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The Medtronic MR8 Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

Additionally, the MR8 Drill System is indicated for the incision/cutting, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy
• Lumbar Stenosis Decompression
• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar Interbody Fusion (ALIF)
• Direct Lateral Interbody Fusion (DLIF)

The Midas Rex MR8 ClearView Tools are used only in conjunction with the MR8 Drill System to perform as intended. Please refer to the Midas Rex MR8 Drill System and associated User's Guides for the Indications of Use.

The Medtronic MR8TM Drill System is comprised of both Electric and Pneumatic powered, rotary cutting handpieces, attachments, surgical dissecting tools, and accessories designed to remove soft and hard tissue, bone, and biomaterials during various surgical procedures. The surgical dissecting tools are provided sterile and are single use, while the rest of the system components are provided non-sterile and are reusable.

The Midas Rex™ MR8TM ClearView™ Tools are designed to interface with Midas Rex™ MR8 Drill System motor to support bone and tissue removal during surgical procedures. The Midas Rex™ MR8™ ClearView™ Tools are part of a larger portfolio of tools and accessories designed to be used with the Midas Rex™ MR8 System/Platform.

This document describes the Medtronic MR8 Drill System and Midas Rex MR8 ClearView Tools. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance claims against specific acceptance criteria. Therefore, the information provided primarily compares the device to existing predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" for the overall device in the typical sense of a clinical trial or performance study with defined thresholds. Instead, it details performance testing conducted for the Midas Rex MR8 ClearView Tools to ensure functionality with the MR8 Drill system and comparability to predicate devices. The "acceptance criteria" for this testing appear to be qualitative (e.g., "similar and/or better," "same or more," "below the burn threshold").

No additional testing was performed on the MR8 Drill System itself as there were no design changes to it for this submission. The Midas Rex MR8 ClearView Tools are the new elements being evaluated for their compatibility and performance within the existing MR8 Drill System.

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

The document does not specify the sample size for the individual performance tests (Tool Chatter and Hand Vibration, Irrigation Rate vs IPC Setting, Thermal Performance)conducted on the Midas Rex MR8 ClearView Tools.

The provenance of the data is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that this is a 510(k) submission for a medical device by Medtronic, a US-based company, it is highly likely that the testing was conducted under standard quality systems and engineering practices, likely within a controlled laboratory environment. The tests appear to be engineering/bench testing rather than clinical studies with human subjects.

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

This information is not applicable to the type of testing described. The tests are engineering performance tests, not clinical evaluations requiring expert interpretation of ground truth (e.g., diagnosis from medical images).

4. Adjudication Method for the Test Set:

This information is not applicable. The tests are objective, quantitative measurements or qualitative observations during engineering performance testing, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable. The device described is a surgical drill system and associated tools, not an AI-assisted diagnostic or interpretative system.

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

This information is not applicable. This is not an AI-driven device or algorithm. The performance evaluation focuses on the mechanical and operational characteristics of the surgical tools.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests effectively refers to the physical and functional parameters of the device as designed and expected, as well as established safety thresholds (e.g., burn threshold for thermal performance). It's based on engineering specifications and safety standards relevant to surgical instruments.

8. The Sample Size for the Training Set:

This information is not applicable. No "training set" is mentioned as this is not a machine learning or AI-driven device.

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

This information is not applicable. As there is no training set mentioned, there is no ground truth established for one.

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ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. ClearView cCAD automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs).

The software allows the user to annotate, and automatically record and/or store selected views. The software also automatically generates reports from user inputs annotated during the image analysis process as well as the automatically generated characteristics. The output of this system will be a DICOM compatible (e.g. grayscale softcopy presentation state (GSPS)) and/or PDF report that can be sent along with the original image to standard film or paper printers or sent electronically to an intranet webserver or other DICOM compatible device.

cCAD includes options to annotate and describe the image based on the ACR BI-RADS® Breast Imaging Atlas. In addition. the report form has been designed to support compliance with the ACR BI-RADS @ Ultrasound Lexicon Classification Form.

When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decision should not be made solely on the results of the cCAD analysis. The ultrasound images displayed on cCAD must not be used for primary diagnostic interpretation.

ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. ClearView cCAD automatically classifies shape and orientation characteristics of user-selected regions of interest (ROIs). The device uses multivariate pattern recognition methods to perform characterization and classification of images.

