The provided text is a 510(k) summary for an infusion set and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed performance study with acceptance criteria and results in the way one would expect for an AI/ML device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not mentioned in this document because it describes a medical device (infusion set) for which performance is typically verified through engineering testing against specifications, rather than clinical studies involving ground truth establishment by experts as seen in diagnostic AI/ML applications.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states: "Verification testing confirmed the product meets their specifications." It does not provide numerical acceptance criteria or specific performance metrics.

Acceptance Criteria	Reported Device Performance
Product meets its specifications	Confirmed

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

Sample Size: Not specified. The document refers to "Verification testing" without detailing the sample size for these tests.
Data Provenance: Not applicable. The "tests" would be engineering/bench tests of the physical device, not data from a human population.
Retrospective/Prospective: Not applicable.

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

Number of Experts: Not applicable. Ground truth as understood in AI/ML (e.g., expert consensus on images) is not relevant for the performance verification of an infusion set.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance. This document describes an infusion set, which is a physical device.
Effect size of human reader improvement: Not applicable.

6. If a Standalone (Algorithm only without human-in-the-loop performance) Was Done:

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

7. The Type of Ground Truth Used:

The term "ground truth" as typically used for AI/ML devices is not applicable here. Performance was likely confirmed against engineering specifications using physical measurements and tests (e.g., flow rate, material compatibility, durability).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable.

Summary Rationale:

The provided document is a 510(k) summary for an infusion set, which is a physical medical device. The 510(k) process primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. For such devices, performance data typically comes from engineering and bench testing to ensure the product meets its pre-defined specifications, rather than from clinical studies involving human data and expert ground truth establishment that is characteristic of AI/ML diagnostic or prognostic devices. Therefore, most of the questions derived from an AI/ML context are not relevant to this specific submission. The key performance statement is general: "Verification testing confirmed the product meets their specifications."

Summary

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K070430

510(K) SUMMARY 8.0 Date Prepared: January 25 2007

APR - 4 2007

SUMMARY OF SAFETY AND EFFECTIVENESS 8.1 John M. Lindskog Submitted By: General Manager Unomedical A/S Infusion Devices Aaholmvei 1-3, Osted DK-4000 Roskilde, Denmark
Paradigm Quick-Set® Il and Quick-8.2 Trade/Proprietary Name: Set® II Subcutaneous Infusion Sets
- Subcutaneous Infusion Set 8.3 Common/Usual Name

Classification Name 8.4

Intravascular Administration Set

8.5 Substantial Equivalence

The Paradigm Quick-Set® II sets are substantially equivalent to the current Paradigm Quick-Set® (K011071) sets. The Quick-Set® II sets are substantially equivalent to the current Quick-Set® (K991759) sets.

Classification 8.6
Class: II Panel: 80 Product Code: 80FPA Cite: 21 CFR 880.5440

Technological Characteristics 8.7

The Quick-Set® I Infusion Sets have the same technological characteristics as the current marketed products.

8.8 Performance Data
Verification testing confirmed the product meets their specifications.

8.9 Conclusion

Unomedical A/S concludes based on the information presented that the new products lines are substantially equivalent to products currently legally marketed in the USA.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.

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

APR - 4 2007

Re: K070430

Trade/Device Name: Paradigm Ouick-Set® II and Ouick-Set II® Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 25, 2007 Received: February 14, 2007

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 your 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, 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

K070430 510(k) Number:

K070430

Paradigm Quick-Set® II and Quick-Set® II

Indications For Use:

Device Name:

These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

cion of Anesthesiology, General Hospital, ാഥാ Control, Dental Devices

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:.2(k) Number: K470434

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.