(116 days)
Care Orchestrator 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. Care Orchestrator 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. In addition, Care Orchestrator can be used for analysis (automatic and manual scoring), display, retrieval, summarization, and report generation of data received from compatible monitoring devices used to categorize sleep-related events that help aid in the diagnosis of sleep-related disorders. The Home Sleep Testing function of Care Orchestrator is indicated for Adult use only. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.
Care Orchestrator is a cloud-based software platform that allows entities including physicians, other professional home and clinical staff, and durable medical equipment providers in a patient's therapy lifecycle the ability to manage patients and referrals, control access to patient information and therapy data, enhance patient compliance management workflow, and gain efficiencies in the overall patient therapy workflow. Care Orchestrator also provides a method for sleep data acquired from a supported home sleep test (HST) devices to be imported, scored and reviewed by a qualified user. The HST function of Care Orchestrator is for adult use only.
The intent of the Care Orchestrator sleep diagnostic functionality is to provide a capability that allows users to analyze, score, review and generate clinical reports for HST acquisitions (i.e. sleep studies) from within a web browser. Users can upload acquisitions to Care Orchestrator and perform these actions all from within the browserbased Care Orchestrator Client application.
Care Orchestrator software has undergone no significant changes since in K181053. The addition of the Home Sleep Testing features, subject of this submission, add a sub-set of Home Sleep Testing functionality.
The provided document is a 510(k) summary for the "Care Orchestrator with Home Sleep Testing" device. It outlines the device's indications for use, its comparison to a predicate device, and a brief statement about performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria, nor does it provide a table of acceptance criteria with reported device performance.
The document states:
- "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- "Software verification and validation included software code reviews, automated testing, bench verification testing and labeling review."
This indicates that general software V&V activities were performed, but the specific details requested in your prompt (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, etc.) are not included in this summary.
Therefore, many of your questions cannot be answered from the provided text.
Here's a breakdown of what can be inferred or directly stated, and what information is missing:
1. A table of acceptance criteria and the reported device performance
- Missing from the document. The document states that software verification and validation testing was done, but it does not provide a table of specific acceptance criteria or quantitative performance metrics for those criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing from the document. The summary mentions "bench verification testing" but does not detail the sample size of the test set, the nature of the data (e.g., patient data, synthetic data), its origin, or whether it was retrospective or prospective.
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)
- Missing from the document. The document does not specify if experts were used to establish ground truth for a test set, nor their number or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing from the document. There is no information provided regarding any adjudication methods for a test set.
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
- Missing from the document. The document does not mention any MRMC comparative effectiveness studies. The device's function involves automatic and manual scoring to aid in the diagnosis of sleep-related disorders, but how it impacts human reader performance through such studies is not discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Partially addressed. The device performs "analysis (automatic and manual scoring)". The "automatic scoring" component implies standalone algorithmic functionality. However, the document does not provide specific performance metrics for this standalone component.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Missing from the document. The type of ground truth used for any validation of the automatic scoring algorithm is not specified.
8. The sample size for the training set
- Missing from the document. This document focuses on the regulatory submission and does not disclose details about the training set size for any machine learning components.
9. How the ground truth for the training set was established
- Missing from the document. Similar to the test set, the method for establishing ground truth for any potential training set is not provided.
§ 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).