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ThyssenKrupp Accessibility's Battery Operated Stair Lift LEVANT is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down straight stairs, indoors and outdoors.

Levant/ HomeGlide is a stair lift for transport of one person up and down straight stairs. The system consist of a drive unit, a foldable footrest and an aluminum rail that is fixed on the stairs. The system can be fixed on either sides of the stairs. It is available standard with a manual swivel for easy getting on and off the seat. It comes with a padded seat. A hinged rail, a heavy duty drive and a intermediate park position are available as options. The Comfort Option provides a premium positioned chair lift with extra options: straight or curved armrests, luxurious seat, fabric- vinyl- or leather upholstery, adjustable seat height, and a powered swivel. The Outdoor Option provides a stair lift for outdoor use in both cold and warm climates. The Outdoor option is created by adding a waterproof control, a waterproof cover, coated electronics, coated switches, waterproof charging contacts and a step up transformer.

The provided text is a 510(k) summary for a medical device called the "LEVANT/HOMEGLIDE" Battery Operated Stair Lift for Straight Stairs. This document does not describe a study to prove the device meets acceptance criteria, but rather a comparison to a predicate device to establish substantial equivalence.

Therefore, many of the requested categories related to acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert involvement, and statistical analyses) are not applicable to the information provided. The document outlines a product comparison rather than a performance study with specific acceptance criteria that would typically be described for software or AI-driven medical devices.

Here's how to address the questions based on the provided text, noting its limitations:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) premarket notification focusing on substantial equivalence to a predicate device rather than a study with defined acceptance criteria and performance against those criteria, a direct "acceptance criteria" table as typically seen in performance studies is not present. Instead, the document compares the technical characteristics of the proposed device to a predicate device to demonstrate equivalence.

Here’s a summary of the comparative characteristics, which implicitly serve as the basis for "performance" from an equivalence standpoint:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document is a premarket notification for substantial equivalence, not a clinical or performance study involving a test set of data. The "comparison" is based on the technical specifications of the devices themselves, not on collected data from a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no test set or ground truth established by experts described in this document. The assessment is based on a technical review by the manufacturer and subsequently the FDA.

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

Not applicable. No test set or related adjudication method is described.

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 device is a mechanical stair lift, not an AI or imaging device that would involve human readers or comparative effectiveness studies of this nature.

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

Not applicable. This is a mechanical device, not an algorithm.

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

Not applicable. There is no ground truth, as this document focuses on substantial equivalence based on technical specifications and adherence to standards (like ASME 18.1 and EN 81-40), rather than a diagnostic or analytical performance study.

8. The sample size for the training set

Not applicable. There is no training set mentioned or relevant for this type of mechanical device submission.

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

Not applicable. There is no training set or ground truth described.

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ThyssenKrupp Accessibility's Battery Operated Stair Lift FLOW2 is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.

Flow2 mono rail chairlift brings one person safely and comfortably up and down the stairs. In the meantime one saves ones energy for long outdoor walks, playing with the children or the daily tasks in house.

Flow2 is capable to swivel during the ride up and down the stairs. This unique and patented feature makes that Flow2 chairlift fits most staircases, straight, around corners and even spiral. The angle of the staircase can vary from -70 degrees up to 70 degrees.

The footrest is mounted directly to the chair. This provides a comfortable and ergonomic seating position of the user with less knee flexion.

Flow2 is easy to use by a simple and light folding operation and the intuitive to use joystick control. Features such as anti squeeze, curved armrest and safety belt provide additional safety for the user and other inhabitants of the home.

The design can be adapted to the home decor by the application of a variety of different seat fabrics and colors. Flow2 is the chairlift on the market which combines the best of 2 worlds; capable to fit on the smallest stairs while transporting the user in the most comfortable and safe way.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ThyssenKrupp Accessibility FLOW2 stair lift:

This 510(k) summary does not contain a traditional performance study comparing the device to acceptance criteria with detailed metrics like sensitivity, specificity, accuracy, or confidence intervals. Instead, it relies on a substantial equivalence approach by comparing the FLOW2 to a predicate device (Bruno CRE-2110 Electra-Ride) and demonstrating compliance with relevant international standards.

For medical devices, especially those that are electromechanical and not diagnostic in nature, "acceptance criteria" often refer to meeting established safety and performance standards, and demonstrating that the new device is as safe and effective as a legally marketed predicate.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

For devices like a stair lift, acceptance criteria often relate to meeting specific safety standards, load capacities, speed limits, and other functional aspects. The "reported device performance" is essentially that the device meets these standards and is comparable to the predicate.

Note on Acceptance Criteria: For this type of device and submission, the primary "acceptance criteria" are the successful demonstration of substantial equivalence to a predicate device and compliance with recognized consensus standards (ASME 18.1, IEC 60601-1-2:2007). The "reported device performance" is essentially that the device meets these standards and its characteristics are within an acceptable range compared to the predicate, even where there are non-equivalent technological characteristics. The non-equivalent characteristics were discussed to show they do not raise new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of a clinical trial or performance study with a test set of data. The submission relies on engineering testing and comparison to standards and a predicate device.
• Data Provenance: Not applicable for clinical data. The data provenance is from engineering and safety standard testing conducted by organizations like ETL and Lift Institute. The country of origin of the manufacturer is The Netherlands.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth establishment. Third-party testing and certification bodies (ETL, Lift Institute) verified compliance with safety and performance standards. Their "expertise" for this type of device lies in their accreditation to test against these specific standards.

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

• Not applicable. There was no "test set" of clinical cases requiring adjudication. Compliance was determined by accredited testing laboratories against engineering standards.

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

• No MRMC study was done. This device is a mechanical stair lift, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a mechanical device with human users, not an algorithm. Its operation involves human interaction (joystick control) for its intended function. The "standalone" performance would be its mechanical and electrical function independent of a specific user, verified by engineering tests.

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

• The "ground truth" for this submission is established by compliance with international consensus safety and performance standards (ASME 18.1, IEC 60601-1-2:2007) as verified by accredited testing bodies (ETL, Lift Institute). For mechanical devices, this often involves physical load testing, endurance testing, electrical safety testing, and functional assessments without human subjects.

8. The sample size for the training set

• Not applicable. There is no AI component or "training set" for this device.

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

• Not applicable, as there is no training set for this device.

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