The AMT Button Replacement Gastrostomy Device is to be used as a replacement gastrostomy tube for a patient with a well established gastrostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. The AMT Button Replacement Gastrostomy Device can also deliver medication and allow for decompression of the stomach.

Device Description

AMT Button is injection molded of Silicone. The Dome is injected molded from Silicone and Barium mixed for radiopaic detection if desired and is glued (with silicone) to the body of the Button. The Anti-Reflux Valve is injected molded from Silicone and Barium mixed for radiopaic detection if desired and is glued (with silicone) to the body of the Button. The device is sold in various sizes. Size is determined by the Physician or Professional Health Giver (dependant on length of existing stoma tract). The AMT Button is packaged in a kit which includes Directions For Use, Obturator Rod, Patient Care Kit, Stoma Measuring Device. The AMT Button Replacement Gastrostomy Device is sterile, single user, and disposable. The Patient Care Kit and Stoma Measuring Device are Non-Sterile and packaged for single user, disposable.

AI/ML Overview

This submission describes a medical device, the AMT Button, and makes a claim of substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and performance data for a new, novel device. Therefore, much of the requested information regarding experimental design, ground truth, and statistical analysis is not applicable.

Here's an analysis of the provided text in relation to your request:

Analysis of the Provided Text:

The document is a 510(k) submission for the "AMT Button" device. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a predicate device already on the market, not to prove safety and effectiveness through clinical trials with defined acceptance criteria for novel performance.

Key Findings from the Document:

Device Type: AMT Button Gastrostomy Feeding Device (a replacement gastrostomy device).
Claim of Substantial Equivalence: The submitter claims the AMT Button is "as safe and effective as other predicate devices cited above" and is "identical in design and manufacture, using the same materials and processes used in 510(k) K843392 of Applied Medical Technology, Inc."
Predicate Devices: K843392 (AMT Button), Microvasive/Boston Scientific Corp. Button, C.R. Bard Button.
FDA Response: The FDA letter confirms the device is substantially equivalent for the stated indications for use.

Given this context, most of the requested points ("acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," "how ground truth for training set was established") are not applicable to this type of submission. This document does not describe the kind of performance study one would typically find for a new diagnostic or AI-driven device with quantifiable acceptance criteria.

Information from the Text (formatted where applicable):

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not present specific quantitative acceptance criteria or performance metrics for this device as it is a claim of substantial equivalence based on material and design similarity to existing devices. There are no performance results (e.g., sensitivity, specificity, accuracy) provided that would be compared against such criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No test set is described. The submission relies on demonstrating similarity to legally marketed predicate devices, not on a performance study with a test set of data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

Not applicable. No experts or ground truth establishment are described in this type of submission.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. No test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. An MRMC study was not done, nor would it typically be required for a 510(k) submission based on substantial equivalence to predicate devices for this product type. There is no mention of human readers or AI assistance.

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

No. This is a physical medical device (gastrostomy button), not an AI algorithm. Therefore, no "standalone" algorithm performance study was conducted.

7. The Type of Ground Truth Used

Not applicable. Ground truth is not a concept applied in this substantial equivalence submission. The basis for safety and effectiveness is the long-standing use and FDA approval of the predicate devices, and the demonstrated similarity of the new device to those predicates in terms of materials and design.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve a training set as it is not an AI/algorithm device requiring machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth established for one.

In summary, the provided text is a 510(k) premarket notification for a medical device seeking substantial equivalence, not a scientific study describing performance metrics against pre-defined acceptance criteria for a novel device or AI.

Summary

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16980305 1- 68 1

APR 16 1998

1. Submitter Name:	Applied Medical Technology, Inc.
2. Address:	15653 Neo ParkwayCleveland, OH 44128 USA
3. Telephone:	216-475-5577
4. FAX:	216-475-5575
5. Contact Person:	Tom Parkinson - Quality Assurance / Regulatory Affairs
6. Date of preparation:	January 22, 1998
7. Device Trade or Proprietary Name:	AMT Button
8. Device Common Name:	AMT Button Gastrostomy Feeding Device
9. Device Classification Name:	Gastrointestinal Tube and Accessories (78KGC)
10. Substantial Equivalency is claimed against the following devices:

510(k) Summary

1. Applied Medical Technology, Inc. -	AMT Button - K843392
2. Microvasive/Boston Scientific Corp. -	Button and Replacement Button
3. C.R.Bard -	Button and Replacement Button

11. Device of Description:

12. Intended Use:

The AMT Button is intended to be used as a replacement gastrostomy feeding device. Other uses are not recommended.

13. Safety and Effectiveness of the device:

The AMT Button is as safe and effective as other predicate devices cited above.

14. Summary comparing technological characteristics with other predicate devices:

The AMT Button identical in design and manufacture, using the same materials and processes used in 510(k) K843392 of Applied Medical Technology, Inc.

AMT Button U.S. Patent No .: 4,863,438

Applied Medical Technology, Inc. - 510(k) Submission AMT Button Replacement Gastrostomy Device Section H - Page H.2.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or head in profile, with three overlapping shapes suggesting multiple faces or layers. The symbol is rendered in black, contrasting with the white background of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1998

Mr. Thomas W. Parkinson · Leader - Quality Assurance / Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway Cleveland, Ohio 44128

Re: K980305 AMT Button Replacement Gastrostomy Device Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT Dated: January 22, 1998 Received: January 27, 1998

Dear Mr. Parkinson:

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 legally marketed predicate 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510 (k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Thomas W. Parkinson

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 Requlations.

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 leqally 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 the labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html".

Sincerely yours,

Robert R Ratting/

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION - I

11480 XV3

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

.. . . . . . .

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

	Division Sign-Off
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K980305

Prescription Use	(Per 21 CFR 801.109)	OR	Over-The-Counter Use
------------------	------------------------------------------	----	----------------------

(Optional Format 1-2-96)

Applied Medical Technology, Inc. - 510(k) Submission

AMT Button Replacement Gastrostomy Device Section 1 - Page 1.10.

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.