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The PM-60 handheld Pulse Oximeter is intended for continuous monitoring, spotchecking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, pediatric and neonatal patients in hospitals, out-of-hospital transport and home care.

The PM-60 Pulse Oximeter is a handheld device that measures parameters of functional pulse oxygen saturation (SpO2) and pulse rate (PR). It suits for adult, pediatric and neonatal patients. The SpO2 measurement of PM-60 is based on the absorption of pulse blood oxygen to red and infrared light by means of sensor and SpO2 measuring unit. The light-electronic transducer in sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The pleth curve and numeral value of SpO2 will be obtained. PM-60 can be used in spot-check mode and continuous monitoring mode, which is selectable. It can be powered by alkaline batteries or Li-ion battery, and the latter is rechargeable with a charger stand. Through a color TFT display, users can view the data and operate the device. The audible and visual alarms are also adjustable. During SpO2 measuring, operators can export the data in real-time through the infrared port, and export trend data through the multi-functional connector. After exporting, operators can review and printing the data with the PC data management system (PMS) software.

The provided text does not contain information about specific acceptance criteria related to numerical performance metrics (e.g., accuracy, sensitivity, specificity) for the PM-60 Pulse Oximeter, nor does it detail a study that evaluated such criteria.

The 510(k) summary states for "Testing":
"Laboratory testing was conducted to validate and verify that the PM-60 Pulse Oximeter met all design specifications, including EMC, electrical, mechanical durability, safety, temperature/humidity, and etc. Results of these tests demonstrate compliance to the requirements of all applied standards."

This indicates that testing was performed against design specifications and applied standards, but it does not provide the specific quantitative acceptance criteria or the reported device performance against those criteria as would typically be presented for clinical performance or AI algorithm validation.

Therefore, I cannot populate the requested information in the table or answer questions 2 through 9 based on the provided text. The document focuses on regulatory compliance, substantial equivalence to predicate devices, and general safety/effectiveness, rather than detailed clinical performance metrics from a specific study.

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