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510(k) Data Aggregation
(247 days)
The Lilliput™ APD System is indicated for adult chronic peritoneal dialysis in home and clinical settings.
The Lilliput APD System is available in one (1) configuration that includes an electromechanical cycler (hereinafter referred to as "Cycler"), disposable set (hereinafter referred to as "Disposable Set''), USB key, and Kinexus Gateway. The Disposable Sets are available in three (3) configurations:
- . Lilliput Disposable Set, One Patient Connector (Low feature)
- Lilliput Disposable Set, One Patient Connector with Extended Drain and Patient Lines (Medium Feature)
- . Lilliput Disposable Set, Two Patient Connectors with Extended Drain and Patient Lines (High Feature)
The Cycler is a software-controlled electromechanical device. The Disposable Sets are single-use Class II devices designed to operate with the Cycler to perform Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Disposable Sets are provided sterile and non-pyrogenic and are sterilized using ethylene oxide (EO).
The provided text describes the acceptance criteria and performance data for the Lilliput™ APD System, but it does not detail a study proving the device meets acceptance criteria in the context of diagnostic performance involving human readers or ground truth established by experts/pathology. Instead, the document focuses on engineering and safety performance criteria typical for a medical device.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided text, particularly for AI/diagnostic performance studies.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists "Essential Performance Specifications/Characteristic" in Table 4 and also describes various performance tests. The reported device performance is generally stated as "verified," "determined," or "acceptable results obtained," without specific numerical outcomes in all cases.
| Feature | Specification (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Dialyzing solution flow rate during inflow | 150-300 mL/min | System essential performance was verified. |
| Dialyzing solution flow rate during outflow | 100-250 mL/min | System essential performance was verified. |
| Dialyzing solution volume balancing (inflow volume) (FILL) | Larger of (at 2X standard deviation): $\leq$ 15 mL or $\pm$ 5% | System essential performance was verified. |
| Dialyzing solution volume balancing (outflow volume) (DRAIN) | Larger of (at 2X standard deviation): $\leq$ 15 mL or $\pm$ 5% | System essential performance was verified. |
| Volume Balancing (Symmetric Volume Accuracy) | Larger of (at 2X standard deviation): $\leq$ 12 mL or $\pm$ 2% | System essential performance was verified. |
| PD dwell time | Dependent on prescription. Dwell time accuracy $\pm$ 1 minute for the calculated dwell time | System essential performance was verified. |
| Dialyzing solution temperature | 37°C $\pm$ 2°C | System essential performance was verified. |
| EO Residuals (Disposable Sets) | < 4.6 mg/device for EO and ECh (in accordance with AAMI/ANSI/ISO 10993-7:2008/(R) 2012) | Acceptable results obtained (< 4.6 mg/device). |
| Bacterial Endotoxin (Pyrogenicity) (Disposable Sets) | < 20 EU/device (in accordance with ANSI/AAMI/ST72:2019) | Determined to be non-pyrogenic (< 20 EU/device). |
| Sterile Barrier Integrity (Vented Caps) | Qualified by microbial challenge tests (in accordance with ANSI/AAMI/ISO 11607-1) | Qualified as part of the sterile barrier. |
| Sterile Barrier Integrity (Tubing & Components) | Qualified through leak testing and structural integrity test adapted from ISO 8638 (after aging and distribution simulation) | Qualified as part of the sterile barrier. |
| Cycler System Functional Requirements | Verified according to pre-determined performance specifications (including user interface, solution management, pressure sensors, pumping system, heating) | Verified. |
| Cycler Safety System Requirements | Verified according to pre-determined performance specifications (including alarms, solution flow stoppage, sensor functionality) | Verified. |
| Shipping and Packaging (Cycler & Disposable Sets) | Verified according to ASTM D4169-16 and ASTM D7386-16 (Cycler); ASTM D4169-16 Distribution Cycle 6, Assurance Level II (Disposable Sets) | Verified; product's structural integrity maintained. |
| Heater Bag Seal | Withstand positive pressure of 1 bar at 39°C for 10 min without leaks or pressure decay | Ability determined by testing (description indicates success). |
| Structural Integrity (Disposable Sets) | Withstand 1.5X the labeled maximum positive and negative pressures | Ability determined by testing (description indicates success). |
| Biocompatibility (Disposable Sets) | Evaluated according to ISO 10993-1:2018 and FDA guidance for specified endpoints (cytotoxicity, sensitization, irritation, etc.) | Evaluated; supports biological safety. |
| Human Factors Validation | Validated for safe and effective use (in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices) | Validated. |
| Electrical Safety | In accordance with IEC 60601-1:2005 | Performed in accordance with standard. |
| Electromagnetic Compatibility (EMC) | In accordance with IEC 60601-1-2:2014 | Performed in accordance with standard. |
| Software Verification and Validation | Demonstrated effectiveness and confirmed operation (unit, software, regression, validation testing in accordance with multiple FDA guidances) | Performed to demonstrate effectiveness and confirm operation. |
2. Sample size used for the test set and the data provenance
The document describes "Simulated Treatments" for the Cycler performance testing, but does not specify the sample size for these or other performance tests. The provenance of the data (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided, as the studies described are engineering and device performance tests, not diagnostic performance studies requiring expert ground truth.
4. Adjudication method for the test set
This information is not applicable and not provided, for the same reason as above.
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 not provided. The device is a peritoneal dialysis system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a physical medical system; its "software verification and validation testing" is for the control system of the device, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and performance tests, the "ground truth" or reference standard would be the specified engineering tolerances and performance requirements for functional parameters (e.g., flow rate, volume accuracy, temperature), and adherence to recognized international standards and guidances for safety, biocompatibility, and software.
8. The sample size for the training set
This information is not applicable and not provided in the context of an AI/machine learning training set. The software testing mentioned is for the control software of a physical device, not an AI model requiring a separate training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reasons stated above.
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