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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™ 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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