(165 days)
The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from pediatric patients (aged 3 years and above) in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
The AeviceMD is designed as an electronic stethoscope to acquire and record lung sounds from users for healthcare professionals (HCP) to playback and interpret the sounds recorded. AeviceMD does not contain any alarm feature and it is not intended for emergency use. It is also not a sleep apnea device. The device is not intended for self-diagnosis.
The AeviceMD consists of hardware and embedded software. It is a five-part system that includes the following components:
- AeviceMD Sensor – an embedded electronic wearable device that detects and records lung sounds and transmits data to an electronic gateway via Bluetooth.
- AeviceMD Silicone Patch – silicone patch that houses and attaches the Sensor to the user's body (i.e., chest). This silicone patch undergoes biocompatibility testings which allow AeviceMD Sensor to be worn on the skin.
- AeviceMD Docking Station – gateway device that serves as a computational hub and linkage from the Sensor to the Cloud Platform, and as a charger for the Sensor.
- AeviceMD App (for patients) / AeviceMD HCP Web App (for healthcare professionals) - The AeviceMD App is a mobile app that downloads the post-processed information from the Cloud Platform and presents users with their recorded lung sounds at the auscultation locations which they can share with their HCP during their next consultation. A separate app, AeviceMD HCP Web App is tailored for HCP to review their patient's data in a clinical setting.
- AeviceMD Cloud Platform – secure cloud server that receives data from gateway units and analyzes user's data using meaningful output information.
I'm sorry, but the provided FDA 510(k) Clearance Letter for AeviceMD (K243603) does not contain the detailed information necessary to fully answer your request.
Specifically, the document does not include any acceptance criteria or a study demonstrating that the device meets such criteria. It primarily focuses on:
- Substantial Equivalence: Comparing the AeviceMD to a predicate device (AeviceMD K223382) and a reference device (Eko CORE K200776) to establish similar intended use and technological characteristics.
- Non-Clinical Performance Data: Listing the standards and additional testing performed (e.g., biocompatibility, electrical safety, usability, shipping validation, cleaning validation, frequency response test, stethoscope performance test). However, it does not provide the results of these tests or specific performance metrics that could be construed as acceptance criteria.
- Indications for Use: Defining what the device is intended for.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: While a "Stethoscope Performance Test against a 510(k) cleared reference stethoscope" is mentioned, no details about the sample size, data provenance, or the results are provided. The statement "The reference device was used to demonstrate effective performance in a pediatric population aged 3 years and above" suggests a study was done, but no details are given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. The device is for recording and analysis by a clinician, but no study on AI assistance is detailed.
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device as recording sounds for later "playback, review, and analysis by a clinician," implying human-in-the-loop. However, it also mentions the "AeviceMD Cloud Platform" analyzes user data using "meaningful output information," which could hint at an algorithm, but no standalone performance data for such an algorithm is provided.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document from the FDA clearance process primarily focuses on demonstrating substantial equivalence through comparison with existing devices and compliance with safety and performance standards, rather than detailing a specific clinical performance study with acceptance criteria and results.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).