The provided 510(k) summary for "My Insulin Doser/IDS" offers limited information regarding specific acceptance criteria and detailed study results that would typically be found in a comprehensive clinical or performance study report. The document primarily focuses on establishing substantial equivalence to a predicate device.

Based on the provided text, here's an attempt to answer your questions, highlighting where information is missing or inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds for insulin dosage calculation) for the "My Insulin Doser/IDS." It broadly states: "Performance testing was performed and all tests showed satisfactory results." and "My Insulin Doser/IDS uses the same fundamental technology features as the Intelligent Dosing System and delivers the same level of effectiveness."

Since the device's function is a "dosing calculator," the implied acceptance criterion would be accuracy of insulin dose calculation. However, no specific metrics or reported performance values (e.g., percentage accuracy, mean absolute error) are provided for this.

The "Labeling Comprehension study" does mention a design target of "6th grade reading comprehension level," which could be considered an acceptance criterion for usability, but no specific performance metric (e.g., percentage of users achieving comprehension) is given for this.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Labeling Comprehension Study:
- Sample Size: 55 patient users.
- Data Provenance: Not explicitly stated, but based on the overall context of an FDA submission in the US, it's likely US-based. It was a usability study, so inherently prospective.
Clinical Performance Data:
- Sample Size: "nursing home residents who were maintained on two or more OADs." The exact number is not specified.
- Data Provenance: Not explicitly stated, but likely US-based given the FDA submission. The study is described as a "Phase IV" study, which by definition is typically prospective, after a drug/device has been broadly marketed. The context suggests a prospective study where insulin titration was employed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided for either the labeling comprehension study or the clinical performance data. For the "Labeling Comprehension Study," the "ground truth" would be related to users' understanding, likely assessed by researchers or observers, but their qualifications are not mentioned. For the "Clinical Performance Data," the "insulin replacement algorithm" was "developed by Dimensional Dosing Systems, Inc.," which implies internal expertise, but no external experts are mentioned for establishing ground truth for individual patient cases in the context of the study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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, an MRMC comparative effectiveness study was not explicitly mentioned for the "My Insulin Doser/IDS."
This device is a "dosing calculator," not an imaging or diagnostic AI, so the concept of "human readers" and "AI assistance" in the typical diagnostic sense does not directly apply. The device is the "AI" (algorithm) assisting the patient or healthcare professional.
The comparison is to the predicate device, which uses the "same algorithm." The effectiveness is derived from the algorithm itself, which calculates doses. The benefit primarily comes from providing a calculation tool.

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

Yes, the device itself is a standalone algorithm, but intended for use by patients (human-in-the-loop). The "Performance testing" mentioned for both the proposed device and the predicate device would likely involve testing the algorithm's calculations against known correct answers or simulated scenarios. However, the details of such standalone testing (e.g., specific test cases, expected outcomes) are not described. For the "My Insulin Doser/IDS," the patient enters values, and the device calculates a dose; thus, the human is intrinsically involved in data input and eventual administration based on the calculation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the "Labeling Comprehension study," the ground truth would be the correct understanding of the instructions as defined by the device manufacturer, assessed through survey or observational methods.
For the "Clinical Performance Data," the study aimed to "help stabilize blood glucose following conversion from OAD therapy." The clinical outcome (stabilized blood glucose) would be the ultimate measure, and perhaps specific blood glucose targets or ranges would define "ground truth" for successful insulin titration per protocol. No specific method for establishing a "ground truth" for individual insulin doses (e.g., expert-derived ideal dose for each patient day) is described. The "ground truth" for the algorithm's accuracy in calculation is not specified beyond being based on the same algorithm as the predicate.

8. The sample size for the training set

The document does not mention a training set specific to the "My Insulin Doser/IDS" algorithm. It states, "Uses the same algorithm" as the predicate device (TRxF Intelligent Dosing System, K011571). This implies the core algorithm was developed and validated prior to this submission. Therefore, if there was a "training set," it would have been for the predicate device's algorithm development, which is not described here.

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

As no training set for the "My Insulin Doser/IDS" is mentioned (due to using an existing algorithm), this information is not provided. For the predicate device's algorithm, the ground truth for developing its dosing logic would typically involve medical expertise, pharmacological models, clinical guidelines, and potentially retrospective patient data, but these details are not present in this document.

Summary

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Korsir

510(k) Executive Summary August 20, 2008

NOV - 7 2008

Company Name:

Dimensional Dosing Systems

Company Address

Telephone:

2465 Dogwood Drive Wexford, PA 15090 (724) 933-7874

Contact Person: John McMichael

Summary Preparation Date: September 4, 2007

Trade Name: My Insulin Doser/IDS

Common Name: Dosing Calculator

Classification Name: Calculator, Drug Dose

Predicate Device Identification: CFR21 868.1890 Dosing Calculator Product Code: NDC Device Class: II

LEGALLY MARKETED EQUIVALENT DEVICE
Company	Product	510(k) #
RxFiles	TRxF Intelligent Dosing System	K011571

DESCRIPTION OF DEVICE

My Insulin Doser/IDS is a next dose calculator for any insulin that can be used by patients with a prescription from a licensed prescriber.

