(70 days)
The products c-max and s-max offer 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 or without manual wheelchair adaption.
The products c-max and s-max offer motorized stair-climbing support for disabled seated persons to move from one level to another with or without manual wheelchair adaption.
The provided text describes two medical devices, c-max and s-max, which are motorized stair-climbing support systems for disabled individuals. The information focuses on a 510(k) premarket notification for substantial equivalence, rather than a clinical study evaluating the device against specific acceptance criteria for performance.
Therefore, much of the requested information regarding acceptance criteria, study data, sample sizes, and expert adjudication methods is not present in the provided document, as it outlines a regulatory submission for device clearance, not a performance study report.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but lists safety and performance standards that the devices are stated to meet and provides technical data. The "acceptance criteria" can be inferred from the "Performance Standards" section.
| Acceptance Criteria (Inferred from Performance Standards) | Reported Device Performance (c-max and s-max families) |
|---|---|
| EN 12182: 1999 Technical aids for disabled persons-general requirements and test methods | Devices meet this standard |
| ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods | Devices meet this standard |
| ISO 7176-16:1997 Wheelchairs - Part 16: Resistance to ignition of upholstered parts --Requirements and test methods | Devices meet this standard |
| ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | Devices meet this standard |
| ISO 7176-23: 2002 Wheelchairs - Part 23: Requirements and test methods for attendant-operated stair-climbing devices | Devices meet this standard |
| Specific Technical Data (Examples from Tables): | |
| Max. Lifting Capacity (s-max) | 120 kg, 135/160 kg, 160 kg (model dependent) |
| Max. Lifting Capacity (c-max) | 140kg / 160kg (model dependent) |
| Climbing Speed (s-max) | app. 300 steps, continually adjustable |
| Climbing Speed (c-max) | 8 - 23 steps / minute, continually adjustable |
| Capacity with one battery charge (s-max) | 15 - 30 floors, depending on the load |
| Capacity with one battery charge (c-max) | app. 300 steps, depending on the load |
| Maximum height of step (s-max) | 22 cm, 25.5 cm (model dependent) |
| Maximum height of step (c-max) | 21 cm |
| Noise level | Typically below 70 dB(A) |
| Vibrations | Weighted RMS value of acceleration the upper body is exposed to lies typically below 2.5 m/s² |
| Biocompatibility Information | Approval for seat material according to DIN EN ISO 10993-5 |
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 document. The document refers to meeting performance standards, but does not detail the testing methodology, sample sizes, or data provenance (e.g., specific test reports, countries of origin, or if the testing was retrospective or prospective).
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)
This information is not provided in the document. The document refers to meeting established performance standards (e.g., ISO, EN) but does not involve expert consensus on a test set for clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As this is a regulatory submission based on technical standards, not a clinical study with subjective interpretations, an adjudication method for a "test set" as typically understood in AI/clinical studies would not apply.
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
This information is not provided in the document. The devices (c-max and s-max) are motorized assistance devices, not AI-driven diagnostic or interpretative tools that would involve human "readers" or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The devices are physical medical devices, and the submission is focused on their engineering and safety standards, not on the performance of a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated as "ground truth" in the context of a clinical study. However, the "ground truth" for demonstrating compliance with performance standards would be the results of standardized tests and measurements carried out according to the specified EN and ISO standards (e.g., measurements of lifting capacity, noise levels, vibration, battery life, step climbing height, and resistance to ignition).
8. The sample size for the training set
This information is not provided in the document. This is not a machine learning or AI-driven device, so there is no concept of a "training set" in the context presented.
9. How the ground truth for the training set was established
This information is not provided in the document. See point 8.
§ 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.