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 Tablo Hemodialysis System is also indicated for use in the home.

Device Description

The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute or chronic care facility or in the home. The device includes the:

Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and
Table Cartridge

AI/ML Overview

The provided text is a 510(k) premarket notification summary for the Tablo® Hemodialysis System (software version 4.8). This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study for a new device requiring a comprehensive performance evaluation against defined acceptance criteria.

Therefore, the information required to answer your specific questions about acceptance criteria and study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information for an AI/software device) is not present in this type of FDA submission.

This document describes a software update (version 4.8) to an existing hemodialysis system. The performance data provided is limited to bench testing, biocompatibility, electrical safety, and software verification and validation testing. The software is considered "major" level of concern, and verification and validation were conducted. However, the document does not detail specific acceptance criteria for performance metrics that would be relevant to an AI/ML-driven diagnostic device.

Here's an attempt to answer based on the limited information available in the provided text:

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

The document provides very high-level acceptance criteria for specific non-clinical tests, rather than detailed performance metrics for an AI/ML system.

Test Performed	Acceptance Criteria	Result
Fungistasis and Bacteriostasis	The system shall not inhibit detection and/or the recovery of potential organisms as per USP 61.	Pass
Reprocessing Disinfection Validation	The system shall be labeled with cleaning instructions in accordance with FDA guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" dated March 2015.	Pass
Human Factors Validation	The system shall be assessed for usability with representative home users in accordance with its intended use/indication for use. The FDA guidance document used is "Applying Human Factors and Usability Engineering to Medical Devices" dated February 2016.	Pass
Software Verification and Validation Testing	"Documentation provided is per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"." (Implication: Passed V&V)	Passed

For an AI/ML device, you would expect detailed performance metrics like sensitivity, specificity, AUC, F1-score, etc., with associated acceptance thresholds for "Pass." This is not present here.

2. Sample sized 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 in the document as it is not a clinical study on patient data for an AI/ML diagnostic. The software V&V would involve testing against various scenarios and inputs, but the "sample size" in the context of patient data for AI model evaluation is not applicable here.

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 information is not provided. Ground truth establishment by experts is relevant for diagnostic AI/ML systems where human-annotated data is used for evaluation. This document describes a software update for a hemodialysis system, not an AI diagnostic.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided, as it pertains to expert consensus on ground truth in studies of diagnostic AI/ML systems.

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 or reported. The document explicitly states: "No clinical studies were conducted to support the modified device." MRMC studies are typically performed for diagnostic AI/ML tools to assess their impact on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

While "Software Verification and Validation Testing" was conducted, the document does not specify standalone algorithm performance in terms of diagnostic metrics. It only states that the testing "passed" and "supports safety and effectiveness." The software's function is to control a hemodialysis system, not to perform a standalone diagnostic task.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. Ground truth in the context of this device's software V&V would relate to the correct functional behavior of the system under various conditions, not diagnostic outcomes based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided. Training set details are relevant for AI/ML model development. This document is about a software update for a medical device's control system, not the development of a predictive AI model.

9. How the ground truth for the training set was established

This information is not provided. As above, this is relevant for AI/ML model training, which is not the focus of this 510(k) submission.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a software update to an existing hemodialysis system. It demonstrates substantial equivalence to a predicate device through non-clinical testing and verification/validation of software changes. It does not contain the detailed performance study information, particularly for AI/ML-driven diagnostics, that your questions are designed to elicit. The "acceptance criteria" presented are for general device performance and regulatory compliance, not for algorithmic diagnostic accuracy.

Summary

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July 29, 2022

Outset Medical, Inc. Saket Bhatt VP. Global Regulatory Affairs 3052 Orchard Drive San Jose, CA 95134

Re: K211370

Trade/Device Name: Tablo® Hemodialysis System (software version 4.8) Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI, FIP Dated: July 29, 2022 Received: July 29, 2022

Dear Saket Bhatt :

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211370

Device Name Tablo® Hemodialysis System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K211370 Page 1 of 4

Outset Medical, Inc.

510(k) Summary

(21 CFR 807.92)

I. SUBMITTER

Name:	Outset Medical, Inc.3052 Orchard DriveSan Jose, CA 95134
Phone:Contact:Date Prepared:	(408) 701-7319Saket BhattJuly 29, 2022
II. DEVICE
Trade/Proprietary Name:	Tablo® Hemodialysis System
Common /Generic Name:	Hemodialysis delivery system and water purification system
Classification Regulations:	21 CFR § 876.5860 – High permeability hemodialysis system21 CFR § 876.5655 - Water purification system for hemodialysis
Product Codes:	KDI; FIP
Regulatory Class:	II

III. PREDICATE DEVICE

The predicate device to which substantial equivalence is claimed is: Tablo Hemodialysis System, K200741

Additionally, the following device is used as a reference device to support the device differences: Tablo Hemodialysis System, K190793

IV. INDICATION FOR USE

The labeled indication for use statement is as follows:

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.

