The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.

Device Description

The SmartBlock™ device comprises of the following components:

Compression unit including solution reservoir (up to 500 ml)
SmartInfuser regulating set (several versions of flow rate ranges, with or without MultiBolus™)
50/60 cc disposable svringe
Wound dressing
Medication labes
Pump lables
Carry pouch
FlowSpliter™ (optional)

The SmartBlock™ Pain Pump is designed for the following flow rate options:

Reference #	Flow Rate Range	Bolus Feature
1	P49520	1-6 ml/hr	Included
2	P49524	5-15 ml/hr	Included
3	P49530	1-6 ml/hr	Not included
4	P49534	5-15 ml/hr	Not included

AI/ML Overview

The provided document is a 510(k) summary for the SmartBlock™ Pain Pump, a medical device for pain management. It does not include detailed information regarding acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/CADe device.

This document focuses on demonstrating substantial equivalence to a predicate device (On-Q Pump), which is a regulatory pathway for medical devices. The "study" mentioned here is primarily about demonstrating that the new device has "equivalent performance characteristics" to the predicate device, not necessarily a performance study against predefined numerical acceptance criteria like one might find for an AI algorithm.

However, I can extract information relevant to the equivalence claim and structure it as an answer, while noting the absence of explicit AI/CADe study details.

Here's an analysis based on the provided text, highlighting what is available and what is not:

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

The document does not explicitly define numerical acceptance criteria for a "study" in the typical sense of evaluating an AI algorithm's performance (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device, the On-Q Pump. The reported "device performance" relies on this equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent intended use as the predicate device (On-Q Pump).	Meets: "The SmartInfuser PainPump™ has the same intended use as the On-Q Pump..."
Equivalent performance characteristics as the predicate device (On-Q Pump).	Meets: "...and has equivalent performance characteristics."
No additional concerns regarding safety and effectiveness compared to predicate.	Meets: "The evaluation... does not raise any additional concerns regarding safety and effectivity..."

The table of flow rates (P49520, P49524, P49530, P49534) and their associated ranges (e.g., 1-6 ml/hr, 5-15 ml/hr) can be considered part of the device's functional specifications, which would have been tested to demonstrate they meet design requirements. However, these are specifications, not performance criteria against a clinical "ground truth" as you'd find for an AI study.

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

This information is not provided in the document. The 510(k) summary does not detail specific "test set" data or studies with sample sizes, as it relies on demonstrating equivalence rather than a de novo clinical trial with defined data sets. It doesn't mention data provenance (country, retrospective/prospective).

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. As there's no mention of a "test set" for performance evaluation in the context of an AI/CADe device, there isn't a discussion of experts establishing ground truth.

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

This information is not provided. (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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human readers improving with AI assistance. This device is a pain pump, not an AI/CADe diagnostic or interpretative tool.

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

This is not applicable. The SmartBlock™ Pain Pump is a mechanical/electronic medical device, not an algorithm.

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

This is not applicable in the context of an AI/CADe device. For this pain pump, the "ground truth" would be related to engineering specifications and performance testing (e.g., verifying actual flow rates against specified ranges, material compatibility, sterility, mechanical integrity). This document does not detail those specific engineering studies or their "ground truth" methods.

8. The sample size for the training set

This is not applicable. There is no AI algorithm involved that would require a training set.

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

This is not applicable. (See point 8).

Summary of what is present:

The document serves as a 510(k) summary, aiming to demonstrate substantial equivalence of the SmartBlock™ Pain Pump to a legally marketed predicate device (On-Q Pump, K063530). The "study" in this context refers to the comparative analysis and testing that allowed the manufacturer to conclude that their device has the "same intended use" and "equivalent performance characteristics" to the predicate, and does not raise "any additional concerns regarding safety and effectivity." It does not provide details of clinical studies or data analysis related to AI performance metrics.

