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510(k) Data Aggregation
(30 days)
The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤ 40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.
bibag System (Optional):
The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
Crit-Line Clip Monitor (CLiC) (Optional):
The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
The 2008T Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms. The 2008T Machine provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the blood into the dialysate circuit. In this separate dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer through platinum cross-linked silicone tubing. Balancing chambers control the dialysate during treatment. During treatment, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood.
The provided text is a 510(k) summary for the Fresenius Medical Care 2008T BlueStar™ Hemodialysis Machine. This document outlines the device description, indications for use, comparison to a predicate device, and performance data to demonstrate substantial equivalence to a legally marketed device.
However, the information provided does not describe acceptance criteria and a study that proves a device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.
The document is for a hemodialysis machine, which is an electro-mechanical device, not an AI/ML device for diagnostic or predictive purposes. The "performance data" sections are related to physical and biological safety, functional verification, and material compatibility of the hemodialysis machine itself, not validation of an AI/ML algorithm's performance on a dataset.
Therefore, I cannot extract the requested information (table of acceptance criteria with reported device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set size, and training ground truth establishment) as this document does not pertain to an AI/ML enabled medical device study.
To answer your request, I would need a document describing the validation of an AI/ML medical device.
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(289 days)
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician. The 2008 Sorbent System operates in a similar manner to standard hemodialysis systems currently approved for use; it is substantially equivalent to the Fresenius 2008T hemodialysis machine (K080964) and the Renal Solutions Allient® Sorbent Hemodialysis System (K070739). The significant difference between the 2008 Sorbent System and standard single-pass hemodialysis machines is that the 2008 Sorbent System utilizes a sorbent cartridge to purify dialysate made from potable tap water and then regenerates fresh dialysate from spent dialysate (like the Allient Sorbent Hemodialysis System). The 2008 Sorbent System consists of two distinct components: the 2008 Machine, and the SORB™ Module. The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system. During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard single-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.
The provided text describes the 2008 Sorbent Hemodialysis System, focusing on its substantial equivalence to predicate devices and the verification testing performed. However, it does not include the specific details required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI-powered medical device.
The document is a 510(k) summary for a Sorbent Hemodialysis System, which is a medical device for dialysate delivery, not an AI or software-intensive diagnostic device in the sense your questions imply (e.g., test sets, ground truth, expert consensus, MRMC studies). The "software testing" mentioned is to ensure the device's control software meets its design input requirements, not for evaluating an AI algorithm's diagnostic or predictive performance.
Therefore, many of your requested items cannot be extracted from this document as they are not relevant to the type of device being described.
However, I can extract what is available:
1. A table of acceptance criteria and the reported device performance:
The document outlines categories of testing and general objectives, implying acceptance criteria were defined for each. However, it does not explicitly state the quantitative acceptance criteria or the specific numerical performance results. Instead, it refers to "pre-defined acceptance or pass/fail criteria" and states that testing "demonstrates the device meets its performance specifications."
| Acceptance Criteria Category | Reported Device Performance (as inferred) |
|---|---|
| 2008 Sorbent System Performance Testing | Functional testing conducted to demonstrate the device performs as designed and expected, meeting its performance specifications. (Specific verification tests, protocols, objectives, test articles, methods, procedures, and pre-defined acceptance criteria were documented in the 510(k) submission, but not detailed here). System-level hazard analysis confirmed the device does not perform in an unexpected and/or unsafe manner. |
| 2008 Sorbent System Safety Testing | Product safety testing conducted demonstrating compliance with FDA Consensus Standards, including: Electrical safety (IEC 60601-1), Electromagnetic compatibility (IEC 60601-2-16), Biocompatibility (AAMI / ANSI / ISO 10993-1) for new patient-fluid contacting materials, and Risk Analysis (ISO 14971). |
| 2008 Sorbent System Software Testing | Software testing conducted demonstrating the device software meets the design input requirements. This included structural charts, development procedures, requirements specifications with traceability to hazard analysis, verification and validation test plans (with pass/fail criteria and traceability), system-level test results, and current software version documentation. |
| Overall Substantial Equivalence to Predicate Devices | Demonstrated the device is as safe, as effective, and performs at least as safely and effectively as the Allient Sorbent Hemodialysis System and Fresenius 2008T Hemodialysis System. |
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 in the given text. The testing described is non-clinical verification testing of a physical medical device, not a study involving patient data in the context of AI performance evaluation.
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 applicable/provided. The ground truth for this type of device (a hemodialysis system) is established through engineering and performance specifications, adherence to standards, and risk analysis, not expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 are typically used in clinical studies involving multiple readers or interpretations, which is not what is described here.
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
An MRMC comparative effectiveness study was not done, as this device is a hemodialysis system and not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The "software testing" refers to the control software of the device, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, regulatory standards (e.g., IEC, ISO), and performance requirements related to the physical and functional operation of the hemodialysis system. The document lists "pre-defined acceptance or pass/fail criteria" as part of the test protocols.
8. The sample size for the training set
This information is not applicable/provided. This device is a physical medical device, not an AI model trained on a dataset.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no AI model or training set in the context of this device.
In summary, the provided document describes a 510(k) submission for a Sorbent Hemodialysis System, focusing on its functional, safety, and software verification to demonstrate substantial equivalence to predicate devices. It does not contain the detailed information typically associated with the evaluation of AI-powered diagnostic or predictive medical devices.
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