(31 days)
The Merits E700 Porch Lift System is a wheelchair elevator, also commonly known as a vertical platform lift. It is a motorized device intended to mechanically transport an individual with mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence.
The Merits E700 Porch Lift basically consists of a platform assembly and a driving machine case assembly. The platform assembly vertically moves along a guide rail welded to the driving machine case assembly. The sides of the platform assembly are guarded by sheet steel plates. The lower landing side of the platform is equipped with an automatic folding ramp to not only offer easy access to the platform but also to prevent the mobility device rolling off the edges. The ramp will be automatically folded up as the lift begins to move upward and remain in elevated position until the platform returns to the lower landing. The underside of the platform is equipped with a safety plate to stop the motion when the platform is obstructed in the downward direction. The driving machine case assembly contains all necessary operation systems in the case. The operation of the lift is controlled by the platform operating panel and the call/send controls. These control devices are designed by means of continuous pressure type, which stop the lift immediately when the switch is released. The Merits E700 Porch Lift is using AC power as its power source.
The provided text concerns a 510(k) submission for a Merits E700 Porch Lift, which is a vertical platform lift. This document is a regulatory submission for a medical device that assists with mobility. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and statistical analysis typical for diagnostic AI/ML devices.
Therefore, many of the requested elements for an AI/ML study (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of device and submission.
Here's the information that can be extracted or deduced based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and reliable operation as a vertical platform lift. | "The results of the testing confirm that the device meets specifications." |
| Substantially equivalent in function to the predicate device Bruno Residential Vertical Platform Lift Model VPL-3100 (K061514). | "Merits E700 Porch Lift is equivalent in functions to the legally marketed predicate device." "The utilization of chain sprocket by Merits E700 Porch Lift is still reliable to satisfy the driving needs." "The technology of chains is mature enough to provide the reliable method to satisfy the specific functional requirements." |
| Mechanically transport an individual with mobility disability, either in a wheelchair device or ambulatory, from one level to another in a private residence. | Stated as the "Intended use" and is the core function for which equivalency is claimed. |
Note: The acceptance criteria are "implied" because the document focuses on demonstrating substantial equivalence rather than explicit, quantifiable performance metrics for a novel technology.
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is for a mechanical device; it does not involve a test set of data in the context of an AI/ML diagnostic algorithm. The "testing" likely refers to engineering verification and validation tests common for mechanical devices (e.g., load testing, cycle testing, safety mechanism verification). The document does not specify the nature or sample size of these engineering tests, nor does it refer to data provenance in the context of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of expert consensus on medical images or diagnostic data is not relevant for this mechanical device. The "ground truth" here would be established by engineering specifications, safety standards, and functional requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. An adjudication method for a test set is not relevant for a mechanical device submission.
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 device, not an AI/ML diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not have an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of diagnostic AI/ML. The "ground truth" for this device would be adherence to established engineering standards, safety regulations (e.g., related to lifts, general mechanical safety), and functional specifications. The performance is assessed against these technical and safety requirements, and by comparison to the established predicate device's performance characteristics.
8. The sample size for the training set:
- Not applicable. This submission does not involve a training set for an AI/ML model.
9. How the ground truth for the training set was established:
- Not applicable. This submission does not involve a training set for an AI/ML model.
§ 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.