V. CONTRAINDICATIONS

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Prescribing physicians should consider the following contraindications for hemodialysis: very low blood pressure, shock, active, uncontrollable bleeding condition, or lack of vascular access. The passing of a patient's blood through an extracorporeal circuit may require anticoagulation to prevent blood clotting. In addition, the parameters of dialysis should be optimized to avoid discomfort to the patient.

The use of third-party external infusion pump is contraindicated with the Tablo System for home users for all fluid infusions including heparin infusion.

VI. DEVICE DESCRIPTION

Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and
Table Cartridge

The following are accessories available from Outset:

Tablo Straws
· Patient Key (USB)
Outset Acid Concentrate 1K, 2K and 3K (Optional)
· Outset Bicarbonate Concentrate jug (Optional)
Non-invasive Blood Pressure Cuff (NIPB) kit
Hand-Crank
· Locking Power Cord
Drain Line
Water Line
Insert and straw for Minncare Cold Sterilant
Tablo Script

Field Replaceable Units:

· Filter, Chlorine/Chloramines (Carbon Filter)
· Filter, Sediment
· Filter, RO Membrane
· Ultrafilter (Water and Dialysate Ultrafilter)

The following are dialysis treatment recommended accessories which are commercially available by other manufacturers:

High Flux Dialyzer
Acid jug (If not using Outset Supplied Acid Concentrates jug)
Bicarbonate jug (If not using Outset Supplied Bicarbonate jug)
Minncare Cold Sterilant ●
Chlorine/Chloramine test kit
Saline bag

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K211370 Page 3 of 4

Outset Medical, Inc.

Syringes and needles
Gloves and mask
Biohazard container
Disinfectant, gauze pads, and tape for access site

VII. SUBSTANTIAL EQUIVALENCE

The modified Tablo Hemodialysis System has the same fundamental technology, principle of operation, and principle functionality as the predicate. The device is a high permeability hemodialysis system, which combines a water purification system and dialysate delivery system as one device system.

The following differences exist between the predicate and subject device:

. Hardware changes: these features are the same as those in the cleared reference device,
. Software changes: these changes align the subject device software to that of the cleared reference device,
. Updated software to restrict functionality by use settings (professional and self-care mode).

VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

In accordance with the FDA Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems, issued August 7, 1998, Section VII, C, Outset Medical followed the alternative path and conducted leachable testing in lieu of biocompatibility tests. Toxicological assessment was performed. Device materials are considered safe for use as intended.

Electrical safety and electromagnetic compatibility (EMC)

The device was tested against and complies with ES 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, and IEC 60601-2-16. RFID testing per AIM 7351731 was also conducted.

Software Verification and Validation Testing

Software verification and validation testing were conducted and passed for the incremental software changes. Documentation provided is per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device is considered a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. Completed software testing supports safety and effectiveness of the device.

Sterilization and Shelf Life

N/A, Tablo Console is reusable, non-sterile. No changes were made to the Table Cartridge within this submission.

Bench Performance Testing

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K211370 Page 4 of 4

Bench testing to support the updated Tablo Console is as described in the reference device 510(k) K190793 and additional testing was conducted as described below:

Test Performed	Acceptance Criteria	Result
Fungistasis andBacteriostasis	The system shall not inhibit detection and/or therecovery of potential organisms as per USP 61.	Pass
ReprocessingDisinfection Validation	The system shall be labeled with cleaninginstructions in accordance with FDA guidance,"Reprocessing Medical Devices in Health CareSettings: Validation Methods and Labeling" datedMarch 2015.	Pass
Human FactorsValidation	The system shall be assessed for usability withrepresentative home users in accordance with itsintended use/indication for use. The FDA guidancedocument used is "Applying Human Factors andUsability Engineering to Medical Devices" datedFebruary 2016.	Pass

Animal Study

No animal studies were conducted to support the modified device.

Clinical Studies

No clinical studies were conducted to support the modified device.

IX. CONCLUSION

Non-clinical testing supports the safety and effectiveness of the Tablo Hemodialysis System. The results from these tests demonstrate that the device system performs comparably to the predicate device and is substantially equivalent to the legally marketed device, K200741.

Regulation Number and Section

§ 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.”