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The Tablo™ 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™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. The console consists of fluidic systems that perform the activities of a Water Purification System (WPS) and a conventional Dialysis Delivery System (DDS). Since the original 510(k) clearance, the Tablo Console has incorporated design and corresponding labeling updates whose purpose was to improve ease of manufacturing, increase reliability, simplify the design, and optimize performance.

This document is a 510(k) summary for the Tablo Console, a hemodialysis system. The primary purpose of this submission is to describe expanded wireless communication capabilities and other design updates.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for a specific diagnostic performance metric. Instead, it details various types of performance testing against established standards and internal requirements. The "reported device performance" is a general statement of compliance rather than specific numerical results.

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

The document does not specify a "test set" in the context of diagnostic performance involving patient data. The various tests performed (biocompatibility, electrical safety, EMC, software, system performance) would have used devices or components of the device as the test "samples." No information is provided regarding the specific number of devices tested for each type of engineering or software verification test.

Since no clinical studies were performed, there is no patient data, and therefore no information on country of origin or whether data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. This submission concerns device modifications and engineering verification, not a diagnostic algorithm requiring ground truth established by medical experts from patient data.

4. Adjudication Method

Not applicable, as there is no diagnostic algorithm performance evaluation against ground truth from patient data.

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

No. The document explicitly states: "No clinical studies were performed in support of the modifications." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. Standalone Performance Study

Yes, in a sense. The entire submission focuses on the standalone performance of the device and its modified components (hardware, software, wireless capabilities) against engineering and safety standards. There is no AI component that would have distinct "standalone algorithm performance" versus "human-in-the-loop performance." The device itself is the "algorithm" in terms of its operational functionality.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests was based on:

• Established international and national standards (e.g., IEC 60601 series).
• Internal functional and performance requirements for software and system operation.
• Design specifications for hardware and fluidic systems.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set of patient data. The "training" for the device would be its initial design, development, and iterative testing/refinement phases.

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

Not applicable, as there is no AI/ML training set in the context of this device. The "ground truth" for the device's design and functionality would stem from engineering principles, medical device regulatory requirements, and user needs for hemodialysis.

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The Tablo 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 device by the prescribing physician.

The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. The console consists of fluidic systems that perform the activities of a Water Purification System (WPS) and a conventional Dialysis Delivery System (DDS).

This document is a 510(k) premarket notification for the Tablo Console, a hemodialysis system. It identifies the device, its intended use, and claims substantial equivalence to a predicate device (K140866). However, the information provided does not describe acceptance criteria for a device's performance, nor does it detail a study that proves the device meets specific performance criteria in the manner requested (e.g., sensitivity, specificity, or other outcome metrics).

The document focuses on:

• Regulatory clearance: The FDA's determination of substantial equivalence (510(k) clearance) to legally marketed predicate devices.
• Device description: What the Tablo Console is and its intended use.
• Technological characteristics: Listing similarities with the predicate device and one difference (wireless data transmission).
• Performance Data (reported): Mentions "performance testing to verify wireless compatibility," "electrical safety and electromagnetic compatibility profiles," and "software verification." However, it does not provide the specific acceptance criteria, study design, or results for these tests in a quantifiable manner (e.g., a table with reported device performance vs. acceptance criteria).

Therefore, based solely on the provided text, I cannot complete the requested table or answer most of the specific questions about the study design, sample size, ground truth, or expert involvement. The document primarily confirms regulatory clearance based on substantial equivalence and general safety/performance testing, rather than presenting a detailed clinical or analytical performance study with defined acceptance criteria and statistical outcomes.

However, I can extract the following limited information from the text that pertains to "performance data" as mentioned within the document:

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

Note: The document only generally states that the device "meets all performance specifications" for these categories and "complies with applicable standards and FDA Guidance Documents." It does not provide numerical or specific pass/fail criteria or quantitative results within this document.

The following information cannot be determined from the provided text:

• Sample sized used for the test set and the data provenance: Not specified. The performance testing is mentioned in a general sense, without details of specific test sets or origin.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or specified. The "performance data" mentioned (wireless, electrical, software) typically involves engineering and functional testing against technical standards, not expert adjudication for a "ground truth" derived from clinical scenarios in the way an AI diagnostic device would.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or specified.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned. The device is a hemodialysis console, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical hemodialysis console, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of the performance tests mentioned (wireless, electrical, software). These tests would rely on established engineering standards and functional specifications as their "ground truth."
• The sample size for the training set: Not applicable. This is not an AI/ML diagnostic device with a training set.
• How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory submission for a medical device (hemodialysis console) seeking 510(k) clearance based on substantial equivalence. It confirms general performance testing was conducted according to standards but does not contain the detailed, quantifiable acceptance criteria or study results for clinical or analytical performance that would typically be described for a diagnostic or AI-powered device.

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The Tablo™ 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 trailable as needed who is considered competent in the use of the device by the prescribing physician.

The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration. The Tablo Console consists of a conventional Dialysis Delivery System (DDS; Upper Module) and a compact Water Purification System (WPS; Lower Module). The Dialysis Delivery System (Upper Module) and the Water Purification System (Lower Module) are stacked and latched together to form a single integrated Console.

The provided text is a 510(k) summary for a medical device called the Tablo Console. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, accuracy for a diagnostic device).

Instead, it describes general performance testing that was conducted to ensure the device functions as intended and complies with relevant standards and guidance documents. This type of regulatory submission often focuses on demonstrating safety and effectiveness compared to an existing device, rather than presenting a performance study with acceptance criteria in the context of, for example, a diagnostic AI model.

Therefore, many of the requested fields cannot be directly extracted from this document as the information is not present. I will fill in what can be inferred or explicitly stated based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a statistical study with a defined sample size (e.g., for an AI algorithm). The performance testing described refers to engineering verification and validation of the physical device and its components. Therefore, information about sample size for a test set and data provenance (country, retrospective/prospective) is not applicable or available in this document.

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 to the type of device and performance testing described. Ground truth established by experts is typically relevant for diagnostic or AI-driven devices where human interpretation is being benchmarked or replicated.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to the type of device and performance testing described. Adjudication methods are usually for expert consensus on diagnostic interpretations.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the Tablo Console is (it's a hemodialysis system).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this refers to an AI algorithm's performance, which is not applicable to the Tablo Console.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be engineering specifications, validated safety standards, and functional requirements. For example, the ground truth for "treated water quality" is defined by specific chemical and microbiological standards for water used in hemodialysis. The document indicates testing was done "in accordance with appropriate FDA guidance documents and relevant standards."

8. The sample size for the training set
This information is not applicable. The Tablo Console is a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established
This information is not applicable. The device does not use a training set as it is not an AI algorithm.

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