The DeRoyal Industries, Inc. Infant Transport Mattress is a device intended for medical purposes to provide warm therapy that helps maintain infant body temperature. Device Design/Materials UsedPhysical Properties: The DeRoyal Infant Transport Mattress is designed similar to those marketed by other manufacturers. The pouch is comprised of a low-density polyethylene (LDPE) film bag which contains the activation ingredient, sodium acetate (food grade).

AI/ML Overview

The provided text describes a 510(k) summary for the DeRoyal Industries, Inc. Infant Transport Mattress, a medical device for providing warm therapy to infants. However, it does not include detailed information about acceptance criteria, specific studies, sample sizes, expert involvement, or ground truth establishment for a device performance study.

The document is a premarket notification (510(k)) indicating that the device is "substantially equivalent" to legally marketed predicate devices. The primary focus of a 510(k) submission is to demonstrate this substantial equivalence through a comparison of technological characteristics and intended use.

Here's a breakdown of what can be inferred from the provided text and why the requested information is largely absent:

1. A table of acceptance criteria and the reported device performance:

The document implicitly uses the performance of the predicate device as an acceptance criterion for the DeRoyal device's key characteristic: temperature achieved at activation.

Characteristic	Acceptance Criteria (based on predicate)	Reported Device Performance (DeRoyal)
Approximate Temperature Achieved at Activation	104° F	105° F

Explanation: The comparison table explicitly states that the predicate device achieves "104° F" for approximate temperature at activation. The DeRoyal device reports achieving "105° F". This indicates that the DeRoyal device meets or exceeds the temperature performance of the predicate. Other characteristics are primarily comparisons of materials and dimensions, not performance metrics with explicit acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. The document does not mention any specific test sets, sample sizes, or data provenance from a performance study. The "test" here refers to a comparison against a predicate, not a clinical trial or extensive standalone performance study with a dedicated test set as you might see for a more complex device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. No "ground truth" in the sense of expert consensus on clinical findings is discussed. The assessment is primarily based on comparing the physical and functional characteristics of the DeRoyal mattress to a known, legally marketed predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/None mentioned. There's no indication of an adjudication process for a test set. The review process is by the FDA, determining substantial equivalence.

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 an infant transport mattress, not an AI-powered diagnostic tool. MRMC studies are used for assessing diagnostic performance, typically for imaging devices with human reader involvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical product for warmth, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Implicitly, the performance of the legally marketed predicate device. For a 510(k) submission like this, "ground truth" for demonstrating safety and effectiveness often comes from the established performance and safety record of the predicate device. The DeRoyal device aims to show it is at least as safe and effective as the predicate, not necessarily to establish new clinical efficacy against a "true" medical condition outcome.

8. The sample size for the training set:

Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device. The design and materials are based on existing technology and knowledge.

9. How the ground truth for the training set was established:

Not applicable/Not provided. No training set exists for this type of device and submission.

In summary:

The provided document details a 510(k) submission for a simple medical device. The "study" referenced is the comparison of the DeRoyal Infant Transport Mattress to a legally marketed predicate device (Prism Technologies). The "acceptance criteria" are implicitly that the DeRoyal device must be substantially equivalent to the predicate in terms of materials, design, intended use, and performance characteristics (like achieving a similar therapeutic temperature). Since this is a comparison for substantial equivalence, formal clinical trials with extensive test sets, expert ground truth establishment, or AI-specific studies are not typically part of such a submission. The FDA's letter confirms that based on the provided information, the device was deemed substantially equivalent.

Summary

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K980804

DeRoyal Industries, Inc. Infant Transport Mattress

FEB 2 6 1998

510(k) Summary

SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

SUBMITTER INFORMATION

NAME:	DeRoyal Industries, Inc.	TELEPHONE:	(423) 938-7828
ADDRESS:	200 DeBusk LanePowell, TN 37849	CONTACT:	Camille Matlock
		DATE OF PREPARATION:	February 9, 1998

DEVICE NAMES

NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Industries, Inc. Infant Transport Mattress . Infant Transport Mattress Pack, Hot, Chemical

PREDICATE OR LEGALLY MARKETED DEVICES

Prism Technologies

DEVICE DESCRIPTION

The DeRoyal Industries, Inc. Infant Transport Mattress is a device intended for medical purposes to provide warm therapy that helps maintain infant body temperature.

Device Design/Materials UsedPhysical Properties: The DeRoyal Infant Transport Mattress is designed similar to those marketed by other manufacturers. The pouch is comprised of a low-density polyethylene (LDPE) film bag which contains the activation ingredient, sodium acetate (food grade).

DEVICE INTENDED USE

The DeRoyal Industries, Inc. Infant Transport Mattress is indicated for use to assist in maintaining infant body temperature.

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

Characteristic	DeRoyal Device	Other Devices
Pouch Dimension	Approximately 16" X 9.5"	Approximately 13" X 9"
Pouch Material	LDPE	LDPE orOther Similar Material
Active Ingredient	Sodium Acetate (Food Grade)	Sodium Acetate (Food Grade)
Trigger	Internally Located	Internally Located
Sterility	Non-Sterile	Non-Sterile
Approximate TemperatureAchieved at Activation	105° F	104° F

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Image /page/1/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 image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected by a single line that runs from the top of the head to the bottom of the chin. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 1998

Ms. Camille Matlock Regulatory Affairs DeRoyal Industries, Inc. 200 DeBusk Lane Powell, Tennessee 37849

K980509 Re: Trade Name: DeRoyal Industries, Inc. Infant Transport Mattress Requlatory Class: I Product Code: IMD February 9, 1998 Dated: Received: February 10, 1998

Dear Ms. Matlock:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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 regulations.

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Page 2 - Ms. Camille Matlock

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 (if known):
Device Name:	DeRoyal Industries Inc. Infant Transport Mattress

Indications for Use:

)

The DeRoyal Industries Inc. Infant Transport Mattress is to be used to assist in maintaining infant body temperature.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Sign-Off of General Restorative Devices Number	K980509

Prescription Use (Per 21 CFR § 801.109)	OR	Over-The-Counter Use ______
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Regulation Number and Section

§ 890.5710 Hot or cold disposable pack.

(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.