The POGO Automatic Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The POGO Automatic Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).

POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Device Description

The POGO BGMS is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The system includes multiple glucose-oxidase-based dry-reagent test strips housed in a cartridge and a photometer to read the glucose-dependent color change from the in-use strip. The meter uses calibration information from a barcode on the disposable cartridge to convert the reflectance information into a plasma-equivalent glucose value. A Bluetooth Low Energy (BLE) module in the meter allows the user to authorize the POGO meter to send data wirelessly, securely, and automatically after each test to specified electronic computing devices.

The POGO BGMS automates finger lancing, blood sample collection and placement onto the test strip, and calculation of the blood glucose result, and so requires significantly fewer steps than existing BGMSs to obtain a glucose result. The POGO BGMS accomplishes this via a 10-test cartridge where each foil-sealed test includes a hollow lancet, spring, and test strip. The user does not need a separate lancing device since the lancing mechanism is built into individual test cells of the cartridge. The blood sample is drawn into the test through capillary action and the meter, by monitoring the time and degree of blood spreading on the reagent pad, can detect when the test is under-filled and allow the user a limited amount of time to add blood to the test trip to obtain a glucose result rather than an error. Additionally, used tests are retained within the cartridge for added user convenience.

AI/ML Overview

The provided document is a 510(k) summary for the POGO Automatic Blood Glucose Monitoring System (POGO BGMS). It describes the device, its intended use, and compares it to a predicate device (an earlier version of the same system).

However, this document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets them. Specifically, it lacks:

A table of acceptance criteria and reported device performance for glucose measurement accuracy. While it lists general characteristics, it does not provide specific performance metrics like accuracy studies (e.g., ISO 15197 compliance data).
Sample sizes used for testing.
Ground truth establishment and expert qualifications.
Information about MRMC studies, standalone algorithm performance, or training set details.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on modifications that are largely non-functional (BLE capability, display changes, speaker, feet). It asserts that the fundamental technological characteristics, blood sampling, blood glucose measurement, and algorithm remain unchanged from the predicate. Therefore, it relies on the predicate's proven performance for establishing substantial equivalence in its core function (glucose measurement).

Based on the provided text, I can infer the following:

The acceptance criteria for the POGO Automatic Blood Glucose Monitoring System's glucose measurement performance is that it performs as safely and effectively as the predicate device (K162203). The document explicitly states: "The subject modifications for the POGO BGMS do not affect any of the above attributes that were included in the substantial equivalence section of the predicate device and relied upon for the substantial equivalence finding for the predicate device, K162203." It also mentions "Same fundamental technological characteristics. The following remain unchanged: blood ● sampling and blood glucose measurement, use of the same cartridge (which contains the reagent system used to measure blood glucose), technology and procedure to acquire a blood sample and monitor the color development on the reagent pad and the algorithm to calculate a glucose value from the reaction at the reagent pad."

Therefore, the "study that proves the device meets the acceptance criteria" for glucose measurement is implicitly the original study data for the predicate device (K162203), as the core measurement technology has not changed. The current submission focuses on demonstrating that the modifications (BLE, display, etc.) do not degrade this established performance.

Here's what can be extracted and what is missing based on your request:

Acceptance Criteria for the POGO Automatic Blood Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criterion (Inferred from non-change)	Reported Device Performance (Inferred/Stated)
Glucose Measurement Accuracy	Equivalent to predicate device (K162203) as core technology is unchanged.	The document states the blood glucose measurement technology and algorithm are "unchanged." Specific accuracy data (e.g., % within ISO 15197 zones) is not provided in this document for either the subject or predicate.
Functional Modifications	Performance specifications established for modified components.	"Pass" result for all performance tests on modified items.
Safety Testing	Compliance with Mechanical, Environmental, and Electrical safety standards for SMBG devices.	"Pass" result for all safety tests.
Cleaning & Disinfection	Efficacy and robustness challenges on raw materials and assembled device.	"Pass" result for efficacy and robustness challenges.
Software V&V	Software V&V requirements met.	"Pass" result for Software V&V.
Wireless Connectivity (BLE)	Bluetooth wireless proximity and coexistence testing requirements met.	"Pass" result for BLE testing.
Labeling	Readability.	"Pass" result for labeling readability.
Under-filled detection	Detects under-filled reagent pad.	"Yes," device detects under-filled reagent pad.
Blood reapplication	Allows blood reapplication for up to 15 seconds.	"Yes," provides glucose result or error code after blood addition; 15 seconds allowed for reapplication.
Blood application time	90 seconds allowed if blood does not reach reagent pad.	"Yes," 90 seconds allowed.
Strip exposure limits	Meter enforces limits on strip exposure (5 min open cell time window).	"Yes," device design prevents strip use after 5 minutes.
Lancet re-use	Prevents lancet re-use.	"No," device design prevents re-use.
Cal Coding	Automated.	"Automated."
Hematocrit Range	20% to 60%.	"20% to 60%."
Humidity Range	10% to 90% RH.	"10% to 90% RH."
Measurement Range	20 - 500 mg/dL.	"20 - 500 mg/dL."
Min. Sample Size	0.25 µL.	"0.25 µL."
Operating Temperature Range	50 to 104° F.	"50 to 104° F."

