(160 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 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
| Performance Metric Category | Acceptance Criteria (Stated or Inferred) | Reported Device Performance (Stated or Inferred) | Details |
|---|---|---|---|
| General Performance | Met all performance specifications. | The Tablo Console meets all performance specifications, complies with applicable standards and FDA Guidance Documents. | General statement about overall device function. |
| Disinfection | Functionality of heat and chemical disinfections. | Performance testing done for heat and chemical disinfections. | Confirms the disinfection methods work as intended. |
| Water Quality | Production of treated water of specified quality. | Performance testing done for treated water quality. | Ensures water used for dialysis meets standards. |
| Dialysate Quality | Production of dialysate of specified quality. | Performance testing done for dialysate quality. | Ensures dialysate used for dialysis meets standards. |
| Key Functions/Features | Proper functioning of all key functions, design features, and components. | Performance testing done for all key functions/design features/components. | Verifies all parts of the device operate correctly. |
| Electrical Safety | Compliance with electrical safety standards. | Testing to confirm compliance with electrical safety standards. | Ensures device is electrically safe. |
| Electromagnetic Safety | Compliance with electromagnetic safety standards (RF emissions Class B). | Testing to confirm compliance with electromagnetic safety standards. The rating for the Subject Device is Class B. | Ensures device operates without harmful electromagnetic interference and meets specified class. |
| Alarms & Alerts | Proper functioning of alarms and alerts. | Performance testing done for alarms and alerts. | Verifies safety mechanisms are functional. |
| Software | Proper functioning of software. | Performance testing done for software. | Ensures software controls and functions correctly. |
| Touchscreen | Proper functioning of touchscreen. | Performance testing done for the touchscreen. | Ensures user interface works as intended. |
| Fluid Path Materials | Suitability/safety of fluid path materials. | Testing of the fluid path materials. | Confirms materials in contact with fluids are appropriate. |
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.
§ 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.”