(106 days)
The Vibrant System is an orally administered Capsule that is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.
The Vibrant System is designed to mechanically induce peristaltic activity in the colon, thus aiding in relieving constipated patients. Constipation relief is achieved by the Capsule's stimulation in the colon, consequently inducing peristaltic activity which promotes transit and facilitates defecation. The stimulation protocol is designed to activate at specific times during the day (i.e., afternoon and evening). The Vibrant System is comprised of two components: a reusable Pod and a single use capsule. The Capsule is expelled from the body during the patient's bowel movements.
The provided text does not contain specific acceptance criteria or a detailed study of the device's performance against such criteria. Instead, it describes general compliance with standards and the substantial equivalence to a predicate device.
However, based on the Performance Data section, we can infer the types of criteria that were considered and the studies conducted to demonstrate compliance, even if specific metrics are not given.
Here's a breakdown of what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (as inferred from the document) | Specific Metrics/Results Provided in Document? |
|---|---|---|
| Mechanical/Physical | Transportation and distribution validation per ASTM D4332-14 and ASTM D4169-22. Bench performance testing to verify Pod meets visual and functional specifications. | No specific metrics (e.g., pass/fail rates, specific functional parameters). |
| Software | Software documentation and validation per IEC 62304:2006/A1:2016. | No specific metrics or validation results. |
| Cybersecurity | Cybersecurity validation. | No specific metrics or validation results. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11. | No specific test results or safety margins. |
| Electromagnetic | Compliance with FCC Part 15, Sub-part C, section 15.209 (Radiated emission limits). | No specific emission levels or compliance details. |
| Functional | Bench performance testing to verify Pod meets functional specifications. | No specific functional parameters or performance curves. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for any of the listed performance data. For example, it's not mentioned how many packages were tested for transportation validation or how many Pods were used for bench testing.
- Data Provenance: Not specified. It does not mention country of origin or whether studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided because the document focuses on engineering and regulatory compliance tests rather than clinical performance based on expert review. There is no mention of ground truth establishment in this context.
4. Adjudication method for the test set
- Not applicable as this document describes technical and regulatory compliance testing, not a clinical study involving human readers and ground truth adjudication.
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
- No, an MRMC comparative effectiveness study was not conducted or described. The device is not an AI-assisted diagnostic tool for human readers; it's an orally administered capsule system for constipation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone system (the capsule and pod). The performance data listed are for the device's technical and safety aspects. There isn't an "algorithm only" performance reported in the sense of a diagnostic AI system, but the software validation (IEC 62304) is a standalone evaluation of the device's software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the technical and safety performance data listed, the "ground truth" would be defined by the standards themselves (e.g., a package either passed ASTM D4332-14 or it didn't; the device either met IEC 60601-1 safety requirements or it didn't). These are objective engineering and regulatory standards rather than clinical ground truth established by medical experts or pathology.
8. The sample size for the training set
- Not applicable. The document describes a medical device, not an AI/machine learning model that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for this device's performance evaluation as described.
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