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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 and observed by a trained individual who is considered competent in the use of the Tablo Hemodialysis System is also indicated for use in the home.

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 or in the home. The device 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
• Table Cartridge

The provided text is a 510(k) premarket notification summary for the Tablo® Hemodialysis System (software version 4.8). This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study for a new device requiring a comprehensive performance evaluation against defined acceptance criteria.

Therefore, the information required to answer your specific questions about acceptance criteria and study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information for an AI/software device) is not present in this type of FDA submission.

This document describes a software update (version 4.8) to an existing hemodialysis system. The performance data provided is limited to bench testing, biocompatibility, electrical safety, and software verification and validation testing. The software is considered "major" level of concern, and verification and validation were conducted. However, the document does not detail specific acceptance criteria for performance metrics that would be relevant to an AI/ML-driven diagnostic device.

Here's an attempt to answer based on the limited information available in the provided text:

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

The document provides very high-level acceptance criteria for specific non-clinical tests, rather than detailed performance metrics for an AI/ML system.

For an AI/ML device, you would expect detailed performance metrics like sensitivity, specificity, AUC, F1-score, etc., with associated acceptance thresholds for "Pass." This is not present here.

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 as it is not a clinical study on patient data for an AI/ML diagnostic. The software V&V would involve testing against various scenarios and inputs, but the "sample size" in the context of patient data for AI model evaluation is not applicable here.

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. Ground truth establishment by experts is relevant for diagnostic AI/ML systems where human-annotated data is used for evaluation. This document describes a software update for a hemodialysis system, not an AI diagnostic.

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

This information is not provided, as it pertains to expert consensus on ground truth in studies of diagnostic AI/ML systems.

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

No MRMC study was conducted or reported. The document explicitly states: "No clinical studies were conducted to support the modified device." MRMC studies are typically performed for diagnostic AI/ML tools to assess their impact on human reader performance.

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

While "Software Verification and Validation Testing" was conducted, the document does not specify standalone algorithm performance in terms of diagnostic metrics. It only states that the testing "passed" and "supports safety and effectiveness." The software's function is to control a hemodialysis system, not to perform a standalone diagnostic task.

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

This information is not provided. Ground truth in the context of this device's software V&V would relate to the correct functional behavior of the system under various conditions, not diagnostic outcomes based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided. Training set details are relevant for AI/ML model development. This document is about a software update for a medical device's control system, not the development of a predictive AI model.

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

This information is not provided. As above, this is relevant for AI/ML model training, which is not the focus of this 510(k) submission.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a software update to an existing hemodialysis system. It demonstrates substantial equivalence to a predicate device through non-clinical testing and verification/validation of software changes. It does not contain the detailed performance study information, particularly for AI/ML-driven diagnostics, that your questions are designed to elicit. The "acceptance criteria" presented are for general device performance and regulatory compliance, not for algorithmic diagnostic accuracy.

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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 and observed by a trained individual who is considered competent in the use of the Tablo Hemodialysis System is also indicated for use in the home.

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. This premarket notification is an indication expansion to include home use of the device. The product described in this submission includes:

• . 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
• . The following accessories/components
  • Tablo Script (optional accessory software) o
  • Tablo Straws O
  • O Outset Acid Concentrate 1K, 2K and 3K
  • Outset Bicarbonate Concentrate O
  • Patient USB Stick O
• Hand Crank O
• O Locking Power Cord
• Drain Line O
• O Water Line
• Disinfectant Straw O

Here's an analysis of the acceptance criteria and supporting studies for the Tablo Hemodialysis System, based on the provided FDA 510(k) summary:

The document describes the acceptance criteria and performance for several bench performance tests and mentions a clinical study to support the device's substantial equivalence and expanded indication for home use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bench Performance Tests: No specific sample sizes (e.g., number of units tested) are provided for these tests within the summary.
• Clinical Study: No specific sample size (number of patients) is explicitly stated in the summary.
• Data Provenance: The clinical study is described as a "prospective, multicenter, open label, non-randomized, cross-over study." This indicates the data was collected prospectively from multiple clinical sites. The country of origin is not specified but is implicitly the US, given the FDA submission context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Bench Performance Tests: Not applicable. Ground truth for these tests is based on established engineering and regulatory standards (e.g., AAMI, USP, FDA guidance).
• Clinical Study: Not applicable in the traditional sense of expert consensus on image interpretation. The "ground truth" for the clinical study involved direct measurement of patient outcomes (adverse events, Kt/V, ultrafiltration) which are objective physiological parameters.

4. Adjudication Method for the Test Set

• Bench Performance Tests: Not applicable. These are objective tests against defined physical or chemical standards.
• Clinical Study: Not explicitly stated. For clinical trial outcome measures like adverse events and adequacy, typically events are recorded as they occur and then reviewed by study investigators and/or an independent data safety monitoring board.

