The Liberty PDx™ Cycler is intended for Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD) in clinical and home settings. The supported peritoneal dialysis therapy types include: Continuous Cycling Peritoneal Dialysis (CCPD), Intermittent Peritoneal Dialysis (IPD), Peritoneal Dialysis Plus™ Therapy (PD+), and Tidal Peritoneal Dialysis (TPD).

Device Description

The Liberty PDx Cycler is a software-controlled electromechanical device designed for use in Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty PDx Cycler is designed as a table-top unit for use with single-use, dedicated disposable set (referred to as Liberty PDx Cycler sets). The Liberty PDx Cycler may be prescribed for either clinical or home treatment settings, as the predicate Liberty Cycler. Treatment settings, such as the amount of solution to be infused and the length of time the solution remains in the peritoneal cavity, are programmed into the cycler. During treatment, the Liberty PDx Cycler heats the peritoneal dialysis solution prior to patient infusion, measures and delivers a predetermined amount of fluid to the patient, and monitors the drained volume.

The Liberty PDx Cycler system consists of a Control Panel (user interface), Pump Module, Cassette Compartment, a disposable Cycler set (single-use), IOdrive, and an optional peripheral cellular modem. The control panel consists of a touchscreen display and front panel keys which provide a user interface. The pump module consists of mushroom-head piston(s) that are linearly displaced to alternately draw the dialysate solution to and from the patient's peritoneal cavity. The cassette compartment provides the interface for the disposable cycler set with the pump module's mushroom-head pistons. The cycler set is connected to a number of tubes which, in turn, connect to the dialysate solution bags, the patient, or a drain and provide a flow path between the cycler and the patient. At the end of each treatment, data generated by the Liberty PDx Cycler and stored in battery-backed memory are read and written to a treatment data set on the IQdrive (USB memory stick). Additionally, an optional peripheral cellular modem can also be used with the Liberty PDx Cycler to transmit treatment data files to an FTP server at the end of each treatment.

The Liberty PDx Cycler set is loaded into the cassette compartment of the Liberty PDx Cycler at the initiation of treatment. The cassette is composed of a ridged molded plastic (polypropylene) body covered with a flexible film/membrane. The cassette contains molded features, such as fluid channels, flexible valve domes and two (2) pumping chambers that are acted upon by the cycler to direct the flow of the peritoneal dialysate to and from the patient's peritoneal cavity.

There are seven (7) fluid lines connected to the cassette:

One (1) drain line
One (1) patient connection line (with one (1) or two (2) stay safe® patient connectors depending on the model)
Five (5) Dialysate Solution Lines (with Safe-Lock® connector):
- One (1) heater bag
- One (1) last dialysate bag/'last bag option'
- Three (3) additional solution bags

The three Liberty PDx Cycler sets designed for use with the Liberty PDx Cycler are constructed from identical materials. The sets differ only in the length of lines or in the number of patient connectors, as described in Table 1.

AI/ML Overview

The user is asking for specific details about the acceptance criteria and the study that proves a medical device, the Liberty PDx Cycler, meets these criteria. I need to extract this information from the provided text and present it in the requested format.

Here's a breakdown of the requested information and how I'll look for it in the document:

Table of acceptance criteria and reported device performance: I'll look for specific performance metrics, thresholds, or statements of compliance.
Sample size for the test set and data provenance: I'll search for information about the number of cases/samples used for testing and where the data came from (country, retrospective/prospective).
Number of experts and qualifications for ground truth: I'll look for details about who established the ground truth (e.g., radiologists, pathologists) and their experience.
Adjudication method for the test set: I'll search for how disagreements in ground truth were resolved (e.g., 2+1, 3+1).
MRMC comparative effectiveness study and effect size: I'll look for any mention of studies comparing human readers with and without AI assistance and their outcomes.
Standalone performance study: I'll check for studies demonstrating the algorithm's performance without human intervention.
Type of ground truth used: I'll search for how the ground truth was defined (e.g., expert consensus, pathology, outcomes).
Training set sample size: I'll look for the number of samples used to train the algorithm.
How ground truth for the training set was established: I'll search for method used to define ground truth for training data.

Upon reviewing the provided text, I found the following:

The document describes the Liberty PDx Cycler, a software-controlled electromechanical device for Automated Peritoneal Dialysis (APD).
Section 5.8 "Performance Data" states: "Performance testing requirements were determined through the application of a risk management process, applicable FDA guidance documents and performance standards (21 CFR §876.5630). Performance testing to support the determination of substantial equivalence included testing to IEC 60601-2-39:2007, ES 60601-1:2005, IEC 60601-1-2:2007, and IEC 60601-1-11:2010. The Liberty PDx Cycler sets were tested to ISO 10993-1:2009, ISO 10993-7:2008, and ISO 11135-1:2007."
Section 5.9 "Conclusion" states: "The information provided in this submission, including design verification, risk management, electrical safety, electromagnetic compatibility (EMC), biocompatibility and usability testing demonstrates the Liberty PDx Cycler functions as intended and supports the determination of substantial equivalence to the predicate device. Test results demonstrate that the differences between the proposed and the predicate device are not significant and do not raise any new concerns with regard to safety or effectiveness."

