(295 days)
iCodeConnect, in conjunction with a Luna CPAP or Auto-CPAP device, is intended for use in treating obstructive sleep apnea (OSA) on adult patients (>30 kg).
iCodeConnect is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted from the patient's Luna CPAP or Auto-CPAP therapy device located in the home to the clinician or healthcare professional. iCodeConnect also provides remote settings capabilities.
iCodeConnect is a web based patient management system used to store and manage sleep compliance and efficacy data uploaded from a Luna CPAP or Auto-CPAP device.
iCodeConnect allows device patient data to be uploaded using a variety of methods, including manual entry, SD Card, and wireless transmission. Use of wireless transmission (i.e. WiFi) can provide wireless compliance monitoring and remote settings update functions.
For wireless transmission, iCodeConnect consists of the wireless data transmission module Wi-Fi kit and web based iCodeConnect patient management software. The Wi-Fi Kit is intended to be used in conjunction with the Luna CPAP System (E-20C-H-O), Auto-CPAP System (E-20A-H-O / E-20AJ-H-O), which were cleared in K141770.
- iCodeConnect Software is an analysis and management platform for the patient's therapy data. This platform, adopting the form of a website, not only realizes the uniform management of the patient's data and the information of the provider, the doctor and the patient, but also allows for the Wi-Fi Kit or other wireless communication module to transmit data and remotely updating therapy device settings, which reduces the inconvenience brought by the traditional mailing of SD card and makes data collection more timely.
Wi-Fi Kit is an accessory module that attaches via USB cable to the data output port of a Luna® CPAP or Auto-CPAP devices. The wireless module Wi-Fi Kit uploads the device's therapy data to the iCodeConnect software with the help of Wi-Fi off-the-shelf technology. After connecting to the internet. the wireless kit shall automatically collect the user information, statistical information and detailed information in the therapy device for uploading.
The provided text describes the iCodeConnect device and compares it to a predicate device, EasyCare Online, to establish substantial equivalence. However, it explicitly states that clinical testing was NOT required to demonstrate the safety and effectiveness of iCodeConnect. Therefore, the document does not contain information about acceptance criteria for device performance based on a clinical study, nor does it detail a study proving the device meets such criteria.
The document focuses on non-clinical testing for functional verification and device performance, and software verification to demonstrate substantial equivalence to the predicate device.
Here's a breakdown of the information available based on your request, with an emphasis on what is not present:
1. A table of acceptance criteria and the reported device performance
- No specific acceptance criteria for a clinical study are provided. The table in the "Substantial Equivalence" section (pages 8-9) compares features and functions of the proposed device (iCodeConnect) with the predicate device (EasyCare Online). This table demonstrates equivalence in various aspects, but these are generally functional and technical specifications, not clinical performance metrics with acceptance criteria.
- Reported device performance (clinical): Not applicable, as clinical testing was not performed/required.
- Reported device performance (non-clinical/functional): The document states that "Non-clinical testing of the iCodeConnect has been carried out to cover functional verification and device performance. The proposed iCodeConnect has been tested to appropriate standards and other applicable requirements." (page 6). It further concludes that "Hardware testing carried out for iCodeConnect indicates it meets design and performance functional requirements. Software verification demonstrates that device features and the system configuration functions are substantially equivalent to the predicate device." (page 11). No specific quantitative performance metrics from these tests are reported in the summary provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as clinical testing was not conducted. Sample sizes for non-clinical functional testing are 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)
- Not applicable as clinical testing was not conducted, and thus there was no "test set" requiring expert-established ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as clinical testing was not conducted.
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
- Not applicable. The iCodeConnect device is a patient management system for CPAP/Auto-CPAP data and remote settings, not an AI-assisted diagnostic tool that would typically involve an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a patient management system and wireless data transmission module. Its "standalone" performance would likely refer to its functional accuracy in data transfer, storage, display, and remote setting capabilities. The document indicates these aspects were verified through non-clinical testing and software verification, concluding they meet design and performance requirements and are substantially equivalent to the predicate (pages 6, 11). However, specific metrics for this "standalone" performance are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Given the absence of clinical testing, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. For functional testing, the "ground truth" would likely be defined by the expected behavior and output based on design specifications and engineering standards.
8. The sample size for the training set
- Not applicable. The iCodeConnect is described as a web-based patient management system and a wireless data transmission module. There is no indication it uses machine learning or AI that would require a "training set" in the context of typical clinical algorithm development.
9. How the ground truth for the training set was established
- Not applicable for the reasons mentioned in point 8.
§ 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).