The provided document is a 510(k) summary for the "Manan™ Galactography Kit," a manual surgical instrument. It primarily outlines the administrative details of the submission and states that the device is substantially equivalent to a previously marketed device.

Based on the content, the document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Here's what can and cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance:
- Not available. The document does not specify any performance acceptance criteria or report performance metrics from a study.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. There is no mention of a test set, sample size, or data provenance.
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 available. There is no mention of ground truth establishment or experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available. No adjudication method is described.
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 manual surgical instrument, not an AI or imaging interpretation device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a manual surgical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available. No ground truth is described.
The sample size for the training set:
- Not applicable. This is a manual surgical instrument, not a learning algorithm.
How the ground truth for the training set was established:
- Not applicable. This is a manual surgical instrument, not a learning algorithm.

Conclusion:

The provided 510(k) summary is a regulatory document indicating the "Manan™ Galactography Kit" is substantially equivalent to a predicate device (Manan Medical Products Galactography Kit, K881671). It does not contain the details of performance studies, acceptance criteria, sample sizes, expert ground truth establishment, or any information related to AI or algorithm performance that your questions seek. Such information is typically found in detailed technical reports or clinical study summaries, which are not part of this 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image is a logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is black and white and features the letters "MDTECH" in large, bold font. The letters are stacked on top of each other, with the "MD" on top and the "TECH" on the bottom. The letters are also stylized with horizontal lines running through them. Below the letters, the words "MEDICAL DEVICE TECHNOLOGIES INC" are written in a smaller font.

Gainesville, Florida TEL: 352/338-0440 FAX: 352/338-0662 APR 2 3 1998

K980227

510(k) SUMMARY

APPLICANT:

Medical Device Technologies, Inc. 4445-310 SW 35th Terrace Gainesville, FL 32608

§878.4800 Manual surgical instrument

Karl Swartz Quality Assurance Manager

TELEPHONE:

TRADE NAMES:

CONTACT:

(352)338-0440 fax (352)338-0662

Manan™ Galactography Kit

Breast biopsy kit COMMON NAME:

CLASSIFICATION NAME:

SUBSTANTIAL EQUIVALENCE:

Company Name	Product Name	510(k) No.
Manan Medical Products	Galactography Kit	K881671

DESCRIPTION OF DEVICE:

The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 23 1998

Mr. Karl Schwartz Quality Assurance Manager Medical Device Technologies Inc. 4445-310 SW 35th Terrace Gainsville, Florida 32608

Re: K980227 Trade Name: Manan™ Galactography Kit Regulatory Class: II Product Code: FMI Dated: January 21, 1998 Received: January 22, 1998

Dear Mr. Schwartz:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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. ਸ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 - Mr. Schwartz

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) 594-4595. 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.qov/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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Image /page/3/Picture/0 description: The image is a logo for MDTECH Medical Device Technologies INC. The logo is black and white and features the text "MDTECH" in large, bold letters. Below the text "MDTECH" is the text "MEDICAL DEVICE TECHNOLOGIES INC" in smaller letters. The logo has a rectangular shape with rounded corners.

4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662

Page_1_of_1_

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Manan™ Galactography Kit

Indications for Use:

The Galactography kit is designed to perform safe and effective, contrast media enhanced radiography of the mammary ducts.

(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 General Restorative Devices
510(k) Number	R980227

Prescription Use
(Per 21 CFR 801.109) X

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).