(13 days)
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.
§ 890.3930 Wheelchair elevator.
(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.