(30 days)
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
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Wireless Compatibility | "meets all performance specifications" |
| Electrical Safety | "maintenance of the Electrical Safety... profiles" |
| Electromagnetic Compatibility (EMC) | "maintenance of the ...Electromagnetic Compatibility profiles" |
| Software Verification | "Software verification" |
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.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”