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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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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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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.

The modified Aveta System is used by physicians in an office or operating room setting. The Aveta Controller acts as the hub of the system. For diagnostic procedures, the Aveta Fluid Management Accessory, the Aveta Handswitch, the Aveta Scale, the Waste Management Bags, saline bags and an external monitor are all connected to the Aveta Controller. The inflow and outflow of the fluid management accessory are connected to the corresponding ports of a compatible hysteroscope. For therapeutic procedures, the Aveta Reusable Resecting Handset or the Aveta Disposable Resecting Handset are connected to the Aveta Controller for powering the Aveta Disposable Resecting Device.

The provided text is a 510(k) summary for the Meditrina Aveta System (K191958). It describes a device that assists gynecologists in hysteroscopic procedures. This document primarily focuses on demonstrating substantial equivalence to a predicate device (K190372) rather than detailed acceptance criteria and study results for device performance in terms of diagnostic or therapeutic accuracy, as would be expected for an AI/ML powered device.

Therefore, many of the requested items (acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth details) are not applicable or not provided in this specific 510(k) document, as it concerns a physical medical device and its accessories, not an AI/ML algorithm.

However, I can extract the available information related to the device's functional performance:

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

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to a functional performance test in a model uterine system, not a clinical data set for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was functional testing, not an expert-driven ground truth assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This document does not describe an AI-powered device or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the functional testing, the "ground truth" was likely the expected physical and operational parameters (e.g., maintaining a set pressure, consistent flow control) within the model uterine system.

8. The sample size for the training set: Not applicable. No AI/ML training set is mentioned.

9. How the ground truth for the training set was established: Not applicable.

Summary of the study conducted to prove the device meets acceptance criteria:

The study conducted involved non-clinical performance testing to evaluate the modified Aveta System.

• Study Type: Functional testing and simulated use with a model uterine system.
• Key Tests:
  • Functional Testing with Aveta Handswitch: Verified that the Handswitch's pressure control and flow control functions operated as expected.
  • Simulated Use with Compatible Hysteroscopes: The device's ability to regulate cavity pressure was demonstrated using two commercially available hysteroscopes (Hologic MyoSure XL and Covidien TruClear 8.0) within a model uterine system. This was performed across various operational modes (diagnostic, therapeutic).
• Results: The results of these tests demonstrated that the subject device met its specifications.
• Conclusion: The non-clinical performance testing confirmed that the differences in the modified Aveta System (inclusion of Aveta Handswitch and compatibility with third-party hysteroscopes) did not raise new questions of safety and effectiveness, and the device performs as safely and effectively as its predicate.

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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.

The Aveta System is an integrated system which allows for visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative hysteroscopic procedures. 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 uterine cavity. The Controller provides continuous monitoring of the intrauterine pressure to the set pressure, as well as monitoring of the volume differential between saline inflow from the uterus. The Controller connects to a sterile, single use Disposable Hysteroscope via a Reusable Hysteroscope Handset that allows visualization of the cervical canal and the uterine cavity and displays the images obtained from the hysteroscope on a standard monitor. For operative procedures, the Aveta System includes a sterile, mechanical Disposable Resecting Device powered by a motorized, Reusable Resecting Handset which is inserted through the sterile hysteroscope working channel to resect and remove endometrial polyps, submucous myomas and retained products of conception under suction.

The provided text describes the 510(k) premarket notification for the Aveta System but does not contain specific acceptance criteria or detailed study results with performance metrics that would typically be found in a clinical study report. The document focuses on demonstrating substantial equivalence to a predicate device.

However, it does list various performance data types that were provided in support of the substantial equivalence determination. Based on these, we can infer the types of acceptance criteria that would have been used, even if the specific numerical thresholds are not explicitly stated.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a 510(k) summary, specific numerical acceptance criteria and detailed performance results are not provided. However, the "Performance Data" section (Page 10) lists the types of tests performed, which inherently implies associated acceptance criteria for each. Without the actual study reports, the exact performance values are unknown.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided document. The listed tests are primarily engineering and bench testing, as well as simulated use. No information is given regarding human subject test sets or the number of cases.
• Data Provenance: The tests are indicated as performance data provided in support of substantial equivalence, which typically means the testing was conducted by Meditrina, Inc. (the manufacturer) or a contracted lab. The country of origin for the data is not specified, but the context implies it was generated to meet US FDA requirements. The data is prospective in the sense that Meditrina, Inc. generated it specifically for this premarket notification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the document. The tests performed are primarily related to device function, safety, and performance against engineering specifications, rather than clinical diagnostic accuracy requiring ground truth established by experts. "Simulated Use" might involve experts, but the details are not given.

4. Adjudication Method for the Test Set

• This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic decisions. The tests listed are not typically subject to such adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The document states "Comparative testing to predicate for pressure control, fluid deficit, fluid control and durability." This refers to technical performance comparisons between the devices, not a clinical study assessing human reader performance with and without AI assistance. The Aveta System appears to be a medical device for hysteroscopy procedures with integrated fluid management and resection capabilities, not primarily an AI-driven diagnostic imaging interpretation device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• The Aveta System is a medical device for hysteroscopy, not an AI algorithm. Therefore, a standalone algorithm-only performance assessment, as it pertains to AI/machine learning, is not applicable and was not performed. The "Software Verification and Validation Testing" addresses the software component of the device, but this is distinct from AI-specific standalone performance.

7. The Type of Ground Truth Used

• For the engineering and functional tests, the "ground truth" would be the engineering specifications, regulatory standards (e.g., ISO, IEC, ASTM), and the expected physical or electrical outcomes of the device's operation.
• For "Simulated Use" tests, the ground truth might come from established clinical protocols or expert assessment of the simulation's success.
• For "Comparative testing to predicate," the predicate device's established performance would serve as a benchmark or "ground truth" for comparison.
• Pathology or outcomes data are not explicitly mentioned as ground truth sources for the performance data presented here, although tissue resection is mentioned, implying that the resected tissue would eventually be sent for pathology in actual clinical use.

8. The Sample Size for the Training Set

• This information is not applicable or not provided as the Aveta System is a hardware/software medical device, not an AI/machine learning system that requires a distinct "training set" for model development in the traditional sense. Software verification and validation are performed, but this is testing against specifications, not training a model.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no mention of a "training set" in the context of AI/machine learning for this device.

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