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The Inclined Platform Lifts "JOURNEY" and "SUPRA" are intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility.

The Thyssenkrupp Ceteco's JOURNEY and SUPRA are unenclosed Inclined Platform Lifts (IPLs) designed to carry a wheelchair and its occupant or a mobility-impaired person seated on a folding seat between floors in a public or private facility. They are composed of two main parts the rail and the carriage. The rail is the part where the carriage is attached to and where it will move along. The carriage is the part where the person to be transported is positioned on.

The provided text is a 510(k) summary for an Inclined Platform Lift. It details the device, its predicate, and declares substantial equivalence. However, it does not include information about specific acceptance criteria or a study proving the device meets them in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth).

The document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, as opposed to a clinical or performance study with quantitative acceptance criteria. Therefore, I cannot extract the detailed information you requested as it is not present in the provided text.

Here is what can be inferred and what is explicitly stated concerning "acceptance criteria" in a regulatory context, but it doesn't align with the quantitative performance study you're asking for:

Implicit "Acceptance Criteria" (Regulatory Intent)

In the context of a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device. This means the new device (SUPRA) is considered to meet the safety and effectiveness requirements if it has:

• The same intended use as the predicate device (JOURNEY).
• The same technological characteristics as the predicate device, or if there are differences, those differences do not raise different questions of safety and effectiveness.
• Performance data (if necessary, though not explicitly detailed as quantitative performance metrics in this summary) that demonstrates the device is as safe and effective as the predicate.

"Study" (Regulatory Declaration of Equivalence)

The "study" in this context is the 510(k) submission itself, which aims to prove substantial equivalence. The key evidence presented for "meeting acceptance criteria" (i.e., substantial equivalence) is the Product Comparison Table and the subsequent declaration.

Here's a breakdown of why each of your requested points cannot be filled from the provided text, or how they relate to the document's purpose:

1. A table of acceptance criteria and the reported device performance: Not present. The "Product comparison Table" lists features and compliance with standards (ASME A17.5, ASME A18.1), but not quantitative performance criteria with reported values against those criteria.
2. Sample sizes used for the test set and the data provenance: Not applicable. There is no traditional "test set" in the sense of a data set for evaluation. The submission relies on design, performance specifications, and third-party certification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic or performance test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 an Inclined Platform 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission (510(k) summary) for an Inclined Platform Lift, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed quantitative performance studies, acceptance criteria, or expert review processes typically found for devices like AI algorithms or diagnostic tools.

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