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510(k) Data Aggregation
(92 days)
Quanta Dialysis Technologies Ltd
SC+ Hemodialysis Device/ Dialysate Cartridge:
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.
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.
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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(120 days)
Quanta Dialysis Technologies Ltd
SC+ Hemodialysis Machine/ SC+ Dialysate Cartridge
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 person who is competent in the use of the device.
Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED), Prolonged Intermittent Renal Replacement Therapy (PIRRT), Isolated Ultration including Slow Continuous Ultrafiltration (SCUF) and Continuous Venovenous Hemodialysis (CVVHD).
SC+ 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 Tube Set is compatible only with the SC+ Hemodialysis System.
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.
SC+ Hemodialysis System 5.4.1
The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.
The 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°C 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.
This document describes the regulatory submission for the SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, and SC+ Blood Tube Set (K222067). It indicates that the device has been found substantially equivalent to a legally marketed predicate device (K210661).
The provided text does not contain detailed acceptance criteria or results from a study that explicitly compares the device's performance against numerical acceptance criteria in a table format. Nor does it include information about sample sizes for test sets, data provenance, expert involvement in ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set details.
Instead, the document focuses on device modifications and a summary of Verification & Validation (V&V) activities. The V&V section lists the types of performance testing performed to support the determination of substantial equivalence, which implies that the device met internal criteria derived from these tests. These tests include:
- Essential Performance testing for dialysate composition
- Essential Performance testing for dialysate flow rate
- Essential Performance testing for Blood Flow Rate
- Essential Performance testing for Net Fluid Removal
- Essential Performance testing for Treatment Time
- Essential Performance testing for Consumables duration testing
- Blood Loss to Dialysate protective system testing
- Net Fluid Removal Protective system testing
- Patient Leakage Current testing
- Hemolysis testing
- Software verification
The conclusion states that the modifications provide "reasonable assurance of safety and effectiveness to demonstrate it is at least as safe and effective as the predicate device and therefore is substantially equivalent." This suggests that the V&V activities confirmed that the modified device's performance, across the listed essential performance and safety aspects, was comparable or superior to the predicate device, within acceptable safety margins.
Without further documentation, it's not possible to populate the requested detailed information regarding specific acceptance criteria, reported performance values, study design specifics, or expert involvement. The provided text is a regulatory summary, not a detailed study report.
Ask a specific question about this device
(161 days)
Quanta Dialysis Technologies Ltd
SC+ Hemodialysis Machine/ SC+ Dialysate cartridge
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 person who is considered competent in the use of the device.
SC+ Blood Tubeset
The SC+ Blood Tubeset 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.
The SC+ is a hemodialysis delivery system intended for acute and chronic dialysis therapy with or without ultrafiltration in an acute of chronic care facility. The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.
The 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.
This document describes the Quanta Dialysis Technologies Ltd SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, and SC+ Blood Tubeset, which received FDA clearance K210661. This device is not an AI/ML device, and thus the requested information regarding acceptance criteria, study details, and AI/ML-specific performance metrics is not applicable.
The submission is for modifications to an existing device (SC+ Hemodialysis System, K193670). The modifications include adding two-way wireless transmission capability for machine data and updated user workflows/interface for the machine, and for the blood tubeset, a luer activated valve on the venous bloodline and replacement of a saline spike with a recirculation luer.
The 510(k) summary concludes substantial equivalence based on performance testing to verify electrical safety and electromagnetic compatibility profiles, software verification, human factors validation testing, and biological safety testing. Precise details of these tests (e.g., specific acceptance criteria, sample sizes, and detailed results) are not provided in this summary document.
Ask a specific question about this device
(358 days)
Quanta Dialysis Technologies Ltd.
SC+ Machine and SC+ Dialysate Cartridge:
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 person who is competent in the use of the device.
SC+ Blood Tube Set:
The SC+ Blood Tubeset 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
The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.
The 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 37oC and subsequently de-aerated 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.
This document is a 510(k) Premarket Notification from the FDA, outlining the substantial equivalence determination for the Quanta SC+ Hemodialysis System. It does not contain the type of acceptance criteria and study data typical for an AI/ML medical device submission, which would include metrics like sensitivity, specificity, AUC, and details on ground truth establishment and expert adjudication.
Therefore, I cannot extract the information required by your prompt regarding acceptance criteria and a study that proves the device meets them, specifically for an AI/ML component. The information provided heavily focuses on the comparison of a hemodialysis machine and its components to predicate devices based on technological characteristics and general performance testing (e.g., dialysate quality, electrical safety, biocompatibility, sterilization, human factors).
To directly address your prompt, using only the provided text, I must state that the document does not contain the requested information about an AI/ML enabled device's acceptance criteria and study as described. It's a regulatory clearance for a traditional medical device, not an AI/ML diagnostic or prognostic tool.
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