Phlebo Press DVT 603 by Mego Afek AC Ltd.

Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
Reduction of pain and swelling after injury and surgery
Enhancement of venous circulation
Prevention of venous stasis
Assistance in healing of cutaneous ulcers
Reduction of compartmental pressures
The device is intended for hospital, home and clinic use

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Phlebo Press DVT 603". This correspondence primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailing a specific clinical study with acceptance criteria and performance data for the Phlebo Press DVT 603 itself.

Therefore, I cannot directly extract the specific information requested about acceptance criteria and a study proving the device meets those criteria from this FDA letter. The letter confirms a regulatory determination of substantial equivalence, which is a different type of assessment than a detailed clinical performance study.

Typically, such information would be found in a separate clinical study report or a different section of the 510(k) submission that details performance testing.

However, based on the information provided:

I can state that the document does not contain the detailed information required to fill out the table about acceptance criteria and device performance, nor the specifics about sample size, data provenance, ground truth establishment, or clinical study design (MRMC, standalone) for the Phlebo Press DVT 603.

To answer your request, if this were a document that did contain the study details you're looking for, the information would ideally be presented as follows:

Acceptance Criteria and Device Performance Study for [Device Name - Hypothetical Example]

Since the provided document is a 510(k) clearance letter and does not contain the specific study details you've requested regarding acceptance criteria and performance, I will provide a framework of how this information would typically be presented in a suitable document.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
[e.g., Sensitivity]	[e.g., ≥ 90%]	[e.g., 92.5% (95% CI: 90.1-94.4%)]
[e.g., Specificity]	[e.g., ≥ 80%]	[e.g., 85.2% (95% CI: 82.3-87.7%)]
[e.g., Accuracy]	[e.g., ≥ 85%]	[e.g., 88.0% (95% CI: 86.1-89.8%)]
[e.g., Cohen's Kappa]	[e.g., ≥ 0.70]	[e.g., 0.75]
[e.g., Time to Result]	[e.g., ≤ 5 minutes]	[e.g., Average 3.2 minutes]
[e.g., Mechanical Reliability (Cycles)]	[e.g., > 1,000,000 cycles]	[e.g., 1,500,000 cycles without failure]

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

Test Set Sample Size: [Insert number of cases/patients, e.g., 500 cases, 300 patients]
Data Provenance: [e.g., Retrospective, multi-center data collected from hospitals in the United States, Germany, and Japan. OR Prospective, single-center study conducted in the United Kingdom.]

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

Number of Experts: [e.g., 3]
Qualifications of Experts: [e.g., Board-certified Radiologists with 10-20 years of experience in diagnostic imaging, specializing in vascular studies. OR Board-certified Pathologists with 15+ years of experience in histopathology.]

4. Adjudication method for the test set

Adjudication Method: [e.g., 2+1 adjudication (two experts independently review, with a third expert adjudicating discordant cases). OR Majority vote among 3 experts. OR Consensus meeting among all experts.]

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 Done?: [Yes/No]
Effect Size (if Yes): [e.g., "Human readers improved their AUC by an average of 0.08 (from 0.82 to 0.90) when using AI assistance, representing a statistically significant improvement (p < 0.001) in diagnostic accuracy." OR "Readers had a 15% reduction in reading time and a 5% increase in sensitivity with AI assistance compared to without AI assistance."]

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

Standalone Study Done?: [Yes/No]
Description (if Yes): [e.g., "A standalone performance study was conducted to evaluate the algorithm's performance independent of human input. The results are reported in the table above under 'Reported Device Performance'."]

7. The type of ground truth used

Type of Ground Truth: [e.g., Histopathology confirmed by two independent pathologists. OR Clinical outcome/follow-up data for 6 months. OR Expert consensus by a panel of specialists, correlated with imaging findings from gold-standard modalities (e.g., MRI for CT device).]

8. The sample size for the training set

Training Set Sample Size: [e.g., 10,000 cases. OR 5,000 images from 2,000 patients.]

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

Training Set Ground Truth Establishment: [e.g., Ground truth for the training set was established through a combination of expert clinician review, confirmed by pathology reports where available, and cross-referenced with electronic health records. Annotation was performed by trained medical professionals under the supervision of domain experts.]

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central graphic. The graphic depicts three stylized human profiles facing to the right, layered on top of each other to create a sense of depth and unity.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2015

Mego Afek AC Ltd Aharon Cohen QA & RA Manager Kibbutz Afek Afek, 30042, Israel

Re: K142772

Trade/Device Name: Phlebo Press DVT 603 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Dated: September 30, 2014 Received: October 3, 2014

Dear Aharon Cohen:

This letter corrects our substantially equivalent letter of December 16, 2014.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely vours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name Phlebo Press DVT 603

Indications for Use (Describe)

The Phlebo Press DVT 603 is intended for use by medical professionals and patients who are under medical supervision, in treating

conditions such as:

- Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
- Reduction of pain and swelling after injury and surgery
- Enhancement of venous circulation
- Prevention of venous stasis
- Assistance in healing of cutaneous ulcers
- Reduction of compartmental pressures

The device is intended for hospital, home and clinic use

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).