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The Puritan Bennett DataFlow™ Data Management Software is intended to augment the Puritan Bennett PB-700 Renaissance® II Spirometer System and the Nellcor Puritan Bennett NPB-500 Simplicity™ Spirometer System's data management capability.

Puritan Bennett DataFlow™ Data Management Software is a software program used in conjunction with the Puritan Bennett PB-700 Renaissance® II Spirometer System and the Nellcor Puritan Bennett NPB-500 Simplicity™ Spirometer System to transfer patient test data from the spirometer to an IBM compatible Personal Computer. Once transferred, the DataFlow software allows the operator to perform any or all of the following: edit or add patient demographic information, archive the test, search for and retrieve archived test(s), print test reports, compare archived tests, and export test data for use by other application software.

The Puritan Bennett DataFlow™ Data Management Software is a data management program for spirometers. The provided text outlines its intended use and summarizes how the manufacturer demonstrated substantial equivalence to a predicate device. However, it does not contain detailed information regarding specific acceptance criteria or a comprehensive study report with quantitative performance metrics.

Based on the provided text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on verifying that the software performs as intended according to its specifications and that its technological characteristics are the same as the predicate device. It does not provide a table of specific acceptance criteria (e.g., "data transfer accuracy > 99%") or quantitative performance metrics for the device itself.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "The performance of the DataFlow software program was comprehensively tested," but it does not specify a sample size for any test set or provide details about data provenance (e.g., country of origin, retrospective/prospective). This likely indicates that the testing was function-based verification and validation rather than a clinical study with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document describes software verification and validation, not a study involving human experts to establish ground truth for a test set. Therefore, this information is not applicable and not provided.

4. Adjudication Method:

Given that the testing described is software verification and validation, an adjudication method in the context of expert review for a test set is not applicable and not provided.

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

An MRMC study is relevant for diagnostic devices that involve human interpretation. This device is data management software. Therefore, an MRMC comparative effectiveness study is not applicable and not mentioned.

6. Standalone Performance:

The software is described as a "PC-based standalone software program." The testing mentioned ("The performance of the DataFlow software program was comprehensively tested") refers to its standalone functional performance in conjunction with the spirometers. However, it's not a "standalone" in the sense of an AI algorithm performing a diagnostic task without human input; it's a data management tool. The document does not provide quantitative standalone performance metrics for specific tasks (e.g., "data transfer success rate").

7. Type of Ground Truth Used:

The ground truth for this type of software (data management) would be its adherence to its own specifications and correct execution of its defined functions. It would not typically involve pathology, outcomes data, or expert consensus in the way a diagnostic AI algorithm would. The document implies that the ground truth was the functional specifications and the correct operation of the software.

8. Sample Size for the Training Set:

This software is not an AI/ML algorithm that requires a training set in the conventional sense. It's a data management program. Therefore, information about a "training set" sample size is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established:

As there is no training set for this type of software, this information is not applicable and not provided.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through functional verification and validation, confirming that the data management software performs as intended according to its specifications and is technologically similar to a predicate device. It does not contain the detailed quantitative performance metrics or study designs typically associated with clinical studies for diagnostic devices or AI algorithms.

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