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This software is an accessory to standard colonoscopy. It is intended for use in the viewing, recording, archival, localization, documentation, and retrieval of still images, video, and patient data during and after a standard colonoscopic procedure. Standard colonoscopy is indicated for the evaluation of results from an abnormality on barium enema or other imaging study, unexplained gastrointestinal bleeding, screening and surveillance for colonic neoplasia, the excision of a colonic polyp, or the management of chronic inflammatory bowel disease.

Captured, compressed videos from previous exams are for viewing and reference purposes and are not intended for primary diagnosis.

Colonoscopy Assistant is a software application designed to provide a streamlined clinical user interface for colonoscopy. The software serves as a portal to useful information before, during, and after a colonoscopic exam. The software displays live video from the colonoscope, enables high-resolution image capture, provides digital noise reduction, displays side-by-side playback of previous exams, estimates the scope camera location during a colon video, and stores all patient and exam information.

This submission (K102949) describes the Colonoscopy Assistant, a software application designed to streamline the clinical user interface for colonoscopy by providing tools for viewing, recording, archiving, localization, documentation, and retrieval of still images, video, and patient data.

Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in the format of a table. Instead, it relies on verification and validation (V&V) testing against system requirements and a comparison to a predicate device to demonstrate safety and effectiveness.

The "Nonclinical Testing" section (Section 7) describes the general approach to validating the device:

• Acceptance Criteria (Implied): The software device must meet its system requirements. Specifically for the image noise reduction feature, the algorithm must decrease image noise without adding artifacts and produce reproducible filtering results.
• Reported Device Performance:
  • V&V test procedures were created and executed on the software using an NTSC analog video input source.
  • The results were compiled into V&V test reports, which presumably showed that the system requirements were met.
  • Planned risk mitigations in the hazard analysis were verified.
  • The image noise reduction feature was verified to ensure it produced safe and effective results, specifically that image noise was decreased without adding image artifacts and that filtering results were reproducible.

Since no specific numerical acceptance criteria or performance metrics are provided, a table of acceptance criteria and reported device performance cannot be generated. The submission emphasizes that all system requirements were met and verified through testing.

Study Details

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

   • The submission mentions "exam-specific imagery" and "colon images" were used for testing the image noise reduction feature, and an "NTSC analog video input source" for general V&V. However, the exact sample size (number of images/videos/exams) for the test set is not specified.
   • Data provenance is not explicitly stated, but the use of an "NTSC analog video input source" suggests a laboratory or controlled setting for general testing. For "colon images," it's unclear if these were from a specific country or whether they were retrospective or prospective.

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

   • The submission does not mention the involvement of experts to establish ground truth for the test set. The validation appears to be primarily engineering-based, comparing the software's output to defined functional requirements for video capture, archiving, noise reduction, etc.

3. Adjudication method for the test set:

   • No adjudication method is described as the ground truth was not established by multiple experts.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done. The device's purpose is as an accessory for viewing, recording, and managing colonoscopy data, not primarily for diagnostic interpretation or aiding human readers in decision-making in a way that would require an MRMC study. Its function is to streamline the workflow and manage visual data.

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

   • While the device is a "software application" and performs functions like digital noise reduction automatically, the submission does not present data specifically illustrating "standalone" diagnostic performance in the way an AI-powered diagnostic tool would. Its functions are assistive to a human-performed procedure (colonoscopy) rather than providing independent diagnostic conclusions. The noise reduction is an algorithmic standalone function, but its "performance" is verified against quality improvement criteria (decreased noise, no artifacts) rather than diagnostic accuracy.

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

   • The description implies a functional ground truth based on system requirements and expected output. For example, for noise reduction, the ground truth is "decreased image noise without adding image artifacts" and "reproducible filtering results," which would be assessed by visual inspection and technical evaluation rather than, for instance, pathology reports for diagnostic accuracy.

7. The sample size for the training set:

   • This submission describes a software accessory for data management and image processing, not a machine learning model that requires a "training set" in the conventional sense of supervised or unsupervised learning. Therefore, no training set sample size is applicable or provided.

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

   • As there is no mention of a training set, the establishment of its ground truth is also not applicable or provided.

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UltraSightHD™ C31 with ImageSense™ and Remote Viewer Telemedicine is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy.

OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The Remote Viewer Telemedicine Technology is a software feature that enables medical personnel to view live video from the UltrasightHD during an ongoing medical exam from a remote viewing station.

