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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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