The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.

Device Description

The WIM-PC™ is a computer based electronic stethoscope that utilizes two contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports. The WIM-PCTM system consists of: Acoustic sensors (attached to the patient using adhesive pads), Sensor pod with a built-in dielectric microphone for ambient noise pick-up, Tension-sensitive respiration belt, A/D data acquisition device, USB cable and signal cable, Laptop PC unit with Data Analysis software.

AI/ML Overview

The provided document is a 510(k) summary for the WIM-PCTM device by KarmelSonix Israel Ltd. It focuses on demonstrating substantial equivalence to a predicate device (PulmoTrack™ model 1010) and outlines the validation tests performed. However, it does not contain detailed information about specific acceptance criteria, comprehensive study results (like sensitivity/specificity, effect sizes), or the detailed methodology of how ground truth was established for a testing or training set in the way a clinical study report would.

Therefore, I can only extract limited information based on what is present in the document.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Wheeze detection validation test" and "Breath detection validation test" as performed on the software, but it does not provide specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or agreement rates) nor does it report the quantitative performance results of these tests.

Criterion	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Software: Wheeze Detection	N/A (implied successful validation)	N/A
Software: Breath Detection	N/A (implied successful validation)	N/A
Hardware Components:
Tension-sensitive Respiration Belt	N/A (electrical response, respiratory activity)	N/A
Acoustic sensors	N/A (frequency response, sensitivity)	N/A
Front End performance	N/A	N/A
Packaging: System integrity	N/A	N/A

2. Sample Size and Data Provenance for the Test Set

The document does not specify the sample size used for the "Wheeze detection validation test" or "Breath detection validation test." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not mention the number of experts used or their qualifications for establishing ground truth in the reported validation tests.

4. Adjudication Method (Test Set)

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size for human reader improvement with AI assistance can be determined from this text.

6. Standalone Performance Study

Yes, a standalone validation was performed for the device's software components. The document explicitly states:

"The following validation tests were performed on the WIM-PCTM software:
- Wheeze detection validation test.
- Breath detection validation test."
  However, the actual performance metrics (e.g., sensitivity, specificity, accuracy) are not reported.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the "Wheeze detection validation test" or "Breath detection validation test." Given the nature of pulmonary sound analysis, it's highly likely to be expert consensus (e.g., auscultation by physicians) or potentially correlated with other clinical findings, but this information is not provided.

8. Sample Size for the Training Set

The document does not specify the sample size used for training the software algorithms.

9. How Ground Truth for the Training Set was Established

The document does not describe how the ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for KarmelSonix Israel Ltd. The logo includes the word "Karmel" written in a decorative font inside of a circular floral design. The words "KarmelSonix Israel Ltd" are written in a plain font to the right of the floral design. The logo appears to be for a company based in Israel.

K071955
Page 1 of 3

KarmelSonix Israel Ltd

ATTACHMENT NO. 7: 510(K) SUMMARY WIM-PCTM

510(K) SUMMARY WIM-PCTM

NOV - 1 2007

Applicant's Name: KarmelSonix 5 Palyam Street Haifa 33095 ISRAEL Tel: (972)4-861-5025 Fax: (972)4-866-7702
Contact Person: Yoram Levy, Osite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837 Fax (972)4-638-0510 Yoram@gsitemed.com
WIM-PCTM Trade Name:
Classification: Name: Diagnostic pulmonary-function interpretation calculator Product Code: BZM Regulation No: 868.1900 Class: II Panel: Anesthesiology

Device Description:

The WIM-PCTM system consists of:

Acoustic sensors (attached to the patient using adhesive pads). .
Sensor pod with a built-in dielectric microphone for ambient noise pick-up. �
Tension-sensitive respiration belt. .
A/D data acquisition device ●
USB cable and signal cable .

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KarmelSonix Israel Ltd

K071955
Page 2 of 3

Laptop PC unit with Data Analysis software. .

Predicate Device:

PulmoTrack™ model 1010 (K980878).

Technological Characteristics

Both the WIM-PC™ device and its predicate device (PulmoTrack™; K980878) implement an algorithm-based set of rules to interpret acoustic pulmonary function and chest impedance measurements with respect to wheeze and respiratory pattern.

Technological Modifications from Predicate Device

The modifications between the WIM-PCTM and its predicate device PulmoTrack™ 1010 (K980878) are:

. Improved Acoustic sensors.
Respiration belt (SleepSense K042253) instead of Impedance electrode .
Laptop PC instead of desk-top PC .
New version of software (Validated) .
Improved Front End Electronics ●

Indications for Use Statement:

The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds.

The WIM-PCTM is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.

Performance Validation:

The following tests were performed on the WIM-PCTM hardware components:

· Tension-sensitive Respiration Belt:
- · Electrical response to tension.
- · Respiratory activity detection
· Acoustic sensors: sensors frequency response and sensitivity.
· Front End performance.

The following validation tests were performed on the WIM-PCTM software:

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Image /page/2/Picture/0 description: The image shows the logo for KarmelSonix Israel Ltd. The logo includes the word "Karmel" in a decorative font, surrounded by a circular wreath. Below the logo is the text "KarmelSonix Israel Ltd" in a simpler font. The image is in black and white.

KC71955
Page 3 of 3

Karmelsonix Israel Ltd

· Wheeze detection validation test.
· Breath detection validation test.

The WIM-PCTM packaging was tested for its durability to shipment conditions.

The following test was performed on the WIM-PC™ packaging:

WIM-PC™ packaging system integrity .

Materials:

Materials of the WIM-PC™ system that are in contact with the human body are biocompatible in accordance with ISO 10993-1.

Substantial Equivalence:

The WIM-PC™ and the PulmoTrack™ model 1010 predicate device, have the same intended use and indication for use, and they are implement the same technology.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right, and its head is slightly tilted upwards. The logo is simple and clean, and it is easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KarmelSonix Israel Limited C/O Mr. Yoram Levy General Manager Osite 31 Haavoda Street Binyamina 33095 ISRAEL

NOV -- 1 2007

Re: K071955

Trade/Device Name: WIM-PC™ Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: II Product Code: BZM Dated: October 15, 2007 Received: October 18, 2007

Dear Mr. Levy:

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. Levy

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.

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 (240) 276-0115. 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 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,

Chiu-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K071955

for

Device Name:

WIM-PCTM

. Indications Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OI

(Division Sign-off)

Device Evaluation (ODE)

(Division Sign-off)

510(k) Number

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K071955

1-5 KarmelSonix, 5 Palyam St. Haifa 33095 ISRAEL Tel: (972)4- 8615025; Fax: (972)4- 8667702

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).