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

Test Set Sample Size: Not specified for any of the performance tests. The document only states that "Multiple nonclinical tests were identified via risk assessment activities as requirements to demonstrate comparable safety and effectiveness."
Data Provenance: Not specified (e.g., country of origin). The document implies the tests were conducted by the manufacturer, Intuitv Medical, Inc. The data is retrospective in the sense that it relies on the predicate's established performance and new testing for the modifications.

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

Not applicable / Not specified. This type of information is usually relevant for AI/ML diagnostic devices where human expert consensus establishes ground truth for image interpretation or diagnosis. For a blood glucose monitoring system, the ground truth for glucose measurements would typically be established by a laboratory reference method (e.g., YSI analyzer), rather than expert consensus.

4. Adjudication method for the test set:

Not applicable / Not specified. See point 3.

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:

No. This is not relevant for a blood glucose monitoring system, which provides a direct quantitative measurement and does not involve human interpretation of complex medical images or data requiring AI assistance.

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

Yes (in principle, for the core function). The device itself performs the glucose measurement and calculation ("algorithm to calculate a glucose value from the reaction at the reagent pad"). The performance refers to the device's accuracy against a known standard. The 510(k) submission states that this core algorithm and measurement technology are unchanged from the predicate device. Therefore, the standalone performance was established for the predicate device.

7. The type of ground truth used:

Laboratory Reference Method. For blood glucose monitoring systems, the ground truth for glucose concentration is typically established by a highly accurate laboratory analyzer (e.g., YSI glucose analyzer) that is well-calibrated and traceable to international standards. This document does not explicitly state the reference method, but it is standard practice for such devices.

8. The sample size for the training set:

Not applicable / Not specified. Blood glucose monitoring systems typically use a chemical reaction and photometric measurement with a pre-defined calibration curve. They are not generally "trained" in the typical machine learning sense with a "training set" of patient data that needs a ground truth established in the same way as an AI algorithm for image recognition. The "algorithm" here refers to the fixed mathematical conversion from optical signal to glucose concentration, derived from chemical principles and calibrated during manufacturing. While calibration data is used, it's not described as a "training set" in this context.

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

Not applicable. As above, the device uses a chemical-photometric principle. Calibration curves are established using samples with known glucose concentrations, typically measured by a laboratory reference instrument (the "ground truth").

Summary

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June 14, 2018

Intuitv Medical, Inc. % Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010

Re: K181316

Trade/Device Name: POGO Automatic Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: May 17, 2018 Received: May 18, 2018

Dear Cindy Domecus:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803); 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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181316

Device Name

POGO Automatic Blood Glucose Monitoring System

Indications for Use (Describe)

POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

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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Image /page/3/Picture/0 description: The image shows the logo for Intuity Medical. The logo consists of a stylized "i" inside a circle, followed by the word "intuity" in a bold, sans-serif font. Below the word "intuity" is the word "MEDICAL" in a smaller, lighter font. To the right of the word "intuity" is the phrase "Simplifying Diabetes" in a light, sans-serif font.

510(k) Summary, K181316

510(k) Owner

Robb Hesley Senior VP Corporate Development Intuity Medical, Inc. 3500 West Warren Avenue Fremont, CA 94538 (510) 946-8861 (phone) (510) 897-0603 (fax) robb.hesley@intuitymedical.com

Submission Correspondent

Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC Regulatory Consultant to Intuity Medical, Inc. Office: 650-343-4813 Fax: 650-343-7822 DomecusConsulting@comcast.net

Date Summary Prepared

June 11, 2018

Device Name and Classification

Trade Name	POGO® Automatic™ BloodGlucose Monitoring System
Common Name	Glucose Test System
Classification	Class II
Regulations	21 CFR 862.1345
Product Codes	NBW
Panel	Clinical Chemistry

Predicate Device

The predicate device for the POGO Automatic Blood Glucose Monitoring System (POGO BGMS) is the earlier version of the system cleared under K162203 on April 6, 2017.

