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510(k) Data Aggregation
(156 days)
LEVANT, HOMEGLIDE
ThyssenKrupp Accessibility's Battery Operated Stair Lift LEVANT is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down straight stairs, indoors and outdoors.
Levant/ HomeGlide is a stair lift for transport of one person up and down straight stairs. The system consist of a drive unit, a foldable footrest and an aluminum rail that is fixed on the stairs. The system can be fixed on either sides of the stairs. It is available standard with a manual swivel for easy getting on and off the seat. It comes with a padded seat. A hinged rail, a heavy duty drive and a intermediate park position are available as options. The Comfort Option provides a premium positioned chair lift with extra options: straight or curved armrests, luxurious seat, fabric- vinyl- or leather upholstery, adjustable seat height, and a powered swivel. The Outdoor Option provides a stair lift for outdoor use in both cold and warm climates. The Outdoor option is created by adding a waterproof control, a waterproof cover, coated electronics, coated switches, waterproof charging contacts and a step up transformer.
The provided text is a 510(k) summary for a medical device called the "LEVANT/HOMEGLIDE" Battery Operated Stair Lift for Straight Stairs. This document does not describe a study to prove the device meets acceptance criteria, but rather a comparison to a predicate device to establish substantial equivalence.
Therefore, many of the requested categories related to acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert involvement, and statistical analyses) are not applicable to the information provided. The document outlines a product comparison rather than a performance study with specific acceptance criteria that would typically be described for software or AI-driven medical devices.
Here's how to address the questions based on the provided text, noting its limitations:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) premarket notification focusing on substantial equivalence to a predicate device rather than a study with defined acceptance criteria and performance against those criteria, a direct "acceptance criteria" table as typically seen in performance studies is not present. Instead, the document compares the technical characteristics of the proposed device to a predicate device to demonstrate equivalence.
Here’s a summary of the comparative characteristics, which implicitly serve as the basis for "performance" from an equivalence standpoint:
| Characteristic | Predicate Device (Bruno SRE-3000/SRE-2000) Performance | Proposed Device (ThyssenKrupp Accessibility Levant) Reported Performance | Discussion / Equivalence |
|---|---|---|---|
| Standards | ASME 18.1 | ASME 18.1 | Equivalent |
| Application | Straight stairs | Straight stairs | Equivalent |
| Rated Load (max) | 181 kg | 146 kg | Both exceed minimum standards; close enough for equivalence |
| Passengers | 1 | 1 | Equivalent |
| Power | 2 pieces 7AH 12 Battery | 2 pieces 7AH 12 Battery | Equivalent |
| Charger | 24VDC/ 2A | Ind: 24VDC/ 1700 mA; Outd: 6 VAC | Different, but considered equivalent based on function |
| Drive | Direct drive worm gear motor | Direct drive worm gear motor | Equivalent |
| Final Drive | 8dp gear rack with spur gear | 8dp gear rack with spur gear | Equivalent |
| Braking | Dynamic, worm gear, el/mech brake | Dynamic, worm gear, el/mech brake | Equivalent |
| Call & Send | IR | IR | Equivalent |
| Control | 3-position momentary rocker switch | 3-position momentary rocker switch | Equivalent |
| Supports | Anchored to stair thread | Anchored to stair thread | Equivalent |
| Angle (max) | 22 to 45 degrees, specials up to 52 | 28 to 53 degrees, heavy duty to 45 | Small difference, caused by design, considered equivalent |
| Speed | 0.08 m/s | 0.12 m/s | Both below standards max; Proposed device is 50% faster but still acceptable |
| Track length (max) | 6.1 meters max | 7.5 meters max | Proposed device offers more length, but both meet implicit needs |
| Construction Rail | Aluminum extrude rail (Indoor), Exterior grade powder coated steel rail (Outdoor) | Anodized aluminum extrude rail (Indoor/Outdoor) | Different materials, but both fulfill safety requirements |
| Safety devices | Multiple | Multiple | Equivalent |
| Footrest | Folding type | Folding type | Equivalent |
| Seat | Folding type | Folding type | Equivalent |
| Indoor use | Yes | Yes | Equivalent |
| Outdoor use | Yes | Yes | Equivalent |
| Temp Range Indoor | Not specified | +5°C to +40°C (41°F to 104°F) | Information provided for proposed device |
| Temp Range Outdoor | -5°C to +50°C (25°F to 125°F) | -15°C to +60°C (5°F to 140°F) | Differences discussed, but considered acceptable |
| Construction Chair | Stainless steel (Outdoor) | ABS Synthetic material (Outdoor) | Different materials, but considered equivalent |
| Electrical Enclosure | IPx3 | IPx5 | Proposed device meets higher standard (EN 81-40 requirement), considered acceptable |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a premarket notification for substantial equivalence, not a clinical or performance study involving a test set of data. The "comparison" is based on the technical specifications of the devices themselves, not on collected data from a test set.
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. There is no test set or ground truth established by experts described in this document. The assessment is based on a technical review by the manufacturer and subsequently the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or related adjudication method is described.
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 mechanical stair lift, not an AI or imaging device that would involve human readers or comparative effectiveness studies of this nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth, as this document focuses on substantial equivalence based on technical specifications and adherence to standards (like ASME 18.1 and EN 81-40), rather than a diagnostic or analytical performance study.
8. The sample size for the training set
Not applicable. There is no training set mentioned or relevant for this type of mechanical device submission.
9. How the ground truth for the training set was established
Not applicable. There is no training set or ground truth described.
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