FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

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.

Summary

Regulation Number and Section

§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.

(a)
Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.(b)
Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”