(15 days)
The Tablet Commander device is for use by patients to collect and transmit general health information, physiological measurements and other data between themselves and a caregiver.
The Tablet Commander makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. The Tablet Commander is not intended as a substitute for medical care.
The Tablet Commander is a software application. Once installed on a commercially-available device, the Tablet Commander software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted back to a database for review by a caregiver. The Tablet Commander software has a user interface which allows the patient and caregiver to communicate using methods which include questions and answers.
The provided text describes a 510(k) premarket notification for the "Tablet Commander" device, a software application for remote patient monitoring. The application focuses on functional and safety analysis rather than diagnostic accuracy. As such, acceptance criteria and performance metrics related to diagnostic accuracy (like sensitivity, specificity, or AUC) are not applicable or provided in this document.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar diagnostic measures. Instead, the acceptance is based on the device functioning according to its requirements and specifications, and demonstrating substantial equivalence to predicate devices in terms of intended use, technology, materials, and principles of operation, without introducing new hazards.
The key performance criterion is that the device "functioned according to its requirements and specifications." The validation activities supporting this are described as:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Device functions according to its requirements and specifications | Risk-based verification and validation testing completed. |
| Adherence to software development standards | Voluntary standard IEC 62304 used as a model for software development. |
| Substantial equivalence to predicate devices | Basic design principle (application on commercial tablet) is identical to tablet-based predicates. Data structuring and network communication design principles are identical to predicate Commander III. No new hazards to safety or effectiveness presented. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention a specific "test set" in the context of clinical data or diagnostic performance. The validation appears to be primarily focused on software functionality and engineering verification and validation (V&V) activities. Therefore, details about the sample size for a test set, data provenance, or whether it was retrospective or prospective are not provided.
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)
Since there is no mention of a "test set" requiring ground truth establishment through expert review for diagnostic purposes, this information is not applicable and not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similarly, as there is no diagnostic "test set" needing ground truth establishment, no adjudication method is described.
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
No MRMC comparative effectiveness study was conducted or is mentioned, as the device is a remote patient monitoring system and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Tablet Commander is described as a "software application" that collects and transmits data for review by a caregiver. It explicitly states, "The Tablet Commander makes no diagnosis," and "Clinical judgment and experience are required to check and interpret the information transmitted." This indicates that the device is not intended for standalone diagnostic performance; it functions as a data collection and transmission tool within a human-in-the-loop system. Therefore, a standalone algorithm-only performance study (in a diagnostic sense) was not done, and would not be relevant to its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the software validation, the "ground truth" implicitly refers to the device's functional requirements and specifications. The V&V testing confirms that the software behaves as designed and meets these predefined requirements, rather than validating against clinical ground truth like pathology or expert consensus on a diagnosis.
8. The sample size for the training set
The document does not describe the use of machine learning or AI models that would require a "training set" for diagnostic algorithm development. The device is a software application for data management and communication.
9. How the ground truth for the training set was established
As there is no mention of a training set for machine learning, this information is not applicable and not provided.
Summary of the study and its purpose:
The study described is not a performance study in the typical sense of evaluating diagnostic accuracy using clinical data. Instead, it is a verification and validation (V&V) study of a software application for remote patient monitoring, conducted as part of a 510(k) premarket notification. The purpose was to demonstrate that the "Tablet Commander" software functions according to its requirements and specifications and that it is substantially equivalent to legally marketed predicate devices without raising new questions of safety or effectiveness.
The key study type conducted was risk-based verification and validation testing of the software, following FDA guidances ("Guidance for the Content of Premarket Submissions for software Contained in Medical Devices" and "General Principles of Software Validation") and using IEC 62304 as a model for software development. This type of study focuses on ensuring the software is correctly built (verification) and that it meets specified user needs (validation) within its intended technical scope, rather than clinical efficacy or diagnostic performance. No clinical tests were conducted because the device was considered to present no new hazards to safety or effectiveness compared to predicate devices.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).