Summary

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K072053

Image /page/0/Picture/1 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters 'mfs' in a stylized font, with a teardrop shape incorporated into the 'f'. The text 'Medical Flow Systems Ltd.' is written below the letters.

P.O.Box 26, Shlomi 22832, Israel ● Tel: +972-4-9808280 ● Fax: +972-4-9875565 E-mail: info@mfs-medical.com ● www.mfs-medical.com

510(k) Summary:

SmartBlock™ Pain Pump

Company Name: Medical Flow Systems Ltd.

NOV 0 6 2007

Contact Person:

Ofer Shai Managing Director

Phone: +972-4-980-9193 +972-4-980-8356 Fax: E-mail: ofrs@mfs-medical.com

Authorized US Agent:

Mark Dollinger - President Trendlines America 2940 West, 123rd Terrace Leawood, Kansas 66200

Phone: (913) 317-8788 Fax: (913) 317-8788 E-mail: mark@trlines.com

Date prepared: July 20, 2007

Trade Name: SmartBlock™ Pain Pump

Classification name: Pump, infusion

Common/usual name: Disposable Pain Management System

Product Code: MEB

Regulation No .: 880.5725

Class: II Panel identification: General Hospital Panel

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Image /page/1/Picture/0 description: The image shows a logo with the letters 'mfs' in a stylized font. The 'm' is in lowercase, while the 'f' and 's' are in uppercase. A teardrop shape is positioned below the 'f', creating a unique design element. Below the logo, the text 'Medical Flow Systems Ltd' is printed in a smaller font, indicating the name of the company or organization associated with the logo.

P.O.Box 26, Shlomi 22832, Israel ● Tel: +972-4-9808280 ● Fax: +972-4-9875565 E-mail: info@mfs-medical.com ● www.mfs-medical.com

Predicate Device:

On-Q Pump, I-Flow Corp. 20202 Widrow Dr., Lake Forest, CA 92630, cleared under 510(k) no. K063530.

Description of the device:

The SmartBlock™ device comprises of the following components:

Compression unit including solution reservoir (up to 500 ml)
SmartInfuser regulating set (several versions of flow rate ranges, with or without MultiBolus™)
50/60 cc disposable svringe
Wound dressing
Medication labes
Pump lables
Carry pouch
FlowSpliter™ (optional)

The SmartBlock™ Pain Pump is designed for the following flow rate options:

Reference #	Flow Rate Range	Bolus Feature
1	P49520	1-6 ml/hr	Included
2	P49524	5-15 ml/hr	Included
3	P49530	1-6 ml/hr	Not included
4	P49534	5-15 ml/hr	Not included

Indications for Use:

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Image /page/2/Picture/0 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters 'mfs' in a stylized font, with a water droplet replacing the dot on the 'i'. The text 'Medical Flow Systems Ltd.' is written below the logo in a smaller font.

P.O.Box 26, Shlomi 22832, Israel ● Tel: +972-4-9808280 ● Fax: +972-4-9875565 E-mail: info@mfs-medical.com ● www.mfs-medical.com

Substantial Equivalence:

The SmartInfuser PainPump™ has the same intended use as the On-Q Pump, cleared under 510(k) no. K063530and has equivalent performance characteristics. It is therefore substantially equivalent to that device.

Conclusion -

The evaluation of the SmartBlock™ Pain Pump does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and a serpent winding around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 6 2007

Medical Flow Systems, Limited C/O Mr. Mark Dollinger President Treadlines America 2940 West 123rd Terrace Leawood, Kansas 66200

Re: K072053

Trade/Device Name: SmartBlock™ Pain Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MEB Dated: September 23, 2007 Received: September 25, 2007

Dear Mr. Dollinger:

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.

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Page 2 - Mr. Dollinger

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

Neil R. P. Ogden

Chiu Lin, Ph.D. Ja 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 (if known):	K072053
Device Name:	SmartBlock™ Pain Pump
Indications for Use:	The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.

Prescription Use X OR (Part 21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

( Infection Control Anosthesionogy, Gene

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).