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The SC+ 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, by a trained clinician who is competent in the use of the device. The SC+ Hemodialysis System is also indicated for use in the home by trained patients in tandem with a trained care partner.

Blood Tube Set

The SC+ Blood Tube Set is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.

Device Description

The SC+ is a haemodialysis delivery system intended for the provision of acute and chronic dialysis therapy, with or without ultrafiltration. The SC+ system utilises incoming Dialysis Water from an external source, with industry standard dialysis concentrate consumables, to manufacture the dialysis fluid used to deliver the treatment. The SC+ system is for use in patients with arteriovenous (AV) fistulas or central venous catheter access.

The SC+ system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.

The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following: conductivity monitors, interfaces for pressure and temperature measurement. membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37℃ and subsequently deaerated within the machine before entering the cartridge.

The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.

AI/ML Overview

The provided text is a 510(k) summary for the Quanta Dialysis Technologies SC+ Hemodialysis Device, Dialysate Cartridge, and Blood Tube Set. The core of this submission is to expand the indications for use of the SC+ Hemodialysis System to include home use.

This document does not include information about AI/ML device performance, interpretation by human readers, or specific quantitative acceptance criteria for features like accuracy, sensitivity, or specificity. Instead, it describes acceptance criteria related to safety and effectiveness for a medical device in a new use environment (home healthcare) and for new user groups (patients and caregivers).

Therefore, a table of acceptance criteria and reported device performance (in the context of AI metrics) cannot be extracted directly from this document. Similarly, details on sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to the information provided.

However, I can extract the information related to the clinical study supporting the new indication for use, which serves as the "study that proves the device meets the acceptance criteria" in the context of this device.

Here's a breakdown of the relevant information from the document:

Study That Proves the Device Meets the Acceptance Criteria:

The study conducted to support the expansion of indications to home use was the HOME RUN clinical trial (G200362).

Type of Ground Truth Used: Clinical outcomes data (mean standardized weekly Kt/V for effectiveness, and rate of AEs for safety).
Sample Size Used for the Test Set (Clinical Study):
- Evaluable Population: n = 32 subjects. This included all subjects who were enrolled in the study and successfully completed at least 75% of their dialysis treatments.
Data Provenance:
- Country of Origin: Multi-center study in the US (13 sites).
- Retrospective or Prospective: Prospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable in the context of "ground truth" for an AI model. However, an Independent Safety and Clinical Ethics Committee (SCEC) was created to oversee trial safety.
- Qualifications of Experts: Comprised nephrologists with experience of hemodialysis, one of whom had significant experience in home hemodialysis.
Adjudication Method for the Test Set: The SCEC was blinded to whether AEs occurred in the in-clinic or in-home phase and had the authority to recommend changes to the trial. Details on specific adjudication rules for AEs (e.g., 2+1, 3+1) are not provided, but the SCEC served an oversight and review role.
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: Not applicable. This is not an AI/ML device in the context of diagnostic interpretation. The study compared device performance (safety and effectiveness) in two settings (in-clinic vs. in-home).
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, and its performance is the "algorithm" in action (the hemodialysis process). The study evaluated its use by human users (patients/caregivers/clinicians).
The Sample Size for the Training Set: Not applicable. This document describes a clinical trial for device efficacy and safety, not an AI model requiring a training set.
How the Ground Truth for the Training Set was Established: Not applicable.

Acceptance Criteria and Reported Device Performance (as related to the clinical study):

The acceptance criteria for the expanded indication were based on demonstrating comparable safety and effectiveness in the home setting as in the clinic, considering the new use environment and user groups.

Acceptance Criteria (Implicit from Study Goals)	Reported Device Performance (HOME RUN Study)
Effectiveness: Mean standardized weekly Kt/V to be consistently above a target (implied from typical hemodialysis standards).	The primary effectiveness endpoint was the mean standardized weekly Kt/V.
Result: The mean weekly standardized Kt/V was consistently above the target of 2.1 during all weeks of the in-clinic phase (≥2.3 in all phases C1-C8) and all weeks of the in-home phase (≥2.8 in all phases H1-H8).
Safety: Rate of AEs and prespecified AEs per 100 treatments to be not worse in the in-home phase compared to the clinic phase (upper bound of 95% CI of difference in AE rate below an acceptable threshold, e.g., 10%).	The primary safety endpoints were the rate of AEs and prespecified AEs per 100 treatments.
Result: The study was deemed successful as the AE rate per 100 treatments was not worse in the in-home phase compared to in the clinic. The AE rate per 100 treatments was low and acceptable as the upper bound of the 95% CI of the difference in the least squares mean AE rate was below 10%, at 2.73%.
One death was reported, which occurred during the clinical period and was ruled unrelated to the device or procedure (COVID-19).
The SCEC concluded that no serious harm AEs related to use error were identified.
Human Factors/Usability: Safe and effective use by lay users (patients and caregivers) without critical errors.	A Human Factors Validation Study was conducted on lay users in a simulated home environment.
Result: The results demonstrated that participants are able to safely and effectively use the SC+ Machine without making critical errors that could lead to a hazard.
Physical/Mechanical Robustness: Device can withstand different physical and mechanical forces in the home environment.	Shock and vibration testing, with subsequent Essential Performance and Basic Safety testing, was performed.
Result: A summary of the bench testing was provided (details not explicitly given in this summary, but indicated as part of the V&V).

In summary, this FDA clearance document primarily focuses on the clinical validation and human factors validation required to expand the intended use of a hemodialysis device to a home setting, rather than AI/ML performance metrics. The "acceptance criteria" here relate to demonstrating equivalent safety and effectiveness in the new use environment.

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