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For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Malleable catheter with distal side ports and a lumen which can accommodate a fiberoptic device to allow visualization of the interior of the uterus. Allows physician to confirm placement of insemination fluid in the uterine cavity.

The provided 510(k) Premarket Notification for the MedWorks Visualization Insemination Catheter does not include any acceptance criteria or a study proving the device meets said criteria.

Instead, the document explicitly states:

"Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Visualization Catheter are equivalent to those of the predicate devices."

Therefore, based on the provided text, none of the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader studies can be provided. This device's submission relied on demonstrating substantial equivalence to predicate devices without presenting new performance data.

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For use in intrauterine artificial insemination procedures using washed spermatozoa or semen.

Malleable catheter with distal side ports and balloon to help position the catheter at the uterus. Balloon is filled with saline: insemination fluid is introduced using a syringe attached to the proximal luer.

The provided text is for a 510(k) Premarket Notification for an Insemination Catheter. It explicitly states:

"Substantial equivalence for this device was based solely on design and performance characteristics, no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the MedWorks Insemination Catheter are equivalent to those of the predicate devices."

Therefore, the following information cannot be extracted from the given document as no performance or safety study was conducted or provided:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance data is present.
2. Sample size used for the test set and the data provenance: No test set information is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No adjudication method is described.
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: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool. No standalone performance study was conducted.
7. The type of ground truth used: Not applicable, as no ground truth was established for performance testing.
8. The sample size for the training set: Not applicable, as no training set was used for a performance study.
9. How the ground truth for the training set was established: Not applicable, as no training set was used for a performance study.

In summary, the MedWorks Insemination Catheter's approval was based on demonstrating substantial equivalence to predicate devices through design and performance characteristics, without the need for new performance or safety studies involving acceptance criteria and clinical data.

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MedWorks Urinary Incontinence Surgical Devices are indicated for use in urethropexy surgical procedures for bladder neck suspension to correct female stress urinary incontinence due to urethral hypermobility.

The devices described in this 510(k) are surgical procedure kits intended for use in urethropexy procedures, and include components such as suture placement templates, bone anchors, bone drills, syringes, suture retrievers and suture cutters.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MedWorks Urinary Incontinence Surgical Devices:

Based on the provided text, the device is not a software/AI device and therefore the questions regarding AI-specific studies, ground truth establishment for AI, sample sizes for AI training/test sets, and expert involvement for AI adjudication are not applicable.

The document describes a device modification for surgical kits. The focus is on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards for medical devices, rather than establishing performance through clinical efficacy studies with specific acceptance criteria in the manner one would for a diagnostic or AI-powered device.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC, as typically seen in AI device submissions, is not present here. Instead, the "acceptance criteria" are implied by compliance with regulatory requirements and demonstration of substantial equivalence.

Study Details (Not Applicable for AI/Software Performance)

Since this is a filing for a physical surgical device modification, the following questions are not applicable in the context of an AI/software performance study:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of AI performance for this device. The validation mentioned ("pull testing, bond integrity testing, simulated use performance testing") would have its own sample sizes, but these are not for AI performance assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this submission is for a traditional medical device (surgical kits) undergoing a modification, and the "study" demonstrating its acceptability revolves around regulatory compliance, quality system adherence, and benchmarking against predicate devices rather than clinical efficacy studies or AI performance metrics.

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