The Synthes (USA) Compartmental Pressure Monitoring System consists of a hand-held monitoring device, a re-sterilizable pressure measurement probe, and an optional extension cable. The hand-held monitoring device houses the operational software and the LCD display. The pressure measurement probe connects directly to the hand-held unit or can be attached using the optional extension cable. A 9-volt battery powers the monitor. The probe is inserted into the target compartment via a 14-gauge catheter supplied by the user.

AI/ML Overview

The provided text does not contain information regarding acceptance criteria, device performance against these criteria, or any details about a study conducted to prove the device meets such criteria.

The document is a 510(k) summary for the Synthes (USA) Compartmental Pressure Monitoring System, which primarily focuses on establishing substantial equivalence to a legally marketed predicate device. It includes:

Sponsor and Device Information: Synthes (USA), Compartmental Pressure Monitoring System.
Device Classification: Class II.
Device Description: Hand-held monitoring device, re-sterilizable pressure measurement probe, optional extension cable, 9-volt battery, and insertion via a 14-gauge catheter.
Indications for Use: Immediate or continuous measurement of intracompartmental pressures.
Substantial Equivalence: A statement that documentation demonstrates substantial equivalence.
FDA Communication: A letter from the FDA confirming the substantial equivalence determination and allowing marketing, subject to general controls.

There is no mention of:

A table of acceptance criteria and reported device performance.
Sample size, data provenance, or study design for any performance testing.
Number or qualifications of experts.
Adjudication method.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How the ground truth for the training set was established.

Therefore, I cannot provide the requested information based on the given input.

Summary

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K031555

3. Summary of Safety and Effectiveness Information [510(k) Summary]

	JUL 0 8 2003
Sponsor	Synthes (USA)1690 Russell RoadPaoli, PA 19301Lisa M. Boyle(610) 647-9700
Name of the Device	Synthes (USA) Compartmental Pressure Monitoring System
Device Classification(s)	Class II - Monitor, Pressure, Intercompartmental
Device Description	The Synthes (USA) Compartmental Pressure Monitoring Systemconsists of a hand-held monitoring device, a re-sterilizable pressuremeasurement probe, and an optional extension cable. The hand-heldmonitoring device houses the operational software and the LCDdisplay. The pressure measurement probe connects directly to thehand-held unit or can be attached using the optional extension cable.A 9-volt battery powers the monitor. The probe is inserted into thetarget compartment via a 14-gauge catheter supplied by the user.
Indications	The Synthes (USA) Compartmental Pressure Monitoring System isintended for the immediate or continuous measurement ofintracompartmental pressures.
Substantial Equivalence	Documentation is provided which demonstrates that the Synthes(USA) Compartmental Pressure Monitor is substantially equivalentto other legally marketed devices.

CONFIDENTIAL

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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 stylized eagle with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 8 2003

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K031555

Trade/Device Name: Synthes (USA) Compartmental Pressure Monitoring System Regulatory Class: Unclassified Product Code: LXC Dated: May 15, 2003 Received: May 19, 2003

Dear Ms. Boyle:

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.

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.

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Page 2 - Ms. Lisa M. Boyle

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 (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) you may obtain. 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,

Miriam C. Provost

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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2. Indications for Use Statement

KOSISSS 510(k) Number (if known):

Device Name: Synthes (USA) Compartmental Pressure Monitoring System

Indications for Use: The Synthes (USA) Compartmental Pressure Monitoring System is intended for the immediate or continuous measurement of intracompartmental pressures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	OR Over-The-Counter Use

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) Number	K031555
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Synthes(USA) Compartmental Pressure Monitoring System 510(k) CONFIDENTIAL

Regulation Number and Section

N/A