(99 days)
The Allient Sorbent Hemodialysis System, including the SORB series and HISORB series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the Physician.
The Allient Sorbent Hemodialysis System is intended for the treatment of THE Allent Oorbont Homoutients where hemodialysis is prescribed by the ohysician. The Allient System functions as a traditional re-circulating sorbent hemodialysis system. Either single-needle or dual-needle access to the nemodialysis bystem . The system consists of the Allient hemodialysis machine, SORB™ series of sorbent cartridges, a single-use, sterile, disposable blood tubing set, a single-use disposable dialysate set, and various dialysate and infusate chemicals. The patient's blood is pumped from the access through a dialyzer and is returned to the patient.
This is a 510(k) summary for a medical device (Allient® Sorbent Hemodialysis System) and not a study describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not available in the provided text.
The document primarily focuses on establishing substantial equivalence to a previously cleared predicate device, rather than presenting a performance study with detailed acceptance criteria and results.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not describe specific acceptance criteria (e.g., performance metrics, thresholds) for the device. Instead, it asserts "substantial equivalence" to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. There is no mention of a "test set" or any specific clinical data used to evaluate the device's performance against predefined criteria. The assessment is based on comparison to a predicate device.
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)
- Not Applicable / Not Available. Since no "test set" or performance study is detailed, there's no mention of experts establishing ground truth for such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. No test set or adjudication method is described.
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
- Not Applicable. This device is a hemodialysis system, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Available. As no detailed performance study with a test set is described, the concept of "ground truth" in this context is not relevant. The substantial equivalence is based on similar design, operating principles, and intended use as the predicate device.
8. The sample size for the training set
- Not Applicable / Not Available. This device is not an AI/ML algorithm that would typically involve a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Available. As above, this concept doesn't apply to the reported device.
Summary of available information related to the device:
- Device Name: Allient® Sorbent Hemodialysis System
- Intended Use: Treatment of acute and chronic uremic patients where hemodialysis is prescribed by the Physician.
- Predicate Device: Allient Sorbent Hemodialysis System K043572 (or K043574 as cited later, which appears to be the same predicate).
- Basis for Equivalence:
- Same indicated use.
- Same operating principles.
- Same basic system design.
- Incorporates the same accessories and generic materials, manufactured, packaged, and sterilized using the same processes.
- Regulatory Classification: Class II, Product Code FKT, Regulation Number 21 CFR §876.5600 (Sorbent regenerated dialysate delivery system for hemodialysis).
In conclusion, the provided text is a regulatory submission for a 510(k) clearance, which aims to demonstrate substantial equivalence to an already legally marketed device rather than providing a detailed performance study with acceptance criteria and results as typically seen for novel diagnostic or AI devices.
§ 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
(a)
Identification. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.(b)
Classification. Class II (performance standards).