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For rapid transcervical aspiration of the uterine cavity.

The Berkeley VC-10 Vacuum Curettage System uses aspiration to remove uterine contents through the cervix. The system includes the vacuum pump, collection containers, connection tubing, and patient contacting vacurettes. The vacuum pump is electrically powered and generates suction through vacuum pressure. The vacuum pump console is not provided sterile and is a multi-use device. The patient contacting vacurettes of the VC-10 system are provided as sterile, single use disposable devices.

Similar to the predicate device VC-10, the modified Berkeley VC-10 includes a high capacity. double diaphragm pump and motor, enclosed in a stainless steel cabinet. Collection canisters sit on top of the cabinet, and a large vacuum gauge and vacuum control knob are easily accessed on the top of the cabinet. A vacurette (available in various shapes and sizes) is attached to a collection set (includes a plastic swivel handle with a slip ring to control the vacuum and PVC tubing) and is attached to the patient port of the first collection container. Two accessories, which can be used to collect tissue, include a tissue trap, which is connected to the collection tubing and the collection container, or a gauze sack, which is placed inside the collection container. The modified VC-10 offers the same foot actuator pedal for vacuum supply.

The provided text describes a 510(k) premarket notification for the Berkeley VC-10 Vacuum Curettage System, focusing on a modification to the vacuum pump motor. This type of submission primarily demonstrates substantial equivalence to a predicate device rather than presenting a comprehensive study on diagnostic performance or AI effectiveness.

Therefore, many of the requested elements regarding acceptance criteria for diagnostic accuracy, sample sizes for AI training/testing, expert adjudication, MRMC studies, and ground truth establishment are not applicable or extractable from this document. The document describes acceptance criteria and testing for the functional performance and safety of the device itself, not for its diagnostic or interpretative capabilities.

Here’s what can be extracted based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All performance testing passed or met the pre-specified acceptance criteria." However, the exact numerical acceptance criteria are not explicitly stated in the provided text. Only the tests performed and the outcomes are mentioned broadly.

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

The document does not describe a "test set" in the context of diagnostic accuracy, image analysis, or AI. The testing performed is bench performance testing of the device's physical functions. Therefore, information on sample size and data provenance in this context is not applicable/available.

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

As this is not a study assessing diagnostic performance or AI, there were no "experts" establishing a "ground truth" for a test set in that sense. The "ground truth" for functional performance tests would be the established engineering specifications and physical measurements, determined by the device manufacturer's engineers.

4. Adjudication Method for the Test Set

Not applicable, as there is no diagnostic test set or human interpretation being evaluated.

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

No, an MRMC study was not done. This document does not describe the evaluation of human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a vacuum curettage system, not an AI algorithm. Its performance is entirely "standalone" in the sense that it performs physical actions.

7. The Type of Ground Truth Used

For the functional bench tests, the "ground truth" would be the pre-specified engineering and performance specifications that the device is designed to meet (e.g., specific vacuum pressure levels, flow rates, evacuation times). For electrical safety and EMC, the ground truth is compliance with the referenced international consensus standards (AAMI/ANSI ES 60601-1 and IEC 60601-1-2).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of the Study and Device Performance:

The study described is a bench performance testing study conducted by the manufacturer (Gyrus ACMI, Inc.) to evaluate the functional and safety performance of the modified Berkeley VC-10 Vacuum Curettage System. The modification involved an upgrade to a 1/2 horsepower vacuum pump motor from a 1/3 horsepower motor.

The study aimed to demonstrate substantial equivalence of the modified device to its predicate (the original Berkeley VC-10) by showing that the technological differences (new motor) do not raise different questions of safety or effectiveness.

Tests performed included:

• Maximum Measured Vacuum Pressure
• Free Flow Rate
• Time to Develop Vacuum
• Time to Reach Full Vacuum
• Time to Evacuate 1L with 7mm Curette
• Time to Evacuate 1L with 6mm Curette
• Electrical Safety (according to AAMI/ANSI ES 60601-1)
• Electromagnetic Compatibility (EMC) (according to IEC 60601-1-2)

All performance testing passed or met the pre-specified acceptance criteria, and the device was found to be in compliance with the relevant electrical safety and EMC standards. This indicates that the modified device functions as intended and safely, maintaining substantial equivalence to the predicate device.

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Output:
For rapid transcervical aspiration of the uterine cavity.

The Berkeley® VC-10 Vacuum Curettage System and Accessories has been tested and compared to similar devices, and is substantially equivalent to the predicates in characteristics described and the parameters tested.

The Berkeley® VC-10 Vacuum Curettage System is a medical device for rapid transcervical aspiration of the uterine cavity. The 510(k) summary provides limited information about the performance testing. However, based on the provided document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

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

• Number of Experts: Not applicable. This type of device (vacuum curettage system) typically does not rely on expert-established ground truth in the same way an AI or diagnostic imaging device would. Performance is measured against engineering specifications and functional testing.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Performance testing for this device would involve objective measurements (e.g., vacuum pressure, flow rate, sterilization effectiveness) rather than subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No, this type of study was not performed or mentioned. MRMC studies are typically relevant for diagnostic devices where human interpretation is involved. This device is a surgical tool.
• Effect Size: Not applicable.

