The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. For Professional Use only. Not for use in individuals under the age of 18 years.

Device Description

The ASI Device is intended to be used to measure pulse waveform in the finger. The measurement oximeter is an optoelectronic sensor consisted of a light- emitting diode (infrared LED) and a photodiode placed on opposite side as a light receiver. The ASI System incorporates an FDA approved pulse oximeter fingertip probe. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and calculating how much light is absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on computer screen. As well as the optoelectronic sensor, the system utilizes a Texas Instrument designed circuit board which in turn transfers the signal to the computer contains the downloaded ASI proprietary algorithm which analysis the generated plethysmograph. The ASI System measures and analyzes the generated pulse waveforms to produce heart rate and plethysmograph of the patient's blood circulation.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the ASI Plethysmograph Analyzer Model 3.01. It details the device's indications for use, description, comparison to predicate devices, and a summary of safety and effectiveness, including references to clinical and non-clinical tests.

However, the document does not contain specific acceptance criteria (e.g., target accuracy, precision, or sensitivity/specificity metrics) or a detailed breakdown of the study that proves the device meets these criteria. The safety and effectiveness section broadly states "The results of both bench testing and clinical trial data indicates that the new device is as safe and effective as the predicate devices," but it does not quantify this.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be extracted directly from this document.

Here's an attempt to answer what can be inferred from the provided text, and where information is missing:

Device: ASI Plethysmograph Analyzer Model 3.01

Indications for Use: The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography. For Professional Use only. Not for use in individuals under the age of 18 years.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Fully Provided in Document.

The document claims the device is "as safe and effective as the predicate devices" based on bench testing and clinical trial data. However, it does not provide a specific table of quantitative acceptance criteria (e.g., specific accuracy ranges for heart rate, or waveform fidelity metrics) or the measured performance results against such criteria.

The similarity table (Section 6) instead focuses on features and intended use rather than detailed performance specifications.

Metric/Criterion	Acceptance Criteria (Target)	Reported Device Performance (Result)
Accuracy of Heart Rate Measurement	Not explicitly stated in document. (Implied: Comparable to predicate devices, within clinically acceptable limits for the intended use.)	Not explicitly stated as a quantitative result in document. (Implied: Deemed "as safe and effective" as predicate.)
Accuracy of Pulse Waveform Measurement	Not explicitly stated in document. (Implied: Comparable to predicate devices.)	Not explicitly stated as a quantitative result in document. (Implied: Deemed "as safe and effective" as predicate.)
Other Performance Metrics (e.g., precision, bias)	Not explicitly stated in document.	Not explicitly stated as quantitative result in document.

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

Information Partially Provided.

Test Set Sample Size: The document mentions "clinical trial data" and "Clinical studies were conducted," but it does not specify the sample size (number of participants/patients) used in these clinical trials.
Data Provenance: The clinical studies were conducted by "independent CRO Prism Research at 1000 Westgate Drive, Saint Paul, Minnesota 55114." This suggests the data is likely prospective given the mention of a clinical study, and the location implies the data is from the USA.

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

Information Not Provided.

The document does not detail how ground truth was established for the clinical trial data, or the number and qualifications of any experts involved in this process.

4. Adjudication Method for the Test Set

Information Not Provided.

There is no mention of any adjudication method (e.g., 2+1, 3+1 consensus) used for the test set data.

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

Information Not Applicable/Provided.

The ASI Plethysmograph Analyzer Model 3.01 is a device that provides measurements (pulse waveform, heart rate) directly, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. Therefore, a MRMC study comparing human readers with and without AI assistance is not relevant for this type of device.
No information about human readers or AI assistance in interpretation is mentioned. The device directly presents the measurements.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Information Partially Inferred.

The device operates by acquiring a signal and then an "ASI proprietary algorithm which analysis the generated plethysmograph." The clinical trial data would inherently represent the "standalone" performance of the device and its algorithm in producing heart rate and pulse waveform measurements. The document states "Clinical and non-clinical tests were performed to support the determination of substantial equivalence." While this implies standalone performance was evaluated, specific metrics of this standalone performance are not provided.

7. Type of Ground Truth Used

Information Not Provided.

The document states "Clinical studies were conducted," but it does not specify the method by which "ground truth" for heart rate and pulse waveform was established in these studies (e.g., comparison to a "gold standard" device, expert consensus on a different measurement, etc.).

8. Sample Size for the Training Set

Information Not Applicable/Provided.