For breast ultrasound, these pattern recognition and classification methods are used by a radiologist to analyze such features as shape, orientation, and putative BI-RADS® category which can then be used to describe the lesion in the ACR BI-RADS® breast ultrasound lexicon as well as assigning an ACR BI-RADS® categorization which is intended to support compliance with the ACR BI-RADS® ultrasound lexicon classification form. Similarly, this process can be used to assist in training, evaluation, and tracking of physician performance.

The cCAD software can be run on any Windows 7 or higher or Windows Embedded platform that has network, Microsoft IIS, and Microsoft SQL support and is cleared for use in medical imaging. The software does not require any specialized hardware, but the time to process ROIs will vary depending on the hardware specifications. ClearView cCAD is based on core BI-RADS models and lesion characteristic extraction algorithms that can use novel statistical, texture, shape, orientation descriptors, and physician input to help with proper ACR BI-RADS® assessment.

The ClearView cCAD processing software is a platform agnostic web service that queries and accepts DICOM compliant digital medical files from an ultrasound device, another DICOM source, or PACS server. To initiate analysis and processing, images are queried from a compatible location and loaded for display within the application. The user then selects an ROI to analyze by clicking and dragging a bounding box around the region requiring analysis. Once selected, the user then clicks the processing button which initiates the analysis and processing sequence. The results are displayed to the user on the monitor and can then be selected for automated reporting, storage, or modification. The output of this system will be a DICOM compatible overlay (e.g. grayscale softcopy presentation state (GSPS)) and/or PDF report that can be sent along with the original image to standard film or paper printers or sent electronically to an intranet webserver or other DICOM compatible devices distributed by various OEM vendors. All fields may be modified by the user at any time during the analysis and prior to archiving.

Here's a breakdown of the acceptance criteria and study details for the ClearView cCAD device, based on the provided text:

ClearView cCAD Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • 1204 cases for shape analysis.
  • 1227 lesions for orientation analysis.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved skilled physicians evaluating a dataset, implying medical images, but whether these were retrospective or prospective, or from specific geographical regions, is not mentioned.

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

• Number of Experts: Three MQSA certified skilled physicians.
• Qualifications of Experts:
  • Each with over 20 years of experience.
  • Each read at least 3000 images per year.

4. Adjudication Method for the Test Set

• Adjudication Method: "Majority decision" was used to establish ground truth for shape and orientation. This implies that if at least two out of the three experts agreed on a characteristic, that was considered the ground truth.

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

• Was an MRMC study done? No, a true MRMC comparative effectiveness study was not explicitly stated as having been performed to measure human reader improvement with AI assistance. The study compared the device's standalone performance to expert performance, showing statistical equivalence, but not how human readers' performance might change with the device.
• Effect size of human reader improvement with AI vs. without AI assistance: Not measured or reported in this document.

6. Standalone Performance Study

• Was a standalone study done? Yes. The study focused on the ClearView cCAD system's "ability to discern BI-RADS® based shape and orientation parameters" independently and compared these results to the ground truth established by expert radiologists.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (majority decision by three MQSA certified skilled physicians).

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated in the provided document. The document describes the "bench testing" for the device's performance but does not specify the size of the dataset used to train the underlying multivariate pattern recognition methods and algorithms.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not explicitly stated. While the document mentions that the device uses "multivariate pattern recognition methods to perform characterization and classification of images" and is "based on core BI-RADS models and lesion characteristic extraction algorithms," it does not describe how the ground truth for these training datasets was established.

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The ClearView™ System provides two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and perspiration on the image and one without the capacitive barrier. The device provides numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin. Clinical management decisions should be made on the basis of routine clinical care and professional judgment in accordance with standard medical practice.

The ClearView System consists of the ClearView Device (hardware) attached to a computer/software system. The measurements are digital photographs acquired when placing a fingertip in contact with a glass electrode. A series of electrical impulses are applied to the glass electrode generating a localized electromagnetic field around the fingertip. Under the influence of this field, an image is generated. A software analysis of the images of the 10 fingers (including the thumbs) provides the inputs for an algorithm-driven Response Scale Report. The ClearView System provides numerical electrophysiological data to the healthcare professional. Any interpretation of this information is the responsibility of the healthcare professional; the device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions.

