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The Given® Diagnostic System with the PillCam™ ESO2 Capsule is intended for visualization of the esophageal mucosa

The Given® Diagnostic System is comprised of three subsystems: PillCam™ Capsule (SB, ESO), Data Recorder Set, and RAPID® Workstation or RAPID® Software.

The modifications to the Given® Diagnostic System, which are subject of this Special 510(k) is the addition of a new model of esophageal capsule, the PillCam™ ESO2 Capsule, and the addition of an alternative ingestion procedure, the simplified ingestion procedure (SIP) for the esophageal capsules.

The provided text describes a 510(k) submission for the Given® Diagnostic System with PillCam™ ESO2 Capsule, focusing on its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study that directly proves the device meets specific performance criteria beyond the general statement of substantial equivalence.

The 510(k) summary explains that the submission is for a modification to an existing device, specifically the addition of a new esophageal capsule model (PillCam™ ESO2) and an alternative ingestion procedure. The core of the submission is to demonstrate that these modifications do not introduce new safety or efficacy issues and that the modified device is "substantially equivalent" to already cleared devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in the provided document. The 510(k) process primarily relies on demonstrating equivalence rather than on de novo performance studies against pre-defined acceptance criteria (unless a special controls guidance document specifies them, which is mentioned as being complied with in a general sense, but no specific performance endpoints are given).

Here's an analysis of the information that can be extracted or inferred based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: NOT PROVIDED. The document doesn't detail a specific clinical study for performance testing of the PillCam™ ESO2 capsule against a ground truth. The submission likely relies on previous studies for the predicate device and potentially bridging studies that confirm the new capsule's similar performance.
• Data provenance: NOT PROVIDED. No information on country of origin of data or whether it was retrospective or prospective.

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

• Number of experts: NOT PROVIDED. Since no specific performance study with a test set is detailed, information on experts used to establish ground truth is absent.
• Qualifications of experts: NOT PROVIDED.

4. Adjudication method for the test set

• Adjudication method: NOT PROVIDED. No test set or corresponding adjudication method is mentioned in this document.

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

• MRMC study: NOT APPLICABLE / NOT PROVIDED. The device is an "Ingestible Telemetric Esophageal Capsule Imaging System" which typically functions as a diagnostic tool for visualization, not an AI-assisted diagnostic. There is no mention of AI integrated into the system described in this document, nor any MRMC study comparing human readers with and without AI assistance.

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

• Standalone algorithm performance: NOT APPLICABLE / NOT PROVIDED. The device is a capsule imaging system, not an algorithm, and the document does not describe any standalone algorithmic performance evaluation.

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

• Type of ground truth: NOT PROVIDED. The document does not describe a specific study with a defined ground truth for the PillCam™ ESO2 capsule's performance. The basis for equivalence is likely derived from the predicate device's demonstrated ability to visualize the esophageal mucosa, which would have implicitly relied on a comparison to standard clinical evaluations (e.g., endoscopy findings by expert clinicians, or possibly biopsy results for pathology).

8. The sample size for the training set

• Sample size for training set: NOT APPLICABLE / NOT PROVIDED. As this is an imaging device and not an AI/ML algorithm that requires a training set in the typical sense, this information is not relevant or provided in the document.

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

• Ground truth for training set: NOT APPLICABLE / NOT PROVIDED. Same as above, not relevant for this type of device and submission.

Summary of what IS provided:

• Device Name: Given® Diagnostic System with PillCam™ ESO2 Capsule
• Intended Use: Visualization of the esophageal mucosa.
• Predicate Device: Given® Diagnostic System with PillCam™ ESO Capsule (cleared under K041149 and K042960).
• Basis for Clearance: Substantial equivalence to the predicate device.
• Modifications: Addition of the PillCam™ ESO2 Capsule and an alternative ingestion procedure (simplified ingestion procedure - SIP).
• Regulatory Compliance: Complies with "Class II Special Controls Guidance in Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA" issued on November 28, 2001. (However, the specific performance requirements from this guidance are not detailed in this 510(k) summary).

In essence, this document is a summary of the 510(k) submission, not a detailed clinical study report. It focuses on the regulatory argument for substantial equivalence rather than reporting explicit performance metrics from a specific new clinical study with the ESO2 capsule.

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The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.

The Given® Diagnostic System with the PillCam™ ESO Capsule is comprised of three subsystems: PillCam™ ESO Capsule, Data Recorder Set, and RAPID® Workstation. The PillCam™ ESO Capsule is a wireless, disposable capsule designed to glide smoothly through the esophagus. During its passage, the capsule transmits digital data that is captured by receiving antennas attached to the patient's body. The images are stored in the DataRecorder that is connected to the receiving antennas and is worn on a belt around the waist of the patient. When the test is over, the antennas and recorder are removed from the patient's body. The images from the recorder are downloaded to the RAPID® Workstation for processing and viewing by the physician.

The provided text is a 510(k) summary for the Given® Diagnostic System with PillCam™ ESO Capsule. It focuses on the device's substantial equivalence to a predicate device due to modifications in the capsule model and software. Therefore, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria, a specific study proving those criteria, sample sizes, ground truth establishment, or MCRM comparative effectiveness.

Here's an analysis of what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics or thresholds.
• Reported Device Performance: Not detailed in this document. The submission is for modifications and asserts substantial equivalence rather than presenting new performance data against specific criteria.

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

• This information is not available in the provided text. The document discusses device modifications and substantial equivalence, not a new clinical study with a test set.

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)

• This information is not available in the provided text.

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

• This information is not available in the provided text.

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

• A MRMC study is not mentioned in the provided text. The device described, the "Given® Diagnostic System with PillCam™ ESO Capsule," is an imaging system, and while it processes images ("RAPID® Workstation"), the submission does not describe it as an AI-assisted diagnostic tool that would typically involve a comparative effectiveness study of human readers with vs. without AI assistance. The modifications are to the capsule's frame rate and the RAPID software, suggesting system improvements rather than AI integration for diagnostic improvement.

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

• This information is not available in the provided text. The system is described as providing images for viewing by a physician, implying a human-in-the-loop workflow.

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

• This information is not available in the provided text.

8. The sample size for the training set

• This information is not available in the provided text.

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

• This information is not available in the provided text.

Summary of available information from the document:

• Device Name: Given® Diagnostic System with PillCam™ ESO Capsule
• Intended Use: For the visualization of esophageal mucosa.
• Predicated Device: Given® Diagnostic System with PillCam™ (M2A®) ESO Capsule (K041149).
• Reason for Submission: Implementation of two modifications:
  1. Improved capsule model (transmits images at 14 frames per second (fps)).
  2. Improved version of the RAPID Software application.
• Equivalence Claim: Substantially equivalent to the predicate device without raising any new safety and/or efficacy issues.
• Regulatory Status: Class II device, reviewed under special controls guidance for "Ingestible Telemetric Gastrointestinal Capsule Imaging System."
• Approval Date: November 24, 2004 (FDA issued substantial equivalence determination).

The provided text serves as a regulatory submission for device modifications and substantial equivalence. It does not include the detailed technical study information that would define acceptance criteria for a new device's performance demonstration. For such details, one would typically need to consult a comprehensive technical report or clinical study summary, which is not part of this 510(k) summary.

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