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The MAKY 21.1 is indicated for use in automating the in-vitro rinsing, cleaning, testing and disinfection of hollow fiber type hemodialyzers in accordance with the AAMI Recommended Practice for Reuse of Hemodialyzers when such automation is chosen for use by a prescribing physician. It is also indicated for record keeping of these functions.

The MAKY 21.1 Dialyzer Reprocessing System is designed and manufactured to reprocess standard, high efficiency, and high flux hollow-fiber dialyzers. Each type of dialyzer can be processed by one of two pre-programmed cycles, or by a custom cycle configured by HDC Maquinolas, LLC. Custom cycles meet the same minimum requirements as the pre-programmed cycles. The MAKY 21.1 may be configured to utilize one of two approved cleaning agents (peracetic acid, bleach), and one of three approved disinfection agents (peracetic acid, glutaraldehyde, formaldehyde). The MAKY 21.1 will automatically dilute the cleaning and disinfection agents, with the exception of glutaraldehyde, which must be diluted by the user.

The provided text does not contain acceptance criteria or detailed information about a study proving the device meets specific performance metrics in the way typically expected for a medical device efficacy study (e.g., sensitivity, specificity, accuracy, or expert agreement).

Instead, the document is a 510(k) summary and an FDA clearance letter for a medical device (MAKY 21.1 Dialyzer Reprocessing System), focusing on substantial equivalence to predicate devices rather than a de novo clinical performance study.

Here's a breakdown of what can be extracted and what is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., "must achieve 90% cleaning efficiency"). The criteria are implicitly tied to performing "as intended" and being "substantially equivalent" to predicate devices.

• Reported Device Performance:

  • "Each function of the MAKY 21.1 System was tested to see if it performed as intended."
  • "In-vitro testing was also performed to assure the MAKY 21.1 properly diluted the cleaner/disinfectant concentrate to the in-use concentrations of active ingredients."
  • "All materials have been tested for material compatibility with the chemicals used in the system as specified in the labeling."
  • "The results from these tests show that the MAKY 21.1 performed as expected."

  Table (based on available information):

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

• Sample Size: Not specified. The document only references "testing" and "in-vitro testing" without detailing the number of dialyzers, tests performed, or the duration/scope of these tests.
• Data Provenance: Not specified.

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)

• Not applicable. This type of information is typically for studies involving human interpretation or subjective assessments. The testing described is functional and chemical, not involving expert interpretation of results to establish ground truth in the context of diagnostic accuracy.

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

• Not applicable. Adjudication methods are used when multiple human experts interpret data to establish ground truth, which is not the nature of the described testing.

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 device is a reprocessing system, not an AI-assisted diagnostic tool.

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

• Not explicitly stated in these terms. The document describes the system performing its functions ("automating the in-vitro rinsing, cleaning, testing and disinfection"). The "testing" mentioned is likely functional testing of the device's automated processes itself, rather than an "algorithm only" performance evaluation against an external benchmark. The closest concept is the "in-vitro testing" to assure proper dilution, which would be a standalone test of that function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the functional tests seems to be the expected operational parameters of the device (performing as intended, accurate dilution) and adherence to established standards/specifications (e.g., "in-use concentrations of active ingredients," "material compatibility"). For the substantial equivalence claim, the ground truth is the performance and characteristics of the predicate devices.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI that would typically require such a data set.

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

• Not applicable for the same reasons as #8.

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