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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 PillCam™ Genius SB Capsule Endoscopy Kit with the PillCam Genius SB Capsule is intended for visualization of the small bowel mucosa.
• It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
· It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
• It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
The PillCam Genius SB Capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults.

The subject device introduces the PillCam Genius Capsule Endoscopy Kit (PillCam Genius SB Capsule and the PillCam Genius Link Device), the PillCam Genius Sync Agent, and the Real Time View Application.
The PillCam Genius Link Device is a single use device that is adhered to the patient's abdomen throughout the PillCam Genius SB procedure that connects to the PillCam Genius SB Capsule. Each Genius Link Device is paired and packaged with a single PillCam Genius SB Capsule. At the end of the procedure, the Link Device is removed and returned to the clinic.
The PillCam Genius Sync Agent is software used by the healthcare provider to setup and manage PillCam Genius SB endoscopy procedures and converts data from the PillCam Genius Link Device to the workstation.
The optional Real Time View Application allows the healthcare provider to view real time images from the capsule for a short period of time during the procedure to estimate the location of the capsule in the gastrointestinal tract.
The PillCam Desktop Software and HCP Software Application have been updated to display PillCam Genius SB Capsule procedures. The HCP Software Application has also been updated to be compatible with the PillCam Genius SB System and allow for uploading multiple procedures.

This 510(k) summary does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria. Specifically, it states that "No clinical testing was conducted in support of this 510(k) submission." Therefore, it's not possible to provide the requested details from the given text.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, including biocompatibility, bench testing, electrical safety, EMC, and software documentation.

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The NaviCam Small Bowel (SB) Capsule Endoscopy System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 2 years of age.

The NaviCam Tether is an accessory of the NaviCam SB Capsule. It is intended to aid the capsule for visualizing the esophagus prior to the capsule's release into the gastrointestinal tract for a SB capsule endoscopy procedure in adults (≥ 22 years).

The NaviCam Small Bowel Capsule Endoscopy System is an endoscopic capsule imaging system intended to obtain images of the small bowel. It is comprised of the following components:

• a. Capsule: The disposable, ingestible NaviCam Small Bowel Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via an RF communication channel to the NaviCam Data Recorder located outside the body.
• Data recorder: The Data Recorder is an external receiving/recording unit that receives b. and stores the acquired images from the capsule.
• ESView Software: The ESView is a software application for processing, analyzing, c. storing, and viewing the acquired images collected from the NaviCam Data Recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports and a capsule endoscopy atlas.
• Locator: The Locator is a handheld device that is used to turn the NaviCam Capsule d. on. It is also used for determining if the capsule is still in the body when the patient is not sure whether he/she expelled it.
• e. Tether: The NaviCam Tether is a disposable product, which serves as an accessory to the NaviCam SB Capsule to allow for examination of the esophagus prior to releasing the NaviCam SB Capsule into the small bowel.

Please note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed acceptance criteria and performance metrics. Therefore, some of the requested information, particularly quantitative acceptance criteria and specific performance metrics of the device itself from a dedicated new study, is not explicitly present in the provided document. The document primarily relies on existing clinical experience with similar devices and bench testing for the new components.

Here's an attempt to extract the information based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the NaviCam Small Bowel Capsule Endoscopy System in the context of a new efficacy study. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device (Given PillCam Platform with PillCam SB Capsules) and confirming safety and effectiveness for expanded indications through existing clinical data and bench testing.

The "reported device performance" is largely framed by demonstrating equivalence to the predicate and showing that the expanded indications are supported by existing clinical experience.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Missing from the document: Specific measurable acceptance criteria (e.g., minimum sensitivity, PPV for lesion detection) from a dedicated clinical study for this specific device.

Additional Information:

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

• Test Set for Pediatric Indication Expansion (2-21 years old): The submission relies on a summary of 1566 pediatric patients from 10 published clinical studies (a meta-analysis from 2001-2010 with 723 patients, and 9 additional studies from 2011-2022 with 843 patients).
• Data Provenance: The data is retrospective, drawn from published clinical trials and meta-analyses. The specific countries of origin for each study are not detailed in this summary, but these are generally international publications.
• Test Set for NaviCam Tether and Packaging: Not specified for a clinical test set. Bench testing was performed for these components.

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

• The document does not describe a new study where experts established ground truth for a test set specifically for this 510(k) submission. It relies on previously published clinical data. Therefore, the number and qualifications of experts involved in the original studies establishing ground truth for the 1566 pediatric patients are not detailed here.

