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AVETA SYSTEM:
Hysteroscopy:
The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor 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 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 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 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. The Controller provides continuous monitoring of the cavity pressure to the set pressure. For hysteroscopy, it also monitors the volume differential between saline inflow from the uterus (fluid deficit). The Controller 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. For operative hysteroscopy procedures, the Aveta System includes sterile, mechanical Disposable Resecting Device (available in various configurations, see below) powered by an integrated motor in the device handset or by use of an external Resecting Handset (available in two configurations, as a disposable device or a reusable device). The resecting device 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 document is a 510(k) Premarket Notification for the Meditrina Aveta System. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch in the same way a PMA (Premarket Approval) would. As such, the information provided focuses on comparative performance and engineering tests, rather than clinical efficacy studies with specific acceptance criteria related to disease detection or treatment outcomes.

Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 as it pertains to acceptance criteria for algorithmic performance, sample sizes for test sets, expert-established ground truth, MRMC studies, or multi-reader studies. The "performance data" section (Section VII) lists various engineering and bench tests, but these are not for the purpose of demonstrating diagnostic or clinical performance in a "study" as implied by the request.

The "study that proves the device meets the acceptance criteria" in this context refers to the bench and engineering tests conducted to demonstrate that the modified Aveta System performs equivalently to its predicate and meets safety standards.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria and reported device performance in the sense of accuracy metrics (e.g., sensitivity, specificity) for a diagnostic AI/ML device. The "performance data" section lists types of tests performed (e.g., "Pressure accuracy and control," "Optical testing," "Motor/Oscillation speed"), but it does not specify the numerical acceptance criteria for these tests nor the exact quantitative results achieved by the device against those criteria. It only states that the tests were performed "per approved test protocols."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information about sample sizes for a clinical "test set" or data provenance (country, retrospective/prospective) is provided. The performance data listed (Section VII) refers to engineering and bench tests on the device's components and system function (e.g., integrity, dimensional inspection, functional testing). These are not data sets for an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided. The study is a 510(k) submission, focused on engineering and functional equivalence rather than clinical diagnostic performance that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/not provided. No clinical test set requiring adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study or any study involving human readers with or without AI assistance is mentioned. The device described appears to be an endoscopic system, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/not provided. The device is a physical system for visualization and surgical procedures, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable/not provided. The "ground truth" in this context would be the design specifications and functional requirements met by the engineering tests, not a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set:
Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable/not provided. This device is not an AI/ML algorithm that requires a training set with established ground truth.

In summary, the provided document details a 510(k) submission for a medical device (Aveta System, a hysteroscope/cystoscope system). It focuses on demonstrating substantial equivalence to a predicate device through engineering and bench testing, rather than reporting on the performance of an AI/ML model for diagnostic purposes as implied by the structure of your questions.

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The Aveta Disposable Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Aveta Disposable Hysteroscope is used by physicians in an office or operating room setting. The subject device includes the Aveta Disposable Hysteroscope and Aveta Controller. Like the Aveta Disposable Hysteroscope cleared under K190372, the modified Aveta Disposable Hysteroscope includes a camera and LED light. The Aveta Disposable Hysteroscope is connected to the Aveta Controller to provide the camera and light functions and to process and store the image obtained from the Aveta Disposable Hysteroscope.

For fluid management, the Aveta Disposable Hysteroscope can be used with gravity fed pressurized saline bag or the fluid management system cleared under K190372. For therapeutic procedures, the Aveta Disposable Hysteroscope is used with the cleared Aveta Disposable Resecting Device (K190372). The only functional buttons on the Aveta Disposable Hysteroscope handle are the image capture and the image transfer buttons. For the modified device, when other buttons on the handle are pressed, the Aveta Controller does not take any action.

Other than minor change to the Aveta Controller software to disable fluid management related buttons on the Aveta Disposable Hysteroscope, there is no change to the components of the cleared Aveta System (K190372).

This document is a 510(k) premarket notification for the "Aveta Disposable Hysteroscope" (K192100). The request is a submission to demonstrate substantial equivalence to a legally marketed predicate device (Aveta System, K190372). The provided text describes the device, its intended use, and a comparison to the predicate device. It also briefly mentions non-clinical performance testing.

However, the document does not contain information about acceptance criteria, clinical study design, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or whether MRMC or standalone performance studies were conducted.

Therefore, I cannot fulfill your request for details on the acceptance criteria and the study that proves the device meets those criteria using only the provided text for the Aveta Disposable Hysteroscope (K192100).

The provided text focuses on demonstrating substantial equivalence through non-clinical performance testing and a comparison of technological characteristics and indications for use to a predicate device. This type of submission (510(k)) typically relies on comparisons to demonstrate safety and efficacy, rather than extensive new clinical studies with detailed acceptance criteria as one might see for a PMA or novel AI/ML device where clinical performance is the primary assessment.

Based on the provided document, the only "study" mentioned is "Non-Clinical Performance Testing," which includes:

• Software verification
• Simulated Use with gravity fed pressurized saline bag: This involved demonstrating regulation of cavity pressure in a model uterine system, flow rate tests, and tissue resection.

Here's what I can extract and what is explicitly missing based on your request categories:

1. A table of acceptance criteria and the reported device performance

• Missing from the document. The document only states that "Results demonstrate the subject device met specifications" for the simulated use testing, but it does not list those specifications or acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing from the document. The non-clinical testing appears to be primarily benchtop and simulated use; therefore, there isn't a "test set" in the context of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Missing from the document. This is a non-clinical evaluation, so expert adjudication of patient data for ground truth is not applicable here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Missing from the document. Not applicable for this type of non-clinical submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Missing from the document. This device is a hysteroscope, not an AI/ML diagnostic tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Missing from the document. Not applicable, as this is a medical device, not an AI algorithm. Its performance is evaluated in conjunction with human use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Missing from the document. For non-clinical testing, "ground truth" would typically refer to established engineering and performance specifications validated through physical measurements and simulations, rather than clinical ground truth from patients. The document does not specify these.

8. The sample size for the training set

• Missing from the document. Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

• Missing from the document. Not applicable.

Summary of available information related to performance:

• Device Name: Aveta Disposable Hysteroscope (K192100)
• Predicate Device: Aveta System (K190372)
• Type of Evaluation: Non-Clinical Performance Testing to demonstrate substantial equivalence to a predicate device.
• Tests Performed:
  • Software verification
  • Simulated Use with gravity-fed pressurized saline bag (demonstrated: regulation of cavity pressure in a model uterine system, flow rate tests, tissue resection).
• Conclusion: "The results of the non-clinical testing described above demonstrate that the subject device is as safe and effective as the predicate device and support the subject device is substantially equivalent to the predicate device."

To obtain the specific details requested in your prompt, you would need access to the full 510(k) submission (e.g., test reports) which is not typically made public in this summarized format.

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