(98 days)
Provide mobility to persons physically challenged and limited to sitting positions.
The Skippi is propelled by two DC Motors, Micro Motor AG PMGST 76/40 L/R 6 Km/H at 24 Volts. The controller is the enAble 40 manufactured by Curtis Instruments, AG. The closed "H" frame is rigid (not foldable), all four wheels are suspended independently. The Skippi has 12.5 inch knobby rear tires. Options available to the end user are the following: Seat Tilt Mechanism, Electric or with Gas Compression Spring. Electric Backrest Angle Adjustment. Seating Shell Adapter. Tray. Control for Attendant. Bumper Bar. Single Panel Footrest. Colors (Yellow, Blue, or Red).
The provided text describes a 510(k) premarket notification for the "Skippi Powered Wheelchair for Children" by Otto Bock Healthcare LP. While it establishes the device's substantial equivalence and general information, it does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics, or the methodologies of a specific study to prove those criteria.
Instead, the document states: "The Skippi was tested by TÜV Product Service to the following standards: EN 12184, ISO 7176 -- Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC with the conclusion that 'the test sample fulfills the requirements.'" This indicates compliance with established industry standards but does not provide the specific performance data or study details typically associated with the requested items.
Therefore, I cannot fully complete the requested table and answer all questions based on the provided text.
Here's an analysis of what can be extracted and a clear indication of what is missing:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Compliance with EN 12184 | "the test sample fulfills the requirements." |
| Compliance with ISO 7176 -- Series | "the test sample fulfills the requirements." |
| Compliance with ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC | "the test sample fulfills the requirements." |
Missing Information for Table: Specific quantitative or qualitative performance metrics (e.g., speed, battery life, weight capacity, stability angles, turning radius) that would usually define acceptance criteria for a medical device are not provided beyond the general statement of fulfilling requirements of broad standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document refers to "the test sample" (singular), implying at least one wheelchair was tested, but a specific number is not given.
- Data Provenance: Not specified. The testing organization, TÜV Product Service, is a German company, suggesting the testing likely occurred in Europe or by a branch of TÜV, but the country of origin of the data itself is not explicitly stated. It is a prospective test, as it was conducted for the purpose of this 510(k) submission.
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 type of information is not applicable to the testing described. The "ground truth" here is compliance with engineering and safety standards, determined through formal testing procedures by a recognized testing body (TÜV Product Service), not through expert clinical consensus or interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This adjudication method is typically used in clinical studies involving multiple expert readers assessing data (e.g., radiological images) to establish a consensus ground truth. The testing for a powered wheelchair's compliance to engineering standards does not involve this methodology.
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. An MRMC comparative effectiveness study is not applicable to this device or the type of testing described. This is a powered wheelchair; its evaluation focuses on safety, performance against engineering standards, and substantial equivalence, not the impact of AI on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question pertains to AI/algorithm performance. The device is a physical powered wheelchair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is adherence to established international and national standards for wheelchairs (EN 12184, ISO 7176 -- Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC). These standards define acceptable performance and safety parameters, which are evaluated through specific test procedures.
8. The sample size for the training set:
- Not applicable. This refers to a "training set" used in machine learning or AI development. The Skippi Powered Wheelchair is a physical device, and its evaluation relies on testing against established standards, not on statistical models trained on data.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).