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The CapsoCam Plus SV-3 capsule endoscopy system is intended for visualization of the small bowel mucosa in adults and children older than two years of age. It may be used as a tool in the detection of abnormalities of the small bowel.

The primary component of the CapsoCam Plus (SV-3) capsule endoscopy system is the eponymous single-use, ingestible capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. It is administered under medical supervision either in-person or remotely under video guidance (available for adult patients only). The capsule is typically excreted within 3 to 30 hours after swallowing. Upon excretion, the patient/authorized caregiver retrieves the capsule using the provided retrieval kit and returns it to the capsules to the download center in a pre-paid envelope) where the capsule is processed and data is downloaded.

The system consists of the following hardware components and accessories:

• CapsoCam Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa.
• CapsoRetrieve (CVR1) Capsule Retrieval Kit, a kit of non-powered tools used for the collection, storage, and transportation of the excreted CapsoCam Plus (SV-3) capsules.
• CapsoAccess (CDAS) Capsule Data Access System, a dock which facilitates download/access of data from the SV-3 capsules.

The system also includes software that is unchanged from K192662.

The provided text does not contain information about acceptance criteria for device performance, nor details about a study that proves the device meets specific performance criteria through metrics like sensitivity, specificity, or accuracy.

The document is an FDA 510(k) clearance letter for the CapsoCam Plus (SV-3) Capsule Endoscopy System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance metrics from a specific clinical or technical validation study with acceptance criteria.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section states that:

• "performance testing was conducted per the appropriate FDA Recognized Consensus Standards and required bench testing specifically included 1) verification and validation of hardware changes to confirm that, upon the design changes these continue to meet the applicable product specifications, and 2) transportation and shelf-life testing..."
• "A human factors evaluation was conducted and supported by real world evidence to demonstrate that there the safely and effectively administered to adult patients in a remote setting."
• "The clinical evidence provided in the submission include (1) a subgroup analysis of the pivotal study for CapsoCam (K151635), which enrolled both transitional adolescents (n=3, age: 19-21) and adult subjects, (2) an analysis of real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia (n=26, age: 3-18), and (3) a review of the clinical literature on the pediatic use of the reference device and other capsule endoscopes cleared by the FDA indicated for use for in patients 2 years and above."

However, it does not provide the specific acceptance criteria (e.g., minimum sensitivity or specificity values) or the reported device performance against such criteria. It also lacks details on:

• The *sample size used for the test set beyond the general mention of "subgroup analysis of the pivotal study for CapsoCam (K151635)" and "analysis of real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia (n=26)". The data provenance is described as "real world data on the pediatric use of CapsoCam in a pediatric gastroenterology clinic in Australia" and a "subgroup analysis of the pivotal study for CapsoCam (K151635)". It implies retrospective analysis of existing data.
• The number of experts used to establish ground truth or their qualifications.
• The adjudication method used.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or any effect size of human reader improvement with AI assistance. (Note: This is a capsule endoscopy system, not an AI-assisted reading device, so MRMC with AI assistance would likely not be relevant here).
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used beyond "facilitate diagnostic evaluation."
• The sample size for the training set (as it refers to minor design changes and clinical evidence from existing data, it doesn't describe a new AI model training process).
• How ground truth for the training set was established.

In summary, the provided document is a 510(k) clearance letter confirming substantial equivalence, and it does not contain the detailed performance study information with specific acceptance criteria, reported metrics, and study design elements regarding ground truth establishment, expert adjudication, or AI model training/testing that your request asks for. This type of information is typically found in the full 510(k) submission, specifically the performance data section, which is not fully included in this clearance letter.

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The CapsoCam ® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

CapsoCam® Plus (SV-3) capsule is a single-use. ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the provided retrieval kit and returns it to the physician who downloads and reviews the images on a computer. The capsule is typically excreted within 3 to 30 hours after swallowing.

CapsoCam® Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The system consists of the following accessories:

• CapsoCam® Plus (SV-3) capsules, which are intended for visualization of the small bowel mucosa in adults and used as a tool in the detection of abnormalities of the small bowel.
• CapsoView (CVV) software program, which is used to download and view CapsoCam® Plus ● (SV-3) capsule images and to generate capsule endoscopy reports.
• CapsoAccess (CDAS) Capsule Data Access System, which accesses data from the ● CapsoCam® Plus (SV-3) capsules.
• CapsoRetrieve (CVR1) Capsule Retrieval Kit, which is used for the collection, storage, and ● transportation of the excreted CapsoCam® Plus (SV-3) capsules.
• CapsoCloud (CLD), which is a cloud-based software application used to manage procedures ● and to review and analyze images from the CapsoCam® Plus (SV-3) capsule.

Here's a breakdown of the acceptance criteria and study information for the CapsoCam® Plus (SV-3) Capsule Endoscopy System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets for clinical performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (CapsoCam® Plus (SV-3) System, K183192).

