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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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