The provided document is a 510(k) Premarket Notification for a 0.9% Sodium Chloride Flush Syringe. This type of regulatory submission is for medical devices and does not typically include information about studies related to AI/ML device performance or clinical outcomes.

The document discusses nonclinical tests to ensure the device meets safety and performance requirements for a sterile saline flush syringe. These tests focus on aspects like stability, container/closure suitability, and functional requirements.

Therefore, I cannot provide the requested information about acceptance criteria and studies as it pertains to AI/ML device performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance), because this type of information is not relevant or present in this specific regulatory document for a non-AI/ML device.

Here's a breakdown of what can be inferred from the document regarding the device's validation, but without the AI/ML specific details:

Acceptance Criteria and Reported Device Performance: This would relate to the nonclinical tests.
- Acceptance Criteria (Inferred): The device is expected to meet or exceed "all functional requirements," and demonstrate "stability" and "container/closure suitability." These criteria would be defined internally by Baxter Healthcare Corporation based on relevant standards for medical devices of this type.
- Reported Device Performance: "Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use." Specific quantitative results or detailed criteria are not provided in this summary.
Study That Proves the Device Meets Acceptance Criteria:
- Type of Study: Nonclinical tests (stability testing, container/closure suitability testing, performance testing).
- Description: "Test data have been generated for stability and container/closure suitability. Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use."

Regarding the specific questions asked that are relevant to AI/ML devices, the information is not applicable or present in this document:

A table of acceptance criteria and the reported device performance: As explained above, the acceptance criteria are general ("all functional requirements," "stability," "container/closure suitability") and specific performance metrics are not detailed.
Sample sized used for the test set and the data provenance: Not relevant for this type of device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for this type of device.
Adjudication method: Not relevant for this type of device.
Multi reader multi case (MRMC) comparative effectiveness study: Not relevant for this type of device.
Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not relevant for this type of device.
The type of ground truth used: Not relevant for this type of device. The "ground truth" for this device would be established by physical, chemical, and biological testing against product specifications.
The sample size for the training set: Not relevant for this type of device.
How the ground truth for the training set was established: Not relevant for this type of device.

This document clearly describes a conventional medical device (a pre-filled syringe) and its regulatory pathway based on substantial equivalence to a predicate device, not an AI/ML powered diagnostic or therapeutic device.

Summary

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984590

OCT 7 1999

510(k) Premarket Notification 0.9% Sodium Chloride Flush Syringe

510(k) SUMMARY

Submitted by:

Marcia Marconi Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073

Date Prepared: December 24, 1998

Proposed Device:

The proposed device consists of various sizes and fill volumes of plastic syringes aseptically filled with sterile 0.9% sodium chloride solution.

Predicate Device:

The predicate device is the Abbott prefilled syringe with 0.9% sodium chloride solution.

Proposed Device Description:

The proposed device consists of various sizes and fill volumes of plastic syringes aseptically filled with sterile 0.9% sodium chloride solution.

Statement of Intended Use:

The device is intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Summary of Technological Characteristics of New Device Compared to Predicate Devices

The proposed device has the same technological characteristics as the predicate device. Both consist of plastic syringes containing sterile 0.9% sodium chloride solution.

Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests

Test data have been generated for stability and container/closure suitability. Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use.

DEC 2 4 1998

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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 emblem featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 1999

Ms. Marcia Marconi Vice President, Regulatory Affairs I.V. Systems Division Regulatory Affairs Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, Illinois 60073-0490

Re : K984590 0.9% Sodium Chloride Flush Syringe Trade Name: Regulatory Class: II Product Code: FOZ Dated: July 29, 1999 Received: August 2, 1999

Dear Ms. Marconi:

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, Druq, and Cosmetic Act (Act). 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, qood 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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

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Page 2 - Ms. Marconi

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.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification 0.9% Sodium Chloride Flush Syringe

Not Available 510(k) Number:

0.9% Sodium Chloride Flush Syringe Device Name:

Indication for Use:

The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

Palucca Crescent

Prescription USE ✓
(Per 21 CFR 801.109)

DEC 2 4

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).