Search Results

The Genesis Vertical Platform Lift is intended to mechanically transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

The Genesis Vertical Platform Lift is designed to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility. It can be located within with its own integrated shaftway enclosure, located within a building shaftway or be unenclosed other than guarding around the platform area. It is designed for both indoor and outdoor locations. The Genesis has a capacity of 750 lbs to accommodate a person in a wheelchair and an attendant. The lifting height is up to 14 feet. It is available with a chain hydraulic drive system or an acme screw drive system. Backup systems are available for emergency operation and evacuation. All controls are low-voltage constant pressure. Use may be restricted to authorized persons with key switches located on the control panels. The Genesis is built in accordance with ASME A17.5 Electrical Code for Elevating Devices and the ASME A18.1 Safety Standard for Platform Lifts and Stairway Chairlifts.

This is a premarket notification for a Class II medical device, specifically a "Wheelchair elevator" or "Vertical Platform Lift." The submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific acceptance criteria based on performance studies in the way one might for diagnostic or AI-driven devices.

Therefore, many of the requested categories for a study proving acceptance criteria are not directly applicable to this type of submission. This document describes the device's function and its adherence to established safety standards, which serves as the basis for its equivalence.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are compliance with relevant safety standards and technical specifications, and the "reported device performance" is its adherence to these.

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

Not applicable. This is a mechanical device, and a "test set" in the context of diagnostic or AI performance studies is not relevant here. The "testing" refers to the device's design and manufacturing to meet the specified engineering and safety standards. There is no mention of a specific clinical or performance test set with human subjects or data.

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

Not applicable. "Ground truth" as defined for diagnostic or AI studies (e.g., expert consensus on medical images) does not apply to this device. The "truth" is whether the device meets the engineering and safety specifications, which would be verified through engineering tests, inspections, and adherence to codes, not expert consensus on performance data in the same way.

4. Adjudication Method for the Test Set

Not applicable. See reasoning for #2 and #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating human performance, often with or without AI assistance, especially in diagnostic fields. It is not relevant for a mechanical device like a vertical platform lift.

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

No. This refers to the performance of an algorithm or AI system. This device is purely mechanical with electrical controls, not an AI or algorithm-driven system.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is its compliance with established engineering and safety standards (ASME A17.5 and ASME A18.1) and its technical specifications (e.g., capacity, lifting height, control types, drive systems). This is verified through engineering design, manufacturing processes, and potentially physical testing against those standards. It does not involve expert consensus, pathology, or outcomes data in the typical medical device sense.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an algorithm or AI-driven system that requires data for machine learning.

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

Not applicable. See reasoning for #8.

Ask a specific question about this device

The Super-Trac TRE-52 is intended to mechanically transport a single individual in a wheelchair up and down stairs in a private or public facility. The Super-Trac must be operated by a trained attendant.

The Super-Trac TRE-52 is a portable wheelchair lift designed to carry a passenger in a wheelchair up and down stairs. It is a mobile, attendant-operated device that will accommodate most child and adult wheelchairs, including power wheelchairs and sports wheelchairs.

The Super-Trac TRE-52 consists of two endless durable belt tracks driven by two 12 volt DC motors. Two 12 volt 24 AH rechargeable batteries are used to power the motors. The device includes a set of auxiliary wheels that assist in maneuverability on landings.

The wheelchair fits onto a platform that is mounted to the drive frame. Loading is by means of an integrated ramp that slides out from below the platform. The wheelchair is secured to the platform using four tie-down straps and a seatbelt that goes around both the passenger and wheelchair. The platform is tilted to the stair-travel position by a hydraulic actuator located on the drive frame.

Super-Trac is equipped with a key switch to restrict use to authorized persons. A stair-slope indicator is provided to determine the stair angle is within the operating range.

The attendant operates Super-Trac TRE-52 from controls located on the operating handle. Super-Trac TRE-52 is designed for use on both indoor and outdoor stairways.

The provided document describes a medical device, the Garaventa Super-Trac TRE-52 Portable Wheelchair Lift, and its FDA 510(k) premarket notification. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested (e.g., typical for diagnostic or AI-driven devices).

Instead, the document details the device's description, specifications, features, benefits, and an FDA letter confirming its substantial equivalence to a predicate device (Stair-Trac K981518). The "Indications for Use" section outlines its intended purpose.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria verification studies, as this information is not present in the provided text. The document is primarily a regulatory submission for a physical medical device, not a performance study report for a diagnostic or AI system.

Summary of missing information:

• Acceptance Criteria and Reported Device Performance Table: Not provided. The document lists "Specifications" (e.g., Load Capacity, Power Capacity, Max Speed, Dimensions, Weight), but these are not presented as "acceptance criteria" against which a study's results are compared.
• Study Design Details (Sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details): None of this information is present. The document describes the device itself and its regulatory clearance, not a performance evaluation study.

The document essentially states:

• Device Name: Super-Trac TRE-52 Portable Wheelchair Lift
• Predicate Device: Stair-Trac K981518
• Regulatory Outcome: Found substantially equivalent to the predicate device by the FDA (K020933). This is the "proof" in a regulatory sense for this type of device, meaning it performs as safely and effectively as a device already on the market.
• Indications for Use: To mechanically transport a single individual in a wheelchair up and down stairs in a private or public facility, operated by a trained attendant.

Ask a specific question about this device