(12 days)
The LEVO combi stand-up electrical power wheelchair is a product which changes peoples position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
The LEVO combi powered wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact power wheelchair controller Pilot+. The joystick is integrated in the controller. The wheelchair is powered by two 12V55Ah batteries with a theoretical driving range of 35km on the fully charged batteries. The wheelchair consists of the following basic sub-sections:
- Base with two direct-drive units with integrated parking brakes, two 12V55Ah batteries, two 14"x2¾" centre wheels, two 8"x2" front wheels, and one 5½"x1½" rear wheel with suspension.
- Penny & Giles power electronics Pilot+.
- Seating system including mechanisms for all possible positions, stand-up actuator and optional lift and/or backrest actuator.
The base is of welded steel construction and includes the base frame, front castor wheels, centre driving wheels with drive unit (motor/gear/brakes), batteries and pivoting rear castor. The motor controller is mounted to the left or right armrest, depending on the user's needs.
The provided 510(k) summary for the LEVO combi device does not contain acceptance criteria or detailed study results to prove the device meets specific performance metrics.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (LEVO mobil LCM) based on intended use, materials, and a comparison of technological characteristics. The manufacturer asserts that the LEVO combi's design is "basically developed on experience of the LEVO mobil LCM" and that "the minor changes declared in the submission do not raise new questions of safety and effectiveness."
Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as this information is not present in the provided text. The document does not describe a clinical study, an MRMC study, or a standalone algorithm performance study.
Here's what can be extracted from the document based on your request, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| (No quantitative or qualitative performance metrics are provided as acceptance criteria for the LEVO combi.) | (The document states the device has "the same safety and effectiveness as the predicate device(s)" but does not present specific performance data.) |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable/Not provided. No dedicated test set for performance evaluation is described.
- Data provenance: Not applicable. The document refers to "experience of the LEVO mobil LCM" but does not detail any data, its origin (country), or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No test set requiring expert ground truth establishment is described.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set requiring an 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
- No MRMC comparative effectiveness study was done. This device is a physical medical device (stand-up electrical power wheelchair), not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device is a physical medical device and does not involve a standalone algorithm in the sense of AI or software performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No ground truth is described as part of a performance evaluation. The substantial equivalence argument relies on comparing the new device's features and safety profile to an existing, legally marketed device.
8. The sample size for the training set
- Not applicable/Not provided. There is no mention of a "training set" in the context of device development or testing as would be seen for an AI/ML device. The device's development leveraged "experience of the LEVO mobil LCM."
9. How the ground truth for the training set was established
- Not applicable/Not provided. As no training set or ground truth in that context is mentioned, this information is not available.
Summary of what the document does state (related to safety and effectiveness):
The LEVO combi's safety and effectiveness claim is based on its substantial equivalence to the predicate device, LEVO mobil LCM (K963817). The core argument is:
- Intended Use: The LEVO combi has the same intended use as the predicate (position changes from sitting to standing and vice-versa, reclining, seat/back lift, indoor and outdoor mobility).
- Materials: Substantially equivalent materials.
- Technological Characteristics: The LEVO combi was "basically developed on experience of the LEVO mobil LCM" and has "in substantial the same technological characteristics" as the predicate.
- Changes: Minor changes (rear suspension, outdoor mobility, different controller - Pilot+ vs. PG8, and additional position capabilities like reclining to lying/relax) are highlighted.
- Conclusion: The manufacturer asserts that these minor changes "do not raise new questions of safety and effectiveness" and that the device therefore has "the same safety and effectiveness as the predicate device(s)."
This type of 510(k) submission relies on a comparative analysis rather than new, extensive performance studies for the device itself, assuming the predicate device has already established its safety and effectiveness.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).