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The Tablo® Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, with a trained individual available as needed who is considered competent in the use of the prescribing physician.

The Tablo® Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.

The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute or chronic care facility. The system's innovative design includes the:

• . Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and
• Tablo Cartridge, a single use blood tubing set attached to an organizer tray. The ethylene oxide (EO) sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment (Figure 1).
• . Tablo Script, an accessory software to the Tablo Console, is designed for use by medical professionals to a) prepare, update and verify patient dialysis prescriptions b) view and export dialysis treatment information and billing activities and c) set and modify Tablo Console settings. Note: Tablo Script is optional, patient prescriptions can still be created or changed directly on the Tablo Console.

Here's a breakdown of the acceptance criteria and study findings for the Tablo Hemodialysis System and Tablo Cartridge, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Non-clinical testing supports the safety and effectiveness of the Tablo Hemodialysis System and Tablo Cartridge. The bench testing demonstrates that the device systems comparably to the predicate device and is substantially equivalent to the legally marketed device." This implies that all listed acceptance criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not explicitly state a general "test set" sample size for all performance tests. Specific sample sizes are mentioned for certain tests:
  • Shelf Life and Sterilization Testing: The specifics of how many cartridges were subjected to accelerated aging are not detailed, but it's implied that the testing was sufficient to justify a 12-month shelf life.
  • Heat and Chemical Disinfection Effectiveness: n=3 consoles per organism, totaling n=6 consoles for disinfection validation.
• Data Provenance: The data is from non-clinical bench performance testing and biocompatibility testing. It is not patient-derived data. The country of origin is not specified but implicitly refers to testing performed by or for Outset Medical, Inc., a U.S. company. The studies are prospective in the sense that they were designed and executed to evaluate the device.

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth for Biocompatibility: Not applicable in the sense of expert consensus on qualitative data. The ground truth here is derived from standardized laboratory tests and their established pass/fail criteria (e.g., cytotoxicity, sensitization, hemocompatibility). Interpretation of these results would be done by qualified laboratory personnel and toxicologists. The specific number and qualifications are not detailed.
• Ground Truth for Performance Testing: Not applicable. Performance tests (e.g., flow rates, pressures, temperatures, disinfection efficacy, ultrafiltration accuracy) are measured against predefined engineering and regulatory specifications and standards (e.g., IEC standards, AAMI standards). The ground truth is the objective measurement comparing the device's output to these quantitative standards.
• Ground Truth for Human Factors Validation: The "ground truth" here is the assessment of usability in accordance with intended use. While representative users (nurses and patient care technicians) are involved, the document does not specify the number of experts (e.g., human factors engineers) who established the protocol or interpreted the findings, nor their specific qualifications.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1, 3+1) typically applies to studies where human readers are interpreting ambiguous data (e.g., medical images, clinical diagnoses) and discrepancies need to be resolved. This is not applicable to the non-clinical, objective functional and safety performance tests described for the Tablo Hemodialysis System. The results are based on direct measurements and adherence to engineering and biological standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically evaluates the diagnostic performance or interpretative accuracy of humans (with or without AI assistance) on a set of cases. The studies presented are non-clinical engineering and safety performance tests of a medical device.

6. Standalone Performance Study (Algorithm Only)

The term "standalone" performance usually refers to the algorithm's performance without human intervention, particularly in the context of AI/software. While "Software Verification and Validation Testing" was performed for the Tablo system, the documentation doesn't describe it as an isolated algorithm performance study in the way an AI diagnostic tool would be evaluated. The software is an integrated component controlling the physical device, and its validation is part of the overall system's functional assessment. Therefore, a standalone algorithm performance study, as typically understood for AI, was not explicitly detailed as such.

7. Type of Ground Truth Used

The ground truth used for these studies is primarily:

• Established industry standards and regulatory guidelines: Examples include ISO 10993-7, ANSI/AAMI ST72, ES 60601-1, IEC 60601-2-16, ANSI/AAMI 13959:2014, ANSI/AAMI 11663:2014, and ISO 23500.
• Engineering specifications and design requirements: These define the expected performance of various components and the system as a whole (e.g., maximum power, dialyzer compatibility dimensions, ultrafiltration accuracy of +/- 100 mL/hr, specified concentrate parameters).
• Biological and chemical pass/fail criteria: For biocompatibility, sterilization, and disinfection effectiveness tests, which are based on scientific principles and regulatory limits.

There are no mentions of expert consensus, pathology, or outcomes data being directly used to establish the ground truth for these specific non-clinical tests.

8. Sample Size for the Training Set

Not applicable. This document describes the performance testing of a physical medical device (hemodialysis system and cartridge), not an AI algorithm that requires a "training set" of data. The software within the device underwent verification and validation, but this is distinct from machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As mentioned above, this is not an AI algorithm document where a training set and its ground truth would be relevant.

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