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The DPILog is intended for use by a single patient under the care or treatment of a physician or licensed healthcare professional. The DPILog is prescribed by the doctor when detailed Dry Powder Inhaler (DPI) usage monitoring is indicated. The DPILog can be used by any patient who regularly uses DPIs as prescribed by a physician.

The DPILog DPC-512 is comprised of a reusable electronics module and a disposable battery sleeve that snaps together around an already cleared/marketed dry power inhaler. The device utilizes previously cleared/marketed accessories, i.e., an infrared docking station to communicate the collected data to a computer via an interface cable and software. The DPILog System has direct application to physicians involved in clinical trial disease management and training patients in proper use of DPIs. The objective data collected by the DPILog allows researchers improved quality of information in clinical trials and increased precision of statistical analysis.

The provided document (K062811) for the DPILog DPC-512 is a 510(k) premarket notification with a summary of its safety and effectiveness. This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed studies with specific acceptance criteria and performance metrics for a novel technology. Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not typically found in a 510(k) summary for a device like this, which is an accessory to a medical device and relies on showing equivalence.

The DPILog DPC-512 is described as a device that "utilizes previously cleared/marketed accessories" and its "proposed device is equivalent to the identified predicate devices with respect to technological characteristics and function." This indicates that the regulatory pathway relies on demonstrating that the new device is functionally the same as existing, cleared devices, rather than proving new performance claims through extensive clinical studies.

However, I can extract information related to the device description, intended use, and equivalence claims.

Here's a breakdown of the available information in response to your request, with an emphasis on what is not provided due to the nature of the submission:

Acceptance Criteria and Study for DPILog DPC-512 (K062811)

The provided document (K062811) describes the DPILog DPC-512 as an accessory to metered dose inhalers (MDI), emphasizing its equivalence to predicate devices rather than presenting novel performance studies with specific acceptance criteria and reported performance metrics. The submission focuses on demonstrating substantial equivalence in technological characteristics and function to already cleared devices. Therefore, direct "acceptance criteria" for novel device performance and detailed "reported device performance" in a quantitative table are not provided in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for an accessory device based on substantial equivalence, explicit quantitative acceptance criteria and reported device performance in the manner of a clinical study for a novel diagnostic algorithm are not present in the provided text. The "acceptance criteria" here are implicitly related to meeting the general safety and effectiveness standards by demonstrating equivalence to predicate devices. The "reported device performance" is essentially that it functions equivalently to the predicate devices.

The submission states: "The proposed device is equivalent to the identified predicate devices with respect to technological characteristics and function." This statement serves as the primary "performance claim" and the basis for regulatory acceptance.

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

This information is not provided in the 510(k) summary. Given that the device is an accessory that monitors DPI usage and relies on existing technologies, a "test set" in the context of an AI or diagnostic algorithm study is not applicable here. The submission does not detail any specific data collection for performance validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. Establishing ground truth by experts is typically relevant for diagnostic or AI-driven devices. The DPILog DPC-512 is a usage monitoring device, not a diagnostic one.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary, as there is no described test set or adjudication process for diagnostic performance.

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

A MRMC comparative effectiveness study was not performed, or at least not described in this 510(k) summary. MRMC studies are relevant for diagnostic devices that involve human interpretation, often with AI assistance. The DPILog DPC-512 is a data collection and monitoring device.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for an algorithm was not performed, or at least not described in this 510(k) summary. The device's primary function is described as collecting data from Dry Powder Inhalers. While it uses "electronics module" and "software" to communicate data, it is not presented as an AI-driven or diagnostic algorithm in the sense requested.

7. Type of Ground Truth Used

This information is not applicable/not provided in the context of this device being an accessory for usage monitoring, rather than a diagnostic tool requiring ground truth for accuracy validation. The "ground truth" for this device would likely relate to the accurate recording of inhaler activations, which is implicitly covered by demonstrating technological equivalence to predicate devices.

8. Sample Size for the Training Set

This information is not applicable/not provided. The device is not described as involving machine learning or a training set in the context of an algorithm.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/not provided, as there is no described training set or ground truth establishment process.

In summary, the K062811 document for the DPILog DPC-512 is a 510(k) premarket notification demonstrating substantial equivalence to existing predicate devices. It is an accessory designed for monitoring the usage of Dry Powder Inhalers. As such, it does not contain the detailed performance studies, acceptance criteria, test/training set information, expert involvement, or ground truth establishment typically found for novel diagnostic algorithms or AI-powered devices. The "study" proving it meets acceptance criteria is the demonstration that its technological characteristics and function are equivalent to those of the predicate devices.

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