The ClearView™ System is intended as a non-invasive measurement tool for detecting electrophysiological signals from the skin. It is explicitly stated that the device is not intended for diagnostic purposes or for influencing any clinical decisions, and the reported numbers have no clinical context. Therefore, the acceptance criteria and study design focus on the repeatability and reproducibility of its measurements, rather than clinical efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion on Acceptance Criteria: The study results for ICCs generally fall within or exceed the "good reliability" and "excellent reliability" thresholds, and the coefficients of variation are reported as "relatively low," indicating the device meets its implicit acceptance criteria for repeatability and reproducibility.

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

• Sample Size: 18 subjects (9 males, 9 females).
• Data Provenance: Prospectively enrolled, single-center study. Subjects were recruited internally from the study site (family and friends of staff members, excluding employees directly involved with the study). This suggests a limited geographic origin, likely the country where EPIC™ Research & Diagnostics is located (Scottsdale, AZ, USA).

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

This information is not applicable as the study did not involve establishing a diagnostic ground truth or expert interpretation of the electrophysiological signals. The "ground truth" for this study was the raw measurement itself, and the goal was to assess its consistency.

4. Adjudication Method (for the test set)

This information is not applicable. The study focused on the technical performance (repeatability and reproducibility) of the device's measurements, not on clinical interpretations that would require adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study design involved three trained and certified operators using three different ClearView Scanners to assess the consistency of the device's measurements, not to compare human reader performance with and without AI assistance. The device is explicitly not intended for diagnostic purposes or for influencing clinical decisions.

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

The study primarily assessed the system's standalone performance in terms of repeatability and reproducibility. While operators initiated scans, the analysis and generation of "numerical measures of electrophysiological signals" are done by the device's software. The study's focus on Coefficient of Variation and ICCs for these numerical outputs directly evaluates the consistency of the algorithm's output under different operators, scanners, and days. The "device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions," implying its output stands on its own as a measurement.

7. The Type of Ground Truth Used

The "ground truth" for this study was the device's own measurements of electrophysiological signals. The study aimed to assess the consistency and reliability of these measurements across different variables (operators, scanners, days), rather than comparing them to an external, independently established clinical ground truth (e.g., pathology, clinical outcome, or expert consensus on diagnosis).

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes a clinical study to assess the performance of the device, but it does not detail any internal training data used for the device's software algorithm development.

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

This information is not provided in the document. As this document describes the regulatory submission for the device and a study on its reliability, details about the development and training of the internal algorithm are not included.

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The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Alere H. pylori tests are lateral flow immunochromatographic assays for the qualitative detection of Immunoglobulin G (IgG) antibodies to Helicobacter pylori (H. pylori) in whole blood, serum and plasma. The test devices consist of a membrane strip coated with immobilized human IgG antibodies and H. pylori antigen encased in a plastic housing. In the test procedure, anti-human IgG is immobilized in the test line region of the cassette. The sample reacts with H. pylori antigen-coated particles that have been applied to the label pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-human IgG. If the sample contains H. pylori IgG antibodies, a colored line will appear in the test line region indicating a positive result. If the sample does not contain H. pylori IgG antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of sample has been added and membrane wicking has occurred.

The provided text describes a 510(k) premarket notification for Alere Signify® H. pylori and Alere Clearview® H. pylori tests, which are rapid chromatographic immunoassays for the qualitative detection of IgG antibodies to Helicobacter pylori.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with specific thresholds (e.g., Sensitivity > X%, Specificity > Y%). Instead, it describes a performance study related to interfering substances and concludes substantial equivalence based on the device's expected performance and lack of interference.

• Implied Acceptance Criterion: The tests should produce expected (correct) positive or negative results in the presence of various interfering substances.
• Reported Device Performance: All negative and positive H. pylori samples tested as expected, with no false results, even in the presence of high levels of triglycerides.

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

• Sample Size:
  • For the interfering substance study related to triglycerides:
    • H. pylori standards: low positive (presumably 1 sample) and high positive (presumably 1 sample).
    • H. pylori negative plasma sample: 1 sample.
    • Each of these 3 samples was spiked with two concentrations of triglyceride reference material.
    • Each spiked sample was tested in replicates of three.
    • Three unspiked replicates of each H. pylori standard and negative sample were also tested.
    • Calculation: (2 positive standards + 1 negative sample) * (2 triglyceride concentrations * 3 replicates + 3 unspiked replicates) = 3 * (6 + 3) = 3 * 9 = 27 tests in total for the triglyceride study. This is a very small sample size focused specifically on interference, not diagnostic accuracy.
  • For other interfering substances (hemoglobin, bilirubin, human serum albumin, hematocrit), the document mentions "samples containing high levels" but does not specify the exact number of distinct samples or replicates tested.
• Data Provenance: Not explicitly stated (e.g., country of origin). However, given the context of a medical device submission to the FDA, it is typically expected to be from a controlled laboratory setting. It is a retrospective analysis of prepared samples designed to evaluate interference.

