(119 days)
The N9+ (OTC) device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.
N9+ (OTC) device is intended for use by adult lay users in a non-clinical environment. Nonagon application enables counseling with the physician and transmission of the information over an IP network.
The oxygen saturation (SpO2) sensor of the device is for Rx only.
The N9+ (OTC) (except for the oxygen saturation function), is a home use device. The device is comprised of a handheld unit that interfaces with a smartphone, a wireless otoscope kit comprised of the otoscope camera, a reusable tongue depressor and 2 reusable ear specula (adult and toddlers) and a dedicated smartphone software application that runs on the user's personal smartphone.
The system uses the smartphone's camera to record images of the patient's skin.
An API is defined to enable healthcare providers to communicate with the device. The pulse oximeter will be a prescription device in the US market.
The Device enables user's examination at home with or without the quidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit and wireless otoscope functionality (besides recording images of the patient's skin) and processes and displays the collected data.
The provided text describes the regulatory clearance of the N9+ (OTC) device and details some performance data, but it does not contain the specific information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding the acceptance criteria and the study that proves the device meets those criteria for the AI/algorithm component.
The document discusses general performance data related to biocompatibility, software validation, electrical safety, EMC, wireless quality of service, and self-selection testing. It does not provide performance metrics (like accuracy, sensitivity, specificity, AUC) for the device's functional capabilities (e.g., measuring auscultation sounds, temperature, SpO2, or image analysis).
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria for device performance as an AI/algorithm.
The document does mention software validation was conducted and the software level of concern is moderate, but it does not specify the performance metrics or studies directly related to the accuracy or effectiveness of the data collection or image acquisition beyond general compliance.
Information provided in the document that somewhat relates to the request:
- Software Validation: "Software verification and validation testing were 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". The N9+ (OTC) software level of concern is moderate." (This confirms software validation was done, but gives no specifics on acceptance criteria or performance metrics).
- Self-Selection Testing: "The study enrolled 31 men and women of different ages and literacy levels. All the participants made a correct purchasing decision. The results of this self-selection study show that consumers are able to decide whether the N9+ (OTC) is right for them based on the information communicated on the outer package (box)." (This is about user understanding of the product, not the device's functional performance.)
The document does NOT include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance for an AI/algorithm.
- Number of experts used to establish ground truth or their qualifications for an AI/algorithm.
- Adjudication method for the test set for an AI/algorithm.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human reader improvement with AI.
- Standalone performance of an algorithm.
- Type of ground truth used for an AI/algorithm.
- Sample size for the training set for an AI/algorithm.
- How the ground truth for the training set was established for an AI/algorithm.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.