The UltraSightHD™ C31 Digital Colposcopy System with ImageSense™ and Remote Viewer Telemedicine Technologies represents a modification to the UltraSightHD (C30) Digital Colposcopy System with ImageSense Technology. It is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy. The illumination and optical design of the device enable the user to capture high resolution digital images. The optical subsystem is augmented by integrated image quality assessment algorithms, ensuring that focused, centered, and balanced-contrast images are acquired. Two liquid crystal displays (LCDs) provide video display and user interface information. The software includes functionality for annotating, filtering and storing the images on external PACS servers via the DICOM protocol. The ImageSense™ filters highlight certain characteristics of the captured images. The Remote Viewer Telemedicine feature enables medical personnel to view live video of an ongoing medical exam from a remote viewing station.

Here's an analysis of the provided text regarding the UltraSightHD™ C31 Digital Colposcopy System:

Based on the provided 510(k) summary, the device is a modification of an existing predicate device (UltraSightHD (C30) Digital Colposcopy System with ImageSense Technology, K090324). The main modification is the addition of "Remote Viewer Telemedicine Technology."

The document states that the device is not patient contacting and therefore no biocompatibility testing was required. This indicates the acceptance criteria and study focus are not on direct patient interaction safety or efficacy in clinical diagnosis but rather on the overall system's electrical safety, electromagnetic compatibility (EMC), and the functionality of the new telemedicine feature.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical performance metrics for clinical efficacy. The acceptance criteria appear to be compliance with relevant safety and EMC standards, and functional equivalence to the predicate device.

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

The document does not report any clinical study with a test set involving patient data for the purpose of demonstrating diagnostic accuracy or clinical efficacy. The testing mentioned refers to engineering and regulatory compliance testing.

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

Not applicable, as no clinical test set requiring expert ground truth was reported for this 510(k). The evaluation focuses on technical equivalence and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was reported for this 510(k).

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to a predicate device and technical compliance rather than clinical comparative effectiveness.

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

The device includes "integrated image quality assessment algorithms" (ImageSense™) and "OpacityViewer™ digital filter for displaying areas of acetowhitening." However, the document does not describe a standalone performance study for these algorithms. The algorithms are described as augmenting the optical subsystem and providing a tool for displaying characteristics, but not as a standalone diagnostic tool. The OpacityViewer™ is explicitly stated as "a tool that should NOT be used as a substitute for a thorough colposcopic evaluation."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical studies requiring ground truth were reported for this 510(k).

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm training data or studies were reported in this 510(k) for the purpose of demonstrating diagnostic performance. The existing ImageSense™ algorithms are mentioned as integrated, but their development or training details are not part of this submission summary.

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

Not applicable, as no machine learning algorithm training data or studies were reported in this 510(k) for the purpose of demonstrating diagnostic performance.

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UltraSightHD™ with ImageSense™ is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy.

OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.

The UltraSight HD™ Digital Colposcopy System with ImageSense™ Technology is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification.

ImageSense™ is an image processing suite available for the UltraSightHD™ digital colposcope. The ImageSense™ suite consists of two different modules: UltraGreen™ filter and Acetownite OpacityViewer™.

The UltraGreen™ filter provides the user with greater contrast than an unprocessed image. UltraGreen™ is displayed as a reqular full color image, and is available to be used on any stillframe image displayed in the Review Hi-Res Imagery, View ImageSense Results, and Annotate lmage modes.

The Acetowhite OpacityViewer™ compares two images, one taken prior to the application of Acetic Acid and an additional image taken 60 seconds after the application of Acetic Acid, otherwise known as the pre- and post- Acetic Acid images. The Acetowhite OpacityViewer™ then generates a difference map that shows the extent of white difference between the two images, which is indicated by a gradient color scale ranging from blue (no measurable difference between the images), through white (some difference) and vellow (moderate difference), to red (large difference). Red, on the difference map, indicates only the greatest color difference between the images.

The illumination and optical design of the device allow the user to capture high resolution digital images. The optical subsystem is augmented by integrated image quality assessment algorithms. ensuring that focused and balanced-contrast images are acquired. Two liquid crystal displays (LCDs) provide video display and user interface information. The software includes functionality for annotating, filtering and storing the images on external PACS servers via the DICOM protocol.

The provided text describes the UltraSightHD™ Digital Colposcopy System with ImageSense™ Technology. However, it does not include specific acceptance criteria with numerical targets or detailed results of a study designed to prove the device meets such criteria.

The document states: "Test results indicate that the device meets the performance specifications." and "Appropriate risk analysis-driven product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device." However, the specific performance specifications and the quantitative results proving conformance are not detailed within the provided text.

Here's an analysis based on the information that is available, and what is explicitly stated as not performed:

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

No explicit table of acceptance criteria with numerical targets is provided in the document. The document lists areas of testing but does not offer specific criteria or quantitative results against them.

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

• Clinical Studies: The document explicitly states: "The only clinical studies conducted were run to validate image registration."
• Sample Size for Image Registration Validation: The sample size for this validation is not specified in the provided text.
• Data Provenance: The provenance of data for the image registration validation is not specified.

