FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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." |

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

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.