(242 days)
The RUMORS Dynamic Air Therapy® Unit is intended to be used on existing bed frames in areas throughout the patient care environment to treat or prevent pulmonary complications and pressure ulcers.
The Unit can operate in rotation mode to reduce pressure shear, friction and maceration while gently rotating the patient from side to side; it can operate in percussion and vibration mode by delivering percussion and vibration to the patient's chest to loosen secretions from the lung wall; and it can also be programmed to operate in a sequential mode of percussion and vibration therapies with and without rotation with patients up to 400 lbs. in weight. The RUMORS Unit also provides low airloss therapy. Low airloss therapy has been demonstrated to reduce the risk of pressure ulcers caused by loss of capillary circulation as well as be a valuable aid in the treatment of bed sores.
The RUMORS Dynamic Air Therapy® Unit is intended to be used to treat or prevent pulmonary complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from Continuous Lateral Rotation Therapy.
The RUMORS Dynamic Air Therapy® Unit consists of an Air Supply Unit, a Mattress, and Valves. The Air Supply Unit contains the blower and controller, which utilizes touchscreen technology and can be programmed for patients up to 84 inches tall and 400 lbs. The controller manages low airloss, rotation, percussion, vibration, and combinations of these therapies. The mattress is 8 inches high, 80 inches long, and has adjustable width (32 or 35 inches). It has two layers of cushions: a top sleep surface with five independently controlled cushions and a bottom working surface containing proportional and percussion/vibration valves. The Unit utilizes twelve proportional valves and one percussion/vibration valve capable of producing percussion from 1Hz to 5Hz and vibration from 6Hz to 25Hz.
This is a 510(k) premarket notification for a medical device (K972111 for the RUMORS Dynamic Air Therapy® Unit), not a study report with acceptance criteria and results. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness is not present in the provided text.
The document primarily focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for approval rather than a scientific study validating specific performance metrics against pre-defined acceptance criteria.
However, I can extract the "Indications for Use" which serve as a high-level description of what the device is intended to do, and which implicitly define the areas where its performance would be assessed if a performance study were to be conducted.
Here's a breakdown of what can and cannot be answered from the provided text:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied from Indications for Use):
- Prevention and treatment of pulmonary complications associated with immobility.
- Prevention and treatment of pressure ulcers.
- Providing medical benefits from Continuous Lateral Rotation Therapy.
- Low airloss therapy to reduce risk of pressure ulcers and treat bed sores.
- Reduction of pressure shear, friction, and maceration through rotation.
- Delivery of percussion and vibration to the chest to loosen secretions.
- Reported Device Performance:
The document does not report specific quantitative performance metrics or test results against these implied criteria. It states that the device "is able to accomplish these functions" and describes its operational modes (rotation, percussion, vibration, low airloss), implying it is designed to meet these needs, but no data or performance values are provided.
2. Sample size used for the test set and the data provenance
- Not Applicable. The document does not describe a clinical performance study with a test set. This is a 510(k) submission, which relies on demonstrating substantial equivalence to existing predicate devices, often through engineering analysis and comparison of features, rather than new clinical trials demonstrating performance against specific endpoints in a patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No clinical test set or ground truth establishment process is described in this regulatory submission.
4. Adjudication method for the test set
- Not Applicable. No clinical test set or adjudication process is described.
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 device is a therapeutic medical bed/mattress system, not an imaging or diagnostic device involving "human readers" or "AI assistance." Therefore, an MRMC study is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware-based therapeutic device with integrated control software, not an "algorithm only" product in the sense of AI/software as a medical device. Its operation is intended to be autonomous based on programmed settings. While it operates "standalone" in terms of its functions (rotation, percussion, etc.), this isn't the same context as standalone performance for an AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. As no performance study is detailed, no ground truth is mentioned. The submission's "ground truth" for regulatory approval is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not Applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of AI.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, this question is not applicable.
§ 890.5225 Powered patient rotation bed.
(a)
Identification. A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.(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 § 890.9.