Crucially, this document is a 510(k) Summary for a medical device (Liberty PDx Cycler), not an AI/algorithm-driven device for image analysis or diagnostic support. The questions provided are highly relevant for AI/ML-based medical devices, which typically require detailed studies on model performance, ground truth establishment, reader studies, and training/test set specifics.

The Liberty PDx Cycler is a piece of hardware with software control, not an AI that analyzes data or images to provide diagnostic or prognostic information. Therefore, the specific types of studies (like those involving expert readers, ground truth for imaging, training/test sets for machine learning models, etc.) that would typically answer the user's questions are not described in this document because they are not applicable to this type of device. The "performance data" refers to compliance with electrical, safety, and biocompatibility standards, not diagnostic accuracy metrics.

Given this, I must state that most of the requested information cannot be found in the provided text as it pertains to a different type of medical device (a physical cycler with software control, not an AI software/algorithm for analysis).

Here's the response based on the available information:

Based on the provided 510(k) Summary for the Liberty PDx™ Cycler, the device is an electromechanical system for Automated Peritoneal Dialysis (APD), not an AI/algorithm-driven device for diagnostic or analytical purposes. Therefore, the majority of the requested information pertaining to AI performance metrics, sample sizes for AI training/test sets, expert ground truth establishment, and reader studies is not applicable to this device and is not present in the document.

The acceptance criteria and performance data provided relate to compliance with regulatory and safety standards for an electromechanical medical device.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
Performance Testing Standards	- IEC 60601-2-39:2007: Specific requirements for peritoneal dialysis equipment. - ES 60601-1:2005: General requirements for basic safety and essential performance of medical electrical equipment. - IEC 60601-1-2:2007: Collateral standard for electromagnetic compatibility (EMC) - requirements and tests. - IEC 60601-1-11:2010: Collateral standard for medical electrical equipment and medical electrical systems used in the home healthcare environment. - ISO 10993-1:2009: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.- ISO 10993-7:2008: Ethylene oxide sterilization residuals. - ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
Overall Conclusion	- "The information provided in this submission, including design verification, risk management, electrical safety, electromagnetic compatibility (EMC), biocompatibility and usability testing demonstrates the Liberty PDx Cycler functions as intended and supports the determination of substantial equivalence to the predicate device." - "Test results demonstrate that the differences between the proposed and the predicate device are not significant and do not raise any new concerns with regard to safety or effectiveness."

Acceptance Criteria Category

Reported Device Performance

Performance Testing Standards

- IEC 60601-2-39:2007: Specific requirements for peritoneal dialysis equipment. - ES 60601-1:2005: General requirements for basic safety and essential performance of medical electrical equipment. - IEC 60601-1-2:2007: Collateral standard for electromagnetic compatibility (EMC) - requirements and tests. - IEC 60601-1-11:2010: Collateral standard for medical electrical equipment and medical electrical systems used in the home healthcare environment. - ISO 10993-1:2009: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.- ISO 10993-7:2008: Ethylene oxide sterilization residuals. - ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

Overall Conclusion

- "The information provided in this submission, including design verification, risk management, electrical safety, electromagnetic compatibility (EMC), biocompatibility and usability testing demonstrates the Liberty PDx Cycler functions as intended and supports the determination of substantial equivalence to the predicate device." - "Test results demonstrate that the differences between the proposed and the predicate device are not significant and do not raise any new concerns with regard to safety or effectiveness."

2. Sample sized 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 performance data refers to compliance with engineering and safety standards rather than clinical data sets.

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 applicable and hence not provided. The device is a peritoneal dialysis cycler, not an AI for image or data interpretation requiring expert ground truth in a clinical diagnostic sense.

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

This information is not applicable and hence 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

This information is not applicable and hence not provided. The device described does not involve human readers interpreting data with or without AI assistance.

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

This information is not applicable and hence not provided. The device is an electromechanical system, not a standalone algorithm in the context of diagnostic AI.

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

This information is not applicable and hence not provided. The "ground truth" for this device would relate to its engineering specifications and functional performance (e.g., accurate fluid delivery, temperature control, safety alarms functioning), which are verified against specific standards, not clinical diagnostic ground truth.

