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510(k) Data Aggregation
(224 days)
GAMBRO, INC.
Exalis is an integrated product able to acquire; process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data. Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.
Exalis is an integrated product able to acquire; process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data. Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.
The provided text describes a 510(k) summary for Gambro Renal Products, Inc.'s Exalis Software 1.15, classified as an accessory to a hemodialysis delivery system. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.
Based on the provided text, I cannot answer the questions regarding acceptance criteria and the study proving the device meets those criteria. The document primarily focuses on regulatory information, indications for use, and substantial equivalence to a predicate device, rather than detailed performance evaluation studies.
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(239 days)
GAMBRO, INC.
The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
Phoenix® is a self-contained, microprocessor-controlled device that provides hemodialysis and ultrafiltration-only therapies. The system consists of the Hemodialysis Machine in use with a blood tubing set designed for the machine, a dialyzer, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates. The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments. Phoenix® has a modular structure.
The provided text describes a 510(k) submission for the Phoenix® Hemodialysis Delivery System 3.35. This document focuses on demonstrating substantial equivalence to a predicate device and includes information about nonclinical testing.
Here's an analysis to extract the requested information:
1. A table of acceptance criteria and the reported device performance
The document uses the predicate device (Phoenix® Hemodialysis Delivery System Version 3.00) as a benchmark for acceptance criteria and performance. The performance metrics for the modified device (Version 3.35) are compared directly against those of the predicate. The "Accuracy" values for the modified device represent the reported device performance.
| Parameter | Acceptance Criteria (Predicate V3.00) | Reported Device Performance (Modified Device V3.35) |
|---|---|---|
| Anticoagulation (Heparin Pump) | Range: 0.5 - 10 ml/hr | |
| Accuracy: ± 5% or ± 0.2 ml/h | Range: 0/0.5 - 10 ml/hr | |
| Accuracy: ± 5% or ± 0.2 ml/h | ||
| Blood Flow Rate | Range: 10 - 500 ml/min | |
| Accuracy: ± 10% | Range: 10 - 580 ml/min | |
| Accuracy: ± 10% if pressure before the pump is not lower (more negative) than – 150 mmHg | ||
| Fluid Removal Rate from Patient | Range: 0 - 4 Kg/h | |
| Accuracy: ± 2.5 % of actual value or ± 50 ml/h, whichever is greater | Range: 0 - 4 Kg/h | |
| Dialysate flow rate at 350 ml/min: Accuracy (on total Weight removed): ±(2% UF rate + 35 g/hr) | ||
| Dialysate flow rate at 500 ml/min: Accuracy (on total Weight removed): ±(2% UF rate + 50 g/hr) | ||
| Dialysate flow rate at 800 ml/min: Accuracy (on total Weight removed): ±(2% UF rate + 80 g/hr) | ||
| Dialysate Flow Rate | Range: 350 - 1000 ml/min | |
| Accuracy: ± 5% | Range: 350 - 800 ml/min | |
| Accuracy: ± 5% | ||
| Transmembrane Pressure | Range: -200 to +500 mmHg | Range: -100 to +450 mmHg |
| Ultrafiltration Rate | Range: 0 - 4 Kg/h | |
| Accuracy: ± 2.5 % of actual value or ± 50 ml/h, whichever is greater | Range: 0 - 4 Kg/h | |
| Accuracy: ± 2 % of actual value. | ||
| Dialysate Temperature | Range: 34 - 40 °C | Range: 34 - 39.5 °C |
| Dialysate Conductivity | Range: 13-17 mS/cm | Range: 13-17 mS/cm |
| Arterial Pressure | Range: -400 to +150 mmHg | Range: -400 to +150 mmHg |
| Venous Pressure | Range: 100 to +450 mmHg | Range: 0 to +450 mmHg |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "component level hardware testing," "static and dynamic software testing (e.g., unit testing, code inspections, testing targeted to the changes implemented in software version 3.35, regression testing)," and "human factors evaluations." However, it does not specify sample sizes for these tests, nor the country of origin or whether the data was retrospective or prospective. The information points to internally conducted engineering and software verification and validation activities.