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

• The document describes an interfering substance study, not a clinical study requiring expert diagnosis of H. pylori. The "ground truth" for the test set in this context refers to whether the samples were genuinely positive or negative for H. pylori, as well as the known concentration of the interfering substances.
• The ground truth (e.g., low positive, high positive, negative H. pylori samples, and known concentrations of spiked triglycerides) would have been established by laboratory methods or reference materials.
• No human experts (like radiologists) were involved in establishing the ground truth for this specific type of performance study presented.

4. Adjudication Method for the Test Set

• None directly applicable as this was not an expert review or clinical trial for diagnostic accuracy. The results were assessed against expected outcomes (positive should remain positive, negative should remain negative).

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

• No, an MRMC comparative effectiveness study was not done. The document describes a laboratory-based interfering substance study, not a clinical study comparing human reader performance with and without AI assistance. The device itself is a rapid immunoassay, not an AI-powered diagnostic system requiring human interpretation.

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

• While the device itself is a standalone diagnostic (a rapid immunoassay, not an algorithm in the traditional AI sense), the performance data presented is for the device's reaction to spiked samples under controlled lab conditions, not its standalone diagnostic accuracy in a clinical population. The device provides a visual result (colored lines) that is interpreted.

7. The Type of Ground Truth Used

• The ground truth used for the interfering substance study was based on known H. pylori positive/negative status of the samples (presumably established by reference methods or manufacturing standards for the "standards" used) and known spiked concentrations of interfering substances. This is a form of laboratory-controlled ground truth.

8. The Sample Size for the Training Set

• The document does not mention a training set in the context of machine learning or AI. This device is a lateral flow immunoassay, which does not typically involve "training data" in the AI sense for its core function. Its design and performance are based on biochemical interactions.

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

• Not applicable as there is no mention of a training set for an algorithm.

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ClearView is a CT reconstruction software. The end user can choose to apply either ClearView or the filter back-projection (FBP) to the acquired raw data.

Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ClearView can help to reduce radiation dose while maintaining Pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose FBP images and reduced dose ClearView images. Additionally, ClearView can reduce body streak artifacts by using iterations between image space and raw data space.

A Model Observer evaluation showed that equivalent low contrast detectability can be achieved with less dose using ClearView at highest noise reduction level for thin (0.625 mm) reconstruction slices in MITA body and ACR head phantoms for low contrast objects with different contrasts.

ClearView are not intended to be used in CCT and Pilot.

ClearView reconstruction technology may enable reduction in pixel noise standard deviation and improvement in low contrast resolution. ClearView reconstruction algorithm may allow for reduced mAs in the acquisition of image, thereby it can reduce the dose required.

In clinical practice, the use of ClearView reconstruction may reduce CT patient dose depending on the clinical task, patient size, and clinical practice. A consultation with a radiologist and physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task.

As a reconstruction option, ClearView can be selected before scanning or after scanning. There are 9 ClearView Levels from 10% to 90%. Users can select t.the level of ClearView that is appropriate for the clinical task being performed. According to the comparison based on the requirements of 21 CFR 807.87, we stated that ClearView reconstruction software is substantially equivalent to the FBP of NeuViz 64 Multi-Slice CT Scanner System.

ClearView is a moderate concern device.

Here's an analysis of the acceptance criteria and study information for the ClearView device as presented in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance claims for ClearView, primarily in comparison to Filtered Back Projection (FBP) and related to dose reduction. It doesn't explicitly state "acceptance criteria" in a numerical table form, but rather describes how the device performs against certain metrics.

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

The provided text does not contain information about the sample size used for a test set based on human patient data. The evaluations mentioned are based on:

• Phantom measurements: Performed on "MITA body and ACR head phantoms." No specific sample size (number of phantom scans) is provided.
• Data Provenance: The studies are described as "Phantom measurements" and "A Model Observer evaluation." This implies laboratory or simulated data, not retrospective or prospective human clinical data. The country of origin of the data is not specified beyond the manufacturer being in China.

