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Ossler Exam Scope, Model OS 100 is indicated to detect and amplify heart, lung, and other body sounds as well as to measure body temperature for infants and adults for diagnostic or monitoring purposes on a patient where by the patient will benefit by uploading these data for diagnostic consultation. This does shall not be prescribed for "active patient monitoring".

The Ossler Exam Scope , Model OS100 is prescribed by a physician to be used by an operator to conduct a limited, examination session to upload heart sounds, temperature, calibrated images of the skin, tonsils, ears, and upload this data to a remote expert for diagnosis. This device is designed to deliver, to a health care provider, the physiological sensory date collected from a remote location. The healthcare provider then makes a diagnostic decision using this data. When the health care provider deems that collection of data provides benefits to the patient and health care provider.

The Ossler Exam Scope "" provides a facility where the patient is remote from health care provider and key physiological inputs are required. Usually a health care provider is placed in the difficult position of making a decision with poor descriptions and little or no real information. With the rise of cell phones, many APPs are created to attempt to develop physiological data. The Ossler Exam Scope , Model OS100 is completely different. At the heart of this device is the founder's goal to conduct an exam at the point of care and measure physiological conditions to develop reliable, sophisticated inputs that can be delivered remotely to a qualified expert for diagnosis.

This device does not affect how physicians "practice medicine". As a prescription device, the physician still conducts an exam and then reaches a diagnostic decision. The only sigmificant change is to the BENEFIT of the patient, it reduces the obstacles necessary for the patient to the physician.

The Ossler Exam Scope, Model OS100 features a stethoscope, camera, thermometer and Otoscope. Contained within a comfortable, durable case, it features a display screen where the user can view the menu and make selections to complete an exam session. Upon completion the device can connect and upload data via WiFi for expert diagnosis. The Exam Scope uses reliable commercial quality embedded microprocessors with a rechargeable battery. The driving firmware is of course custom designed to meet the challenges of this sophisticated diagnostic device.

The Ossler Exam Scope, Model OS100 is not an AI-powered device, but rather a multi-functional medical device combining a stethoscope, camera, and thermometer, designed to capture and transmit physiological data for remote expert diagnosis. There is no mention of AI or machine learning algorithms driving any of its diagnostic or analytical functions.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them specifically for an AI-driven component cannot be extracted from the provided text, as this information is not applicable to the described device. The document focuses on performance testing related to its physical functions (stethoscope, thermometer), usability, and compliance with medical device standards, rather than AI model performance metrics.

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