(315 days)
Powered patient stairway chair lift; Intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.
The product c-max+ (plus) offers motorized stair-climbing support for disabled seated persons e.g. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc. to move from one level to another.
With the c-max+ people can transport a patient safely and comfortably up- and downstairs. The maximum load is 300kg. The device is safe due to automatic brakes and a rigid frame. It is suitable for almost all kinds of stairs, winding stairs excluded. The climbing system requires low maintenance and care.
On stairs as well as on level ground C-Max+ proves its versatility. Removable arm rests make easy transferring from one chair to another possible. Due to its compact dimensions and foldable foot rest, the C-Max+ is easy to manoeuvre even on very narrow stair cases. For small, compact apartments with narrow doorways, the C-Max+ represents the ideal solution.
At the heart of the matter lies the patented climbing mechanism, which virtually climbs stairs all by itself. It also makes the C-Max+ particularly versatile and safe.
Once the patient has seated and fastened the seat belt, the care attendant needs little physical power to handle the C-Max+. The C-Max+ is individually adjustable. Wheels make the transport on the floor easy. The battery-powered stair-climbing mechanism is usercontrolled with adjustable speed and climbing-direction. The attendant can also choose a single-step-mode alternatively to fluent climbing. A safety-brake ensures safe stops during the stair-climbing.
The provided text describes a 510(k) summary for the "c-max+ (plus)" powered patient stairway chair lift and its substantial equivalence to a predicate device, the "c-max". The document focuses on regulatory compliance through non-clinical testing against recognized standards rather than a clinical study with human subjects or AI-assisted performance.
Therefore, many of the requested sections related to clinical studies, AI performance, ground truth establishment, expert adjudication, and associated sample sizes are not applicable to the information contained in this 510(k) summary.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
The acceptance criteria are established by various international standards for safety, function, and performance of patient transport devices. The "reported device performance" is essentially that the device performed in accordance with these standards, demonstrating its safety and effectiveness.
| Acceptance Criteria (Applicable Standard) | Reported Device Performance |
|---|---|
| General Safety (EN 12182) | Tests performed successfully |
| Climatic Tests (ISO 7176-9) | Tests performed successfully |
| Electrical Safety (ISO 7176-14) | Tests performed successfully |
| Flammability (ISO 7176-16) | Tests performed successfully |
| Electromagnetic-compatibility (ISO 7176-21) | Tests performed successfully |
| Mechanical & Functional Safety (ISO 7176-23) | Tests performed successfully |
| Biocompatibility (ISO 10993-5) | Tests performed successfully |
| Max. Load | 300 kg (meets internal design criteria, higher than predicate) |
| Steps per charge | Approx. 300 (meets internal design criteria) |
| Speed | 3-8 steps / minute continually adjustable (meets internal design criteria, slower than predicate due to higher load capacity) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable as this document describes non-clinical engineering and performance testing of the device itself, not a clinical study with a "test set" of patients or data. The "sample" would be the device prototypes tested.
- Data Provenance: The tests were performed according to recognized international standards (EN, ISO). The manufacturer is AAT Alber Antriebstechnik GmbH, located in Germany. These would be considered prospective non-clinical tests.
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. "Ground truth" in this context would refer to the successful execution and results of the non-clinical tests, which are objectively measured against the specified standards by qualified testing personnel and facilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical testing report, not a clinical study requiring adjudication of expert opinions.
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 device is a powered patient stairway chair lift and does not involve AI or "human readers" in its intended use or in the described testing for regulatory clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical/electrical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is established by its adherence to the technical and safety requirements outlined in the cited international standards (EN 12182, ISO 7176 series, ISO 10993-5). This is a form of objective technical compliance and engineering performance data.
8. The sample size for the training set:
Not applicable. This is a physical device, not a machine learning model requiring a "training set."
9. How the ground truth for the training set was established:
Not applicable.
§ 890.5150 Powered patient transport.
(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair 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 American Society of Mechanical Engineers (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 chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(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; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.