INTENDED USE OF THE DEVICE

My Insulin Doser/IDS allows a diabetic patient to calculate the best next dose of insulin to achieve a personal glucose target.

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TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE AS COMPARED TO PREDICATE DEVICE [

Predicate Product Comparison Table:

Manufacturer	Dimensional DosingSystems	Dimensional Dosing Systems
Trade Name	"My Insulin Doser/IDS"	TRXF Intelligent Dosing System(IDS)
K Number		K011571
Intended Use	My Insulin Doser/IDS allowsa diabetic patient to calculatethe best next dose of insulinto achieve a personal glucosetarget.	Software based drug dosingcalculator designed for use bythe physician to calculate nextdose of any drug to achieve adesired target
DeviceDescription	My Insulin Doser/IDS a nextdose calculator for any insulinthat can be user by patientswith a prescription from alicensed prescriber.	The IDS™ is a "next" dosecalculator for any drug that canbe used by physicianstocalculate the next doseforpatients.
Targetpopulation	Diabetic Patient	Healthcare professional
Where used	Home	Healthcare facility
HumanFactors	Patient enters their ownglucose values and amountsof insulin taken.Warnings are presentedwhen values are out of rangeand/or insulin doses are < or> 20% of the most recentdose.	Physicians enter patient'sglucose values and amounts ofinsulin. Warnings arepresented when values are outof range and/or insulin dosesare < or > 20% of the mostrecent dose.
Performance	Performance testing wasperformed and all testsshowed satisfactory results.	Performance testing wasperformed and all tests showedsatisfactory results.
Softwarebased	Yes	Yes
Dosecalculation	Yes	Yes

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Discussion of Similarities and Differences with the Predicate Product:

The Intelligent Dosing System (IDS) for Physicians was chosen as a substantially equivalent device. My Insulin Doser/IDS has the following similarities to those of the predicate device:

Uses the same algorithm .
Uses the same operating principles .
Uses a similar graphical user interface. �
Available via the Palm, PC or Website. .
User enters same variables. .

The only modifications made are:

. Single Patient only
. Insulin only

Conclusion:

My Insulin Doser/IDS is identical to the predicate device in functionality except for a few features that allow the device to be a single patient dosing calculator devised for insulin dosing only. The predicate device, the Intelligent Dosing System IDS) was developed as a dosing calculator for the healthcare professional and was approved for all drugs, including insulin. The IDS for Insulin takes the same software and technology and is a dosing calculator developed for a single patient and single drug. This device allows the patient to participate in insulin dosing, but has the added benefit of a remote patient management that allows the healthcare professional to view patient data anytime from anywhere with internet access

My Insulin Doser/IDS uses the same fundamental technology features as the Intelligent Dosing System and delivers the same level of effectiveness. Therefore, it is concluded that there is no significant difference in the basic function, safety and effectiveness between the Intelligent Dosing System (Predicate Device) and My Insulin Doser/IDS.

NON-CLINICAL PERFORMANCE DATA AND CONCLUSIONS FROM NON-CLINICAL TESTS

Labeling Comprehension study for 55 patient users to implement and understand My Insuiln Doser system. The system was designed around a 6th grade reading comprehension level. Subjects ranged in age from 18-80 years old.

Subjects were given My Insulin Doser/IDS users manual to read as well as given a demonstration of the software on any of the 3 platforms (PALM, PC and WEB),

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CLINICAL PERFORMANCE DATA AND CONCLUSIONS FROM CLINICAL TESTS

The study was a Phase IV in which nursing home residents who were maintained on two or more OADs were converted to an insulin replacement algorithm. The insulin titration algorithm developed by Dimensional Dosing Systems, Inc. was employed to help stabilize blood glucose following conversion from OAD therapy.

SOFTWARE INFORMATION
Software Documentation	Concern
Level of Concern	Major
Software Description	Provided
Device Hazard Analysis	Provided
Software Requirements Specifications	Provided
Architecture Design Chart	Provided
Software Design Specifications	Provided
Traceability Analysis	Provided
Software Development Environment Description	Provided
Verification and Validation Documents	Provided
Revision Level History	Provided
Unresolved Anomalies (Bugs or Defects)	Provided

SOFTWARE INFORMATION

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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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black line drawing, and the text is also in black. The overall design is clean and professional.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2008

Dimensional Dosing Systems C/O Mr. E.J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Rc: K082512

Trade/Device Name: My Insulin Doser/IDS Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: NDC Dated: August 29, 2008 Received: August 29, 2008

Dear Mr.Smith:

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 ffor 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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Please be advised that FDA's issuance of a substantial equivalence determination docs 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sxythe y. Michino ms
FOR DR. CHIU LIN

Chiu S. Lin, Ph. D Division 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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Indications for Use

510(K) Number:

Device Name: My Insulin Doser/IDS

Intended Use Statement:

My Insulin Doser/IDS allows a diabetic patient to calculate the best next dose of insulin to achieve a personal glucose target.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Centering Di non

Page of

flo

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

K # 8 2512____________________________________________________________________________________________________________________________________________________________________ 510(k) Number: _

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).