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tekno-medical obstetrical forceps are used for helping delivering the baby. The forceps is consisting of two parts and you are introducing every part from the forceps(blades) seperately into the vagina.

The Obstetrical forceps consist of two parts. Each of these two parts is introduced from the forceps (blades) seperately into the vagina.

This document is a 510(k) premarket notification decision letter from the FDA regarding "Techno-Medical Obstetrical Forceps." It communicates that the device is substantially equivalent to legally marketed predicate devices.

This type of document (a 510(k) clearance letter for a physical medical device like obstetrical forceps) typically does not contain the detailed information about acceptance criteria and a specific study proving device performance as would be found for a software-as-a-medical-device (SaMD) or AI-based device.

For a physical device like obstetrical forceps, "acceptance criteria" generally refer to design specifications, material properties, sterilization methods, and manufacturing quality control, rather than performance metrics like sensitivity, specificity, or AUC as seen in diagnostic algorithms. The "study" would typically involve biocompatibility testing, mechanical testing (e.g., tensile strength, fatigue), and potentially cadaveric or animal studies for safety and function, rather than human subject clinical trials focused on diagnostic accuracy.

Therefore, based solely on the provided text, I cannot extract the information required for your specific prompt. The document indicates that the device is "substantially equivalent" to predicate devices, meaning its safety and effectiveness are considered comparable to devices already on the market, but it does not detail the specific studies and acceptance criteria that led to this determination in the way you've outlined for an AI/software product.

Here's a breakdown of why each specific point you requested cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document only states the device is "substantially equivalent."
2. Sample size used for the test set and the data provenance: Not applicable/not present. This is a physical device, and the focus is on equivalence, not diagnostic test performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present. Ground truth as typically defined for AI/diagnostic algorithms is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not present.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not present.
8. The sample size for the training set: Not applicable/not present. This is a physical device.
9. How the ground truth for the training set was established: Not applicable/not present.

To find the kind of information you are looking for (acceptance criteria and detailed study results), you would need to examine the actual 510(k) submission document (if publicly available) which would contain engineering specifications, test reports, and comparisons to predicate devices, but these would not be structured in the same way as studies for an AI/SaMD product.

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