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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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