The document describes the device as performing measurement and analysis of a signal using a proprietary algorithm. It does not explicitly state that this algorithm involves machine learning or what would be considered a "training set" in that context. If the algorithm is rule-based or derived from physiological models, a "training set" for an AI model might not exist in the traditional sense.

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

Information Not Applicable/Provided.

As a "training set" is not explicitly mentioned or implied for an AI model, the method for establishing its ground truth is also not provided.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 26, 2021

Arterial Stiffness Inc. Nida Shoubash Partner 1000 Westgate Drive Suite 101B Saint Paul, Minnesota 55114

Re: K200567

Trade/Device Name: ASI Plethysmograph Analyzer Model 3.01 Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic, Or Photoelectric Plethysmographs Regulatory Class: Class II Product Code: JOM Dated: February 28, 2020 Received: March 4, 2020

Dear Nida Shoubash:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200567

Device Name ASI Plethysmograph Analyzer Model 3.01

Indications for Use (Describe) The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.

For Professional Use only. Not for use in individuals under the age of 18 years.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary of Safety and Effectiveness

Arterial Stiffness Inc. Contact: Marshall Ring, CEO 300-136 Market Street Winnipeg, Canada R3B 0P3 Phone: 204.272.2406

February 8, 2020 Contact: US Agent: Joseph Shaw c/o International Life Science Enterprises Inc. 1000 Westgate Drive, St Paul, MN55114 Phone: 651.208.9596 Fax: 651.641.2801 Email: jshaw@il-se.us

1. Identification of Device

. Proprietary Trade Name: ASI Plethysmograph Analyzer 3.01
Classification Name: Class II Device, Plethysmograph, Photelectric, Product Code . JOM
. Common/Usual Name: Photoelectric Plethysmograph

2. Equivalent legally marketed devices

This product is similar in function to the McPulse Photoelectric Plethysmograph . (AKA Meridian DPA) 510(k) No. K023238, Applicant Meridian Co. Ltd.
Also, Novametrix Pulse Oximeter, Model 500, 510(k) K853124 .

3. Indications for Use (intended use):

The device provides non-invasive measurement of pulse waveform and heart rate . by photoelectric plethysmography - For professional use only. Not for use individuals under the age of 18 years.

4. Description of the device

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5. Safety and Effectiveness, comparison to predicate device

The results of both bench testing and clinical trial data indicates that the new device is as safe and effective as the predicate devices.

Feature	McPulse (Meridian DPA)	ASI PlethysmographAnalyzer 3.01
INDICATION OF USE	The device provides non-invasive measurement ofpulse waveform and heartrate by photoelectricplethysmography	The device provides non-invasive measurement ofpulse waveform and heartrate by photoelectricplethysmography
MODE	Noninvasive	Noninvasive
PRACTITIONER USE	For professional use only	For professional use only
DISPLAY	Digital LCD Display	Computer LCD screen
POWER SOURCE	AC (100-240Vac)	USB power source, A USB3.0 cable supplies up to 900milliamps of power to readingdevice
TYPE OF SENSOR	LED - Photodiode/fingerprobe	LED - FDA approvedOximeter. 510(k) 822909,NellcorTM, (Medtronic)
ANATOMICAL SITE	Finger	Finger
RECORDER OUTPUTS	Pulse WaveformHear rate	Pulse WaveformHear rate
HEART RATE & DISPLAYRESOLUTION	30-230 bpm	30-230 bpm
SIZE (UNIT: MM)	305x296x92.5 mm	80x160x40 mm (not includingcomputer)
WEIGHT	Approx. 5.5 kg	Approx. 0.18 kg (Not includingcomputer)
CONFIGURATION	Integrated unit includingprinter, pre-programed CPUand software program built in.	CPU and software included inseparate computer andprovided on disc. Operatingsystem Windows 10

6. Substantial Equivalence chart

7. Non-clinical and Clinical Tests

Clinical and non-clinical tests were performed to support the determination of substantial equivalence. These tests were performed at independent CRO Prism Research at 1000 Westgate Drive, Saint Paul, Minnesota 55114. Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812- Investigational Device Exemptions, Part 50- Protection of Human Subjects and Parts 56-Instituational Review Boards. Statistical Analysis was performed by ASI Staff.

8. Conclusion

After analysis the bench responses and considerations of electrical safety combined with clinical trial data it is the conclusion of Arterial Stiffness Inc., that the ASI Plethysmograph Analyzer has few technological differences and those that do exist represent little or no significance thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).