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

Not applicable, as no detailed clinical study is described where experts established ground truth for a test set to evaluate the ImageSense™ features (e.g., OpacityViewer™). The clinical studies were limited to "image registration," and details are missing.

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

Not applicable, as no detailed clinical study is described that involved multiple readers or adjudication for establishing ground truth for the test set.

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. The document explicitly states: "No clinical studies were conducted to demonstrate improved clinical performance using the new OpacityViewer digital filter."

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

This is difficult to ascertain directly from the provided text for the ImageSense™ features. The "ImageSense™ Technology" (UltraGreen™ filter and Acetowhite OpacityViewer™) are described as image processing tools available to the user, suggesting they are meant to be used with a human in the loop. The document states "OpacityViewer™ is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation," further emphasizing the human's role.

The clinical studies were only to validate "image registration," which is a technical aspect of the device's image processing rather than a standalone clinical performance study of the ImageSense™ diagnostic features.

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

• For the image registration validation, the type of ground truth is not specified.
• For the ImageSense™ features (UltraGreen™ and OpacityViewer™), no clinical studies were performed to establish ground truth for their "improved clinical performance." The OpacityViewer creates a "difference map that shows the extent of white difference between the two images," which is an algorithmic output, not a ground truth derived from expert consensus, pathology, or outcomes data in the context of clinical effectiveness.

8. The sample size for the training set

Not applicable. The document describes a medical device with image processing features, not a machine learning model that would require a distinct "training set" in the conventional sense for a clinical algorithm.

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

Not applicable, as there is no mention of a training set for a machine learning model in the context of the ImageSense™ features.

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Cervical MD™ is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.

Cervical MD is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for hiopsy. The illumination and optical design of the device allow the user to carture ligh resolution quality images. The optical subsystem is augmented by integrated image quality assessment algorithms ensuring that focused, centered and balanced-contrast images are acquired. A liquid crystal display (LCD) provides a video display and user interface information. The acquired images can be transferred to a computer and viewed on a monitor.

The provided text describes the Cervical MD device, a digital colposcope, and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a specific study proving the device meets quantitative performance criteria. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than a detailed performance study with defined acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported performance, nor can I answer questions related to sample sizes, ground truth establishment, expert involvement, adjudication methods, or MRMC studies, as this information is not present in the provided text.

Based on the available information:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document states that "Design verification testing has been conducted to verify that the device satisfies the performance requirements of the device specification and that the device performance is equivalent to the predicate device in relevant areas of comparison." However, the specific acceptance criteria and the results are not detailed.

2. Sample size used for the test set and the data provenance: This information is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.

4. Adjudication method for the test set: This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, a multi-reader multi-case comparative effectiveness study is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "integrated image quality assessment algorithms ensuring that focused, centered and balanced-contrast images are acquired" and "software that indicates when quality (focused, centered and balanced contrast) imagery has been acquired." This suggests some level of algorithmic performance. However, there is no standalone performance study detailing its metrics. The focus is on the device as a whole for image acquisition rather than an AI-driven diagnostic algorithm.

7. The type of ground truth used: This information is not provided. The device is intended to "diagnose abnormalities and select areas for biopsy," implying clinical assessment or pathology as potential ground truth, but this is not confirmed or detailed in the document.

8. The sample size for the training set: This information is not provided as there is no mention of a machine learning model requiring a training set in the context of a performance study.

9. How the ground truth for the training set was established: This information is not provided.

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When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed health care professional. This product will be sold as an OTC device with the appropriate FDA cautionary labeling.

The STI OneFlow is a hand held, battery operated, electronic peak flow (PEFR) and FEV1 monitoring device with internal memory capable of storing 120 sets of readings. The product is available with or without software that downloads stored readings from the device and statistically analyzes this data as per criteria set in the patient information section of the program.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "OneFlow Tester," indicating it has been found substantially equivalent to a legally marketed predicate device.

The letter mentions:

• The device is a handheld, battery-operated electronic peak flow (PEFR) and FEV1 monitoring device.
• It has internal memory for 120 sets of readings.
• It's available with or without software for data download and statistical analysis.
• It's to be used under the direction of a physician for monitoring conditions like asthma.
• It will be sold as an OTC device with appropriate FDA cautionary labeling.
• It has been calibrated according to the American Thoracic Society "Standardization of Spirometry, 1994 Update."

However, none of this constitutes a description of acceptance criteria for a study or details of a study conducted to demonstrate performance against such criteria. The document is primarily an FDA regulatory approval notice.

Therefore, for all the requested information categories (1-9), the answer is: Not provided in the given text.

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