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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 TRUCLEAR™ Morcellator System is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.

The TRUCLEAR Morcellator System was first introduced in K031787. The method of operation is mechanical resection and suction to cut and remove submucous myomas and endometrial polyps from the uterine lining. The system consists of a control unit, handpiece and footswitch. The system is used in conjunction with disposable hysteroscopic blades.

The provided text describes a 510(k) submission for the TRUCLEAR Morcellator System, which is a medical device for gynecological procedures. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and a detailed analysis of a new device's performance against those criteria.

Therefore, the specific information requested cannot be fully extracted as it pertains to a different type of submission (e.g., a study proving a device meets specific performance criteria, often seen in AI/CADe submissions).

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided directly. The document states: "The TRUCLEAR Morcellator System performance testing has demonstrated that the proposed device is substantially equivalent to the predicate device and the proposed modifications to increase the blade speed range does not raise new questions of safety and efficacy."
• This implies that the "acceptance criteria" were primarily demonstrating equivalence and ensuring that the modification (increased blade speed range) did not negatively impact safety or efficacy, rather than meeting specific quantifiable performance metrics in a new clinical study.
• The "reported device performance" is essentially that it performs equivalently to the predicate and the modification is safe.

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

• Cannot be provided. The document does not describe a clinical study with a test set of patient samples. Performance testing was likely mechanical/bench testing to demonstrate the safety and equivalence of the increased blade speed.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Cannot be provided. This information is relevant for studies involving human interpretation or annotation (e.g., image-based AI studies), which is not described here.

4. Adjudication Method for the Test Set:

• Cannot be provided. Not applicable due to the nature of the submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size:

• No, an MRMC study was not done. This type of study is common in AI/CADe for comparing human performance with and without AI assistance. This submission is for a mechanical tissue resection system.

6. If a Standalone Performance Study Was Done:

• No, a standalone performance study as typically understood for AI algorithms was not done. The performance testing focused on demonstrating substantial equivalence to the predicate device and the safety/efficacy of the increased blade speed, not a standalone clinical validation against a specific disease outcome in a patient cohort.

7. The Type of Ground Truth Used:

• Not explicitly stated as "ground truth" in the AI sense. For this device, "ground truth" would be related to the functional performance and safety parameters of the device (e.g., cutting efficiency, tissue removal, maintaining sterility, structural integrity). This would likely be assessed through engineering tests, material testing, and potentially simulated tissue models, rather than clinical patient outcomes.

8. The Sample Size for the Training Set:

• Cannot be provided. This concept is not applicable. There is no AI component or machine learning model that would require a training set.

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

• Cannot be provided. Not applicable.

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The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.

The IUR Reciprocating Morcellator is a disposable, sterile, reciprocating morcellator used in conjunction with the currently cleared Smith & Nephew IUR Morcellation System (K031787), to remove submucous myomas and endometrial polyps from the uterus. The reciprocating design utilizes both a rotational and reciprocating cutting mechanisms. The predicate design utilizes a rotational cutting mechanism only.

The provided text describes a 510(k) premarket notification for a medical device, the Smith & Nephew IUR Reciprocating Morcellator. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or safety through extensive clinical trials as would be required for a novel device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

Explanation: In the context of a 510(k) submission, the "acceptance criteria" for the new device often revolve around demonstrating that it is as safe and effective as a previously cleared predicate device. For this specific device, the primary acceptance criterion was that its design modifications (reciprocating vs. rotational cutting) and new materials did not negatively impact its safety and performance when compared to the predicate IUR Rotary Morcellator (K031787). The reported device performance, based on in vitro testing, affirmed that this criterion was met.

Study Details

1. Sample size used for the test set and the data provenance:

   • The document mentions "in vitro testing." This suggests that the test set consisted of samples used in a laboratory setting (e.g., excised tissue, phantom materials) rather than human subjects.
   • The specific sample size (e.g., number of tissue samples, number of test runs) is not specified in the provided text.
   • The data provenance is not explicitly stated beyond being "in vitro testing." There is no mention of country of origin or whether it was retrospective or prospective in a human clinical sense. Being "in vitro" typically implies a controlled laboratory environment.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not provide any information regarding experts used to establish ground truth. In vitro testing typically relies on standardized measurements and objective outcomes rather than expert interpretation of results, unless the "safety and performance" criteria involve expert assessment of tissue quality post-morcellation, which is not detailed here.

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

   • The document does not mention any adjudication method. This is consistent with in vitro testing where objective measurements are usually the primary endpoints, reducing the need for human adjudication of subjective findings.

4. 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, an MRMC comparative effectiveness study was not done. This device is a surgical instrument (morcellator), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

   • Not applicable. This device is a physical surgical tool and does not involve algorithms or AI. It inherently requires human-in-the-loop operation. The "standalone" performance here refers to the device's functional characteristics (e.g., cutting ability, structural integrity) as measured in vitro.

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

   • For in vitro testing of a mechanical device, the "ground truth" would likely be based on:
     • Objective physical measurements: such as cutting efficiency, tissue fragmentation size, power consumption, blade sharpness retention, or structural integrity under stress.
     • Comparison to predicate device performance: confirming that the new device performs within the same range or better than the predicate's known performance characteristics.
   • The text does not specify the exact parameters measured, but it implies that the "safety and performance" were assessed against objective criteria through "in vitro testing."

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of algorithm development. The in vitro testing performed is for validation, not AI training.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no AI or machine learning involved, there is no training set and thus no ground truth to be established for it.

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