The AlcoDigital Breathalyzer AT576, AT577, AT578, AT579 are designed to measure deep lung air to determine the level of alcohol in the blood. The relationship between alcohol in the blood and in the deep lung breath is well established by Henry's law in ratio of 2100:1. The alcohol sensor is electrochemical fuel cell type, and the unit has been designed to blow 6 seconds to get the sample of alcohol, the sensor generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood. The unit is powered by 1 pcs 9V battery or DC12V input.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the AlcoDigital Breathalyzer, organized according to your request:

Acceptance Criteria and Device Performance Study

The 510(k) summary presents a comparison between the subject device (AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579) and a predicate device (AlcoHAWK PT500 Digital Alcohol Detector, K080848) to establish substantial equivalence. The primary acceptance criterion highlighted and the related performance is "Accuracy."

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance (AlcoDigital Breathalyzer)
Accuracy	±0.005% at 0.05%

Note: The document implicitly suggests that the predicate device met similar accuracy criteria, and thus established a benchmark for substantial equivalence. However, the specific accuracy of the predicate is not explicitly stated in this segment.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary states that "A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device." However, it does not specify the sample size used for this clinical trial (test set) or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. The "clinical trial" mentioned focuses on user understanding and proper device use, not on validating the accuracy against an expert-established ground truth. Breathalyzers typically establish ground truth against laboratory-grade reference instruments or blood alcohol content (BAC) measurements.

4. Adjudication Method for the Test Set

The 510(k) summary does not specify any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI, where multiple human readers interpret cases with and without AI assistance. This device is a direct measurement tool, not an interpretive aid for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The document mentions "bench and user testing" and "A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device." The "Accuracy" specification (±0.005% at 0.05%) suggests some level of standalone technical performance evaluation was conducted, likely in a laboratory bench setting to assess the sensor's precision against controlled alcohol concentrations. However, a dedicated study explicitly labeled "standalone performance" is not described with methodological detail. The clinical trial focused on user interaction with the device.

7. The Type of Ground Truth Used

The most common ground truth for breathalyzers is Blood Alcohol Content (BAC) measured through a laboratory reference method (e.g., gas chromatography) or a highly accurate, calibrated reference breath alcohol instrument. While the 510(k) summary states the device "generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood," it does not explicitly state how the ground truth for the accuracy claim (±0.005% at 0.05%) was established for the testing that generated this figure. It's implied a reference standard was used, but not specified.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set sample size. Breathalyzers, particularly those based on electrochemical fuel cells, utilize established physical principles and calibrated sensors rather than machine learning algorithms that require large training datasets in the same way an AI diagnostic device would. Therefore, the concept of a "training set" for an algorithm isn't directly applicable in the typical sense for this device.

9. How the Ground Truth for the Training Set Was Established

As there's no mention of a "training set" in the context of an algorithm, the document does not describe how ground truth for a training set was established.

Summary

{0}------------------------------------------------

K091714

NOV 1 8 2009

Skyfine Inc. Limited 5 İÖ(k) Notification

AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579

510(k) Summary

This summary of 5 10(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.)

Prepared: May 22, 2009

Revised: Sep 9, 2009

Traditional 1.1 Type of Submission:

Skyfine Inc. Limited 1.2 Submitter: Flat A, 10/F., Block A, Tung Chun Industrial Building, 9-11 Address: Cheung Wing Road, Kwai Chung, N.T., HONG KONG (852) 6827-6600 Phone: (852) 2448-8918 Fax: Jason Chiang, President Contact: Establishment Registration Number: 3007776657

1.3 Identification of the Device:

Proprietary/Trade name: AlcoDigital Breathalyzer, Model AT576, AT577, AT578,

AT579 Breath Alcohol Test System Common Name: Devices, Breath Trapping, Alcohol Classification Name: Device Classification: I 862.3050 Regulation Number: Panel: Toxicology Product Code: DJZ

1.4 Identification of the Predicate Device:

Predicate Device Name:

AlcoHAWK PT500 Digital Alcohol Detector

Manufacturer:

Q3 INNOVATIONS LLC

510(k) Number or Clearance Information: K080848

{1}------------------------------------------------

AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579 Skyfine Inc. Limited 510(k) Notification

1.5 Intended Use and Indications for Use of the subject device.

This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

1.6 Device Description

1.7 Safety and Effectiveness

The result of bench and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device.

