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AVETA SYSTEM 2.0: USING BIPOLAR RF DEVICE:
-Hysteroscopy:
Aveta System 2.0 for Hysteroscopy: The Aveta System 2.0 is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect, remove and coagulate tissue such as submucous myomas, endometrial polyps, adhesions and retained products of conception using a bipolar resecting device.
USING MECHANICAL RESECTING DEVICES:
-Hysteroscopy:
The Aveta System 2.0 is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.
-Cystoscopy:
The Aveta System 2.0 is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the system allows the user to perform various diagnostic and therapeutic procedures.
AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral):
The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
AVETA DISPOSABLE CYSTOSCOPE (Coral):
The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to perform various diagnostic and therapeutic procedures.

The Aveta System 2.0 is an integrated system which allows for visualization of the intended cavity for the purpose of performing diagnostic and operative procedures (hysteroscopy and cystoscopy). The Aveta System consists of the components listed in Table 1. The system includes a Controller 2.0 with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the cavity. Controller 2.0 provides continuous monitoring of the cavity pressure to the set pressure. For hysteroscopy, it also monitors the volume differential between saline inflow and outflow from the uterus (fluid deficit). Controller 2.0 connects to a sterile, single use disposable Scope (available in various configurations, see below) that allows visualization of the cavity and displays the images obtained from the Scope on a standard monitor. The Controller 2.0 provides bipolar Radiofrequency (RF) energy to deliver to the Aveta Glo Disposable RF Device for CUT and COAG functions. For operative hysteroscopy procedures, the Aveta System also includes sterile, mechanical Disposable Resecting Device (available in various configurations, see below) powered by an integrated motor in the device handset. The resecting device (RF or mechanical) is inserted through the working channel of the sterile hysteroscope to resect the target tissue/pathology. For cystoscopy, when combined with accessory instruments the cystoscope is used for diagnostic and therapeutic procedures.

The provided text is a 510(k) summary for the Meditrina, Inc. Aveta System 2.0. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, the document does not contain the specific acceptance criteria or the study details proving the device meets those criteria, especially not in the format of a table of reported device performance.

The "Performance Data" section (VII) lists various tests performed (e.g., Software Verification and Validation, Functional Testing, Biocompatibility, Sterilization Validation, Electrical Safety & EMC). It briefly mentions "Simulated Use: Tissue resection, regulation of cavity pressure, imaging, CUT, COAG" and "Comparative Testing." This implies that some performance evaluation was done through bench testing, but no quantitative acceptance criteria or detailed results are provided in this summary.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the specific details requested in points 1-9, as this information is not present in the provided document.

To answer your request, I would need a different document that details the specific performance studies, including:

1. A table of acceptance criteria and reported device performance values.
2. Sample sizes used for testing.
3. Qualifications and number of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC study details and effect sizes (if applicable).
6. Standalone performance data (if applicable).
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

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