(73 days)
The ES-125 Stair Platform Lift is intended to mechanically transport one person in a wheelchair up and down stairs in a private residence or public facility.
The ES-125 Stair Platform Lift is an unenclosed stair platform lift designed to carry a wheelchair and its occupant between floors in a residential or public facility. It is accessible via automatic dual access ramps (straight or 90 degree entry) and is driven by a cable/drum unit that incorporates a 3/16" aircraft cable with a breaking load of 4,200 lbs, a deviator pulley, and winding drum. It can be controlled from either end at a key-controlled station or from an on- board, hand-held control panel. The entire carriage unit is designed with ASTM 30 tubular steel, and the fold-away platform contains a non-skid surface. The unit travels at a rated speed of approximately 14 ft/min and possesses a mechanical emergency brake in case of drive cable failure. The lift can be used with stairways at an incline of up to 45 degrees and has a rated carrying load of up to 450 lbs. The power supply is 110 VAC, 1Ph, 60 Hz, 15 amp. The lift complies with ANSI-A17.1 Code specifications regarding elevating devices for the handicapped
The provided text is a 510(k) Summary for a medical device called the "Savaria ES-125 Stair Platform Lift." This document is a pre-market submission to the FDA to demonstrate that the device is as safe and effective as (substantially equivalent to) a legally marketed predicate device.
Crucially, a 510(k) summary does not typically contain information about clinical studies, acceptance criteria, or performance data in the same way a clinical trial report or a performance study for an AI/ML medical device would.
The "acceptance criteria" and "device performance" in this context refer to the device's design specifications and its compliance with industry standards, rather than statistical performance metrics against a defined ground truth. The study that "proves" the device meets the acceptance criteria is generally a bench test and verification of these design specifications against standards like ANSI-A17.1.
Therefore, many of the requested fields cannot be filled as they are not applicable to the type of information presented in this 510(k) summary.
Here's an attempt to answer the questions based only on the provided text, acknowledging its limitations for typical AI/ML device performance reporting:
1. A table of acceptance criteria and the reported device performance
Since this is a non-AI/ML device, the "acceptance criteria" are the design specifications and compliance with safety standards, and the "reported device performance" is the confirmation that the device meets these specifications.
| Acceptance Criteria (Design Specification / Standard Compliance) | Reported Device Performance |
|---|---|
| ANSI-A17.1 Code specifications regarding elevating devices for the handicapped | The lift complies with ANSI-A17.1 Code specifications. |
| Cable breaking load | 4,200 lbs |
| Maximum inclination of stairways | Up to 45 degrees |
| Rated carrying load | Up to 450 lbs |
| Rated speed | Approximately 14 ft/min |
| Power supply | 110 VAC, 1Ph, 60 Hz, 15 amp |
| Mechanical emergency brake in case of drive cable failure | Possesses a mechanical emergency brake |
| Control from either end at key-controlled station | Yes |
| On-board, hand-held control panel | Yes |
| Automatic dual access ramps (straight or 90 degree entry) | Yes |
| ASTM 30 tubular steel construction | Yes |
| Non-skid surface on fold-away platform | Yes |
| Electric motor | Yes |
| Chain/sprocket drive unit | Yes* (*Standard on ES-125 Plus model) |
| Optional manual operation | Yes |
| Key-operated station controls | Yes |
| On-board control with key switch | Yes |
| Continuous pressure directional controls | Yes |
| Upper & lower limit controls | Yes |
| Foldable platform | Yes |
| Automatic access ramp | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a mechanical device like this, testing would typically involve engineering validation and verification tests on prototypes or production units, not a "test set" or "data provenance" in the sense of clinical data.
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. The "ground truth" for a stair lift is its mechanical function and safety compliance, established through engineering specifications and adherence to standards like ANSI-A17.1, verified through testing, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is relevant for clinical studies, especially those involving human interpretation of medical images. For a mechanical device, performance is typically verified against design specifications and 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
Not applicable. This is a mechanical stair lift, not an AI-powered diagnostic or assistive tool for human readers.
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)
The "ground truth" for this device is its adherence to engineering specifications, safety standards (e.g., ANSI-A17.1 Code), and functional requirements for transporting a wheelchair and occupant. This is established through design documents, material specifications, and performance testing against those predefined criteria.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved for this mechanical device.
§ 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.