(147 days)
The intended use of Permobil powered wheelchair 1280 is to provide indoor and outdoor mobility to persons restricted to a sitting position.
The Permobil powered wheelchair 1280 is front wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact powered wheelchair controller Pilot +. The joystick is integrated in the controller. The wheelchair is powered by two 12V 73 Ah batteries. Theoretical driving range on the fully charged batteries is 35 km. The wheelchair consists of two basic sub-sections. These are the base with motor controller and the body supporting system. In this submission, only the design changes made to base is included. The base is of welded steel construction and includes the base frame, front drive wheels with drive unit (motor/gear/brakes), batteries and pivoting rear casters. The motor controller is mounted to the left or right armrest, depending on user needs. The motor controller, including the joystick, is housed in a pressure die cast aluminum enclosure.
This document is a 510(k) Summary of Safety and Effectiveness for the Permobil Powered Wheelchair 1280. It concludes that the device is substantially equivalent to predicate devices and does not raise new questions of safety and effectiveness due to minor design changes.
Based on the provided text, the Permobil Powered Wheelchair 1280 is not an AI/ML device and therefore the concept of "acceptance criteria" for AI performance, "study that proves the device meets the acceptance criteria," "sample size," "ground truth," "MRMC study," or "standalone performance" do not apply in the context of this traditional medical device submission.
The document discusses the "substantial equivalence" of the Permobil Powered Wheelchair 1280 to existing predicate devices (Permobil Chairman L/CS 8 (K960951) and G-424 power wheelchair (K983677)). Substantial equivalence is the primary regulatory pathway for many devices, where the new device is compared to a legally marketed predicate device.
Here's an analysis of what is provided, framed in terms of a traditional medical device submission, and how it relates to the questions:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied by Substantial Equivalence): The Permobil Powered Wheelchair 1280 must have "substantially the same technological characteristics and the same safety and effectiveness as the predicate device(s)." The "minor design changes declared in this submission do not raise new questions of safety and effectiveness."
- Reported Device Performance: The document does not provide a table of performance metrics in the way an AI/ML study would. Instead, it asserts its equivalence based on:
- Intended Use: Identical to predicate device(s) ("to provide indoor and outdoor mobility to persons restricted to a sitting position").
- Energy Source: Identical to predicate device(s).
- Materials: Identical to predicate device(s).
- Key Changes: Frame suspension and use of Penny & Giles Pilot + controller instead of PG8 controller. The document explicitly states these changes do not raise new questions of safety and effectiveness.
- Theoretical Driving Range: 35 km on fully charged batteries (this is a performance spec, but not tied to a specific "acceptance limit" or comparison in a table within this document).
2. Sample sized used for the test set and the data provenance:
- Not Applicable. This is not an AI/ML study. Performance is asserted through comparison to predicate devices, and the inherent safety/effectiveness of its components (e.g., standard wheelchair frame, motor, battery, controller). There is no "test set" in the sense of a dataset for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No "ground truth" establishment in the context of AI/ML evaluation. Regulatory review is performed by FDA staff (e.g., Division of General and Restorative Devices).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No "test set" requiring adjudication.
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/ML device, so no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device (a powered wheelchair), not an algorithm.
7. The type of ground truth used:
- Not Applicable. No "ground truth" in the AI/ML sense. The "truth" for this submission revolved around demonstrating that the device's design, materials, and function align with established safe and effective powered wheelchairs (the predicate devices).
8. The sample size for the training set:
- Not Applicable. No training set for an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. No training set for an algorithm.
In summary: The provided document is a 510(k) submission for a non-AI powered wheelchair. The "acceptance criteria" are implicitly defined by the FDA's substantial equivalence requirements, which focus on comparing the device's intended use, technological characteristics, and safety/effectiveness to previously cleared predicate devices, rather than a quantifiable performance study against a ground truth dataset as would be seen for an AI/ML device.
§ 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).