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)
The document states that testing was performed by "internal and external independent personnel with the appropriate skills" for the nonclinical testing and human factors evaluations. However, it does not specify the number of experts, their qualifications, or their role in establishing a ground truth for a test set. The context is about engineering and system performance validation, not clinical image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for a test set. This type of method is typically associated with studies involving human interpretation (e.g., radiology reads) where discrepancies need resolution. The testing described is primarily technical performance validation.
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 comparative effectiveness study was done or mentioned. This submission is for a medical device (hemodialysis system), not an AI-powered diagnostic tool, and therefore, the concept of "human readers improving with AI assistance" is not applicable to the context of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the "algorithm only" in this context refers to the device's automated functions). The entire nonclinical testing section, which evaluated parameters like flow rates, accuracies, and pressures, represents standalone performance testing of the Phoenix® System 3.35. The tables directly report these standalone performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical testing, the "ground truth" would be established by controlled engineering measurements against known standards and specifications. For example, a calibrated flow meter would provide the "ground truth" for blood flow rate accuracy, or a calibrated pressure sensor for pressure measurements. These are physical and electrical measurements, not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
The document does not mention a training set sample size. This is not an AI/machine learning device that typically requires a large training dataset. The development and testing revolve around hardware and software engineering principles.
9. How the ground truth for the training set was established
Since there is no mention of a training set, there is no information on how its "ground truth" was established.
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(40 days)
GAMBRO, INC.
Indicated for use with the Prisma Control Unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both.
The Prisma Disposable Sets are sterile disposable extracorporeal circuits containing an AN 69 HF hemofilter/dialyzer and fluid circuit for use with the Prisma Control Unit. These Prisma Disposable Sets allow the following fluid management and renal replacement therapies to be performed: SCUF - Slow Continuous Ultrafiltration CVVH - Continuous Venovenous Hemofiltration CVVHD - Continuous Venovenous Hemodialysis CVVHDF - Continuous Venovenous Hemodiafiltration
The provided text is a 510(k) summary for the Gambro Prisma M60/M100 Sets, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove performance against those criteria in the context of advanced AI/ML device evaluations.
Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as the submission predates the common methodologies and requirements for AI/ML device evaluations.
Here's the information that can be extracted or deduced from the provided document, with notes on what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a dedicated table format, nor does it present specific performance metrics like sensitivity, specificity, or AUC as would be found in an AI/ML device study. Instead, it relies on demonstrating "substantial equivalence" through "in vitro testing" to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain performance comparable to predicate devices in design, function, composition, and operation. | "The results of the in vitro testing demonstrate that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended use." |
2. Sample sized used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document only mentions "in vitro testing" without details on the number of tests or specific test runs.
- Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The testing was "in vitro," implying laboratory-based testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for this type of device (hemofilter and blood tubing set) would be established through engineering specifications, material properties, and functional performance benchmarks rather than expert clinical consensus on diagnostic images or patient outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, typically in diagnostic imaging or clinical assessment, to establish a consensus ground truth. This is not relevant for in vitro functional performance testing of a physical medical device.
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
- MRMC Study: No, this type of study was not done. MRMC studies are specific to evaluating AI's impact on human diagnostic performance, which is not relevant for a hemofilter and blood tubing set.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is not an algorithm and does not have a "standalone" performance in the sense of AI/ML evaluation. Its performance is inherent to its physical design and function. The "in vitro testing" assesses the physical device's performance directly.
7. The type of ground truth used
- Type of Ground Truth: For "in vitro testing" of a physical device like this, the 'ground truth' would be defined by established engineering and medical standards, performance specifications for flow rates, filtration efficiency, material compatibility, and sterility, as measured by standard laboratory equipment and protocols. It is not expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
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