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Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

The A-22 Hemodialyzer is a high permeability hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer. Each A-22 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box. It is sterilized by gamma radiation and intended, and labeled, for single use only.

The Althin medical device, A-22 Hemodialyzer, does not have clear, distinct acceptance criteria and reported device performance values laid out in a table format within the provided text. The document states that "Functional testing has been conducted to evaluate the functional performance of the A-22 Hemodialyzer. Testing was based on the specification cleared for the predicate device and test results showed significant equivalence. Moreover, the results of the functional testing attest that the A-22 Hemodialyzer conforms to its specifications and has demonstrated that it is suitable for its intended use."

However, specific numerical acceptance criteria or performance metrics for clearance or ultrafiltration, for example, are not detailed in the summary. The core of the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Altra Nova 200 Hemodialyzer, K926379), rather than meeting a pre-defined set of quantitative acceptance criteria for de novo approval.

Therefore, I cannot generate the table as requested with distinct acceptance criteria and reported performance values.

Here's what can be extracted and inferred based on the provided text for the other requested information:

1. A table of acceptance criteria and the reported device performance:

As explained above, specific numerical acceptance criteria and reported device performance values are not explicitly provided in the submitted text. The basis of the submission is "substantial equivalence" to a predicate device. The general statement is: "Testing was based on the specification cleared for the predicate device and test results showed significant equivalence."

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "functional testing" and "biocompatibility testing" but does not give the number of devices or data points used in these tests.
• Data Provenance: Not explicitly stated. Given the company is "Althin Medical AB" in Sweden, it is reasonable to infer the testing was conducted internally or outsourced within a similar region. The text does not specify if the studies were retrospective or prospective, but functional and biocompatibility testing for a new device are typically prospective.

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

This is not applicable as the evaluation is for a physical medical device (hemodialyzer) based on functional and biocompatibility testing, not on interpretation of data requiring expert radiographic or clinical review.

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

This is not applicable for the same reason as 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:

This is not applicable. This is a submission for a physical medical device (hemodialyzer), not an AI-powered diagnostic or assistive tool for human readers.

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

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

7. The type of ground truth used:

The "ground truth" for the device's performance is established through:

• Functional Testing: Demonstrating the A-22 Hemodialyzer conforms to its specifications and is suitable for its intended use, likely by measuring parameters like ultrafiltration coefficient and clearance. These specifications are "based on the specification cleared for the predicate device."
• Biocompatibility Testing: Performed on the finished sterile device in accordance with ISO10993 to ensure safety when in contact with blood.

8. The sample size for the training set:

This is not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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