4. Adjudication method for the test set:

• Not applicable, as a new clinical study with a prospectively adjudicated test set was not conducted for this submission. The information is derived from a compilation of past clinical trials.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done according to the provided text. The submission focuses on substantial equivalence based on technological characteristics and existing clinical data for similar devices, rather than a direct comparison of human readers with and without AI assistance for this specific device.

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

• The document does not describe a standalone performance study of an algorithm for lesion detection or diagnosis. The device is described as an "endoscopic capsule imaging system" that acquires images for processing, analyzing, storing, and viewing by a software application to create a video for "physician review." This implies an always human-in-the-loop design.

7. The type of ground truth used:

• For the pediatric population data, the ground truth would have been established within the original clinical studies from which the meta-analysis and publications were drawn. Typically for capsule endoscopy, this might involve:
  • Expert Consensus: Review of capsule endoscopy videos by experienced gastroenterologists.
  • Follow-up Endoscopy/Colonoscopy with Biopsy: If medically indicated and feasible, direct visualization and histological confirmation.
  • Clinical Outcomes/Diagnosis: Correlation with patient symptoms and other diagnostic test results.
    The specific method for each of the 10 included studies is not provided here.

8. The sample size for the training set:

• The document does not describe a training set for an AI algorithm, as the submission focuses on hardware and software for image acquisition, storage, and viewing, and relies on existing clinical experience for its indications. Therefore, the sample size for a training set is not applicable or provided.

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

• Not applicable, as no AI training set is described in this submission.

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The PillCam SB 3 capsule is intended for visualization of the small bowel mucosa.

• . It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
• . It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
• It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.

The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

The PillCam SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

The subject device, PillCam Cloud Reader SW, is an additional cloud data management option which enables users to review PillCam CE videos stored on the public cloud repository.

The PillCam Cloud Reader SW utilizes Amazon Cloud Services (also referred to as "HCP Cloud" or "AWS") offering a vast standardized, robust, and verified platform that facilities multiple containers while utilizing various cloud services. AWS enables easy and efficient scaling up and down, leveraging the system's efficiency for the PillCam Cloud Reader SW.

The AWS cloud environment is comprised of 2 components: the Cloud Reader Video Storage and HCP Software Application, refer to Section 5.3 for further technological details of each component.

The PillCam Sync Agent is a local software component that is installed in the PillCam Software 9.0E workstation. The PSA continuously sycronizes the local data from the local database (predicate component #4 in the figure below) back and forth to the PillCam Cloud Reader Video Storage component.

The provided text describes the regulatory submission for the PillCam SB 3 Capsule Endoscopy System with PillCam Software 9.0E (including PillCam Cloud Reader Software). This submission focuses on the addition of a cloud data management option (PillCam Cloud Reader SW) to an already cleared device.

Crucially, the document states: "PillCam Cloud Reader is a software application that is utilized to view videos and create reports and does not process and/or analyze acquired images. Input videos are displayed with no processing or alteration. The compilation of the video from the acquired images is still conducted using the predicate device PillCam capsule endoscopy system with PillCam Software 9.0E workstation component." This means the device itself (the cloud reader software) does not have performance characteristics related to diagnostic accuracy, as it merely displays previously processed video.

Therefore, the typical acceptance criteria and study design for evaluating the diagnostic performance of an AI-powered medical device are not applicable here. The "acceptance criteria" for this device relate to its functionality as a cloud-based viewing and reporting tool, and its compliance with software and cybersecurity standards. The document outlines a Non-Clinical Performance Assessment, focusing on software verification and risk management.

Here's an interpretation based on the provided text:

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

The document does not provide a table with specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, AUC) because the PillCam Cloud Reader SW is a viewing and reporting tool, not an image analysis or diagnostic device. Its performance is evaluated based on software functionality, data integrity, and compliance with regulatory standards.

The "acceptance criteria" would be met by demonstrating:

• Functional performance: The ability to correctly display video, create reports, and utilize cloud services as intended.
• Data integrity and security: Ensuring that video data is accurately stored, retrieved, and secure within the AWS cloud environment.
• Compliance: Adherence to established software development lifecycle processes, risk management, and relevant FDA-recognized consensus standards.

The reported device performance in this context is that the device has undergone "Non-Clinical Performance Assessment" involving "protocols, test methods, and acceptance criteria used for verification of the proposed PillCam Cloud Reader are well established methods." It states: "The information summarized in Table 7-1: Design Controls Activities Summary for PillCam Cloud Reader Software, including related risks and risk mitigations, are based on the PillCam Cloud Reader Software risk management plan and summary. These well established methods are in agreement with recommendations in the applicable FDA recognized census standards listed in Section 9.0."

