The Smith & Nephew CDS System consists of a control unit with a fluid delivery module with user interface, a remote control, and a sterile, single-use fluid delivery syringe, tube set, and remote sleeve.

AI/ML Overview

The provided 510(k) summary for the Smith & Nephew CDS System describes a medical device, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance evaluation relevant to diagnostic accuracy or clinical outcomes.

Instead, the documentation focuses on:

Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to a predicate device (Integra® Spinal Specialties Accu-Disc® Pressure Monitoring Syringe - K960082).
Safety and Engineering Standards: The summary reports compliance with biocompatibility and electrical safety standards, as well as software verification and validation.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Reported Device Performance	Comments
Biocompatibility	Meets ISO 10993-1	Compliance with established standard.
Electrical Safety	Meets UL 60601-1-1, IEC 60601-1-1, and IEC 60601-1-2	Compliance with established standards.
Electromagnetic Compatibility (EMC)	Meets EN 55011	Compliance with established standard.
Software Functionality	Software verification and validation testing performed	Indicates proper software function, but no specific performance metrics are given.
Bench Performance	Additional bench performance testing performed	General statement; no specific performance data or criteria provided.
Clinical Performance (Accuracy/Effectiveness)	Not specified	No specific clinical or diagnostic accuracy acceptance criteria or performance metrics are provided. The claim is "as safe and effective, and performs at least as well as the legally marketed devices for the same intended use" based on the above engineering and safety tests and comparison to the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not Applicable / Not Provided: The summary indicates "software verification and validation testing" and "additional bench performance testing," but does not specify sample sizes for these engineering tests. There is no mention of a clinical test set, or data provenance in terms of patient data.

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

Not Applicable / Not Provided: This device is for fluid dispensing and pressure monitoring during discography, not for image interpretation or diagnosis. Therefore, the concept of "ground truth" derived from expert consensus for a test set (e.g., image-based diagnosis) is not relevant to the information presented. The ground truth for functional verification would be the device's ability to accurately dispense fluids and monitor pressure, assessed through engineering and bench testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable / Not Provided: Adjudication methods are typically used in studies involving expert interpretation (e.g., radiology reads) to establish a consensus ground truth. This is not relevant to the type of testing described for the Smith & Nephew CDS System.

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 / Not Provided: This device is a fluid dispensing and pressure monitoring system, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study and effects on human reader performance with AI assistance are not relevant.

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

Not Applicable / Not Provided: This is not an algorithm-only device in the diagnostic sense. The device is an automated system for fluid delivery and pressure monitoring. Its "standalone" performance would be its ability to perform its mechanical and electronic functions as designed, which is generally covered by the software verification and validation, and bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Engineering/Performance Specifications: For the reported tests (biocompatibility, electrical safety, EMC, software verification, bench testing), the "ground truth" would be the predefined engineering specifications and regulatory standards. For example, the ground truth for electrical safety is successful adherence to the parameters set forth by UL 60601-1-1.

8. The sample size for the training set:

Not Applicable / Not Provided: As this is primarily an electro-mechanical device with specific software functions, the concept of a "training set" in the context of machine learning (AI) is not relevant or mentioned in the summary. Development would involve iterative design and testing, but not a "training set" in the common AI sense.

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

Not Applicable / Not Provided: See point 8. No training set is mentioned.

In summary: The provided 510(k) documentation focuses on essential safety and engineering performance standards, software validation, and demonstrating substantial equivalence to a predicate device. It defines performance in terms of meeting these foundational requirements rather than through a clinical study with detailed acceptance criteria for diagnostic accuracy or clinical outcomes that would typically be seen for devices like AI-powered imaging tools.

Summary

{0}------------------------------------------------

KOS1136

JUL 1 - 2005

SECTION IV

510(k) SUMMARY

Date Prepared: May 2, 2005

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

B. Company Contact:

Diane Minear Director, Regulatory Affairs Phone: 978-749-1441 978-749-1443 Fax:

C. Device Name

Trade Name:	Smith & Nephew CDS System
Common Name:	Discography System
Classification Name:	Image - intensifiedPhotofluorographic X-ray System Accessory892.1736 1650

D. Predicate Devices

The Smith & Nephew CDS System is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: The Integra® Spinal Specialties Accu-Disc® Pressure Monitoring Syringe - K960082.

{1}------------------------------------------------

Description of Device ﻟﻨﺎ

Intended Use F.

The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.

G. Comparison of Technological Characteristics

The Smith & Nephew CDS System is substantially equivalent in function and intended use to the Integra® Spinal Specialties Accu-Disc® Pressure Monitoring Syringe - K960082. The main technological difference between the two devices is that the Smith & Nephew device is an automated system with data display and storage capacity and the Integra device is operated manually.

G. Summary Performance Data

The Smith & Nephew CDS System meets the biocompatibility requirements of ISO 10993-1 and electrical safety standards in UL 60601-1-1, and IEC 60601-1-1, and IEC 60601-1-2 and EN 55011. Software verification and validation testing and additional bench performance testing all demonstrate that the Smith & Nephew CDS System is as safe and effective, and performs at least as well as the legally marketed devices for the same intended use.

{2}------------------------------------------------

Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diane E. Minear Director, Regulatory Affairs Smith & Nephew, Inc. Endoscopy 150 Minuteman Road ANDOVER MA 01810

Re: K051136

JUL I - 2005

Trade/Device Name: Smith & Nephew CDS System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: May 2, 2005 Received: May 9, 2005

Dear Ms. Minear:

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 (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 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 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.

{3}------------------------------------------------

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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): - Kost 36 --

Smith & Nephew CDS System Device Name:

Indications For Use:

The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.

Prescription Use J J _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marcyc Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A