a few units representative of the production model) was subjected to performance tests. The testing focuses on mechanical, electrical, and safety aspects according to standards, rather than statistical sampling from a large test set.
   • Data Provenance: The testing was conducted by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin (a German testing and certification body). This is in Europe (Germany/Austria). The study is prospective in the sense that the device was manufactured and then tested according to defined protocols to assess its conformance to standards and specifications. It is not a retrospective analysis of existing data.

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

   • This type of information (number and qualifications of experts for ground truth) is not applicable to this 510(k) submission. For a device like a powered patient transport, "ground truth" is established by direct physical measurement, engineering analysis, and evaluation against technical standards (e.g., measuring weight capacity, step height, battery life, and confirming compliance with ISO 7176-23). The "experts" involved would be the technical engineers and certifiers at BERLIN CERT, whose qualifications are implicit in the accreditation of the certification body, but not explicitly stated here (e.g., "radiologist with 10 years of experience" is for diagnostic devices).

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where subjective interpretation plays a role and consensus among experts is needed for ground truth. For a mechanical device tested against engineering standards, the results are objective measurements and pass/fail determinations based on those standards.

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:

   • No. An MRMC study is not applicable to this device. This is a powered patient transport device, not a diagnostic imaging device with AI assistance for human readers.

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

   • Not applicable. This device is a physical mechanical/electrical apparatus, not an algorithm. Its operation inherently involves a "human-in-the-loop" (the certified attendant).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" used for this device's performance evaluation is based on objective physical measurements and engineering assessments against recognized international standards (ISO 7176-23:2002 for requirements and test methods for attendant-operated stair climbing devices, and DIN EN ISO 10993-5 for biocompatibility/cytotoxicity testing). The device's specifications (e.g., weight capacity, maximum stair height, battery life) are the defined parameters that the tests verified.

7. The sample size for the training set:

   • Not applicable. This device does not use an AI algorithm that requires a "training set." The training relates to the attendant who uses the device, not an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no AI algorithm training set, this question is irrelevant. Any "training" mentioned refers to the certification of the human attendant who operates the device.

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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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