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Insemination Catheters are used for transferring spermatozoa into the uterine cavity.

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This is a 510(k) premarket notification for a medical device (Morton IUI Catheter) and does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria. The provided document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

The letter acknowledges the submission and allows the device to be marketed, subject to general controls. It does not include:

1. Acceptance criteria table or device performance reports.
2. Details on sample sizes, data provenance, or ground truth establishment.
3. Information on expert qualifications, adjudication methods, or MRMC studies.
4. Standalone algorithm performance or training set specifics.

The document is primarily an administrative communication regarding market authorization based on substantial equivalence, not a summary of performance studies.

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The Mona Lisa Aspiration Needle is intended for ultrasoundguided, transvaginal recovery and collection of oocytes from ovarian follicles.

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The provided document is a 510(k) clearance letter from the FDA for the Mona Lisa Aspiration Needle. It primarily concerns the regulatory approval of the device and does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

Therefore, I cannot provide the requested information based on the given document. The document does not describe a study or specific acceptance criteria for the Mona Lisa Aspiration Needle.

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To be used for the introduction of embryo(s) into the uterine cavity.

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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)

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The Lifetek Medical Embryo Glide™ Embryo Transfer Catheter is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.

The Embryo Glide™ Embryo Transfer Catheter and accessory stylet (ETC) is used during In-Vitro Fertilization (IVF) procedures to introduce embryo(s) into the female body. The embryo passes through the clear, 5 Fr polyurethane catheter, which is open on the end. The 5 Fr catheter is available in 18 cm and 23 cm lengths. Catheters have color-coded hubs to indicate different lengths. Each ETC comes with a 7 Fr sheath which provides a smooth passage into the uterus. An optional stylet (accessory) is available to aid in the initial placement of the 7 Fr sheath. Both the Embryo Transfer Catheter and stylet accessory (optional) are protected within a polypropylene sheath in a sterile, peel-able pouch.

This submission (K992307) for the Embryo Glide™ Embryo Transfer Catheter and accessory stylet does not contain the kind of detailed information typically found in acceptance criteria and study results for performance claims of AI/ML-enabled medical devices.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices under the 21 CFR §884.6110 Assisted Reproduction Catheters (Procode 85 MQF) and conformance with general biocompatibility standards. The "Summary of Testing" section is brief and outlines general safety testing rather than performance metrics related to a specific clinical outcome or the analytical/clinical performance of an algorithm.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or details about a study evaluating AI/ML performance because that information is not present in the provided text.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: Not available. The document mentions biocompatibility testing (cytotoxicity, vaginal mucosal and dermal sensitization) and Mouse Embryo Assays as "testing," but it does not specify performance criteria (e.g., cell viability thresholds, irritation scores) or quantitative results from these tests. These are general safety tests, not performance tests in the context of an AI/ML algorithm.
• 2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI/ML performance evaluation for this device. The biocompatibility tests would have their own sample sizes (e.g., number of animals for assays), but these are not for algorithm performance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment for an AI/ML algorithm.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for AI-assisted diagnostic or interpretative devices, which this catheter is not.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. There is no algorithm.
• 7. The type of ground truth used: Not applicable for performance of an AI/ML algorithm. For biocompatibility, the "ground truth" would be the biological response observed in the assays (e.g., cell death, irritation).
• 8. The sample size for the training set: Not applicable. There is no AI/ML algorithm to train.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission pertains to a conventional medical device (an embryo transfer catheter) and focuses on demonstrating its safety and substantial equivalence to legally marketed predicate devices, not on the performance evaluation of an artificial intelligence or machine learning algorithm. The testing mentioned (biocompatibility and Mouse Embryo Assays) are standard safety tests for devices that come into contact with biological tissues and embryos, not performance studies for an AI/ML component.

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