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

The document does not detail the use of human experts to establish ground truth for a test set. The evaluations primarily relied on phantom measurements and a model observer, which are objective, quantitative metrics. While "A consultation with a radiologist and physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task," this refers to clinical practice guidance and not a component of the device's validation study itself as described.

4. Adjudication Method for the Test Set

Not applicable. The reported evaluations (phantom measurements, Model Observer) do not involve human adjudication for a test set's ground truth.

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

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focuses on standalone phantom performance and model observer results, not on how human readers' performance improves with or without the AI (ClearView) assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes. The described studies are standalone evaluations of the ClearView reconstruction software's performance, primarily using phantom measurements and a "Model Observer evaluation." These do not involve a human in the loop for the performance assessment. The device itself is a reconstruction software.

7. Type of Ground Truth Used

The ground truth used in the described studies is:

• Physical Phantom Measurements: For pixel noise, high contrast resolution, and effectively for low contrast detectability (as measured by the Model Observer on phantoms). These are objective physical properties measured with specific phantoms and known targets.
• Model Observer Results: Used for low contrast detectability, which is a quantitative measure from a computational model mimicking human perception, applied to phantom data with known contrast objects.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for any training set. ClearView is described as CT reconstruction software, but details on its development or any machine learning training data are absent.

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

The document does not provide any information on a training set or how its ground truth might have been established.

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The ClearView Total is intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.

Clinical Innovations' ClearView Total is a single-use sterile device used for uterine manipulation. Uterine manipulation is essential for laparoscopies involving the female pelvic organs (uterus, tubes, ovaries) when a uterus is present. Uterine manipulators may be helpful when clinicians perform tubal ligations, diagnostic laparoscopies for evaluating pelvic pain and infertility, treatment of endometriosis, removal of pelvic scars (adhesions) involving the uterus, fallopian tubes and ovaries, treatment of ectopic pregnancy, removal of uterine fibroids, removal of ovarian cysts, removal of ovaries, tubal repair, laparoscopic hysterectomy, laparoscopic repair of pelvic bowel or bladder, sampling of pelvic lymph nodes, laparoscopic bladder suspension procedures for treatment of incontinence, and biopsy of pelvic masses.

The ColpoCup accessory is a plastic cup which is mechanically screwed into the uterine manipulator. The ColpoCup is compatible with typical surgical devices, including harmonics and electrosurgical tools. Three different sizes of ColpoCups will be included with the device; 3.0cm, 3.5cm. and 4.0cm. Each ColpoCup will be a high contrast color in order to provide the surgeon with clear visibility during laparoscopic dissection.

At the base of the ColpoCup, past the tip pivot point, is a pre-attached Occluder constructed of an inflatable balloon and will be included to seal off the vagina and prevent pnuemoperitoneum loss. The Occluder Balloon is connected to a separate inflation valve which is located proximally from the balloon and allows for inflation after placement.

The provided text is a 510(k) Summary for a medical device called the "ClearView Total," a uterine manipulator. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices, but it does not outline specific acceptance criteria or report performance in the format of a clinical study assessing a device against predefined performance metrics.

Instead, the document focuses on demonstrating that the ClearView Total is "substantially equivalent" to existing, legally marketed predicate devices through comparison of indications for use, technical characteristics, and various integrity and biocompatibility tests.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth type, training set size) are not applicable or cannot be extracted from this document, as the study described is not a clinical effectiveness study with performance metrics in the way these questions imply for an AI/diagnostic device.

However, I can extract information related to the device integrity and biocompatibility testing that served as the "study" for this submission.

Here's a breakdown of the information available based on your request, with relevant sections marked as "Not Applicable" or "Not Provided" where the document does not contain the specific information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present quantitative acceptance criteria or device performance in the typical format of a clinical study for diagnostic or AI devices. Instead, it states that all tests "met the specified requirements" or "met the appropriate acceptance criteria."

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

This document describes engineering and biocompatibility tests, not a clinical test set with patient data.

• Sample Size: Not specified (refers to device units tested for engineering and biocompatibility).
• Data Provenance: Not applicable (these are laboratory/bench tests on device components/materials).

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. (Testing results would likely be determined by laboratory technicians or engineers against predefined test specifications.)