Since this acceptance is for a cloud viewer and not an image analysis tool, detailed performance metrics like sensitivity/specificity are not relevant given the information provided.

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

Not applicable, as this is a software functionality and cybersecurity evaluation, not a diagnostic performance study using a medical image test set. The testing would involve simulated or real operational scenarios for the software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as there is no diagnostic "ground truth" to establish for this particular software component. The software does not interpret images or provide diagnoses.

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

Not applicable.

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. The PillCam Cloud Reader SW does not involve AI assistance for image interpretation.

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

Not applicable. The PillCam Cloud Reader SW is a viewing platform, not a standalone diagnostic algorithm.

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

Not applicable for diagnostic performance. If "ground truth" were to be considered for software functionality, it would refer to the expected behavior of the software according to its design specifications.

8. The sample size for the training set

Not applicable, as this device does not involve a machine learning model that requires a training set.

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

Not applicable.

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The NaviCam Small Bowel Capsule Endoscopy 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.

The NaviCam Small Bowel Capsule Endoscopy System is an endoscopic capsule imaging system intended to obtain images of the small bowel. It is comprised of the following components:

1. Capsule (AKES-11SW, AKES-11SI): The disposable, ingestible NaviCam Small Bowel Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via an RF communication channel to the NaviCam Data Recorder located outside the body.
2. Data recorder (AKR-1, AKRI-1): The Data Recorder is an external receiving and recording unit that receives and stores the acquired images from the capsule.
3. ESView Software: The ESView is a software application for processing, analyzing, storing, and viewing the acquired images collected from the NaviCam Data Recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports and a capsule endoscopy atlas.
4. Locator: The Locator is a handheld device that is used to turn the NaviCam Capsule on. It is also used for determining if the capsule is still in the body when the patient is not sure whether he/she expelled it.

The NaviCam Small Bowel Capsule Endoscopy System was assessed for its performance primarily through a comparative clinical study against a predicate device, the PillCam SB3 Capsule Endoscopy System, and also through various bench/in-vitro tests.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions that the clinical study was a prospective study (NCT05086471).
However, the specific sample size (number of patients or cases) used for the test set is not provided in the given text.
The data provenance (e.g., country of origin) for the clinical study is also not stated.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text. The text only states that the NaviCam system was compared to the PillCam SB3 in terms of diagnostic performance, but it doesn't detail how discrepancies or consensus was handled for establishing ground truth or comparing diagnostic findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs Without AI Assistance

A comparative clinical study was performed, but it was to compare the device's performance (NaviCam Small Bowel Capsule Endoscopy System) to a predicate device (PillCam SB3 Capsule Endoscopy System), not specifically an MRMC study assessing human reader improvement with or without AI assistance. The study evaluates the diagnostic agreement between the two capsule endoscopy systems. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable/not reported in this context.

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

The NaviCam Small Bowel Capsule Endoscopy System includes "ESView Software...for processing, analyzing, storing, and viewing the acquired images... The software also includes a reporting function". While the software performs analysis, the clinical study appears to evaluate its overall diagnostic performance in detecting abnormalities, which would typically involve human review of the generated images/reports. The text does not explicitly state if a standalone algorithm-only performance study was conducted separate from human interpretation. The reported "diagnostic Overall Percent Agreement" is for the system, which implies the combined interpretation of the images.

7. The Type of Ground Truth Used

The ground truth for the clinical study is based on the detection of abnormalities of the small bowel by both the NaviCam system and the predicate PillCam SB3 system. The phrase "diagnostic Overall Percent Agreement" implies that the agreement was measured against the findings of another diagnostic tool (the predicate device), which often serves as a form of "ground truth" in equivalence studies when a gold standard (like pathology) is not universally available for every finding. The document does not explicitly state that pathology or outcomes data were used as the definitive ground truth for every finding. It strongly suggests the predicate device's findings were used as the reference point for comparison.

8. The Sample Size for the Training Set

This information is not provided in the given text. The document focuses on the performance study data, not the training dataset for any underlying AI/software components.

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

This information is not provided in the given text, as details about a training set are absent.

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The PillCam SB 3 capsule is intended for visualization of the small bowel mucosa.