6. Standalone Performance Study:

• Standalone Study: Yes, performance testing of the Berkeley® VC-10 Vacuum Unit was conducted to determine its vacuum performance, and sterilization validation was performed for the disposables. This represents a standalone assessment of the device's functional capabilities. The results concluded substantial equivalence to predicate devices.

7. Type of Ground Truth Used:

• Ground Truth: For this device, "ground truth" would refer to objective engineering and functional specifications, as well as adherence to established sterilization standards. For example, vacuum performance would be measured against a predefined range of acceptable vacuum pressure and flow, and sterilization validation against established sterility assurance levels (SALs).

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This document describes a medical device clearance based on substantial equivalence, not an AI/ML algorithm that requires a training set. The performance testing conducted is for the device itself, not for an algorithm.

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

• Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML algorithm mentioned in this submission.

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The device is intended for the use of physicians and other professionals authorized to take sample cells from the cervix of the uterus, transfer them to a fluid suspension (or smear them on a slide, in the case of a traditional PAP test) for further preparation of cytological slides. CYTOPREP® was designed for use in conjunction with Liquid Based Cytology procedures. However, recent tests at the University of Munich. Germany, have proven it equally effective as a sampling device for the traditional PAP smear test.

The device is used to sample the cervix of patients for the purpose of obtaining ecto-cervical, endo-cervical and T-zone sample cells. These sample cells are used for the "PAP" test.

While the product is designed to be used in conjunction with liquid based cytology procedure (monolayer method), it can also be used in conjunction with the traditional "PAP" test procedure.

CYTOPRED® consists of two parts, the handle and the head.

The handle is 214mm in length, cylindrical and on one end it carries the name of the product. On the other end , there are two recesses (female) to accommodate the bottom part of the head. These two recesses, along with a special edge (male) on the bottom of the head. secure the head. When the physician has inserted the head in the endocervical canal and is turning the handle to obtain sample cells, the head turns (follows the physician's manipulations) and there is no slippage. Tests made (see XI Performance for attached laboratory report), prove that it will be impossible for a bristle to break and remain in the patient's cervix and almost impossible for the head to accidentally separate from the handle and remain in the cervix.

The head consists of:

The "male" edge on the bottom that is secured in the handle recess (female), stabilizing the head on the handle;

The base, upon which sit lengthy bristles on both sides of the center brush.

The center brush end sits upon the base of the head and its center stem extends beyond the lengthy bristles. On its center stem, perpendicular to the lengthy bristles, sit bristles which extend from the base of the head to the end of the center stem.

Here's a summary of the acceptance criteria and study information for the CYTOPREP® device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Over 60,000 CYTOPREP® devices were used by physicians in the testing stage.
• Data Provenance: The studies were conducted at the University of Geneva and independent laboratories. The document also mentions "recent tests at the University of Munich, Germany," proving its effectiveness for traditional PAP smear tests, but the primary clinical performance data cited for the acceptance criteria seems to stem from the Geneva/independent lab studies. The nature of the studies (retrospective or prospective) is not explicitly stated, but the mention of "testing stage of the device's development" suggests a prospective evaluation.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth within the 60,000+ device usage context, beyond "physicians who have used more than 60,000 CYTOPRED devices." For the morphology comparison, it states "morphology of the collected cells is maintained in 95% of the cells, as compared to 80% for the conventional sampling techniques," which implies expert evaluation, but the specifics are not detailed.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth regarding cell collection or morphology in the studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No MRMC comparative effectiveness study involving human readers and AI assistance was mentioned. The comparison is between the CYTOPREP® device and the combined use of Spatula and Cytobrush®, not an AI-assisted human reading scenario.

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

This device is a physical cervical brush, not an AI algorithm. Therefore, no standalone algorithm-only performance study was conducted or is applicable.

7. The Type of Ground Truth Used:

The ground truth appears to be based on:

• Expert assessment: Physicians observed the presence of endo-cervical cells, total cell count, and maintained cell morphology.
• Comparison to established standards: The performance metrics (e.g., "93-95% of the cases" for endocervical cells, "equal to or exceeding" total cell count, "95%... as compared to 80%" for morphology) are presented in relation to reported results of the "most widely used sampling method, i.e., the combined use of Spatula and Cytobrush®," and "conventional sampling techniques."

8. The Sample Size for the Training Set:

The document does not mention a "training set" in the context of machine learning or AI. The development of the device involved "tests made" for mechanical properties (bristle breakage, head separation) and clinical observations/studies from the 60,000+ devices. This information pertains to the evaluation and validation of the physical device's performance directly.

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

As there's no mention of a "training set" in the AI/ML sense, this question is not applicable. The device's "training" was through iterative design and physical testing, with performance validated through clinical usage and studies as described.

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