The key performance aspect tested for the new CapsoCloud software application was image comparison and Image Substantial Equivalence Analysis between the proposed and predicate software.

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

The document states "in-vivo testing for the image comparison from the proposed and the predicate software."

• Sample Size: Not explicitly stated.
• Data Provenance: "in-vivo testing" suggests data from live subjects, but details like country of origin or whether it was retrospective or prospective are not provided.

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

This information is not provided in the document.

4. Adjudication Method

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not conducted or reported in this document. The focus was on demonstrating substantial equivalence to a predicate device, specifically regarding the addition of a new cloud-based software. There is no mention of human reader performance improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance

A standalone performance study focused purely on the algorithm's diagnostic capabilities without human interaction was not explicitly described for this submission. The validation focused on the CapsoCloud software and image equivalence to the predicate system, which implies the system as a whole maintains its performance characteristics when the cloud software is introduced.

7. Type of Ground Truth Used

The ground truth for the "image comparison from the proposed and the predicate software" would be rooted in the images generated by the predicate device's software. The goal was to show that the new software (CapsoCloud) processes and presents images that are substantially equivalent to those processed by the predicate's CapsoView software. The document doesn't detail how the ground truth for actual abnormalities or diagnoses in these images was established, as the primary comparison was between software versions, not necessarily clinical diagnostic accuracy.

8. Sample Size for the Training Set

This information is not provided in the document.

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

This information is not provided in the document.

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The CapsoCam® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

CapsoCam Plus (SV-3) capsule is a single-use, ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the capsule using the provided retrieval kit and returns it to the physician who downloads and reviews the images on a computer. The capsule is typically excreted within 3 to 30 hours after swallowing.

CapsoCam Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The overall system consists of an ingestible Capsule CapsoCam (SV-3), the CapsoRetrieve® (CVR1) Capsule Retrieval Kit, the CapsoAccess® Capsule Data Access System (CDAS) and the CapsoView® (CVV) software. The capsule contains a panoramic color digital video camera, two silver-oxide watch batteries, white-LED light sources, a laser diode for data download and system-control and nonvolatile flash-memory data-storage electronics.

The provided text is a 510(k) summary for the CapsoCam Plus (SV-3) video capsule system. This document outlines the device's indications for use, its description, and its substantial equivalence to a previously cleared predicate device. It also briefly mentions non-clinical and clinical testing performed.

However, the document does not contain specific acceptance criteria, study details demonstrating performance against criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or information about AI assistance or standalone algorithm performance.

The clinical summary states that the testing demonstrated:

• Images are captured throughout an entire small bowel exam, with complete small bowel exam defined as the ability of the capsule to reach the cecum while still recording images.
• Images are correctly downloaded using the CapsoAccess® capsule data access system (CDAS3).
• Small bowel images of diagnostic quality are able to be reviewed using the CapsoView® CVV Software and determined to be effective for diagnostic purposes by the study investigator.

It concludes that "the results of this clinical testing demonstrate that it meets the primary endpoints per the study protocol and the performance of the CapsoCam Plus (SV-3) Capsule Endoscope System does not raise new issues of safety or effectiveness when compared to the predicate device (K161773)."

The purpose of this 510(k) submission appears to be related to minor changes or reaffirmation of substantial equivalence to an already cleared device (K161773). Therefore, the detailed performance study information, including specific acceptance criteria and quantitative results, would have been part of the original K161773 submission, not this K183192 summary.

Therefore, based solely on the provided text, I cannot provide the requested information in detail because it is not present. The document focuses on showing substantial equivalence rather than detailing a de novo performance study with specific metrics and acceptance criteria.

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The CapsoCam® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

CapsoCam Plus (SV-3) Capsule Endoscope System is a single-use, ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the capsule using the provided retrieval kit and returns it to the physician who downloads and reviews the images on a computer. The capsule is typically excreted within 3 to 30 hours after swallowing. The device is contraindicated in patients:

• · Who have known or suspected gastrointestinal obstructions, strictures or fistula
• · Who are pregnant
• · Who have gastroparesis
• · Who have a swallowing disorder

CapsoCam Plus (SV-3) capsule endoscope system is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The overall system consists of an ingestible CapsoCam (SV-3), the CapsoRetrieve® (CVR1) Capsule Retrieval Kit, the CapsoAccess® Capsule Data Access System (CDAS) and the CapsoView® (CVV) software. The capsule contains a panoramic color digital video camera, two silver-oxide watch batteries, white-LED light sources, a laser diode for data download and system-control and nonvolatile flashmemory data-storage electronics.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device (CapsoCam SV-1) and the studies conducted to demonstrate equivalence and improved performance. However, explicit numerical acceptance criteria are not presented in a formal table within this document. The studies' results are presented as evidence of meeting performance expectations relative to the predicate and overall diagnostic quality.