• It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
• It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
• It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
  The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
  The PillCam SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

The PillCam SB 3 Capsule endoscopy system is a device that provides visualization of the small bowel mucosa. The device was previously cleared under 510(k) submission K123864 for the SB 3 Capsule, PillCam DR3 recorder and accessories, and K170210 incorporated the PillCam Software 9.0 to the device is comprised of four main subsystems further described below.
Ingestible PillCam SB 3 Capsule: The disposable, ingestible PillCam SB 3 Capsule is designed to acquire images during the natural propulsion through the digestive system. The capsule transmits the acquired images via a RF communication channel to the PillCam DR3 recorder located outside the body.
PillCam DR3 Recorder: The PillCam DR3 recorder is an external receiving/recording unit that receives and stores the acquired images from the capsule.
PillCam Software: The PillCam Software 9.0E is a software application that is utilized to process, analyze, store, and view the acquired images collected from the PillCam DR3 recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms. PillCam Software 9.0E supports PillCam capsule endoscopy of the gastrointestinal (GI) tract with all PillCam capsules (SB, COLON, UGI and SBC (renamed Crohn's)).
Workstation and Accessories: The Workstation is a user-provided modified standard personal computer, that is the operational platform for the PillCam software. The Sensor array or sensor belt receive data from the PillCam capsule and transfer the data to the PillCam Recorder DR3.

The provided text does not contain detailed acceptance criteria for standalone device performance and specific study data to prove that the device meets these criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a new remote administration option.

However, based on the information provided, here's a breakdown of what can be inferred about the device's performance characteristics and the supporting evidence:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Since explicit acceptance criteria for a "new" device performance study are not provided, we must infer that the accepted performance is based on the previously cleared predicate devices. The document explicitly states: "Prior testing provided in support of the Given PillCam SB 3 capsule endoscopy system (K123864) and PillCam Desktop Software 9.0 (cleared in K170210 with SBC capsule endoscopy system), verified the device's components, as well as the performance."

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

• For remote administration usability and safety:

  • Test Set Sample Size: 35 procedures.
  • Data Provenance: Commercial centers, since October 2020. This indicates prospective real-world use data. The country of origin is not explicitly stated, but the submitter is an Israeli company.

• For core device performance (visualization, lesion detection):

  • The document implies that the performance data for these aspects come from the predicate device clearances (K123864 and K170210). The sample sizes and data provenance for those original studies are not provided in this document.

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

• For remote administration usability: The document mentions "usability testing... consisted of simulated-use sessions with the device and a healthcare provider." It does not specify the number of healthcare providers or their qualifications.
• For remote administration safety: The 35 procedures involved patients, and "no complications reported" would likely be based on clinical observation by medical staff. No independent experts establishing "ground truth" are mentioned for this aspect, as it relates to complication rates rather than diagnostic accuracy.
• For core device performance: This information would be within the predicate device submissions (K123864, K170210) and is not provided in this document.

4. Adjudication Method for the Test Set

• The document does not describe any formal adjudication method for the remote administration usability and safety data. For usability, errors were "captured," but the process for classifying or adjudicating these errors (e.g., by multiple experts) is not detailed.
• For the core device performance, information on adjudication from the predicate studies is not provided in this document.

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

• No, a MRMC comparative effectiveness study was not done for this submission. The submission is primarily focused on demonstrating substantial equivalence for a labeling change (remote administration) based on existing device performance. There is no mention of human readers improving with or without AI assistance, as the "AI" component here (SBI feature) is already part of the predicate and not being newly evaluated in a comparative effectiveness study against human readers.

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

• The document refers to the "Suspected Blood Indicator (SBI) feature" which "is intended to mark frames of the video suspected of containing blood or red areas." This feature, while part of the software, is an assistive tool for human readers.
• The document does not report a standalone performance study (i.e., algorithm only without human-in-the-loop performance) for the SBI feature or any other automated detection capability. Its performance is implicitly considered acceptable through its inclusion in the predicate device.

7. Type of Ground Truth Used

• For remote administration usability: Ground truth was established through observing and recording user performance and errors in simulated use, likely against pre-defined success criteria for the procedure steps.
• For remote administration safety: Ground truth was the absence of reported complications in real-world clinical use.
• For core device performance (e.g., lesion detection): This information would be in the predicate device submissions and is not provided in this document. Typically for such devices, ground truth might involve endoscopic findings, histological confirmation (pathology), or clinical follow-up/outcomes data.

8. Sample Size for the Training Set

• The document does not provide any information on the sample size used for training any algorithms within the PillCam Software 9.0E, including the SBI feature. This is likely because the software itself (including the SBI feature) existed in the predicate device.

