The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System is intended for the immediate or continuous measurement of intracompartmental pressure and for the withdrawal of fluid for subsequent analysis. The measured pressures and the withdrawn fluid serve as an aid in the diagnosis of compartment syndrome.

Device Description

The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System Consists of two major components i.e., an Introducer and an indwelling Catheter. The Introducer consists of a plastic sheath placed over a stainless steel trocar. The Introducer provides an access to the targeted muscle compartment to facilitate the placement of the indwelling Monitoring and Fluid Collection Catheter. The indwelling Catheter is designed to measure intramuscular compartment pressure as well as provide a means to collect a sample interstitial fluid for laboratory analysis. The indwelling Catheter is designed for use up to 24 hours. The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System is designed to be used with currently marketed equipment including a vacuum pump, infusion pump, pressure transducer and monitor.

AI/ML Overview

The provided text describes a 510(k) submission for the "Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System." However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt. The document primarily focuses on establishing substantial equivalence to a predicate device.

Based on the available text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Missing	Missing

The document states: "Documentation has been provided which demonstrates that the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System is substantially equivalent to other legally marketed predicate devices such as the Stryker Intra-Compartment Pressure Monitor System: Comparison of the Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection Catheter System with the predicate system to measure intracompartment pressure in an animal model and a human clinical study."

This indicates that a comparison was made, but the specific acceptance criteria (e.g., accuracy within a certain mmHg, sensitivity, specificity, or specific performance metrics) for the Twin Star device are not explicitly stated. The document implies that the performance was comparable to the predicate device to establish substantial equivalence, but the quantitative results are not provided.

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

Sample Size (Test Set): Not specified. The document mentions "an animal model and a human clinical study" were used for comparison, but the number of animals or human subjects is not provided.
Data Provenance: The studies included "an animal model and a human clinical study." No information on the country of origin or whether the data was retrospective or prospective is available in this text.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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

MRMC Study: No, this device is a physical catheter system for measuring pressure and collecting fluid, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance is not applicable.

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

Standalone Performance: Not applicable. This is a hardware device for direct physiological measurement, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: The document implies that the ground truth for performance comparison was obtained by measuring intracompartmental pressure using a "predicate system" (Stryker Intra-Compartment Pressure Monitor System) in both animal and human studies. This suggests the predicate device's measurements served as the reference for comparison, which is a form of comparative ground truth against an established device. For the fluid collection aspect, presumably, the ability to collect fluid for subsequent analysis was assessed.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Ground Truth (Training Set): Not applicable, as there is no training set for this type of device.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence for a physical medical device. It lacks detailed information regarding specific acceptance criteria, study sizes, expert qualifications, or ground truth methodologies that would typically be found in a study report for an AI/ML or image-based diagnostic device.

Summary

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SEP 1 4 2004

K041771 1 of 1

510(k) Summary Summary of Safety and Effectiveness Information

Sponsor:

Twin Star Medical, Inc. 914 South 8th Street Mail Code 860c Minneapolis, Minnesota 55404 Tele: 763.576.5172 Fax: 763.576.9273

Device Name:

Twin Star Compartment Monitoring and Fluid Collection Catheter System

Device Classification:

Class II - Monitor, Pressure, Intracompartmental

Device Description:

The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System The Twin Oth Othpartners i.e., an Introducer and an indwelling Catheter. The Consists of two major componentic sheath placed over a stainless steel trocar. The Introducer provides an access to the targeted muscle compartment to facilitate the Introducer provides an associety in the Monitoring and Fluid Collection Catheter. The placement of the mawelling intramuscular compartment pressure as well indwelling outhority a sample interstitial fluid for laboratory analysis. The indwelling as provide a means to campio into 24 hours. The Twin Star Compartment Pressure Oather is dong. But as a long Catheter System is designed to be used with currently Monitoring and Find equipment including a vacuum pump, infusion pump, pressure transducer and monitor.

Indications:

Includions:
The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System is intended for the immediate or continuous measurement of intracompartmental 15 intended for the withdrawal of fluid for subsequent analysis. The measured pressures and the withdrand of the diagnosis of compartment syndrome.

Substantial Equivalence:

Substantial Equivalences
Documentation has been provided which demonstrates that the Twin Star Compartment Documentation nas boon provided with Niew Catheter System is substantially Synuronie Tressure Moniconing and devices such as the Stryker Intra-Compartment equivalent to other logally mamorean testing during animal and human clinical studies Fressure Monitor Oyoton: Semparisone Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection Catheter System with the predicate system to measure intracompartment pressure in an animal model and a human clinical study.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

SEP 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Twin Star Medical, Inc. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, NW Washington, DC 20004

Re: K041771

Trade/Device Name: Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System

Regulatory Class: Unclassified Product Code: LXC Dated: June 22, 2004 Received: June 30, 2004

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use battled in 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 r ou may, merere, mains 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 or any I 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 - Mr. Jonathan S. Kahan, Esq.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yourse organ finding of substantial equivalence of your device to a legally prematicated 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 If you desire specific arrioliance 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 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,

Muriam C. Purvost

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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KO417 1_ of 1

Indications for Use

510(k) Number (if known): #041771

Device Name: Device Name.
Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System

Indications For Use:

Indications For Ose.
The Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter System The Twill Star Oompartment Prossation.ous measurement of intracompartmental ls intended for the immediate of contificassubsequent analysis. The freessured pressures and the withdrawarer half for oubseques has an aid in the diagnosis of compartment syndrome.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Miriam C. Provost
(Division Sign-Off)

Concurrentision of Gefficeal; Restoration (ODE) and Neurological Devices

510(k) Number k04177/

Regulation Number and Section

N/A