The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

Device Description

The Smith & Nephew Graft Delivery System is used to conveniently pre-mix desired fluid components and bone graft materials, with delivery of the resultant mixture to an orthopedic surgical site. The system contains several components including a manifold, manifold housing, graft chamber, and accessory syringes.

AI/ML Overview

The provided text focuses on the 510(k) summary for the Smith & Nephew Graft Delivery System, which is a regulatory document asserting substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in detail.

Here's a breakdown of why the requested information cannot be fully provided based on the input:

Acceptance criteria and reported device performance: The document states, "A review of the test data indicated that the Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components." However, it does not list specific acceptance criteria (e.g., minimum mixing efficiency, maximum residual material, etc.) nor does it provide quantitative reported device performance against such criteria. It's a high-level summary of a positive test outcome.

The remaining points (2-9) are typically found in detailed study reports, clinical trial protocols, or technical documents that would underpin such a regulatory submission, but they are not present in this 510(k) summary. These summaries typically focus on equivalence and safety, not detailed performance study methodologies.

Therefore, based on the provided text, I can only extract limited information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
(Specific criteria not provided in document)	"The Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components."

2. Sample size used for the test set and data provenance: Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not provided in the document.

4. Adjudication method for the test set: Not provided in the document.

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: Not applicable. This device is a physical delivery system, not an AI-assisted diagnostic or interpretive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical delivery system, not an algorithm.

7. The type of ground truth used: Not explicitly stated, as detailed study methods are absent. The "test data" referred to likely involved engineering or performance testing to confirm mixing capability.

8. The sample size for the training set: Not applicable (no algorithm training mentioned).

9. How the ground truth for the training set was established: Not applicable (no algorithm training mentioned).

Summary of what the document does indicate regarding "study":

The document refers to a "review of the test data" that "indicated that the Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components." This implies some form of performance testing was conducted. However, the details of that testing, including methodologies, specific criteria, sample sizes, and how "ground truth" (in this context, effective mixing) was established, are not included in this 510(k) summary. The primary basis for clearance is "Substantial Equivalence Information" to predicate devices.

Summary

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AUG 2 3 2004

Summary of Safety and Effectiveness Smith & Nephew, Inc. Graft Delivery System

Contact Person and Address

Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566

Device Description

Device Classification Name

21 CFR 880.5860 Piston Syringe, Class II

Indications for Use

Test Data

A review of the test data indicated that the Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components.

Substantial Equivalence Information

The substantial equivalence of the Smith & Nephew Graft Delivery System is substantiated by its similarities in design features, principal of operation, indications for use, and material composition as existing graft delivery components and syringes distributed by other competitive predicate systems.

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Public Health Service

AUG 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kun P. Kelly Project Manager. Regulatory and Clinical Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K041976

Trade/Device Name: Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: July 19, 2004 Received: july 22, 2004

Dear Ms. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device w on a re row 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 for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of provised in accordance with the provisions of the Federal Food. Drug, de reces mar na re over 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. Iisting 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.

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 ( FR 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.

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Page 2 - Ms. Kim P. Kelly

This letter will allow you to begin marketing your device as described in your Section 510(k) prematics 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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 other general miternational 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,

Miriam C. Provost

tal Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Smith & Nephew Graft Delivery System Indications Statement

The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, playma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

Prescription Use X (Per 21 CFR 801, Subpart D)

Over-The Counter Use (Per 21 CFR 807, Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

Miriam C. Proust

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).