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

• As no information on a training set is provided, the method for establishing its ground truth is also not available in this 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 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 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa.

• It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.

• It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.

• It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia(IDA) not detected by upper and lower endoscopy.

The Red Lesion Detector is intended to mark frames of the video suspected of containing active bleeding. angioectasia, red spot, ulcer or erosion.

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine and is intended for use in adults only.

The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is a capsule imaging system used for visualization of the small intestine mucosa.

This system consists of capsule endoscopes which capture images and transmit the data, an antenna unit and a recorder which are secured around the patient and receive data from the capsule, and workstation software which downloads the image data from the recorder and processes images for visualization.

The provided document, a 510(k) summary for the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM, details the device and its performance testing, specifically focusing on the "Red Lesion Detector" function.

Here's a breakdown of the acceptance criteria and study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

1. Sample Size and Data Provenance:

   • Test Set Sample Size: The document does not explicitly state the sample size of the clinical test set (i.e., the number of patients or capsule endoscopy videos used). It only refers to "the clinical performance testing."
   • Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not provide details on the number of experts used to establish the ground truth for the test set or their specific qualifications. It only mentions "clinical performance testing" and the evaluation of the Red Lesion Detector's performance.

3. Adjudication Method:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set's ground truth establishment.

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

   • No MRMC comparative effectiveness study involving human readers is mentioned. The study described focuses on the comparison of the algorithm's performance (Red Lesion Detector) against that of the predicate device's algorithm (Red Color Detection function of PD), not on how AI assistance improves human reader performance.

5. Standalone (Algorithm Only) Performance:

   • Yes, a standalone (algorithm only) performance study was implicitly done. The "clinical performance testing" evaluates the Red Lesion Detector's performance in terms of specificity and sensitivity for various red lesions and specifically for active bleeding, and compares it directly to the predicate device's algorithm. This suggests an evaluation of the algorithm's capability independent of direct human interaction during the detection process.

6. Type of Ground Truth Used:

   • The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, for a device visualizing lesions, it is highly probable that the ground truth for "red lesions" and "active bleedings" would have been established by expert clinical review (e.g., gastroenterologists or endoscopists) of the capsule endoscopy videos themselves, possibly with additional clinical context or follow-up.

7. Training Set Sample Size:

   • The document does not provide any information regarding the sample size of the training set used for the development or training of the Red Lesion Detector algorithm.

8. Ground Truth Establishment for Training Set:

   • The document does not describe how the ground truth for the training set was established. It only mentions "Updating the software for the workstation - Improvement of the Red Color Detection function by updating the software algorithm (Red Lesion Detector)." This implies that the algorithm was refined or retrained, but the specifics of that process and its ground truth are not provided.

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The MiroCam® Capsule Endoscope System is intended for visualization of the small bowel mucosa.

• It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
• It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
• It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy.
  It may be used as a tool in the detection of abnormalities of the small bowel and this device is indicated for adults and children from two years of age.
  The Suspected GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.

The MiroCam® Capsule Endoscope System is comprised of the following core components:

• MiroCam® Capsule: MC1600-B
• MiroCam® Receiver: MR2000
• Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
• MiroView™ Software: MiroView™ U 4.0
  The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the GI tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.

The provided text describes the MiroCam® Capsule Endoscope System and its substantial equivalence to predicate devices, including performance testing results for the MiroView™ Express 3.0 software. While it refers to "acceptance criteria" through comparison with predicate devices and mentions performance testing, explicit, quantifiable acceptance criteria are not clearly laid out in a dedicated table format with corresponding performance metrics for the AI component (Suspected GI Bleeding Indicator - SGIB).

However, the closest information to acceptance criteria for the software component's performance (specifically the MiroView™ Express 3.0 with its "informatics algorithm" for detecting significant images) can be inferred from the clinical study summary.

Here's an attempt to extract and present the information based on the provided text:

Table of Acceptance Criteria (Inferred) and Reported Device Performance

The document does not provide a formal table of acceptance criteria with "pass/fail" thresholds. Instead, it describes a clinical study to evaluate the performance of the "express view reading mode" (which includes an "informatics algorithm") for the MiroCam® Capsule Endoscope System, particularly concerning the detection of "significant lesions" and "significant images." The implicit acceptance criterion is that the new system's performance, particularly in terms of sensitivity and reading time, is comparable or improved compared to standard reading, while also demonstrating clinical utility.

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