8. The sample size for the training set

This information is not applicable and hence not provided. The device is not an AI/ML model trained on a data set in the context of the questions asked. Its software controls are likely developed and validated through traditional software engineering and regulatory compliance processes.

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

This information is not applicable and hence not provided.

Summary

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5. 510(K) SUMMARY

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.

Submitter's Information 5.1.

Name:	Fresenius Medical Care Renal Therapies Group, LLC(FMC-RTG)
Address:	920 Winter StreetWaltham, MA 02451-1457
Phone:	(781) 699-4479
Fax:	(781) 699-9635
Contact Person:	Denise Oppermann,Senior Director, Regulatory Affairs - Devices
Date of Preparation:	01 May 2014

5.2. Device Name

Trade Name:	Liberty PDx™ Cycler
Common Name:	System, Peritoneal, Automatic Delivery
Classification Name:	Peritoneal dialysis system and accessories
Classification Number:	Class II per 21 CFR §876.5630
Product Code/Classification Panel:	FKX/Gastroenterology/Urology

5.3. Legally Marketed Predicate Device

Fresenius Liberty Cycler (K123630)

5.4. Device Description

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Image /page/1/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

peritoneal dialysis solution prior to patient infusion, measures and delivers a predetermined amount of fluid to the patient, and monitors the drained volume.

There are seven (7) fluid lines connected to the cassette:

. One (1) drain line
. One (1) patient connection line (with one (1) or two (2) stay safe® patient connectors depending on the model)
. Five (5) Dialysate Solution Lines (with Safe-Lock® connector):
- One (1) heater bag
- One (1) last dialysate bag/'last bag option' ।
- Three (3) additional solution bags -

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Cycler SetProduct Codes	Features
050-87220	• Dual Patient Connector• Patient Line - 10 feet• Drain Line - 28 inches
050-87221	• Single Patient Connector• Patient Line - 10 feet• Drain Line - 28 inches
050-87222	• Single Patient Connector• Patient Line - 20 feet• Drain Line - 20 feet

Liberty PDx Disposable Cycler Sets Table 1:

5.5. Indications for Use

The Liberty PDx™ Cycler is indicated for acute and chronic peritoneal dialysis.

5.6. Intended Use

Technological Characteristics 5.7.

The Liberty PDx Cycler system and the predicate Liberty Cycler have equivalent technological characteristics:

1. Fundamental Scientific Technology/Operating Principle: Software-controlled electromechanical pumping system with actuating linear pump heads interfacing with the cassette fluid chamber to direct the flow of dialysis solution between the cycler and the patient. Flow direction is controlled by the pump movement.
1. Design/Configuration: Software-controlled electromechanical device with control (pumps and valves) and monitoring (sensors) components which interface with a disposable cycler set for fluid displacement. The single-use disposable cycler set is comprised of dialysate fluid-contacting components such as a pump cassette assembly, male Safe-Lock connectors, tubing, and stay safe patient connector to allow for the movement of peritoneal dialysate to and from the patient.

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Image /page/3/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three stacked chevrons, with the top two chevrons being larger than the bottom one. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

K141145 Page 4 of 4

1. User Interface: Control panel with integrated touchscreen display and front panel keys.
1. Sterility (Cycler Set): Ethylene oxide, fluid path only

5.8. Performance Data

Performance testing requirements were determined through the application of a risk management process, applicable FDA guidance documents and performance standards (21 CFR §876.5630). Performance testing to support the determination of substantial equivalence included testing to IEC 60601-2-39:2007, ES 60601-1:2005, IEC 60601-1-2:2007, and IEC 60601-1-11:2010. The Liberty PDx Cycler sets were tested to ISO 10993-1:2009, ISO 10993-7:2008, and ISO 11135-1:2007.

5.9. Conclusion

The information provided in this submission, including design verification, risk management, electrical safety, electromagnetic compatibility (EMC), biocompatibility and usability testing demonstrates the Liberty PDx Cycler functions as intended and supports the determination of substantial equivalence to the predicate device. Test results demonstrate that the differences between the proposed and the predicate device are not significant and do not raise any new concerns with regard to safety or effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 30, 2014

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs - Devices 920 Winter Street Waltham, MA 02451

Re: K141145

Trade/Device Name: Liberty PDx Cycler Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: May 1, 2014 Received: May 2, 2014

Dear Denise Oppermann,

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.

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Page 2 - Denise Oppermann

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141145

Device Name

Liberty PDx Cycler

Indications for Use (Describe) The Liberty PDx Cycler is indicated for acute and chronic peritoneal dialysis.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@ida.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 876.5630 Peritoneal dialysis system and accessories.

(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.