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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 Cartridge is a single use blood tubing set attached to an organizer tray. The E-beam sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment.

The provided document is a 510(k) summary for the Tablo Cartridge, a medical device used in hemodialysis. It outlines the performance data submitted to the FDA to demonstrate substantial equivalence to a predicate device. However, this document does not describe a study involving an AI/machine learning device, nor does it detail acceptance criteria and a study proving an AI device's performance in the way implied by the prompt's structured questions.

Specifically, the device in question is a physical "blood tubing set" for hemodialysis, and the changes discussed are related to manufacturing processes (sterilization method) and minor design improvements. The "performance data" refers to validation tests for sterilization, shelf-life, biocompatibility, and bench performance of the physical cartridge, not the performance metrics of an AI algorithm.

Therefore, many of the questions asked in the prompt, such as "Number of experts used to establish the ground truth for the test set," "Adjudication method," "MRMC comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and "How the ground truth for the training set was established," are not applicable to the information provided in this 510(k) summary.

Based on the provided document, here's what can be extracted, acknowledging that it does not fit the typical AI/ML device study format requested:

Device: Tablo® Cartridge (Hemodialysis blood tubing set)
Nature of Submission: 510(k) for a modified device (change in sterilization method from Ethylene Oxide (EO) gas to E-beam radiation, and minor design changes).

Given the nature of the device and the modification, the "acceptance criteria" and "study proving the device meets the acceptance criteria" are related to the safety and performance of the physical medical device and its manufacturing process, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a single table with explicit "acceptance criteria" alongside "reported device performance" values in a quantitative, pass/fail format in terms of algorithm accuracy (e.g., sensitivity, specificity, AUC). Instead, it lists various types of tests conducted to ensure the device's safety and functionality after the modification. The acceptance criteria for these tests are implied to be compliance with relevant ISO standards, USP standards, and FDA guidance documents.

Overall Conclusion: "The Tablo Cartridge (Modified Device) is substantially equivalent to the Predicate Device, and the minor difference between the Modified and the Predicate Device do not raise any new or different questions of safety or effectiveness."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated numerically (e.g., number of cartridges tested). For sterilization validation, often a statistically significant sample size based on standards like ISO 11137 is used, but the exact number isn't provided here. The same applies to shelf-life and bench performance testing.
• Data Provenance: Not specified regarding country of origin or whether it was retrospective/prospective. This is typical for device performance testing performed by the manufacturer, rather than clinical trial data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for this device would be objective measurements and laboratory test results demonstrating physical, chemical, and biological properties.

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

• Not Applicable. There's no human interpretation or subjective assessment that would require an adjudication method.

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. This is a physical medical device, not an AI/ML algorithm that assists human readers.

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

• Not Applicable. This is a physical medical device.

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

• For this device, the "ground truth" is established through objective laboratory testing, established chemical/biological assays, and physical performance measurements against predefined specifications and internationally recognized standards (e.g., ISO, USP). It's based on empirical measurements of device properties rather than human diagnostic interpretation.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML model.

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

• Not Applicable. There is no "training set" or corresponding ground truth establishment process in the context of AI/ML.

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

The Tablo™ Cartridge comprises a single-use, sterile Blood Tubing Set attached to an Organizer. The Organizer ensures proper placement of the Blood Tubing Set with the Tablo Hemodialysis System. The Blood Tubing Set consists of an arterial line, a venous line, an adaptor to connect the two lines, a saline line, a pressure transducer protector, a venous drip chamber, an arterial pressure pod, and a heparin syringe line. The Tablo Cartridge is developed exclusively for use with the Tablo Hemodialysis System. It is single-use, offered in one configuration, and provided sterile.

This document is a 510(k) summary for the Tablo™ Cartridge, a blood tubing set used for hemodialysis. It does not present a study proving the device meets acceptance criteria in the way one might expect for a clinically-oriented AI/software device. Instead, it describes performance testing to demonstrate substantial equivalence to a predicate device for a hardware medical device.

Therefore, many of the requested fields (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance for AI, and training set details) are not applicable to this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be common for AI/software devices. Instead, it lists types of performance testing and a general conclusion of compliance.

2. Sample size used for the test set and the data provenance

This information is Not Applicable to this document as it describes testing of a physical medical device (blood tubing set) rather than an AI/software device with a distinct "test set" of data. The testing mentioned would involve laboratory and engineering tests on physical devices.

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. Ground truth, in the context of expert review for medical images or data, is not relevant for the performance testing described for a blood tubing set.

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

This information is Not Applicable. Adjudication methods are typically used for expert consensus on ambiguous cases in the context of diagnostic AI/software.

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. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a physical device like a blood tubing set.

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

This information is Not Applicable. There is no algorithm discussed for standalone performance.

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

This information is Not Applicable. The "ground truth" for the performance of a blood tubing set would be established by validated engineering specifications, material standards, and functional requirements rather than medical expert consensus or pathology.

8. The sample size for the training set

This information is Not Applicable. Training sets are relevant for machine learning algorithms, which are not described in this submission for a physical medical device.

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

This information is Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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