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.

Device Description

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.

AI/ML Overview

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.

Summary

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K972111

FEB

Tab 11

510(k) Summary RUMORS Dynamic Air Therapy® Unit

5-12-97 Date Prepared:

1. SUBMITTER NAMES:

Submitter:	Hill-Rome4349 Corporate RoadCharleston SC 29405
Contact:	Edwin BillsManager Quality Services & Regulatory Affairs4349 Corporate RoadCharleston SC 29405(803)740-8380FAX: (803)740-8059

2. DEVICE NAMES:

Common or Usual or Powered Patient Rotation Mattress Classification Name: RUMORS Dynamic Air Therapy® Unit Proprietary Name:

3. PREDICATE DEVICES:

EFICA CC® Dynamic Air Therapy® Unit manufactured by Hill-Romø PULMONEX™ Dynamic Air Therapy® Unit manufactured by Hill-Romø SYNERGY F.A.S.T. manufactured by Cardio Systems TriaDyne™ Critical Care Healing System manufactured by KCI Therapeutic Services

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SUBJECT DEVICE: 4.

Air Supply Unit a)

The blower and controller are located in an air supply unit which hangs on the foot board of the bed. The controller can be programmed to accommodate patients of different heights (up to 84 inches) and weights (up to 400 lbs.) respectively. The controller, which utilizes touchscreen technology, controls the functions of the RUMORS Dynamic Air Therapy® Unit. These are low airloss; rotation; percussion; vibration; and combinations of rotation, vibration, and percussion.

b) Mattress

The mattress of the RUMORS Dynamic Air Therapy® Unit is designed to be used on different Med-Surg or ICU beds. The mattress is 8 inches high, 80 inches long and width can be set at 32 inches or 35 inches depending upon whether it is being used on a Med-Surg or ICU bed. There are two lavers of cushions in the mattress. The top layer is the sleep surface. It has five independently controlled cushions set at customized pressure based upon the patient's height and weight. The bottom layer is the working surface, or substrate, in which the proportional valves and the percussion/vibration valve are installed. The air cushions of the sleep surface are connected to each other by snaps. The working surface is secured to the hospital bed frame by the means of six double polyurethane coated nylon straps.

C) Valves

The RUMORS Unit utilizes twelve (12) proportional valves. The proportional valve is a stand alone valve that controls itself to a set pressure and will match the output pressure with the signal from the controller. The Unit also utilizes a percussion/vibration valve capable of producing a percussion range from 1Hz to 5Hz and a vibration range from 6Hz to 25Hz.

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5. INDICATIONS FOR USE:

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.

6. COMPARISON TO PREDICATES:

Differences in design between the subject device and the predicates (none of which have significant effect on safety and efficacy) are as follows:

a) Adiustable Width Mattress

The mattress width can be set at 32 inches to accommodate the ICU bed frame and at 35 inches for the Med-Surg bed frame.

b) Touchscreen Control Panel

Touchscreen technology instead of membrane switches is used to control the functions on this produce.

(See Tab 9: Comparison Chart for further complications.)

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7. SUMMARY:

The functions of the RUMORS Dynamic Air Therapy® Unit and the predicate devices are designed for:

the prevention and treatment of pressure ulcers through low airloss; a)
the reduction of pressure shear, friction and maceration through rotation; b)
the prevention and treatment of pulmonary complications related to C) immobility;
any other use where benefits may be derived from rotation therapy. d)

The RUMORS Unit is able to accomplish these functions through the operation of proportional and percussion/vibration valves in selected combinations which are configured and controlled through resident software in the controller.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profile graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 1998

Mr. Edwin L. Bills · Official Correspondent Hill-Rom® 4349 Corporate Road Charleston, South Carolina 29405-7445

K972111 Re: RUMORS Dynamic Air Therapy® Unit Regulatory Class: II Product Codes: IKZ and IOQ November 17, 1997 Dated: November 19, 1997 Received:

Dear Mr. Bills:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance withthe current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Edwin L. Bills

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

RUMORS Dynamic Air Therapy®

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K972111

Prescription Use
------------------	--

Over-The-Counter-Use	X
----------------------	---

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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.