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

• MRMC Study Done: No. This document describes a submission for a physical medical device, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.
• Effect Size of Human Readers with vs. without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. This device is a physical surgical instrument, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the engineering tests (Accelerated Age, Balloon Leak/Burst, Cup Security/Break), the "ground truth" would be the pre-defined engineering specifications and performance limits for the device's physical properties. For biocompatibility tests, the "ground truth" would be established by industry standards (e.g., ISO 10993 series) for material safety.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable.

Summary of the Study Description:

The "study" described in the 510(k) summary involves device integrity testing and biocompatibility testing.

• Device Integrity Testing: Included Accelerated Age Testing, Balloon Leak/Burst Testing, and Cup Security and Cup Break tests. The document states that "All device integrity tests for the ClearView Total met the specified requirements." These tests would assess the physical and mechanical performance of the device under various conditions to ensure its structural integrity and functionality.
• Biocompatibility Testing: Included Cytotoxicity, Intracutaneous Reactivity Irritation, and Sensitization tests. The document states that "All testing met the appropriate acceptance criteria." These tests are conducted to ensure that the device materials are safe for contact with human tissue and do not elicit adverse biological reactions.

The purpose of these studies was to support the claim that the ClearView Total is "substantially equivalent" to predicate devices, meaning it is as safe and effective as devices already on the market, without introducing new questions of safety or effectiveness.

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The ClearView Image Enhancement System is intended for use by a qualified technician or diagnostician to reduce speckle noise, enhance contrast, and transfer ultrasound images. The software provides a DICOM-compliant ClearViewHD-enhanced image along with the original ultrasound image interpretation by the trained physician.

The ClearViewHD image processing software reduces noise and enhances contrast of medical ultrasound images. The software is a Windows XP or higher, Windows Embedded, and DICOM-compatible platform that may be installed on a standalone PC, laptop, or tablet The software does not require any specialized hardware but the time to process an image will vary depending on the hardware specifications. ClearViewHD is based on a core noise reduction and contrast enhancement algorithm that uses novel statistical techniques to determine whether each pixel location is due to mostly noise or signal (tissue structure) and attenuates the regions due to noise while preserving and accentuating the regions due to tissue structure. The statistical method is based on the a priori knowledge that the ultrasound signal is sparse and compressive sampling theory can be used to reconstruct the signal with fewer samples than the Nyquist Rate specifies.

The Clear ViewHD image processing software is a DICOM node that accepts DICOM3.0 digital medical files from an ultrasound device or another DICOM source. ClearViewHD processes the image and returns the original and/or enhanced image to another DICOM node such as a specific PC/workstation or the PACS system. The ClearViewHD software is designed to be compatible with any of the DICOM-compliant medical devices distributed by various OEM vendors.

Here's a breakdown of the acceptance criteria and the study information for the ClearViewHD device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document does not explicitly state numerical acceptance criteria thresholds. Instead, it implies that improvement in SNR and CNR, along with positive visual inspection, constitutes meeting the performance goals.

Study Information

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

• Test Set Sample Size: 10,000 simulated A-Scans (for SNR improvement). The number of previously collected clinical images used for CNR and visual inspection is not specified.
• Data Provenance: Bench testing on phantoms and previously collected clinical images. The country of origin is not specified, and it appears to be retrospective as it uses "previously collected clinical images."

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

• No information is provided regarding the number of experts or their qualifications for establishing ground truth for the test set. The evaluation seems to rely on objective metrics (SNR, CNR) and general "visual inspection" by unnamed individuals.

4. Adjudication Method for the Test Set:

• Not specified. The document only mentions "visual inspection" alongside objective metric measurements.

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, an MRMC comparative effectiveness study was not reported. The study focuses on the standalone performance of the algorithm in enhancing images, not on human reader performance with or without AI assistance. The indication for use states the enhanced image assists in interpretation by a trained physician, but this is not scientifically measured in the provided summary.

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

• Yes, a standalone performance evaluation was done. The bench testing on phantoms and previously collected clinical images directly assesses the algorithm's ability to reduce noise and enhance contrast, independent of human interaction.

7. The Type of Ground Truth Used:

• The ground truth for the quantitative metrics (SNR and CNR) appears to be derived from the simulated A-Scans and the original (unenhanced) clinical images, serving as a baseline for measuring improvement. For the visual inspection, the "ground truth" seems to be expert consensus on ideal image quality (less speckle, enhanced contrast).
• It's not pathology or outcomes data.

