Search Results

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.

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.

Ask a specific question about this device