(150 days)
ThyssenKrupp Accessibility's Battery Operated Stair Lift FLOW2 is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.
Flow2 mono rail chairlift brings one person safely and comfortably up and down the stairs. In the meantime one saves ones energy for long outdoor walks, playing with the children or the daily tasks in house.
Flow2 is capable to swivel during the ride up and down the stairs. This unique and patented feature makes that Flow2 chairlift fits most staircases, straight, around corners and even spiral. The angle of the staircase can vary from -70 degrees up to 70 degrees.
The footrest is mounted directly to the chair. This provides a comfortable and ergonomic seating position of the user with less knee flexion.
Flow2 is easy to use by a simple and light folding operation and the intuitive to use joystick control. Features such as anti squeeze, curved armrest and safety belt provide additional safety for the user and other inhabitants of the home.
The design can be adapted to the home decor by the application of a variety of different seat fabrics and colors. Flow2 is the chairlift on the market which combines the best of 2 worlds; capable to fit on the smallest stairs while transporting the user in the most comfortable and safe way.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ThyssenKrupp Accessibility FLOW2 stair lift:
This 510(k) summary does not contain a traditional performance study comparing the device to acceptance criteria with detailed metrics like sensitivity, specificity, accuracy, or confidence intervals. Instead, it relies on a substantial equivalence approach by comparing the FLOW2 to a predicate device (Bruno CRE-2110 Electra-Ride) and demonstrating compliance with relevant international standards.
For medical devices, especially those that are electromechanical and not diagnostic in nature, "acceptance criteria" often refer to meeting established safety and performance standards, and demonstrating that the new device is as safe and effective as a legally marketed predicate.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
For devices like a stair lift, acceptance criteria often relate to meeting specific safety standards, load capacities, speed limits, and other functional aspects. The "reported device performance" is essentially that the device meets these standards and is comparable to the predicate.
| Acceptance Criteria / Standard | Reported Device Performance (FLOW2) | Predicate Device (Bruno CRE-2110 Electra-Ride) |
|---|---|---|
| General Safety and Performance Standards | Compliant with ASME 18.1, IEC 60601-1-2:2007 (Certified by ETL and Lift Institute) | Compliant with ASME 18.1, IEC 60601-1-2:2007 |
| Intended Use | Mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors. | Mechanically transport one mobility impaired person in a fold-down seat, up and down stairs, indoors. (Implied for curved stairs as well given "Straight and Curved stairs" application) |
| Rated Load (Maximum) | 275 lb (125 kg) | 400 lb (181 kg) |
| Passengers | 1 | 1 |
| Power Supply | 2 pieces 7AH 12 Battery | 2 pieces 7AH 12 Battery |
| Charger | 24VDC/ 2A | 24VDC/ 2A |
| Drive Mechanism | Planetary motor with worm gear | Direct drive worm gear motor |
| Final Drive | Lasered rack and pinion | 8dp gear rack with spur gear |
| Braking System | Dynamic, worm gear, el/mech brake | Dynamic, worm gear, el/mech brake |
| Call & Send Functionality | RF | RF |
| Support/Mounting | Anchored to stair thread | Anchored to stair thread |
| Maximum Stair Angle | 70 degrees | 50 degrees |
| Speed | 0.15 m/s | 0.13 m/s |
| Track Length (Maximum) | 34 m | 15 m |
| Safety Devices | Multiple | Multiple |
| Footrest Type | Folding type | Folding type |
| Seat Type | Folding type | Folding type |
| Control Mechanism | 3 position switched RF unit | 3 position momentary rocker switch |
| Construction Material | Bended round steel tube 80mm | Steel welded shape |
| Leveling Mechanism | Patented electronic leveling (multiple sensor controlled) | Mechanically forced |
| Swiveling Mechanism | Patented "en route" swiveling | End of rail |
Note on Acceptance Criteria: For this type of device and submission, the primary "acceptance criteria" are the successful demonstration of substantial equivalence to a predicate device and compliance with recognized consensus standards (ASME 18.1, IEC 60601-1-2:2007). The "reported device performance" is essentially that the device meets these standards and its characteristics are within an acceptable range compared to the predicate, even where there are non-equivalent technological characteristics. The non-equivalent characteristics were discussed to show they do not raise new questions of safety or effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a clinical trial or performance study with a test set of data. The submission relies on engineering testing and comparison to standards and a predicate device.
- Data Provenance: Not applicable for clinical data. The data provenance is from engineering and safety standard testing conducted by organizations like ETL and Lift Institute. The country of origin of the manufacturer is The Netherlands.
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. This is not a diagnostic device requiring expert interpretation for ground truth establishment. Third-party testing and certification bodies (ETL, Lift Institute) verified compliance with safety and performance standards. Their "expertise" for this type of device lies in their accreditation to test against these specific standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no "test set" of clinical cases requiring adjudication. Compliance was determined by accredited testing laboratories against engineering standards.
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
- No MRMC study was done. This device is a mechanical stair lift, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical device with human users, not an algorithm. Its operation involves human interaction (joystick control) for its intended function. The "standalone" performance would be its mechanical and electrical function independent of a specific user, verified by engineering tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is established by compliance with international consensus safety and performance standards (ASME 18.1, IEC 60601-1-2:2007) as verified by accredited testing bodies (ETL, Lift Institute). For mechanical devices, this often involves physical load testing, endurance testing, electrical safety testing, and functional assessments without human subjects.
8. The sample size for the training set
- Not applicable. There is no AI component or "training set" for this device.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 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.