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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.

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.

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