(456 days)
The LEVO stand-up electrical power wheelchair is a product which changes peoples position from seating to standing and standing to seating.
An electrical stand-up mechanism is integrated in an electrical power wheelchair which allows the user to stand up easily when and where ever he wants to.
This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device effectiveness. The provided text is a premarket notification for a medical device (a power wheelchair) and focuses on substantial equivalence rather than a detailed performance study with statistical results.
Here's an analysis based on the provided information, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Function: | Allow user to change position from seating to standing and standing to seating. | "The LEVO mobil LCM allows the user to stand up easily when and where ever he wants to." |
| Target Population: | Individuals requiring an electrical power wheelchair who cannot stand on their own feet (e.g., spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism). | "For whole those who needs an electrical power wheelchair and can not stand on their on feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc .." |
| Mechanism: | Electrical stand-up mechanism integrated into an electrical power wheelchair. | "An electrical stand-up mechanism is integrated in an electrical power wheelchair which allows the user to stand up easily when and where ever he wants to." |
| Material - Main Frame: | (Not specified in "Acceptance Criteria" column, as this is a device characteristic, not a performance criterion) | Colour painted steel. |
| Material - Major Stressed Parts: | (Not specified) | Reinforced brass casting. |
| Material - Upholstery: | (Not specified) | Flame impeded. |
| Material - Batteries: | (Not specified) | 2 x 12 V/25 Ah (serial connected) Gel, sealed lead acid batteries or 2 x 2 x 12 V/25 Ah for higher range (50 Ah). |
| Material - Stand-up Motor: | (Not specified) | Bosch-24 V DC, 3.5 A, 84Ah (CE marked). |
| Material - Driving Motors: | (Not specified) | Schmid 24 V DC, 8 A, 0.16 KW with 12 V brakes |
| Electronic: | (Not specified) | Penny & Giles PG8 Controller |
| Benefits/Therapy: | Enable users to reach things, participate in discussions standing up, do daily therapy individually. | "Whether . to reach things without help of others, whether take part in discussions standing up and show influence, whether just to do daily therapy individually." |
Missing Information:
- Quantitative Acceptance Criteria: The document describes the device's function and features but does not provide specific, measurable acceptance criteria (e.g., "must allow user to stand in X seconds," "must support Y weight," "must operate for Z cycles without failure"). The "Performance" section is descriptive rather than quantitative.
- Formal Study Results: The document states "Performance" in a descriptive manner but does not reference a formal study with reported performance metrics against predefined acceptance criteria. This is common for 510(k) submissions focusing on substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
Information Not Found in the Document.
This document is a 510(k) premarket notification, which typically focuses on demonstrating "substantial equivalence" to an already legally marketed predicate device rather than presenting extensive de novo clinical trial data. Therefore, details about a "test set" in the context of AI/software performance are not applicable or provided here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Information Not Found in the Document.
Given that this is a mechanical power wheelchair (not an AI/diagnostic device), the concept of "ground truth" established by experts for a test set is not relevant to this submission.
4. Adjudication Method for the Test Set
Information Not Found in the Document.
This information is not applicable to the type of device and submission provided.
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
Information Not Found in the Document.
This is a physical medical device (power wheelchair), not an AI-assisted diagnostic or imaging system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or included.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Information Not Found in the Document.
This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Information Not Found in the Document.
The concept of "ground truth" (expert consensus, pathology, outcomes data) is not applicable to this type of device and submission. The "ground truth" for a power wheelchair's function would be its ability to physically perform the described actions (e.g., lift a user from sitting to standing) and meet safety standards, typically demonstrated through engineering testing and compliance with recognized standards, not by expert interpretation of data.
8. The Sample Size for the Training Set
Information Not Found in the Document.
As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Information Not Found in the Document.
As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment process.
§ 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).