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

• Study 1 (CVI-006 "Validation of CapsoCam® SV-3 Capsule Endoscopy System"):
  • Sample Size: 42 "Per-Protocol" subjects (from 49 enrolled healthy volunteers).
  • Data Provenance: Prospective, healthy volunteers, country not specified but implied to be in a clinical trial setting.
• Study 2 (Comparisons of reads of select video clips from CVI-006 by Independent Blinded readers):
  • Sample Size: Not explicitly stated as a number of subjects, but refers to "images of landmarks and pathologies" extracted from the 42 subjects of Study 1. The tables show N=42 for overall consensus.
  • Data Provenance: Retrospective analysis of clips from the prospective Study 1.
• Study 3 (Comparison of SV-1 and SV-3 software performance):
  • Sample Size: 40 video clips (11 normal, 29 with pathology) from the original SV-1 study.
  • Data Provenance: Retrospective analysis of clips from an earlier SV-1 study.

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

• Study 1: The "principal investigator" assessed landmarks, completion of exam, pathologies, and image quality. The number of principal investigators is not specified (implied to be one for reporting purposes). Their qualifications are not explicitly detailed but should be a medical professional qualified to read capsule endoscopy studies.
• Study 2: "Independent Blinded readers" assessed landmark video quality, pathologies, and subjective questions. The number of independent readers is not explicitly stated in detail for consensus; however, the "Consensus Amongst readers with video clips of Landmarks" table implies multiple readers reached consensus. An example note clarifies for "discordant finding was identical for all 3 readers" in Study 3, suggesting at least 3 readers were involved in such assessments. Their qualifications are not explicitly detailed again, but should be experts in capsule endoscopy interpretation.
• Study 3: "Independent blinded readers" were used. As noted above, the text mentions "all 3 readers" for the discordant findings, suggesting 3 readers were involved in comparing the software versions. Their qualifications are not explicitly detailed.

4. Adjudication Method for the Test Set

• Study 1: The Principal Investigator made the assessments. No explicit adjudication method among multiple initial readers is mentioned for this phase.
• Study 2 & 3: "Consensus Amongst readers" and "Consensus agreement" are mentioned for various aspects. This implies an adjudication process where readers' opinions were reconciled into a single agreed-upon finding. While the specific mechanism (e.g., majority vote, discussion to consensus, expert adjudicator) is not detailed, it indicates a method was used to arrive at a single 'ground truth' for these multi-reader assessments. For Study 3, it notes that "The discordant finding was identical for all 3 readers," which means even where there wasn't full agreement with the original finding, the readers were consistent with each other.

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

• Yes, Study 3 involved multiple readers comparing the performance of the SV-3 software to the SV-1 software on the same set of video clips. This constitutes a form of MRMC study in terms of software comparison.
• Effect Size of Human Readers Improve with AI vs. without AI Assistance:
  • This document describes a comparison between two versions of a device/software (SV-1 vs SV-3 software), not AI assistance for human readers versus human readers alone. The SV-3 software is an improvement to the device's image processing and viewing capabilities.
  • The results show improvement in image quality preference: "28 (70%) Ranked the SV-3 image as better than the SV-1 image; 12 (30%) Ranked both SV-3 image and SV-1 image as comparable; 0 (0%) Ranked the SV-1 image as better than the SV 3-image."
  • For clinical assessment quality, "39 (97.5%) Ranked both SV-3 image and SV-1 image as comparable; 1 (2.5%) Ranked the SV-3 image as better than the SV-1 image."
  • This indicates the newer device/software improved image quality, but there was largely comparable clinical assessment quality, and slight improvements in ease of use and reviewing experience for a small percentage of readers.

6. Standalone Performance Study

• Yes, Study 1 appears to be a standalone performance study for the CapsoCam Plus (SV-3) capsule endoscope system. It assesses the device's diagnostic quality, small bowel completeness, and ability to identify pathologies and landmarks in healthy volunteers using the SV-3 device alone. The results in the tables for Study 1 directly reflect the performance of the SV-3 system.

7. Type of Ground Truth Used

• Expert Consensus/Clinical Assessment:
  • Study 1: The ground truth for pathologies, landmarks, diagnostic quality, and completeness was established by the "Principal Investigator's" clinical assessment during the study.
  • Study 2 & 3: The ground truth for landmark and pathology identification in these studies appears to be based on "Consensus Amongst readers" or agreement with the "original pathologies identified" from the prior studies. This points to expert consensus as the primary ground truth.

8. Sample Size for the Training Set

• The document does not provide information about a training set. This document describes clinical validation studies for the device itself and its software, not the development or training of an AI algorithm. If the device incorporates AI, the training data for that AI is not detailed here.

