(94 days)
To be used for the introduction of embryo(s) into the uterine cavity.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Tucker Embryo Catheter." This document approves the device based on substantial equivalence to a legally marketed predicate device.
Crucially, the document does NOT contain a study that proves the device meets acceptance criteria, nor does it detail any specific acceptance criteria for performance.
Instead, it confirms that the device is substantially equivalent to existing devices. This means that a comprehensive study demonstrating performance against a set of acceptance criteria for a novel AI/software device, as requested in the prompt, is not present here.
Therefore, most of the information requested in the prompt cannot be extracted from this document, as it outlines a regulatory approval based on equivalence, not a performance study report.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. This document is an FDA approval letter based on substantial equivalence, not a performance study report. It does not list specific acceptance criteria or performance metrics for the Tucker Embryo Catheter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. No test set or data provenance details are mentioned as this is not a study report.
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)
- Cannot be extracted. No ground truth establishment is described, as this is not a study report.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No adjudication method is mentioned as this is not a study report.
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
- Cannot be extracted. This device is a physical embryo catheter, not an AI or software device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. This is a physical medical device (embryo catheter), not an algorithm or AI system. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be extracted. No ground truth is discussed as this is a regulatory approval letter, not a device performance study.
8. The sample size for the training set
- Cannot be extracted. No training set is mentioned as this is not an AI/ML device or a study report.
9. How the ground truth for the training set was established
- Cannot be extracted. No ground truth for a training set is mentioned as this is not an AI/ML device or a study report.
Summary of Device Information Available:
- Device Name: Tucker Embryo Catheter (Models ftr123 & ftr120)
- Intended Use: To be used for the introduction of embryo(s) into the uterine cavity.
- Regulation Number: 21 CFR 884.6110
- Regulation Name: Assisted Reproduction Catheter
- Regulatory Class: II
- Product Code: 85 MOF
- Approval Type: 510(k) Premarket Notification (substantial equivalence to predicate devices)
- Approval Date: December 13, 2002
- Prescription Use: Yes (Per CFR 801.109)
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).