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Device Description

Indications for Use

POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

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	POGO BGMS	POGO BGMS K162203
Characteristic	Subject Device	Predicate Device
Intended Use	Quantitative measurement of blood glucose	Same
Indications For Use	The POGO Automatic Blood GlucoseMonitoring System is intended to be usedfor the quantitative measurement ofglucose (sugar) in fresh capillary wholeblood samples drawn from the fingertips.The POGO Automatic Blood GlucoseMonitoring System is intended to be usedby a single person and should not beshared.The POGO Automatic Blood GlucoseMonitoring System is intended for selftesting outside the body (in vitro diagnosticuse) by people with diabetes at home as anaid to monitor the effectiveness of diabetescontrol. The POGO Automatic BloodGlucose Monitoring System should not beused for the diagnosis of or screening ofdiabetes or for neonatal use. The POGOAutomatic Blood Glucose MonitoringSystem is indicated for use in adults andadolescents (13 and up).POGO Automatic Test Cartridges are foruse with the POGO Automatic Meter toquantitatively measure glucose (sugar) infresh capillary whole blood samples drawnfrom the fingertips.	Same
Rx/OTC	OTC	Same
ClassificationRegulation	862.1345	Same
Product Codes	NBW	Same
Product Design	Battery-powered handheld meter	Same
Delivery of Blood toReagent Pad viaCapillary Action	Yes	Same
Automatic BloodSample Collection	Yes	Same
Detects Under-filledReagent Pad	Yes	Same
Characteristic	POGO BGMS	POGO BGMS K162203
	Subject Device	Predicate Device
Allows BloodReapplicationto Complete Test	Yes, provides glucose result or error codeafter blood addition to under-filled strip	Same
Time period allowedfor patient to addmore blood whenreagent pad is under-filled	15 seconds	Same
Time period allowedfor patient to applyblood when blood doesnot reach reagent pad	90 seconds	Same
Meter enforces limitson strip exposure?	Yes, device design prevents strip use after5 minute exposure (open cell time window)	Same
Patient able to re-uselancet?	No, device design prevents re-use	Same
Cal Coding	Automated	Same
Detection Method	Photometric (LED)	Same
Enzyme	Glucose oxidase	Same
Hematocrit Range	20% to 60%	Same
Humidity Range	10% to 90% RH	Same
Lancing Device	Integrated in Meter with Strip/Lancet inCartridge	Same
MeasurementRange	20 - 500 mg/dL	Same
MinimumSample Size	0.25 µL	Same
Monitor Memory	500 results	Same
OperatingTemperature Range	50 to 104° F	Same
Principle of Operation	Glucose is oxidized by the enzyme glucoseoxidase and electrons are transferred toform the intermediate hydrogen peroxide.Horseradish peroxidase catalyzes thetransfer of electrons between hydrogenperoxide and precursor dye molecules toform a blue oxidation product, theconcentration of which is proportional tothe concentration of glucose in the sample.The amount of color formed is read by aphotometer in the meter.	Same

Comparison to Predicate Device -- POGO BGMS

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The subject modifications for the POGO BGMS do not affect any of the above attributes that were included in the substantial equivalence section of the predicate device and relied upon for the substantial equivalence finding for the predicate device, K162203. Similarities between the between the subject and predicate POGO BGMS include:

Same fundamental technological characteristics. The following remain unchanged: blood ● sampling and blood glucose measurement, use of the same cartridge (which contains the reagent system used to measure blood glucose), technology and procedure to acquire a blood sample and monitor the color development on the reagent pad and the algorithm to calculate a glucose value from the reaction at the reagent pad
Same intended use and indications for use

Differences between the subject and predicate POGO BGMS include:

the addition of BLE capability,
a pixelated versus a segmented display screen,
a new hard coat material on the display lens,
addition of graphical elements, settings, and alerts to the display, ●
a speaker versus a piezo annunciator, and ●
a replacement of rubber feet on the bottom of the device for one large slip-resistant label. .

The modifications do not alter fundamental technologies or principles of operation of the POGO BGMS.

Summary of Nonclinical Performance Data

Multiple nonclinical tests were identified via risk assessment activities as requirements to demonstrate comparable safety and effectiveness between the predicate and subject devices. The subject device achieved a "Pass" result for all of those tests, namely:

1. Performance tests conducted to demonstrate that items modified or replaced from the predicate device met the performance specifications established for those components;
1. Mechanical, Environmental, and Electrical safety tests appropriate for SMBG devices;
1. Cleaning and Disinfection efficacy and robustness challenges on raw materials and the assembled device;
1. Software V&V:
1. Bluetooth wireless proximity and coexistence testing; and
1. Labeling readability.

Conclusion

Results from the nonclinical testing using the modified POGO BGMS demonstrate that it is substantially equivalent to the predicate device. The modifications to the POGO BGMS do not raise different questions of safety and effectiveness and the testing performed to evaluate the modifications confirms that the modified device is as safe and effective and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.