(7 days)
The intended use of the Harmar Summit RPL/CPL Vertical Platform Lifts is to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.
The Harmar Summit, LLC Models RPL and CPL Vertical Platform Lifts are AC powered, patient transport devices designed for use in both residential and commercial applications. Their intended function and use is to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.
The RPL lift is designed for residential applications and will support a maximum load of 600 lbs. The CPL lift is designed for commercial or public applications, and will support a maximum load of 750 lbs.
The provided text is a 510(k) Premarket Notification for the Harmar Summit RPL/CPL Vertical Platform Lifts. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to industry standards, rather than presenting a clinical study with detailed acceptance criteria and performance data for a new medical device.
Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission. The device in question is a wheelchair elevator, which is more of a mechanical and electrical safety device than a diagnostic or therapeutic medical device requiring extensive clinical trials with human subjects for efficacy.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standards Conformance) | Reported Device Performance |
|---|---|
| ASME A18.1, Section 2 Vertical Platform Lifts | The RPL lift is designed to conform with this standard. |
| CSA B44.1 / ASME 17.5 Elevator and Escalator Electrical Equipment | The RPL lift is designed to conform with this standard. |
| ASME A18.1, Section 5 -- Private Residence Vertical Platform Lifts | The RPL lift is designed to conform with this standard. |
| Maximum Load (RPL - Residential) | 600 lbs |
| Maximum Load (CPL - Commercial/Public) | 750 lbs |
| Intended Use | Transport persons with a mobility disability (wheelchair or ambulatory) up and down between levels of a residential or public facility. |
Regarding the other points, based on the provided text, the following apply:
- 2. Sample size used for the test set and the data provenance: Not applicable. This submission relies on conformance to engineering standards, not on a clinical test set from human subjects.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this type of device is defined by the technical specifications and safety standards.
- 4. Adjudication method 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 is not an AI-enabled diagnostic or analytical device.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical transport device.
- 7. The type of ground truth used: Conformance to established engineering and safety standards (ASME A18.1, CSA B44.1 / ASME 17.5) and the stated load capacities for the RPL and CPL models.
- 8. The sample size for the training set: Not applicable. There is no "training set" in the context of machine learning for this device. The design and validation are based on engineering principles and standard compliance.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.