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The Hysteroscopy System is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.

The Hysteroscopy System is designed to visualize the uterus and to facilitate physicians in the procedure of vacuum aspiration of the uterine cavity during the first trimester of pregnancy. Components of the Hysteroscopy System include an EOsterilized single-use cannula and reusable image processing unit. The Hysteroscopy System is available in five sizes that differ in length and width. Each cannula includes an internal channel to draw vacuum or negative pressure up to 500 mmHg. The optical system, which includes a CMOS image sensor, lens, and 40 mW LED, is located at the distal end of the cannula. A lens cover shields the electronics from bodily fluids. The Hysteroscopy System has two connectors: one is an electrical/data connection and the second connection is for vacuum. The cannula is not indicated for use with any other accessories. The patient-contacting materials are medical grade stainless steel, polycarbonate, medical glue, and medical nylon.

This document does not contain an acceptance criteria table or a detailed study of device performance to meet such criteria. It is a 510(k) summary for a Hysteroscopy System. While it lists various performance tests conducted, it does not provide quantitative acceptance criteria or the specific results demonstrating compliance.

Here's a breakdown of what is available based on your request, and what is missing:

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

Missing. The document lists performance tests but does not define acceptance criteria (e.g., minimum tensile strength, maximum leak rate, specific image resolution targets) nor does it present the numerical results from these tests against any defined criteria. It only states, "The protocol and results of all performance testing were acceptable."

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

Missing. The document mentions various performance tests (e.g., biocompatibility, electrical safety, mechanical performance, image quality) but does not provide details on:
* The sample sizes used for any of these tests.
* The provenance of the data (e.g., country of origin, retrospective or prospective nature). These tests appear to be bench testing or material-level assessments, not clinical trials on human subjects.

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. This type of information would typically be relevant for studies involving diagnostic accuracy or clinical interpretation. The performance tests described are largely engineering and safety evaluations (e.g., tensile strength, vacuum integrity, electrical safety, biocompatibility, image quality parameters like field of view, resolution). There's no indication of any expert-based ground truth establishment in the context usually meant by this question (e.g., for image interpretation or diagnosis).

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

Missing. Adjudication methods are typically used in clinical studies where multiple observers or methods are used to establish a definitive diagnosis or outcome. The performance tests listed are technical validations, not clinical outcome adjudications.

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. An MRMC study is not mentioned. The device is a "Hysteroscopy System" used for visualization and vacuum aspiration. There is no mention of AI or human-in-the-loop performance improvement in this document, as it describes a medical device, not an AI software.

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

Missing. Not applicable, as this document describes a physical medical device (Hysteroscopy System), not an algorithm or AI software requiring standalone performance testing in that context.

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

Missing. As noted above, the performance tests described are largely technical/engineering validations. For example, for "image quality testing," the ground truth would be objectively measured parameters such as actual field of view, photometric measurements for illumination, and resolution targets. For "mechanical performance testing," ground truth would be defined by engineering specifications (e.g., expected tensile strength, vacuum pressure). There's no mention of clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Missing. This is not an AI device, so there is no concept of a "training set" for an algorithm.

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

Missing. Not applicable, as there is no training set for an AI algorithm.

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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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For transcervical aspiration of the uterine cavity.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria and the study details for a device. The document is an FDA 510(k) premarket notification letter for "Panpac Disposable Vacuum Curettes," indicating its substantial equivalence to a predicate device. It defines the device's indications for use but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size or data provenance for a test set.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method for a test set.
5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
6. Results from a standalone algorithm-only performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Therefore, I cannot fulfill your request based on the provided input.

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The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the first trimester of pregnancy. It has an additional feature of visualization.

The Disposable Endoscopic Cannula is a sterile, single patient use device composed of transparent cover, suction orifice, dual-function cannula, handle, suction port, connection port, and data cable. The patient contacting components of this device are transparent cover, suction orifice and dual function cannula that are manufactured with polycarbonate.

The transparent cover contains a LED light source and CMOS camera at the distal end for visualization of the cervical canal and uterine cavity. This device has two channels, one for transcervical aspiration of the uterine cavity and the other for transmitting the image signal through a cable connected to the Endoscopic Workstation. The images captured by the camera are transmitted to the endoscopic workstation through the cable for display. When the embryo tissues are located, the operator sucks out the embryo tissues through the suction orifice connected to a vacuum source.

The Disposable Endoscopic Cannula is provided with five sizes based on outer cannula diameter: 5mm (RL1205 model), 6mm (RL1206 model), 7mm (RL1207 model), 8mm (RL1208 model), and 9mm (RL1209 model) (outer diameter). All models have a length of 170mm.

This document is a 510(k) premarket notification for a medical device called the "Disposable Endoscopic Cannula". It is not a study demonstrating machine learning algorithm performance. Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance in the context of AI/ML.

The document focuses on demonstrating substantial equivalence to a predicate device (Rigid Uterine Cannulae) for the purpose of FDA clearance. This involves comparing the new device's features, intended use, technology, and safety aspects to a legally marketed predicate device.

Here's what the document does provide regarding acceptance criteria and performance, but it's for a traditional medical device, not an AI system:

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

The document doesn't provide a direct table of acceptance criteria with corresponding performance values in the way you might expect for an AI algorithm's metrics (e.g., sensitivity, specificity). Instead, it states that the device is in "compliance with requirements" for various standards.

Here's a summary of the compliance stated:

The remaining points (2-9) are not applicable because this document describes a hardware medical device, not an AI or machine learning system. There are no test sets, training sets, ground truth, experts for annotation, or multi-reader multi-case studies described. The "performance" referred to is about the physical and electrical integrity and functionality of the device, not the accuracy of an algorithm.

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For uterine aspiration/uterine evacuation in obstetric and gynecological patients. Indications for use are rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy.

The Rigid Cannulae are injection molded plastic devices approximately 190mm in length, made from a styrenic copolymer manufactured in sizes 6mm. 7mm. 8mm. 9mm. 10mm, 11mm, and 12mm (outer diameter), straight and curved.

The provided text describes a 510(k) submission for "Rigid Uterine Cannulae." This type of device is a physical instrument, not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance (such as acceptance criteria for AI, sample sizes for test/training sets, experts for ground truth, or MRMC studies) are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, and bench testing for physical strength and vacuum performance.

The questions you've asked are relevant for AI/ML powered medical device submissions, which typically involve software that processes data (like medical images) to generate an output. This submission describes a physical medical tool.

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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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