8. The Sample Size for the Training Set:

• The document does not specify the sample size used for the training set. It only mentions the "core noise reduction and contrast enhancement algorithm" is based on "novel statistical techniques" and "a priori knowledge."

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

• The document does not specify how the ground truth for the training set was established. It describes the algorithm as using "novel statistical techniques" and "a priori knowledge" of ultrasound signal sparsity and compressive sampling theory, suggesting a model-driven approach rather than human-annotated ground truth for training.

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The Clearview® Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The Clearview Exact II Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip. Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. A Clearview Exact II Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence or absence of pink-to-purcle colored Sample Lines. The yellow Control Line turns blue in a valid test.

Here's a breakdown of the acceptance criteria and study information for the Clearview® Exact II Influenza A & B Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance figures, as the device was deemed "substantially equivalent" which indicates these performance metrics were acceptable to the FDA. The document doesn't explicitly state pre-defined acceptance thresholds, but rather presents the results of the clinical study for evaluation.

Analytical Sensitivity (LOD) - Reported Device Performance:

Analytical Reactivity Testing - Reported Device Performance:

2. Sample size used for the test set and the data provenance

• Sample Size: 478 prospective clinical specimens.
• Data Provenance: Multi-center, prospective clinical study conducted at seven U.S. trial sites during the 2008-2009 respiratory season. Specimens were nasal swabs collected from symptomatic patients.

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

The ground truth for the clinical study was established using viral culture. This is a laboratory method and does not involve human experts in the typical "expert consensus" sense for image interpretation or diagnosis. Therefore, information about the number and qualifications of experts in this context is not applicable.

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

Not applicable, as the ground truth was "viral culture," which is an objective laboratory method rather than expert interpretation requiring adjudication. However, for the 19 samples where the Clearview test was negative for influenza B but viral culture was positive, an investigational RT-PCR assay was used as a follow-up ("Ten (10) of these samples were negative for influenza B by PCR"). This could be seen as a form of secondary verification for discrepant results.

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 device is an immunochromatographic rapid diagnostic test for direct antigen detection, not an AI-powered diagnostic imaging or interpretation tool that assists human readers.

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

Yes, the primary clinical performance study evaluated the device in a standalone manner. The results (sensitivity and specificity) represent the performance of the device itself (Clearview® Exact II Influenza A & B Test) compared to the viral culture gold standard, without human interpretation influence (other than reading the test strip, which is part of the device's intended use and not considered "human-in-the-loop AI assistance"). The reproducibility study also assessed the device's inherent performance characteristics.

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

The ground truth for the clinical study was viral culture.

8. The sample size for the training set

This information is not provided in the 510(k) summary. Given that this is an immunochromatographic assay using monoclonal antibodies, it's a traditional in vitro diagnostic, not a machine learning or AI-driven device that requires a "training set" in the computational sense. The "training" of such a device involves developing and optimizing the biochemical components and manufacturing processes, rather than training an algorithm on a dataset.

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

Not applicable, as the device is not an AI/ML-based system requiring a training set with established ground truth in the traditional sense. The analytical studies (sensitivity, reactivity, specificity) demonstrate the performance of the developed assay against known viral strains and other microorganisms.

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The Clearview Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The Clearview® Exact II Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip. Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. A Clearview Exact II Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence of pink-to-purple colored Sample Lines. The yellow Control Line tums blue in a valid test.

Here's a breakdown of the acceptance criteria and the study details for the Clearview® Exact II Influenza A & B Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in numerical terms (e.g., "Sensitivity must be > 90%"). Instead, it presents the device's performance against a gold standard (viral culture) as the evidence for substantial equivalence. The predicate device's performance often serves as an implicit benchmark for acceptance.

However, we can infer what constitutes acceptable performance from the presented results, as there's no indication that the results were unacceptable.

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

• Sample Size: 486 prospective specimens
• Data Provenance:
  • Country of Origin: U.S. (multi-center, seven trial sites)
  • Retrospective or Prospective: Prospective study, conducted during the 2008-2009 respiratory season. Specimens were collected from symptomatic patients.

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

The document does not explicitly state the number or specific qualifications of experts involved in establishing the ground truth. It relies on viral culture as the ground truth. Viral culture is a laboratory method, not typically performed by "experts" in the sense of clinicians or radiologists, but by trained laboratory personnel.

