The provided text is a 510(k) Summary of Safety and Effectiveness for the Miethke Shunt System. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, the document explicitly states, "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Miethke Shunt System conforms to applicable ASTM and ISO standards."

This crucial statement indicates that

No specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy) were required or defined for this device in the context of this 510(k) submission. The regulatory pathway here is substantial equivalence, meaning the device is compared to existing legally marketed devices, not assessed against novel performance benchmarks derived from clinical studies.
No study proving the device meets performance-based acceptance criteria is presented. The "performance data" section only mentions conformity to ASTM and ISO standards, which are related to manufacturing, materials, and mechanical aspects, not clinical efficacy or diagnostic accuracy.

Therefore, many of the requested items cannot be answered from the provided text because they pertain to a type of performance study (e.g., comparative effectiveness, standalone algorithm performance, clinical validation with ground truth) that was not conducted or required for this 510(k) clearance based on substantial equivalence.

Here's an attempt to fill in as much as possible based on the given information, with explanations for what cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Type	Acceptance Criteria	Reported Device Performance
Regulatory	Substantial equivalence to predicate devices (J & J Hakim Micro Programmable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K911410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429), and the Cordis NMT Hakim Standard/Pediatric Valves (K861377)).	The Aesculap Miethke Shunt System is stated to be "essentially identical" to the listed predicate devices. This claim was accepted by the FDA for clearance (K020728).
Standards Conformity	Conformity to applicable ASTM and ISO standards.	The new Miethke Shunt System "conforms to applicable ASTM and ISO standards." (Specific standards are not enumerated, but general conformity is asserted).
Clinical Performance	(No specific clinical performance standards (e.g., success rates, complication rates relative to a benchmark) were promulgated or required for this 510(k) submission.)	(No clinical performance metrics are reported in this document beyond the claim of substantial equivalence to predicate devices for its intended use.)

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

Not applicable / Not provided. No specific test set for evaluating device performance against clinical outcomes or diagnostic accuracy was used or reported in this 510(k) summary. The clearance was based on substantial equivalence to existing devices and conformity to design/manufacturing standards.

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

Not applicable / Not provided. No test set requiring ground truth establishment by experts was part of this submission for performance evaluation.

4. Adjudication method for the test set

Not applicable / Not provided. No test set requiring adjudication was part of this submission. The regulatory pathway focused on technical and design equivalence.

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 cerebrospinal fluid shunt system, not an AI-assisted diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant and was not conducted.

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

Not applicable. This is a hardware medical device (shunt system), not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant and was not assessed.

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

Not applicable. No clinical ground truth was established for a performance study in this 510(k) submission. The basis for clearance was a comparison of device characteristics and intended use to predicate devices, and conformity to relevant engineering standards.

8. The sample size for the training set

Not applicable / Not provided. There is no mention of a training set as this is not an AI/ML device.

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

Not applicable / Not provided. Not relevant for this type of device.

Summary

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APR - 5 M

Miethke Shunt System

Kolo728

Page 1 of 1

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

MIETHKE SHUNT SYSTEM

November 26, 2001

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Joyce Kilroy, Director of Regulatory Affairs/Quality Assurance800-258-1946 (phone)610-791-6882 (fax)joyce.kilroy @ aesculap.com (email)
TRADE NAME:	Central Nervous System Fluid Shunt and Components
COMMON NAME:	Miethke Shunt System
DEVICE CLASS:	Shunt System - Class IIVentricular Catheter - Class II
PRODUCT CODE:	Shunt System - JXGVentricular Catheter - HCA
CLASSIFICATION:	Shunt System - 882.5550Ventricular Catheter - 882.4100
REVIEW PANEL:	Neurology

INTENDED USE

The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

DEVICE DESCRIPTION

The ventricular catheter is a part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for removal of excess CSF.

PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Miethke Shunt System conforms to applicable ASTM and ISO standards.

SUBSTANTIAL EQUIVALENCE

The Aesculap Miethke Shunt System is essentially identical to the J & J Hakim Micro Programmable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K911410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429) and the Cordis NMT Hakim Standard/Pediatric Valves (K861377).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

Ms. Joyce Kilroy Director, Regulatory Affairs and Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034

2002 APR

Re: K020728

Trade/Device Name: Miethke Shunt System Regulation Number: 882.4100 Regulation Name: Ventricular Catheter Regulatory Class: II Product Code: HCA Dated: March 4, 2002 Received: March 6, 2002

Dear Ms. Kilroy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(x) premained in substantially equivalent (for the indications for use stated in the enclosure) the devices the devices marketed in interstate for use stated in the encrosule) to regally mancted producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Food Frya commerce prior to May 28, 1770, the enactions with the provisions of the Federal Food. Drug, devices that have been reclassified in accerative will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket of the Ac and Cosmetic Act (Act) that to hot require approvide on trols provisions of the Act. The Act. The You may, therefore, market the devices, belyer to the more of registration, listing of general controls provisions of the 110th line, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into etails rates in the major regulations affecting your device can
may be subject to such additional controls. Existing major regu may be subject to such additional controller a marketing and to 898. In addition, FDA may be found in the Code of I sacka 11.5gmming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of woulderice complies with other requirements of the Act that IDA has made a decommation administered by other Federal agencies. You must of ally Federal statutes and regulations adminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercaing, and manufacturing practice requirements as set CFK Fart 807), adomig (21 CFR Part 820); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000-1050 forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping human figures. The image is in black and white.

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Page 2 - Ms. Joyce Kilroy

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

R. Mark N. Millican

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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Special 510(k) Premarket Notification

Miethke Shunt System

Page 1 of 1

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

020728

Device Name: Miethke Shunt System

Indication for Use:

The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
			In the control of the consisted on the commended to comments of the many of the many of the many of the many of the many world and the many would be comments of the many of t

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of General. Restorative and Neurological Devices 020728

510(k) Number__

Prescription Use X or Over-the-Counter Use _

(per 21 CFR 801.109)

(Optional Format 3-10-98)

Regulation Number and Section

§ 882.4100 Ventricular catheter.

(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).