(243 days)
The Tablo® Hemodialysis 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 and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.
The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute, chronic care facility or in the home. The Tablo Hemodialysis System consist of:
- Tablo Console
- Tablo Cartridge
The provided document is a 510(k) summary for the Tablo® Hemodialysis System, specifically for a new software version. This document focuses on demonstrating substantial equivalence to a predicate device (K211370), rather than a study defining acceptance criteria for AI or a detailed performance study as would be required for a novel AI device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, etc.) is not directly applicable to this document. The document primarily discusses verification and validation of software changes and bench performance testing to support the extension of treatment duration.
However, I can extract the relevant information from the document regarding the device's performance data and the types of studies conducted to support its substantial equivalence.
Here's a breakdown based on the provided text, reinterpreting "acceptance criteria" as the deemed "substantial equivalence" established through various tests:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a software update to an existing device, the "acceptance criteria" are implicitly tied to maintaining or improving the safety and effectiveness of the device as cleared under the predicate (K211370) and extending the treatment duration. The "reported device performance" is primarily about the successful completion of various tests to demonstrate this.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: No change in material or manufacturing/processing from predicate. | Materials and manufacturing/processing are identical to the predicate Tablo Hemodialysis System (K211370). No additional biocompatibility data deemed necessary. |
| Electrical Safety and EMC: No difference in EMC and electrical safety from predicate. | The subject device has no difference in EMC and electrical safety from the predicate device (K211370). No additional EMC testing conducted. |
| Software Verification and Validation (V&V): Software V&V conducted and passed, meeting FDA guidance for "major" level of concern. | Software verification and validation testing were conducted and passed. Documentation provided per FDA guidance. Testing supports safety and effectiveness. |
| Sterilization and Shelf Life: Console is reusable, non-sterile; cleaning/disinfection methods are same as predicate. No changes to cartridge. | Tablo Console is reusable, non-sterile. Cleaning and disinfection methods are the same as predicate (K211370). No changes to the Tablo Cartridge within this submission. |
| Bench Performance Testing: Performance characterization same as predicate; human factors validated for software updates; ability to provide safe/effective treatment up to 24 hours demonstrated. | No additional bench testing was deemed necessary as performance characterization is the same as the predicate (K211370). Additional Human Factors validation data was provided for software updates. Performance testing demonstrated the device can provide safe and effective treatment for a duration of up to 24 hours. A summary of system-level, essential performance, alarms, software V&V, mechanical hemolysis, and protective systems testing is presented. |
Information not directly applicable or available from the provided text, as it relates to AI-specific studies:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided as the document describes a 510(k) for a software update to a hemodialysis system, not an AI/ML device with a distinct "test set" in the context of an algorithm's performance. The "test set" would implicitly be the entire system undergoing the verification and validation processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable to the type of device and study described. Ground truth in this context would be defined by engineering specifications, regulatory standards, and established medical safe use practices for hemodialysis machines.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as there's no "ground truth" derived from expert consensus for an AI algorithm's output.
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 MRMC study was conducted. This device is a hemodialysis system, not an imaging or diagnostic AI tool. The "Human Factors validation data" mentioned relates to the usability and safety of the system's interface for operators, not to AI-assisted interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance in the AI sense is not explicitly discussed. The device itself (Tablo Hemodialysis System) performs its function either autonomously or with user interaction, but it's not described as an AI algorithm in the context of image analysis or diagnostic support. The software performance here refers to the operating system controlling the device's functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance of the hemodialysis system software and hardware would be based on engineering specifications, adherence to ISO/IEC standards, regulatory requirements, and safe operational parameters for dialysis treatment. For the extended 24-hour treatment capability, the ground truth would be the ability to maintain specified performance (e.g., fluid removal, solute clearance, alarm responsiveness) over that duration without compromise to safety.
8. The sample size for the training set
- This information is not applicable to a traditional software update for a hemodialysis machine. "Training set" typically refers to data used to train AI/ML models, which is not the subject of this 510(k). Verification and validation are performed against requirements, not a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable, see point 8.
§ 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.”