(12 days)
The Intended Use of the Pride Mobility C5 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
The Pride Mobility C5 Lift Chair is an upholstered chair assembly constructed of a welded steel frame, and foam and fabric compliant to Cal 117 Flammability requirements. The chair is assembled to a welded steel lifting frame mechanism having a 24 VDC motor / actuator powered by standard 110 volt AC power from a wall outlet. A Hand Held Switch Control Device engages the actuators to position the chair to a recline, sitting, or standing position.
Based on the provided text, the Acceptance Criteria and Study information for the Pride Mobility C5 Lift Chair is as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Tested To) | Reported Device Performance (Compliance) |
|---|---|
| CAL 117 Sections A, D, & E - Flammability Testing for Upholstered Furniture | Compliant |
| EN 61000-6-3 - Electromagnetic Emissions | Compliant |
| EN 61000-6-1 - Electromagnetic Immunity | Compliant |
| EN60601-1 / A2: 1995 / EN60601-1 / A2: 1995 - Medical Electrical Equipment - General Requirements for Safety | Compliant |
2. Sample size used for the test set and the data provenance:
- The document states "The Pride Mobility C5 Lift Chair was tested to the following Safety Standards". This implies that one or more C5 Lift Chair units were tested. The exact number of units or the "sample size" is not explicitly stated.
- Data Provenance: The testing was conducted by Pride Mobility Products Corporation as a "Non-Clinical Testing" phase during the development and submission of the 510(k) application. This is internal testing data. The country of origin is implicitly the United States (where Pride Mobility is located). The testing is prospective in nature, as it's part of the development and validation of a new product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a mechanical lift chair, and the testing outlined is non-clinical safety standard compliance. It does not involve interpretation of medical images or patient data that would require "experts to establish ground truth" in the way a diagnostic AI would. The "ground truth" here is compliance with established engineering and safety standards, which is determined through laboratory testing and measurement.
4. Adjudication method for the test set:
- Not Applicable. As mentioned above, the testing is for compliance with engineering and safety standards. There is no concept of "adjudication" in the sense of resolving disagreements between human expert interpretations. The results are objective measurements against predefined thresholds of the standards.
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. This document explicitly states "Discussion of Clinical Testing Performed: N/A". This device is a physical product (a lift chair), not a diagnostic AI or an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a mechanical lift chair, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.
7. The type of ground truth used:
- The "ground truth" for this device's performance is compliance with established safety and performance standards (CAL 117, EN 61000-6-3, EN 61000-6-1, EN60601-1/A2:1995). These are objective, measurable criteria defined by regulatory bodies and industry associations.
8. The sample size for the training set:
- Not Applicable. This is a mechanical device, not a machine learning model. There is no "training set" in the context of AI.
9. How the ground truth for the training set was established:
- Not Applicable. As stated in point 8, there is no training set for this type of device.
§ 890.3110 Electric positioning chair.
(a)
Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.(b)
Classification. Class II. The electric positioning chair is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;
(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and
(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.