(50 days)
To provide added comfort during periods of bedrest by permitting the user to adjust the surface contour of the bed to various positions.
The Model 720 Series Full/Semi Electric and 1120 Full Electric Beds are a series of nursing home beds with an intended function of providing added comfort during periods of bedrest. Additionally they permit the user to adjust the surface contour of the bed to various positions which best suit the specific needs of the bed user.
The 720 and 1120 product lines include a steel frame construction with motorized adjustments which are controlled through a pendant. The pendant controls are completely sealed and are available in four or six button configurations. Each series has variety of options and accessories which vary according to model number. Some options include floor locks, lock-out switches and perforated pans. Accessories include various side rails, IV sockets, IV rods and trapeze.
The provided document, K974296, is a 510(k) summary for Invacare Corporation's Model 720 Series Full/Semi Electric and 1120 Full Electric Beds. It describes typical regulatory submission information for medical devices, focusing on substantial equivalence to predicate devices and adherence to relevant safety standards.
Based on the content of the document, here's a breakdown regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet U.L. 544 Standard for Safety for Medical and Dental Equipment | The 720 Series and 1120 Electric Beds have all been tested for and meet the requirements listed with Underwriters Laboratories (U.L.) under the 544 Standard for Safety, for Medical and Dental Equipment. |
| Include a low voltage control system | The beds include a low voltage control system. |
| Include thermal protection on the motors | The beds include thermal protection on the motors. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical or performance data for the device. The testing mentioned refers to compliance with safety standards. Therefore, information on sample size and data provenance for a test set in the sense of clinical evaluation is not applicable or provided.
3. Number of Experts and Their Qualifications for Ground Truth
This information is not applicable. The device is a hospital bed, and its compliance is assessed against engineering safety standards (U.L. 544), not through expert-derived clinical ground truth.
4. Adjudication Method
This information is not applicable. Adjudication methods are typically used in studies involving subjective assessments or disagreements among experts, which is not the nature of the testing described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or image interpretation devices where human performance with and without AI assistance is evaluated. The Invacare beds are mechanical devices.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study for an algorithm was done. This device is a bed, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's acceptable performance is defined by the requirements and standards outlined in the Underwriters Laboratories (U.L.) 544 Standard for Safety, for Medical and Dental Equipment. This is a set of objective engineering and safety criteria.
8. Sample Size for the Training Set
This information is not applicable. The product is a physical device, not an AI model that requires a training set.
9. How Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for an AI model. The "ground truth" for the device's safety and effectiveness is established by compliance with the U.L. 544 standard, which is determined through defined testing procedures.
§ 880.5100 AC-powered adjustable hospital bed.
(a)
Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.