The provided text does not contain detailed acceptance criteria or a study that proves the device meets those criteria in the way typically expected for an AI/algorithm-driven device. This document is a 510(k) summary for a medical device (subcutaneous infusion set), not a software or AI product. As such, the information requested in the prompt (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) is largely irrelevant to this type of device submission.

However, I can extract the relevant information based on the provided text, while also noting what is not applicable.

Here's a breakdown of the information and what is not available from the text:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Reported Performance
Meets specifications	Verifications testing confirmed the product meets its specifications.
Substantially equivalent to predicate devices	Concluded to be substantially equivalent to unmodified Contact™ sets, Comfort Sets™, Maersk Medical Paradigm Quick Set Infusion set (K011071), and Maersk Medical Pureline Comfort Subcutaneous Infusion Set (K972135).
Technological characteristics unchanged	Modification does not change the technological characteristics of the current product.

2. Sample size used for the test set and the data provenance

Sample size: Not specified. The document states "Verifications testing has confirmed the product meets their specifications," but does not detail the sample sizes used for this testing.
Data provenance: Not applicable in the context of AI/algorithm testing. The "testing" referred to is likely engineering and performance testing for a physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/algorithm-driven device where expert ground truth interpretation is typically required for image or data analysis. The "ground truth" for a physical device would relate to engineering specifications and physical performance.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned or relevant to the nature of this physical device's testing.

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

No. This is not an AI/algorithm-driven device; therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

No. This is not an AI/algorithm-driven device.

7. The type of ground truth used

The "ground truth" for this medical device would be based on engineering specifications and physical performance measurements rather than expert consensus, pathology, or outcomes data in the context of diagnostic interpretation. The document broadly states "Verifications testing has confirmed the product meets their specifications."

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-driven device and therefore does not have a "training set" in the machine learning sense.

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

Not applicable. This is not an AI/algorithm-driven device.

Summary

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8.0 510(K) SUMMARY Date Prepared: May 20, 2004
K041545
8.1 SUMMARY OF SAFETY AND EFFECTIVENESS Submitted By: John M. Lindskog General Manager Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark
8.2 Trade/Proprietary Name: Contact Detach TM
8.3 Common/Usual Name Subcutaneous Infusion Set
8.4 Classification Name Intravascular Administration Set

8.5 Substantial Equivalence

The modified sets are substantially equivalent to the unmodified Contact™ sets and the Comfort Sets™, the Maersk Medical Paradigm Quick Set Infusion set (K011071) and the Maersk Medical Pureline Comfort Subcutaneous Infusion Set (K972135).

8.6 Technological Characteristics

This modification does not change the technological characteristics of the current product.

8.7 Performance Data

Verifications testing has confirmed the product meets their specifications.

8.8 Conclusion

Unomedical A/S concludes based on the information presented that the modified product is substantially equivalent to products currently legally marketed in the USA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

JUN 3 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John M. Lindskog General Manager Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, DENMARK

Re: K041545

Trade/Device Name: Contact Detach™ Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 1, 2004 Received: June 9, 2004

Dear Mr. Lindskog:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lindskog

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.

Olin L. Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number:

K041545

Device Name:

Contact Detach™

Indications for Use:

The Contact Detach™ is indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Arthur Lemay

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anesthoolorology
Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.