This infusion device has been manufactured since 1978 and has, during all this time, proved to be highly reliable in terms of sturdiness, reliability, accuracy and easy operation. Moreover, it does not require particular maintenance work. Microjet CD4 is a portable, battery-operated infusion device for use with 5 ml and 10 ml syringes (20 ml syringes are used with model CD4/20). A special micromotor actuates mechanical members that transform the motor rotary motion into the pusher linear motion which, in turn, causes the syringe piston to advance. The infusion device operating features enable to make infusions with varying amounts of medicine and different infusion times. During infusion, the motor is controlled by a special electronic circuit with regular pulses; therefore, infusion is carried out by delivering small amounts of medicine repeated with the passing of time.

AI/ML Overview

The provided text describes a 510(k) summary for the Microjet CD4, CD4/20 Ambulatory Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device for market clearance.

Therefore, most of the requested information regarding AI/ML device performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's characteristics and compares them to a predicate device, but it does not specify quantitative acceptance criteria or performance metrics in the way one would for an AI/ML system (e.g., sensitivity, specificity, AUC).

Instead, the "performance" is implicitly deemed acceptable by demonstrating substantial equivalence to a legally marketed predicate device. The characteristics compared are:

Characteristic	Cadd-Legacy 1 (Predicate)	Microjet CD4, CD4/20 (New Device)
Intended Use	Intravenous, Intra-arterial, Subcutaneous, Intraperitoneal, Epidural, Intrathecal	Subcutaneous only
Physical characteristics:
Power Source	2 AA alkaline batteries, AC Adapter	9 volt Alkaline battery
Size	4.4 x 3.8 x 1.6 in (112x 95x41 mm)	170 x 70 x 20 mm
Weight	13.8 oz (392 grams)	Approximately 220 g (including alkaline battery)
Capacity	10 ml	Disposable 5 ml or 10 ml syringes (CD4/20 model accommodates 20 ml syringes)
Warranty	1 year	SAME

The "study" that proves the device meets acceptance criteria is described as "bench, EMC, and user testing," which concluded that the new device is "as safe and effective as the predicate device" and has "few technological differences."

Missing Information (Relevant to AI/ML Performance):

Specific quantitative acceptance criteria (e.g., accuracy, precision, recall) for AI/ML performance.
Reported device performance against such criteria.

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

Sample Size: Not specified. The document mentions "bench, EMC, and user testing" but does not quantify the number of units or users involved in these tests.
Data Provenance: Not specified, other than it being part of internal testing by CANÈ S.r.l. (Italy).
Retrospective/Prospective: Not specified.

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

Not applicable to this type of device submission. Ground truth, in this context, would relate to the physical and functional performance of the infusion pump itself, not diagnostic interpretations by experts.

4. Adjudication method for the test set:

Not applicable.

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:

Not applicable. This is not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a standalone medical device (infusion pump), not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device would be established through engineering specifications, laboratory measurements for accuracy and reliability, and possibly usability assessments during user testing. The document refers to "bench, EMC, and user testing data" to support its claims of safety and effectiveness, implying these physical and functional validations served as the basis for comparison.

8. The sample size for the training set:

Not applicable. This device does not use an AI/ML training set.

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

Not applicable. This device does not use an AI/ML training set.

Summary

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EXHIBIT 2

CANÈ S.r.l. Via Pavia, 105/I 10090 Rivoli-Cascine Vica (Torino) Italy Tel.: ++39-011-957.48.72 Fax ++39-011-959.88.80 Contact: Mario Cané, President January 30, 2002

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: Microjet CD4, CD4/20 Classification Name: 80 FRN Common/Usual Name: Ambulatory Infusion Pump
1. Equivalent legally marketed devices This product is similar in function to the Cadd-Legacy 1 Ambulatory Infusion Pump , Sims Deltec, Inc., K982838
1. Indications for Use (intended use) The portable CD4, CD4/20 infusion devices have been designed only for use in subcutaneous infusion of prescribed liquid medicines.
1. Description of the Device: This infusion device has been manufactured since 1978 and has, during all this time, proved to be highly reliable in terms of sturdiness, reliability, accuracy and easy operation. Moreover, it does not require particular maintenance work. Microjet CD4 is a portable, battery-operated infusion device for use with 5 ml and 10 ml syringes (20 ml syringes are used with model CD4/20). A special micromotor actuates mechanical members that transform the motor rotary motion into the pusher linear motion which, in turn, causes the syringe piston to advance. The infusion device operating features enable to make infusions with varying amounts of medicine and different infusion times. During infusion, the motor is controlled by a special electronic circuit with regular pulses; therefore, infusion is carried out by delivering small amounts of medicine repeated with the passing of time.
1. Safety and Effectiveness, comparison to predicate device. The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device.

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6. Substantial Equivalence Chart

Characteristic	Cadd-Legacy 1Ambulatory InfusionPump , Sims Deltec, Inc.,K982838	Microjet CD4, CD4/20
Intended Use:	IntravenousIntra-arterialSubcutaneousIntraperitonealEpiduralIntrathecal	Subcutaneous only
Physical characteristics:
Power Source	2 AA alkaline batteries, ACAdapter	9 volt Alkaline battery
Size	4.4 x 3.8 x 1.6 x in (112x95x41 mm)	170 x 70 x 20 mm
Weight	13.8 oz (392 grams)	Approximately 220 g(including alkaline battery)
Capacity	10 ml	Disposable 5 ml or 10 mlsyringes (the CD4/20 modelhas metal jaws toaccommodate 20 mlsyringes)
Warranty:	1 year	SAME

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.1. that the Microjet CD/4, CD4/20 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cane S. R. I C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield. Illinois 60015 APR 2 6 2002

Re: K013776

Trade/Device Name: Microjet CD4/20 Ambulatory Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 23, 2002 Received: May 8, 2002

Dear Mr. Kamm:

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 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.

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Page 2 - Mr. Kamm

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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j) Indications for Use

510(k) Number K013776

Device Name: Microjet CD4, CD4/20 ambulatory infusion pump

Indications for Use: The Microjet CD4, CD4/20 ambulatory infusion pump device has been Indications 101 Overboutaneous infusion of prescribed liquid medicines.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use

Patricia Cucenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number X013776

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).