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

• As no training set is mentioned for an AI algorithm, this information is not available in the provided text.

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The CapsoCam SV-1 video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

CapsoCam® SV-1 is a single-use, ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the capsule using the provided retrieval kit, and returns it to the physician who downloads and reviews the images on a personal computer (PC). The capsule is typically excreted within 3 to 30 hours after swallowing.

The CapsoCam® SV-1 video capsule is a panoramic imaging system which includes a panoramic lens system and a multi-array CMOS image sensor. The CapsoCam® has four side-facing cameras arrayed about the circumference of the capsule that together image a full 360° circumference and capture high-resolution color images of the mucosa.

The CapsoCam® SV-1 acquires video images while moving through the patient's gastrointestinal tract. The frame rate is 5 frames per second (FPS) for each of 4 cameras (20 FPS total) the first two hours, and then decreases to 3 FPS per camera (12 FPS total). The initial frame rate is higher because the capsule moves more quickly in the duodenum than in the jejunum or ileum.

After excretion, the capsule is retrieved by the patient using CapsoRetrive, a capsule retrieval system, including a strainer which is placed in the patient's toilet to retrieve the capsule while passing fecal matter and rinse water. The patient then returns the capsule to the clinic, where a technician disinfects the capsule and retrieves the data using the CapsoAccess, Capsule Data Access System (CDAS). The CDAS is comprised of a capsule carrier for holding the capsule opener for cutting off one end of the capsule, and a docking system for forming an electrical contact to the capsule printed circuit board (PCB) through the open end. The data is transferred to the workstation over the link shown schematically in Figure 4 below, from the capsule to the docking system by a serial peripheral interface (SPI) and to the workstation by a universal serial bus (USB).

The reviewing workstation is a personal computer (PC) with the Capso Vieweimage review software installed. The CapsoView@(CVV) software displays the video and employs a variety of image-enhancement, video navigation, and image analysis features to facilitate the physician's diagnosis. The software allows the physician to efficiently annotate individual frames from the video and compile a procedure report.

1. Acceptance Criteria and Device Performance:

The document outlines acceptance criteria based on two co-primary endpoints and several secondary endpoints.

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

• Sample Size: 121 subjects (age 18 to 85)
• Data Provenance:
  • Country of origin: USA (Multi Center Pivotal Study)
  • Retrospective or Prospective: Prospective (clinical trial was performed "on the CapsoCam® Capsule Endoscope System per Protocol Number SV-1- Comparison of Capso Vision SV-1 to PillCam® SB2")

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

• Number of Experts: Three (3) independent readers per set of images.
• Qualifications of Experts: The document states "independent readers, who were blinded to the subject clinical information or suspected diagnosis." Specific medical qualifications (e.g., "radiologist with 10 years of experience") are not provided in the submitted text. They are likely gastroenterologists or other medical professionals specializing in capsule endoscopy review.

4. Adjudication Method for the Test Set:

• Adjudication Method: If any of the three (3) readers in a group disagreed with the Primary Diagnosis or complete exam, the findings were discussed by members of the group until a 2/3 majority or consensus agreement for Primary Diagnosis was reached.

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

• Yes, a comparative effectiveness study was done. The study compared the CapsoCam® SV-1 to the predicate device, PillCam® SB2.
• Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance:
  • The provided text does not contain information on human readers improving with AI assistance vs. without AI assistance. The study design involved humans reading images from two different capsule devices (CapsoCam SV-1 and PillCam SB2) in a blinded fashion. It does not describe an AI assistance component for human readers. This was a direct comparison between two devices through human interpretation.

6. Standalone (Algorithm Only) Performance:

• No, a standalone (algorithm only) performance study was not described. The study evaluates the "CapsoCam® Capsule Endoscope System," which includes the capsule and the CapsoView® software. Performance metrics are based on the interpretations of human readers utilizing the device's output, making it a human-in-the-loop assessment rather than a standalone algorithm evaluation. The software primarily focuses on image display, enhancement, navigation, and report generation for human review.

7. Type of Ground Truth Used:

• Type of Ground Truth: Expert Consensus. The ground truth ("Primary Diagnosis" and "completed exam" status) for each case was established by a 2/3 majority or consensus agreement among a group of three independent readers comparing the findings from both CapsoCam and PillCam. The document refers to "the most clinically significant Primary Diagnosis."

8. Sample Size for the Training Set:

• Not explicitly provided. The document describes a "Multi Center Pivotal Study" (test set) but does not detail the sample size or specific methodology for a separate training set. The descriptions of training sets are typically associated with machine learning models, and this document focuses on clinical performance comparison of a diagnostic device through human review.

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

• Not applicable / Not provided. As the document does not describe a distinct training set for a machine learning model, the method for establishing its ground truth is not mentioned. The document primarily focuses on the validation study (test set) for regulatory approval.

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