(134 days)
This device is intended to distend the uterus by filling the uterine cavity with CO2 gas to facilitate viewing with a hysteroscope.
This device is intended to distend the uterus by filling the uterine cavity with gas to facilitate viewing with a hysteroscope.
The provided text describes a medical device, the BEI Medical Systems Automatic Electronic Hysteroscopic Insufflator (AEH-200), and its premarket notification (510(k)) summary. However, it does not contain detailed information about acceptance criteria and a specific study proving the device meets those criteria in the format requested.
The document primarily focuses on:
- Device Identification: Name, common name, classification, and equivalent devices.
- Intended Use: To distend the uterus with CO2 gas for hysteroscopic viewing.
- Technological Summary: Compliance with Draft: August 1, 1995 Submission Guidance for a 510(k) Submission on Hysteroscopic and Laparoscopic Insufflators.
- Nonclinical Performance: Mentions "In house testing in accord with label claims demonstrated compliance. Data Summary with these parameters."
- Conclusion: Device is comparable to existing devices and has no safety issues.
- FDA Clearance Letter: Confirming substantial equivalence.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what needs further information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "In house testing in accord with label claims demonstrated compliance. Data Summary with these parameters." |
| Compliance with Draft: August 1, 1995 Submission Guidance for a 510(k) Submission on Hysteroscopic and Laparoscopic Insufflators (Specifically Sections II B through II F). | Demonstrated compliance. |
| Device comparable to similar devices already available. | Proved comparable. |
| No safety issues. | Not demonstrated any safety issues. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: "In house testing." No country of origin or retrospective/prospective nature specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was "in house testing" for compliance with label claims and guidance, not a clinical study requiring expert ground truth for interpretation of medical images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was engineering/performance testing, not a study requiring adjudication of expert readings.
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 MRMC study was done. This device is an insufflator, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- For performance criteria related to the device's function (e.g., CO2 flow, pressure), the "ground truth" would be established engineering specifications and measurement standards. The document mentions "label claims" which would define these.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "in house testing" refers to performance verification.
9. How the ground truth for the training set was established:
- Not applicable.
§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.