(90 days)
The Atmo® Gas Capsule System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal transit times are used for evaluating motility disorders.
Gastric Emptying Time (GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia.
Colonic Transit Time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation, to aid in differentiating slow and normal transit constipation. In the case where ileocecal junction transit cannot be determined, the system will report combined Small and Large Bowel Transit Time (SLBTT).
Transit times are derived from measures of temperature, hydrogen concentration, and carbon dioxide concentration, and indicators of oxygen level, Capsule tumble, and antenna reflectance.
Not for use in pediatric patients.
The Atmo Gas Capsule System is a prescription only ingestible telemetric medical device system used to measure transit times of the gastrointestinal (GI) tract. The system consists of a single-use Capsule, reusable Receiver, Mobile Device with Clinician App, and an online Clinician Portal.
Sensors onboard the Capsule provide measurements for temperature, hydrogen concentration, and carbon dioxide concentration, along with indicators of oxygen level, capsule tumble, and antenna reflectance that are used to identify regional gastrointestinal anatomical landmarks. The Capsule data is transmitted from within the GI tract via radiofrequency communication to a Receiver worn by the patient. The Mobile Device runs the Atmo Clinic App, a software application which guides the clinician through the pairing process, Capsule administration, and subsequent transfer of stored data from the Receiver to a cloud server. The Atmo Clinician Portal, accessible through a web browser, displays the resulting data and provides guidance for the physician to review, confirm and create a downloadable Motility Study Report containing whole and regional gut transit times.
The provided FDA 510(k) clearance letter and its associated 510(k) summary pertain to the Atmo Gas Capsule System. However, this document does not contain specific acceptance criteria or the detailed results of a study designed to prove the device met those criteria in the format requested.
The information provided largely describes the device, its intended use, comparison to a predicate device, and general details about the clinical study (e.g., multi-site, prospective, sample size, Bland-Altman analysis for agreement) and non-clinical testing. It states that "all pre-determined end points successfully met" for agreement with the predicate device, but it does not specify what those pre-determined endpoints/acceptance criteria were (e.g., a specific agreement percentage, limits of agreement, maximum allowable difference, or statistical p-value for non-inferiority).
Therefore, based on the provided text, I cannot complete most of the requested table and details about the study that proves the device meets the acceptance criteria. I can only extract what is present.
Here's what can be inferred and what information is missing:
Acceptance Criteria and Device Performance
Since the document does not explicitly state the acceptance criteria for GET and CTT agreement, I cannot fill this table as requested. It only says "all pre-determined end points successfully met."
Table of Acceptance Criteria and Reported Device Performance (Information Not Provided in Source):
| Metric | Acceptance Criteria (e.g., % agreement, LOA, etc.) | Reported Device Performance (Atmo Gas Capsule System) | Result (Met/Not Met) |
|---|---|---|---|
| Gastric Emptying Time (GET) Agreement | Not explicitly stated in the document. | "Bland-Altman analysis showed agreement between Atmo Gas Capsule System and the Predicate device for GET." | "all pre-determined end points successfully met." |
| Colonic Transit Time (CTT) Agreement | Not explicitly stated in the document. | "Bland-Altman analysis showed agreement between Atmo Gas Capsule System and the Predicate device for CTT." | "all pre-determined end points successfully met." |
| Safety | Minimal Adverse Events | "No serious adverse events (SAE) were associated with the Atmo Gas Capsule system. No device deficiencies led to SAEs or serious adverse device effects. Minimal adverse events (AE) were observed with all reported AEs being expected and common to the study population." | Met |
Study Details Proving Device Meets Acceptance Criteria
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Sample size used for the test set and the data provenance:
- Sample Size: 213 participants.
- Data Provenance: Multi-site, prospective study across 12 US sites and 1 OUS (Outside US) site. Participants had "confirmed or suspected dysmotility issues of the gastric and/or colonic regions."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The study assessed agreement between the Atmo Gas Capsule System and a predicate device (SmartPill GI Monitoring System, version 2.0). It doesn't explicitly mention external expert consensus for ground truth on transit times, but rather the comparative performance against an already cleared device. For a "gastrointestinal motility monitoring system," the ground truth for transit times is typically derived from the measurements themselves, not from expert interpretation of images or other subjective data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. This type of adjudication (e.g., for image interpretation or diagnosis) is generally not applicable to the direct measurement of physiological parameters like transit times by a capsule system. The study focused on agreement between two devices.
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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:
- No, an MRMC study was not done. This device is a measurement system, not an AI-assisted diagnostic tool that humans interpret. The study compared the device's measurements to those of a predicate device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the context of the device itself. The Atmo Gas Capsule System and the predicate device both automatically identify transit markers, with the user then manually confirming them. The study evaluated the agreement of the Atmo system's derived transit times against the predicate, implying the performance of the system's algorithm in calculating these times. The "human-in-the-loop" aspect (manual confirmation of markers) is part of the system's operation, but the core measurement and algorithm for transit time derivation is standalone.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the Atmo Gas Capsule System's performance was the measurements obtained by the legally marketed predicate device, the SmartPill GI Monitoring System, version 2.0. The study's primary objective was assessing agreement between the investigational device and the predicate device.
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The sample size for the training set:
- Not provided. The document describes a clinical validation study (test set) but does not mention details about the training data used for the device's algorithms.
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How the ground truth for the training set was established:
- Not provided, as training set details are absent.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).