(415 days)
Patients in wheelchairs present problems to clinicians who need to treat them and the patients themselves can be seriously disadvantaged by their situation. This is particularly true of dental treatment. To be treated the dentist would need to bend around the patient in the wheelchair, that cusses back pain and sometimes injury. An alternate approach is to transfer the patient to a conventional chair by slings and hoists or other approaches, all of which hold significant health and safety risks. The wheelchair platform offers a safe environment for both clinician and patient. The wheelchair is moved onto the platform up against a back wall support and the wheelchair and patient are then supported by a backrest and a head support. The platform is reclined, and possibly raised and lowered, to present the patient in the best position for treatment.
The device accommodates wheelchairs in a secure way, to enable them to be tilted backwards. Patient support is by an adjustable backrest with head support using an adjustable head cushion. The primary use is with patients who cannot be easily transferred from their chairs for such procedures as dentistry, Podiatry, Ear, nose and throat, maxio-facial work. Basic Platform shape: Steel fabrication. Drive mechanism: Electrical Linear Drive. Power source: Battery 24v and Power supply delivering 24v. Backrest support: Pivots in and out adjustable by worm and wheel. Headrest: Adjustable using a slotted arm with an adjustable headrest cushion for neck and head support. Motions command input: Tilt only Fixed switches and radio remote control. Foot crush protection: Pressure sensitive mat and guarding. Max. angle of tilt: 45deg. Rated capacity: 594lb (BSEN1570:1999). Proposed uses: Dental and medical applications. Static or mobile: Mobile on air cushion pads or ball castors.
Here's a breakdown of the acceptance criteria and the study information for the Wheelchair Platform, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Wheelchair Platform are primarily derived from the standard BSEN1570:1999. The submission confirms that the device meets these requirements.
| Acceptance Criteria (from BSEN1570:1999) | Reported Device Performance (Adherence) |
|---|---|
| Allowable stresses at design load: 60% of yield stress | Met: Implied by the statement "Testing is carried out under the requirements as set out in BSEN1570:1999," which specifies this stress limit. |
| Full dynamic test at rated load recording operation times | Met: Implied by the statement "Testing is carried out under the requirements as set out in BSEN1570:1999," which lists this as a test. |
| 10 min delay under load to determine sink | Met: Implied by the statement "Testing is carried out under the requirements as set out in BSEN1570:1999," which lists this as a test. |
| Load increase by 10% and full dynamic test | Met: Implied by the statement "Testing is carried out under the requirements as set out in BSEN1570:1999," which lists this as a test. |
| Static test to 25% increase load | Met: Implied by the statement "Testing is carried out under the requirements as set out in BSEN1570:1999," which lists this as a test. |
| Rated capacity | 594lb (269.4 kg): Explicitly stated as per BSEN1570:1999. |
Note: The provided text states that testing was carried out under BSEN1570:1999 and that this standard specifies the allowable stresses and types of tests. It then explicitly states the rated capacity of 594lb as per this standard. This implies that the device successfully met all the specified criteria within that standard.
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The testing seems to be focused on a single device prototype or production model, as is typical for mechanical device performance testing against a standard. It's not a study involving a "test set" in the sense of a population of patients or data points.
- Data Provenance: Not explicitly stated, however, the standard BSEN1570:1999 is a European standard, suggesting testing might have been done in a location adhering to these standards, possibly the UK given the "Ltd" in "Design Specific Ltd". The submission date is October 21, 2008, indicating retrospective data collection relative to the submission.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is not a study requiring expert-established ground truth for a test set. The performance is assessed against engineering and safety standards.
4. Adjudication Method
Not applicable. This is not a study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a mechanical device, not an AI or imaging diagnostic device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a mechanical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth used for proving device performance is defined by the engineering and safety standards outlined in BSEN1570:1999. This standard specifies objective, measurable criteria related to stress, load capacity, and operational tests.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning model, so there is no "training set."
9. How Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, there's no ground truth established for it.
§ 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.