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

Model PSN-120 PSN Hemodialyzer
Model PSN-140 PSN Hemodialyzer

Here's an analysis of the provided documents regarding the Polysynthane (PSN) Hemodialyzer, focusing on the acceptance criteria and the study that proves the device meets these criteria.

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter from 1996/1997. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial with detailed acceptance criteria and performance metrics for an entirely novel device. Therefore, much of the requested information, particularly regarding specifics of clinical studies, AI performance, and expert ground truth, is not present or applicable.

Acceptance Criteria and Device Performance

The acceptance criteria for the Polysynthane (PSN) Hemodialyzer are derived from demonstrating equivalence to predicate devices and meeting established safety and performance standards for hemodialyzers. The "reported device performance" columns below reflect how the device was shown to meet these criteria, primarily through bench testing and adherence to existing standards rather than clinical study outcomes.

Note: The 510(k) summary explicitly states "Clinical data: N/A". This indicates that the regulatory clearance was not based on a clinical study demonstrating patient outcomes or comparative effectiveness in a clinical setting. Instead, it relied on bench testing, material compatibility, and adherence to established performance standards for similar devices.

Study Details

Given that the "Clinical data" section is marked as "N/A" and the submission is a 510(k) summary for a hemodialyzer, many of the requested details about human-in-the-loop studies, ground truth establishment by experts, and sample sizes for clinical trials are not applicable. The "study" here refers to the non-clinical testing and validation summarized in the document.

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified in terms of clinical subjects. For non-clinical tests (material, sterilization, pyrogenicity, etc.), the sample sizes would refer to the number of device units or material samples tested, which are not detailed in this summary.
• Data Provenance: Not specified. Testing for biocompatibility, sterility, etc., would typically be conducted in laboratories adhering to relevant standards.

2. 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. The ground truth for this medical device submission is established through adherence to recognized international and national standards (e.g., USP, ISO, AAMI) for material safety, sterilization efficacy, and physical performance. It does not involve expert consensus on clinical diagnoses or interpretations in the way AI/radiology devices might.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is needed. For this device, "ground truth" is determined by empirical measurements against pre-defined physical, chemical, and biological standards.

4. 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. This is a hemodialyzer, not an AI-assisted diagnostic or assistive tool. MRMC studies are not relevant to its type of evaluation.

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

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

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for this device's submission is derived from:
  • Validated Standards: Meeting specifications outlined in USP, ISO, AAMI guidelines for material biocompatibility, sterility, and pyrogenicity.
  • Bench Test Results: Direct measurements of physical integrity and clearance characteristics.
  • Equivalence to Predicate: Comparison of performance characteristics (like clearance values) to legally marketed predicate devices to establish substantial equivalence.

7. The sample size for the training set

• Not Applicable. This is a physical medical device, not an algorithm that requires a training set.

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

• Not Applicable. As there is no training set, this question is not relevant.

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