(141 days)
Sapphire is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Sapphire provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. Sapphire allows read-only access to patients. Sapphire is intended to be used in hospital, institutional, provider, and home care settings.
Sapphire is a web application that is used to manage patients utilizing compatible sleep and respiratory devices, view therapy data, generate reports and update device settings for applicable therapy devices. Sapphire is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in hospital, institutional, provider and home settings. Device data is transferred either wirelessly or from an SD card to a centralized database. A user can view this data through a web based application on their computer.
The provided document, a 510(k) summary for the Sapphire device, offers limited details regarding specific acceptance criteria and detailed study results. Based on the available information, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance metrics. Instead, it broadly states that "The testing of Sapphire verified that all product requirements have been met with passing test results." The description of "product requirements" is general and includes:
- Displaying patient and device information.
- Displaying therapy data, including compliance and therapy reports.
- Allowing a user to create and/or edit a patient's prescription for applicable therapy devices.
- Verification of cybersecurity requirements (encryption of data at rest and in transit).
The "reported device performance" is a high-level statement that these requirements were met. No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) are provided.
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 explicitly state the sample size used for the test set or the data provenance. It mentions "complete system testing to verify data transfer from therapy devices to Sapphire, through both wireless data transfer." This implies patient data was used, but the quantity, origin, or retrospective/prospective nature of that data is 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)
This information is not provided. The testing described appears to be software verification and validation, not a study involving expert-adjudicated ground truth data for diagnostic performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No adjudication method is mentioned, as the nature of the testing described does not involve expert adjudication of diagnostic outcomes.
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 done. The Sapphire device is a data management system, not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data from that perspective.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The testing performed was standalone in the sense that it verified the software's ability to correctly process and display data, and manage settings, without explicitly assessing human interaction improvements. However, it's a data management system, so its "standalone performance" refers to its functional correctness in handling data and settings as intended, not diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail how "ground truth" was established for the data processed by Sapphire. Given the functionality (data transfer, display, report generation, setting adjustment), the "ground truth" would likely refer to the accuracy of the transferred data matching the source device data and the correct application of prescribed settings. This would be established through comparison with the original therapy device data and verification of setting changes.
8. The sample size for the training set
The document does not mention a training set, as Sapphire is a data management system and not explicitly described as having a machine learning component that would require a distinct training set (in the typical AI/ML sense).
9. How the ground truth for the training set was established
Not applicable, as a training set is not mentioned.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).