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The 800 series RAPIDO BLS HOLLOW-FIBRE DIAL YZERS are single-use devices intended for hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF) to treat conditions of acute or chronic renal failure when conservative therapy is judged to be inadequate. They are also indicated in the treatment intoxicated with poisons or drugs.

The above mentioned devices are dialyzers consisting of a cylindrical polycarbonate transparent body containing a bundle of microporous hollow fibers in highly-permeable polyethersulfone (Diapes® HF) secured to the ends by means of hot-melt polyurethane resin.

The provided text is a 510(k) Premarket Notification for the RAPIDO BLS HOLLOW-FIBRE DIALYZER. It describes the device, its intended use, and comparative testing against predicate devices to demonstrate substantial equivalence, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and device.

However, I can extract the relevant information regarding the acceptance criteria and the study type used for this medical device, which is an in-vitro performance study.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The results of these tests met established specifications." However, the specific numerical acceptance criteria for each performance parameter are not provided in this summary. The reported performance is implicitly that the device performs substantially equivalently to the predicate devices.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the document. The testing mentioned is "in vitro test results" and refers to "the device" (singular) implying testing on a sample, but the specific number of units tested is not given.
• Data Provenance: In vitro test results. The device manufacturer is Bellco Srl, located in Mirandola (MO), Italy. The tests were conducted internally or by a contracted lab. The document describes these as "non-clinical" and "in vitro" tests, not involving human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is an in-vitro performance study for a physical medical device, not an AI/algorithm-based device relying on expert-annotated ground truth.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI/algorithm. However, the performance described is of the device itself (standalone), not in conjunction with a human operator making clinical decisions based on its output (beyond operating the dialysis machine it connects to).

7. The type of ground truth used

• Established Specifications/Predicate Device Performance: The "ground truth" or reference for evaluating the RAPIDO BLS was its ability to meet established specifications for various performance parameters and to demonstrate substantial equivalence to legally marketed predicate devices (Xenium Dialyzer, Syntra, and Polyflux 6H). This relied on comparing the numerical values obtained from the in-vitro tests against these benchmarks.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study was an in vitro and non-clinical performance evaluation comparing the RAPIDO BLS HOLLOW-FIBRE DIALYZER to existing predicate devices (Xenium Dialyzer, Syntra, and Polyflux 6H).

The testing included:

• Biocompatibility testing: Conducted in accordance with ISO 10993-1.
• Sterility, pyrogenicity, EtO residual, and package integrity testing.
• In vitro functional performance testing:
  • Mechanical integrity
  • Priming volume
  • Blood side pressure drop
  • Ultrafiltration rate
  • Sieving coefficient
  • Hemolysis

For comparative purposes, the same in-vitro functional performance tests were also conducted on the predicate devices where applicable.

Conclusion of the Study:
The document concludes that the results from these in vitro studies demonstrate that the RAPIDO BLS performs in a manner substantially equivalent to the predicate devices and that it is biocompatible and safely manufactured (sterile, non-pyrogenic). All tests "met established specifications." This substantial equivalence argument is the basis for FDA clearance.

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Hemodialysis with a PUREFLUXTM-L hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

The device is for prescription use only.

This product is intended for single use only. The performance properties of reused dialyzers have not been established.

The PUREFLUXTM-L hemodialyzer is a medical device used as an artificial kidney system for the treatment of patients with renal failure. During treatment. blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment.

The PUREFLUXTM-L hemodialyzer is composed of polyethersulfone fiber and is available in various sizes, which are differentiated by membrane surface area.

The provided document is a 510(k) summary for the Nipro PUREFLUX™-L Hemodialyzer. It details the device's description, intended use, and a comparison to predicate devices, but it does not contain the information requested in points 1-9 regarding specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study that would typically be associated with AI or diagnostic imaging devices.

The document discusses non-clinical studies for "analyte clearance (urea, creatinine, phosphate, Vitamin B12), ultrafiltration coefficient and pressure drop" to establish substantial equivalence to predicate devices (K062079 Baxter Xenium Hemodialyzer, K926005 Fresenius Hemoflow, K043244 Fresenius Optiflux). However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size or ground truth establishment for a training set.

This type of information is generally not relevant for 510(k) submissions of hemodialyzers, which rely on demonstrating substantial equivalence in physical and performance characteristics (like clearance rates and ultrafiltration) to already approved predicate devices, rather than the types of clinical performance evaluations and AI model validation studies relevant to the provided questions.

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Hemodialysis with a PUREFLUX-H hemodialyzer is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.

The device is for prescription use only.

This product is intended for single use only. The performance properties of reused dialyzers have not been established.

The PUREFLUX-H hemodialyzer is a medical device used as an artificial kidney system for the treatment of patients with renal failure. During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment.

The PUREFLUX-H dialyzers are composed of polyethersulfone fiber and are available in six sizes, which differentiate by membrane surface area.

The provided text is a 510(k) summary for the Nipro PUREFLUX™-H Hemodialyzer, describing its substantial equivalence to a predicate device, rather than a study detailing acceptance criteria and performance against those criteria in the context of an AI/ML device. Therefore, much of the requested information regarding AI/ML study design, such as sample sizes for test and training sets, expert consensus, adjudication methods, and MRMC studies, is not applicable to this document.

However, I can extract the information relevant to the device and its testing as described in the provided text.

Here's the closest analog to the requested table and study information based on the provided hemodialyzer documentation:

Acceptance Criteria and Device Performance for Nipro PUREFLUX™-H Hemodialyzer

The Nipro PUREFLUX™-H Hemodialyzer's acceptance criteria and performance were established through non-clinical studies demonstrating substantial equivalence to a predicate device (K062079 Baxter Xenium Hemodialyzer). The primary acceptance criterion was that the PUREFLUX-H dialyzer performs as well as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Urea
• Creatinine
• Phosphate
• Vitamin B12
• Myoglobin |
  | Ultrafiltration Coefficient | Comparable ultrafiltration coefficient to predicate. | Results demonstrate substantial equivalence. |
  | Pressure Drop | Comparable pressure drop characteristics to predicate. | Results demonstrate substantial equivalence. |

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided document. The studies were non-clinical, likely involving in vitro testing of multiple units of each of the six available sizes of the PUREFLUX-H dialyzer.
• Data Provenance: The studies were non-clinical, meaning they were conducted in a laboratory setting, not with human or animal subjects. The country of origin of the data is not specified beyond the submitter being Nipro Medical Corporation in Miami, FL, USA. The data is prospective in the sense that it was generated for the purpose of demonstrating equivalence, but it is not clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of medical device (hemodialyzer), ground truth is established through validated physical and chemical testing methods, not by expert consensus on interpretations of images or other data typically found in AI/ML studies. Performance metrics like analyte clearance, ultrafiltration coefficient, and pressure drop are measured directly.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is based on direct measurements from non-clinical tests, not expert interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical hemodialyzer, not an AI/ML diagnostic tool or an assist device for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on direct measurements from non-clinical (laboratory) studies that quantify the physical and chemical performance characteristics of the hemodialyzer. This includes measurements of analyte clearance (urea, creatinine, phosphate, Vitamin B12, myoglobin), ultrafiltration coefficient, and pressure drop. The "ground truth" for equivalence was the performance of the legally marketed predicate device (K062079 Baxter Xenium Hemodialyzer).

8. Sample Size for the Training Set

Not applicable. This is 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

Not applicable. No training set was used.

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