HYDROTEC LOW AIR LOSS THERAPY BED by APEX METAL, INC.

The provided documents (K970363) are a 510(k) clearance letter for the HydroTec™ Low Air Loss Therapy Bed. This kind of document typically doesn't contain a detailed report of a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study report would.

The FDA 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving efficacy through new, rigorous clinical trials with detailed acceptance criteria for a new class of device. Therefore, much of the requested information (like specific acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in these specific documents.

However, based on the provided text, I can infer some information relevant to the device's intended use and the nature of product clearance:

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

No specific acceptance criteria or tabulated performance data are present in these documents. The 510(k) clearance indicates that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use and similar technological characteristics, or if there are differences, they do not raise new questions of safety and effectiveness.
Intended Use (from the document): "The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers (bed sores)."

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

Not explicitly mentioned in these documents. For a 510(k) submission, the "test set" would typically refer to data submitted to demonstrate substantial equivalence, which could include engineering testing, biocompatibility data, or potentially clinical data if differences from the predicate raised new questions. However, the details of such studies (sample sizes, provenance) are not provided in this clearance letter.

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 mentioned. The concept of "ground truth" established by experts, particularly regarding interpretations like in imaging, is not relevant to this type of device (a therapy bed) and the documentation provided.

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

Not applicable/not mentioned. Adjudication methods are typically used in studies involving subjective assessments (e.g., image interpretation), which is not the primary focus for a therapy bed's substantial equivalence demonstration.

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 type of study (MRMC for AI assistance) is not relevant to a low air loss therapy bed.

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

Not applicable. This concept pertains to AI/software as a medical device, not a physical therapy bed.

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

Not applicable in the sense of expert review for diagnostic purposes. For a therapy bed, "ground truth" would relate to performance characteristics (e.g., pressure redistribution, air loss rates, safety features) verified through engineering tests, and potentially clinical outcomes if clinical data were required to demonstrate substantial equivalence, but such details are not in the clearance letter itself.

8. The sample size for the training set

Not applicable. This concept is relevant for machine learning algorithms, not a physical therapy bed.

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

Not applicable. As above, this relates to machine learning.

Summary

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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized design that resembles a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 1997

Ms. Jean Rozint Apex Metal, Inc. c/o Clinically Effective Outcomes, Inc. P.O. Box 1026 Mount Pleasant, South Carolina 29465-1026

K970363 Re: HydroTec™ Low Air Loss Therapy Bed Trade Name: K970364 AirTec2™ Low Air Loss Therapy Bed Trade Name: Requlatory Class: II Product Code: IOQ Dated: August 18, 1997 Received: August 19, 1997

Dear Ms. Rozint:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 chat have boon Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 devices in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Ms. Jean Rozint

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.

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

If you desire specific advice for your devices on our labeling requlation (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 devices, 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,

n Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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510(k) Number (if known): ____________________

Device Names: HydroTec™ Low Air Loss Therapy Bed ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for Use:

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers ( bed sores).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Genera	ces
510(k) Number	K970363

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use X
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(Optional Format 1-2-96)

Regulation Number and Section

§ 890.5170 Powered flotation therapy bed.

(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(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.