The Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel.

Device Description

The Stethographic STG Monitor Multichannel Lung Sound Analysis System Comprises Chest pad with electronic stethoscopes, back pad, pre-amplifier, connection hub, and a PC computer. The system also includes a printer, a cart, speakers, headphones, re-writable CDs for data storage and custom software. The system is non-invasive with patient contact disposable cotton cover.

AI/ML Overview

The provided text describes the STG Monitor Multichannel Lung Sound Analysis System and its 510(k) submission. However, it does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance.

The document explicitly states:

"Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Stethographic STG Monitor Multichannel Lung Sound Analysis System is same as the predicate device." This indicates that the device's performance was evaluated by demonstrating equivalence to a predicate device (Pulmotrack, Model 1010, K980978), rather than against specific, quantitative acceptance criteria for its own performance.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, with clear indications where information is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The device aimed to be "substantially equivalent" to its predicate.	"Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Stethographic STG Monitor Multichannel Lung Sound Analysis System is same as the predicate device."

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

Sample size for test set: Not provided.
Data provenance: Not provided. The document mentions "bench and laboratory testing," which typically implies controlled environments but does not specify the origin or nature of the data.
Retrospective or prospective: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. The document focuses on demonstrating equivalence to a predicate device, and does not detail a process for establishing ground truth via expert consensus for a test set.

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

Not provided.

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 explicitly stated or implied. The device's primary function is for "recording, audio reproduction, graphic display and automated identification of lung sounds." While it's a "Pulmonary Function Interpretator," the document does not mention studies involving human readers or AI assistance in a comparative effectiveness context. The focus is on the device's functional equivalence to a predicate.

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

The device's description, particularly "automated identification of lung sounds," suggests a standalone algorithmic component. However, specific standalone performance study details (metrics, results) are not provided. The performance statement only refers to being "same as the predicate device."

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

Not explicitly stated. Given the device's purpose, "automated identification of lung sounds," the ground truth likely related to correctly identifying specific lung sounds or their characteristics, but the method for establishing this ground truth is not detailed. The comparison to a predicate device implies that the predicate's established performance served as a de facto benchmark.

8. The sample size for the training set

Not provided. This document discusses regulatory approval for a device, not the specifics of its internal algorithm training.

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

Not provided.

Summary

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APR 2 3 2002

510(k) Submission, New, STG Monitor Stethographics, Inc., Boston, MA 02130

Summary

21 CFR Part 807.92

K012387 K#

Date: January 22, 2002

S....... H

Contact:	Raymond L. H. Murphy, Jr., M.D.Stethographics, Inc.1153 Centre Street, Suite 4990Boston, MA 02130 USA617-983-7258617-522-4156 fax
SubmissionCorrespondent:	J. Harvey KnaussDelphi Consulting Group11874 South Evelyn CircleHouston, Texas 77071-3404713-723-4080713-723-4080 faxharvey@delphiconsulting.com
Device Name:	STG Monitor Multichannel Lung Sound Analysis System
Common Name:	Pulmonary Function Interpretator
Classification:	The classification name, 21 CFR Part and Paragraph Number,product code, classification and tier categorization follows:

	ClassificationName	21 CFRSection	ProductCode	Class	Tier
	Calculator,Pulmonary FunctionInterpretationcalculator	868.1900	BZM	II	2

Predicate Devices:	The Stethographic STG Monitor Multichannel Lung SoundAnalysis System is substantially equivalent to the followingreleased to market device:
--------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------

	Device	Manufacturer	510(k) #
	Pulmotrack, Model 1010	Karmel Medical AcousticTechnologies, Ltd.	K980978

Device Description:	The Stethographic STG Monitor Multichannel Lung SoundAnalysis System Comprises Chest pad with electronic
---------------------	--------------------------------------------------------------------------------------------------------------

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K012387

APR 2 3 2002

510(k) Submission, New, STG Monitor Stethographics, Inc., Boston, MA 02130

Summary

21 CFR Part 807.92

K# K012387

Date: January 22, 2002

Contact:	Raymond L. H. Murphy, Jr., M.D.Stethographics, Inc.1153 Centre Street, Suite 4990Boston, MA 02130 USA617-983-7258617-522-4156 fax
SubmissionCorrespondent:	J. Harvey KnaussDelphi Consulting Group11874 South Evelyn CircleHouston, Texas 77071-3404713-723-4080713-723-4080 faxharvey@delphiconsulting.com
Device Name:	STG Monitor Multichannel Lung Sound Analysis System
Common Name:	Pulmonary Function Interpretator
Classification:	The classification name, 21 CFR Part and Paragraph Number,product code, classification and tier categorization follows:

ClassificationName	21 CFRSection	ProductCode	Class	Tier
Calculator,Pulmonary FunctionInterpretationcalculator	868.1900	BZM	II	2

Predicate Devices:	The Stethographic STG Monitor Multichannel Lung SoundAnalysis System is substantially equivalent to the followingreleased to market device:
--------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------

Device	Manufacturer	510(k) #
Pulmotrack, Model 1010	Karmel Medical AcousticTechnologies, Ltd.	K980978

Device Description:	The Stethographic STG Monitor Multichannel Lung SoundAnalysis System Comprises Chest pad with electronic
---------------------	--------------------------------------------------------------------------------------------------------------

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	stethoscopes, back pad, pre-amplifier, connection hub, and a PCcomputer. The system also includes a printer, a cart, speakers,headphones, re-writable CDs for data storage and customsoftware. The system is non-invasive with patient contactdisposable cotton cover.
Indications:	The Stethographics STG Multichannel Lung sound Analysissystem is intended for the recording, audio reproduction, graphicdisplay and automated identification of lung sounds. It can beconfigured to record from one or more than one channels.
TechnologicalCharacteristics:	The Stethographic STG Monitor Multichannel Lung Sound SystemAnalysis device is virtually the same as the Pulmotrack, Model1010.
Performance:	Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of the Stethographic STGMonitor Multichannel Lung Sound Analysis System is same as thepredicate device.
Conclusions	In accordance with the Federal Food, Drug and Cosmetic Act and21 CFR Part 807, and based on the information provided in thepremarket notification, Stethographics, Inc., concludes that theStethographic STG Monitor Multichannel Lung Sound AnalysisSystem is safe and effective and substantially equivalent to thepredicate devices as described herein.
Other:	Stethographics, Inc., will update and include in this summary anyother information deemed reasonably necessary by the FDA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized representation of a human profile with three overlapping faces, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2002

Mr. Harvey Knauss Stethographics, Inc. c/o Delphi Consulting Group 11874 S. Evelyn Circle Houston, TX 77071

Re: K012387

STG Monitor Multichannel Lung Sound Analysis System Regulation Number: 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: II (two) Product Code: BZM Dated: December 20, 2001 Received: January 24, 2002

Dear Mr. Knauss:

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.

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Page 2 -- Mr. Harvey Knauss

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of the 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 1 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 SI it rat 807), its 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter will and my of the FDA finding of substantial equivalence of your device to a legally premated predicated 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) 594-4646. 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,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K012387

STG Monitor Multichannel Lung Sound Analysis System. Device Name:

Indications for use: The Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel.

Prescription Device.

Federal Law (US) restricts this device to sale by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012387

Section 4 Page 2

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.1900 Diagnostic pulmonary-function interpretation calculator.

(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).