1.8 Substantial Equivalence Determination

{2}------------------------------------------------

AlcoDigital Breathalyzer
odel AT576, AT577, AT578, AT578, AT575

: 上

Skyfine Inc. Limited
510(k) Notification

Similarit

Feature	Shape	AlcoDigital Breathalyzer AT576	AlcoDigital Breathalyzer AT577	AlcoDigital Breathalyzer AT578	AlcoDigital Breathalyzer AT579
Construction		Plastic case with internal circuit board	Same	Same	Same
Type of Sensor		Fuel Cell Sensor	Same	Same	Same
Accuracy		$±0.005%$ at 0.05%	Same	Same	Same
Blowing time		6 seconds	Same	Same	Same
Blowing flow		10L/min	Same	Same	Same
Warm up Time		15 seconds	Same	Same	Same
Testing Time		10 seconds	Same	Same	Same
Repeat test		less than 60 seconds	Same	Same	Same
Audible sound alarm if above 0.05%BAC		Yes	Same	Same	Same
Show "HI" if above the display range		Yes	Same	Same	Same
Anatomical Site		Mouth	Same	Same	Same
Mouthpiece		Replaceable	Same	Same	Same
Power supply		9V battery or DC 12V	Same	Same	Same
Battery for standard testing		about 500 times	Same	Same	Same
Low battery indication and auto power off function		Yes	Same	Same	Same



Feature	AlcoDigital Breathalyzer AT576	AlcoDigital Breathalyzer AT577	AlcoDigital Breathalyzer AT578	AlcoDigital Breathalyzer AT579
Shape	Image: AlcoDigital Breathalyzer AT576	Image: AlcoDigital Breathalyzer AT577	Image: AlcoDigital Breathalyzer AT578	Image: AlcoDigital Breathalyzer AT579
Operation	10°C~40°C	Same	Same	Same
Store:	-10°C~60°C	Same	Same	Same
Recalibration interval	12 months	Same	Same	Same
Blowing pressure and interrupt detection	Yes	Same	Same	Same
Size	115x60x23mm	Same	Same	Same
Display range	0.000-0.200%BAC	Same	Same	Same

{3}------------------------------------------------

. .

・・

Skyfine Inc. Limited
510(k) Notification

Similarity

Differences
4 digits display with status	Image: 4 digits display with date and time	Image: 4 digits display
Temperature/Date/Time display	YES	NO
Print/Download	YES	NO
Memory	1000 records	5 records
Buttons	3 buttons: Test, Set Up, Print	2 buttons: Test, Memory
Weight	110g	100g

: 上

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

NOV 1 8 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Skyfine Inc. Ltd. c/o Michael Lee Acmebiotechs Co. Ltd. No.45, Minsheng Rd., Danshui Town (Innovation and Incubation Center of Mackey Memorial Hospital) Taipei County, TW 251

Re: K091714

Trade Name: Skyfine Inc. AlcoDigital Breathalyzer Models AT576, AT577, AT578, AT579 Regulation Number: 21 CFR §862.3050 Regulation Name: Breath-Alcohol Test System Regulatory Class: Class I, reserved Product Codes: DJZ Dated: October 30, 2009 Received: November 5, 2009

Dear Mr Lee .:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21

{5}------------------------------------------------

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Skyfine Inc.Limited 510(k) Notification

AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579

510(k) Number (if known): K091714

Device Name: AlcoDigital Breathalyzer, Model AT576, AT577, AT578, AT579

Indications for Use:

This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X (21 CFR 807 Subpart C)

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091714

Regulation Number and Section

§ 862.3050 Breath-alcohol test system.

(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.