4. Adjudication Method for the Test Set

The document does not mention an explicit adjudication method (e.g., 2+1, 3+1). The primary comparison is the Clearview® Exact II test result directly against the viral culture result. For discrepant results with Influenza B (19 samples positive by culture, negative by Clearview), an investigational RT-PCR assay was used as a secondary check, showing 10 of these were negative by PCR. This suggests a form of post-hoc investigation for specific discrepancies, rather than a pre-defined adjudication process, but not a consensus reading among multiple human readers.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a standalone performance evaluation of a rapid diagnostic test against a gold standard (viral culture), not a study involving human readers or AI assistance.

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

Yes, a standalone performance study was done for the device. The Clearview® Exact II Influenza A & B Test is itself a rapid immunoassay, a "device-only" test. The "performance vs. viral culture" is the standalone performance of the diagnostic test without human interpretation of complex images or data beyond reading simple color lines.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was Viral Culture. For the 19 discrepant Influenza B samples, an investigational RT-PCR assay was also used as a secondary reference.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" for the clinical performance evaluation. The clinical study described is a prospective validation set. For a device like this, the "training" (development and optimization) would typically involve internal efforts during the assay development process, using laboratory-prepared samples or retrospective samples, but a dedicated "training set" for clinical evaluation is not described for this type of diagnostic device.

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

As no specific "training set" for clinical performance is described, the method for establishing its ground truth is not provided. For analytical studies (e.g., analytical sensitivity, reactivity), the ground truth is typically precisely quantified viral cultures or preparations.

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The Clearview® Exact PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Clearview® Exact PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.

The Clearview® Exact PBP2a Test is a rapid immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect the PBP2a protein directly from bacterial isolates. These antibodies and a control antibody are immobilized onto a nitrocellulose membrane as two distinct lines and combined with a sample pad, a blue conjugate pad, and an absorption pad to form a test strip.

Isolates are sampled directly from the culture plate and eluted into an assay tube containing Reagent 1. Reagent 2 is then added and the dipstick is placed in the assay tube. Results are read visually at 5 minutes.

The Clearview® Exact PBP2a Test is a rapid immunochromatographic assay for detecting penicillin-binding protein 2a (PBP2a) in Staphylococcus aureus isolates, aiding in the detection of methicillin-resistant Staphylococcus aureus (MRSA).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria. However, it reports sensitivity and specificity performance values for the device compared to a reference method. We can infer that the reported performance values were considered acceptable for regulatory clearance.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: A total of 457 S. aureus samples were evaluated in the clinical performance study.
• Data Provenance: The study was a multicenter clinical study conducted in 2009 at three geographically-diverse laboratories. The analytical performance section also mentions bacterial strains obtained from the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA), American Type Culture Collection (ATCC), and a collection from the Department of Infectious Disease Epidemiology of the Imperial College in London, England. This indicates a mix of strains from reference collections and clinical isolates, and at least some data provenance from England in addition to the diverse US laboratories. The study appears to be retrospective in the sense that existing S. aureus samples were evaluated by the new device.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compares the device's performance to a standard method (cefoxitin disk diffusion), not to human readers' performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone study was done. The clinical performance study directly evaluated the performance of the Clearview® Exact PBP2a Test against the reference method without human intervention in the interpretation of the device's results, as it is a visual read test that relies on the device's output. The reproducibility study also tested the device in a standalone manner.

7. Type of Ground Truth Used

The ground truth used for the clinical performance study was cefoxitin (30 ug) disk diffusion, interpreted according to CLSI (Clinical and Laboratory Standards Institute) standards. This is a recognized phenotypic method for determining methicillin resistance in S. aureus.

8. Sample Size for the Training Set

The document does not explicitly mention a dedicated "training set" or its size for the development of the Clearview® Exact PBP2a Test. The analytical performance section mentions that 162 MRSA strains and 112 MSSA strains were tested for analytical reactivity and specificity, which might represent samples used during later stages of development or validation, but it's not explicitly labeled as a training set.

9. How Ground Truth for the Training Set Was Established

Since a distinct training set is not explicitly defined, the method for establishing its ground truth is not detailed. However, for the strains used in analytical performance (162 MRSA and 112 MSSA), it is implied that their methicillin-resistant/sensitive status was known, likely established through standard microbiological identification and susceptibility testing methods (e.g., CLSI guidelines, reference lab testing) given their origin from reputable collections (NARSA, ATCC, Imperial College).

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