(15 days)
ATP is intended to measure intra-ocular pressure and comeal thickness of the eye for the purpose of aiding in the diagnosis and monitoring of glaucoma.
Not Found
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "ATP (Auto Non-Contact) Tonometer/Pachymeter)" and an "Indications for Use Form" for a diagnostic ultrasound.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample sizes and data provenance for the test set
- Number and qualifications of experts for ground truth establishment
- Adjudication method
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study
- Results of a standalone performance study
- Type of ground truth used
- Sample size for the training set
- Method for establishing ground truth for the training set
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.