(55 days)
The Amertek Template is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer.
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The provided text is a 510(k) summary for the Amertek™ Brachytherapy Template, a device designed to assist in brachytherapy treatments. It focuses on establishing substantial equivalence to existing predicate devices rather than presenting a performance study with acceptance criteria and results.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove the device meets them. The summary primarily addresses:
- Device identification and classification
- Substantial equivalence claims based on intended use, technological characteristics, and materials compared to predicate devices.
- Indications for Use.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets or how their ground truth was established.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.