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 is typically used for diagnostic imaging devices where human readers interpret medical images. The Tablo Hemodialysis System is a medical device for therapy, not diagnosis.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

A "standalone" performance evaluation in the context of an AI algorithm is not applicable here. The Tablo Hemodialysis System is a physical medical device that interacts directly with patients, albeit with software control. Its performance is evaluated through its direct physical and physiological effects, not through an algorithm's interpretive ability. The software reliability improvements mentioned refer to the device's operational software, not an AI diagnostic algorithm.

7. Type of Ground Truth Used

• Bench Performance Tests: Regulatory and engineering standards (e.g., ANSI/AAMI, USP, FDA guidance for reprocessing).
• Clinical Study: Objective physiological measurements of patient outcomes:
  • Safety: Adverse event rates.
  • Adequacy: Weekly standardized Kt/V (a measure of dialysis efficacy).
  • Ultrafiltration: Achievement of ultrafiltration goals.

8. Sample Size for the Training Set

• Software Verification and Validation: No specific sample size (e.g., lines of code, test cases) is provided for the "training set" of the software. Instead, the summary states that "Software verification and validation testing were conducted and passed for the incremental software changes," following FDA guidance for "major" level of concern software. This implies a comprehensive testing process, but not a "training set" in the machine learning sense.
• Clinical Study: Not applicable; the clinical study evaluated the device's performance, it did not "train" a model.

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

• Software Verification and Validation: Not applicable in the context of a machine learning "training set." The "ground truth" for software validation would be the defined functional and non-functional requirements and specifications against which the software's behavior is tested.
• Clinical Study: Not applicable.

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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

• Water from the Post RO sample port meets ISO 23500 electrolyte concentration limits when prepared from water with hardness of 150 mg/L. | Pass |
  | 17. Water Treatment System (Bench Performance Testing) | The system shall meet requirements for a water treatment system. | Pass |
  | 18. Dialysate flow and Conductivity Monitoring (Bench Performance Testing) | The system shall meet requirements for dialysate flow, temperature, volume, and conductivity monitoring. | Pass |
  | 19. Air-In-Line (Bench Performance Testing) | The system shall meet requirements related to the system's purging and detection of air bubbles in the extracorporeal circuit. | Pass |
  | 20. Pre-Treatment Mode (Bench Performance Testing) | The system shall meet requirements for pre-treatment mode. | Pass |
  | 21. Post-Treatment Mode (Bench Performance Testing) | The system shall meet requirements for post-treatment mode. | Pass |
  | 22. Blood Pump and Pinch Valve Control, and Saline Delivery Performance (Bench Performance Testing) | The system shall meet requirements for operation, performance, and control of the peristaltic blood pump. | Pass |
  | 23. Heat Disinfection Mode (Bench Performance Testing) | The system shall meet requirements for heat disinfection mode. | Pass |
  | 24. Chemical Disinfection Mode (Bench Performance Testing) | The system shall meet requirements for chemical disinfection mode. | Pass |
  | 25. Ultrafiltration Accuracy (Bench Performance Testing) | The system shall provide a treatment fluid removal accuracy of +/- 100 mL per hour of the treatment time. | Pass |
  | 26. Maintenance and Service User (Bench Performance Testing) | The system shall meet requirements for maintenance and service user. | Pass |
  | 27. Maintenance and Service User (Mock Treatments) (Bench Performance Testing) | The system shall allow the user to run mock treatments in Service Interface without the need of a Patient USB. | Pass |
  | 28. Heat and Chemical Disinfection Effectiveness (Bench Performance Testing) | Disinfection validation was performed on n=3 consoles per organism, totaling n=6 consoles to demonstrate that chemical and heat disinfection cycles reduce vegetative bacterial species (e.g., Pseudomonas aeruginosa) by six logs and non-tuberculous Mycobacterium species (e.g., Mycobacterium terrae) by three logs. | Pass |
  | 29. External Disinfectant Chemical Compatibility Testing (IEC 60601-2-16 Test) (Bench Performance Testing) | The system and its accessories shall be capable of withstanding daily cleaning, using specified chemicals (70% Isopropyl Alcohol, 10% bleach, PDI Super Sani Cloth Germicidal Wipes, CaviWipes, CaviWipes1 Disinfecting Wipe, Oxivir 5, Oxivir TB Wipes) over the service life of the device per the chemical manufacturer instructions. | Pass |
  | 30. Bring Your Own Concentrate Conductivity Test (Bench Performance Testing) | The system shall be compatible with dialysis fluid concentrates intended for a 45X-proportioning ratio. When mixed at a 45X ratio, the acid concentrate should comply with the following labeled formulation range: Sodium 100 mEq/L, Potassium 0 - 4 mEq/L, Calcium 0 - 3.5 mEq/L, Acetate 4 mEq/L. | Pass |
  | 31. Human Factors Validation (Bench Performance Testing) | The system shall be assessed for usability with representative users (i.e., nurses and patient care technicians in clinical settings and acute-care facilities) in accordance with its intended use/indications for use. | Pass |

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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