(51 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controls the drive leftright motor to realize the wheelchair forward, backward and turn functions. The frame of the device is aluminum alloy. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the controller joystick to achieve the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.
The provided document is a 510(k) Premarket Notification for an Electrically Powered Wheelchair (HP206). It primarily details the device's characteristics and compares it to a predicate device (HP358EA) to demonstrate substantial equivalence.
However, the document does not contain information about a study proving device performance against specific acceptance criteria, especially not in the context of an AI/human reader study as typically associated with the comprehensive questions asked. The device in question is an Electrically Powered Wheelchair, not a medical imaging or diagnostic AI device that would involve expert readers, ground truth establishment for a test set, multi-reader multi-case studies, or AI algorithm performance metrics like sensitivity, specificity, etc.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the device's compliance with established performance standards and safety requirements for electrically powered wheelchairs.
Therefore, I cannot populate the requested table or answer most of the specific questions about AI performance, expert adjudication, or MRMC studies for this device, as these concepts are not applicable to the information provided in the 510(k) submission for a powered wheelchair.
I can, however, extract the performance data and compliance standards mentioned:
1. Table of acceptance criteria and the reported device performance
The document frames "acceptance criteria" as compliance with various ISO standards and FDA guidance. "Reported device performance" is demonstrated through testing against these standards. There isn't a specific quantitative "acceptance criteria" table with corresponding numerical "reported performance" easily extractable for each parameter the way one would for an AI diagnostic device. Instead, the document states that the device "met all design specifications" and provided "support of the substantial equivalence determination" by undergoing the listed tests.
Here's an attempt to structure it based on the available information, understanding that "acceptance criteria" is implied by compliance with the standards, and "reported performance" is that it passed the tests:
| Acceptance Criterion (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ISO 10993-5 (In Vitro cytotoxicity) | Met requirements; material is safe |
| ISO 10993-10 (Skin sensitization) | Met requirements; material is safe |
| ISO 10993-23 (Irritation) | Met requirements; material is safe |
| ISO 14971:2019 (Risk Analysis) | Risk Analysis developed in accordance. |
| Software validation | Software validation carried out and meets requirements. |
| ISO 7176-1:2014 (Static stability) | Compliance stated (implied by "met all design specifications" and "positive conclusion") |
| ISO 7176-2:2017 (Dynamic stability) | Compliance stated |
| ISO 7176-3:2012 (Brake effectiveness) | Compliance stated; meets ISO 7176-3 |
| ISO 7176-4:2008 (Energy consumption) | Compliance stated |
| ISO 7176-5:2008 (Dimensions, mass, maneuvering) | Compliance stated |
| ISO 7176-6:2018 (Max speed, acceleration) | Compliance stated |
| ISO 7176-7:1998 (Seating & wheel dimensions) | Compliance stated |
| ISO 7176-8:2014 (Static, impact, fatigue strength) | Compliance stated |
| ISO 7176-9:2009 (Climatic tests) | Compliance stated |
| ISO 7176-10:2008 (Obstacle-climbing) | Compliance stated; meets ISO 7176-10 |
| ISO 7176-11:2012 (Test dummies) | Compliance stated |
| ISO 7176-13:1989 (Coefficient of friction) | Compliance stated |
| ISO 7176-14:2022 (Power & control systems) | Compliance stated; meets ISO 7176-14 |
| ISO 7176-15:1996 (Information & labeling) | Compliance stated |
| ISO 16840-10:2021 (Resistance to ignition) | Compliance stated; test carried out according to standard |
| ISO 7176-21:2009 (EMC) | Compliance stated; IEC 60601-1-2 & ISO7176-21 |
| ISO 7176-22:2014 (Set-up procedures) | Compliance stated |
| ISO 7176-25:2013 (Batteries & chargers) | Compliance stated |
| IEC 60601-1-2:2020 (EMC) | Compliance stated |
| FDA Regulatory Guidance (Label and labeling) | Conforms to FDA Regulatory |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "sample size" in the conventional sense for a clinical trial or algorithm test set with individual cases. The testing refers to the device prototype(s) themselves. For mechanical and electrical performance tests, a limited number of test units (often 1-3) are typically used per test type, depending on the standard. For biocompatibility, material samples are tested.
- Data Provenance: The tests are performed to demonstrate compliance with international standards (ISO, IEC) generally by test labs. The document does not specify geographical provenance for the testing data in terms of "country of origin of the data" being retrospective or prospective from patient cohorts. It's device performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to an electrically powered wheelchair device. "Ground truth" in this context would refer to the physical and electrical safety and performance parameters measured against established engineering and medical device standards. No "experts" are establishing "ground truth" in the diagnostic sense. Compliance is verified by testing according to published, objective standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This refers to consensus reading for diagnostic purposes, which is not relevant here.
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 is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on established international performance and safety standards (ISO and IEC, as listed in the document) and FDA guidance for electrically powered wheelchairs. Compliance is demonstrated through physical, electrical, and materials testing.
8. The sample size for the training set:
- Not applicable. This is not an AI device trained on data.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).