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INSTRUMED gynaecological forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynaecological examination.

Instrumed gynaecological forceps are heavy forceps which have special designed jaws to hold securely without slipping during vaginal and abdominal hysterectorny procedures, yet do not lacerate the tissue to which it has been applied to even when it is necessary to exert traction.
The Instrumed gynaecological forceps are reusable surgical instruments.
To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:

• length and bending of the forceps and jaws .
• ring handles with a ratchet closure to adjust the amount of tension applied.
• jaw design, option of longitudinal grooves, teeth or cross serrations .
• the choice of jaw style depends on the surgeon's preference .
  The surgeon chooses the gynaecological forceps based on the anatomy of the site and the designs desired are based on the type of the surgical procedure.
  Instrumed gynaecological forceps are made of the ASTM F 899-07 standardized Stainless Steel.
  The instruments are offered in non-sterile condition.

This document is a 510(k) summary for a medical device called "Instrumed Forceps Gynaecological." It's a regulatory filing to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no acceptance criteria or dedicated study described that proves the device meets specific performance criteria in the way typically associated with advanced AI/Software as a Medical Device (SaMD) clearances or certain diagnostic devices.

Here's an analysis based on your requested information:

1. Table of acceptance criteria and the reported device performance

Explanation: This 510(k) is for a set of manual surgical instruments (gynecological forceps). For such devices, the "acceptance criteria" and "performance" are typically assessed through comparisons to predicate devices in areas like material composition, manufacturing processes, intended use, and general safety/effectiveness, rather than quantitative performance metrics like sensitivity/specificity for diagnostic AI. The document asserts comparability and successful completion of standard evaluations for surgical instruments like biocompatibility and sterilization.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. This document does not describe a clinical study with a "test set" of patient data in the context of device performance in a diagnostic or AI-driven sense. The "testing" mentioned is non-clinical and bench testing of the instruments themselves.
• Data Provenance: Not applicable.

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)

• Not applicable. There is no mention of a "test set" requiring ground truth established by experts. The device is a manual surgical instrument.

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 device is not an AI/SaMD product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is not an algorithm or SaMD.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable in the context of diagnostic performance. For manual surgical instruments, "ground truth" relates to their physical properties, material conformity (e.g., ASTM F 899-07 standardized Stainless Steel), sterility, and ability to perform their mechanical function compared to similar devices. The document implies compliance with these standards through "non-clinical and bench testing."

8. The sample size for the training set

• Not applicable. This device is not an AI/Machine Learning model.

9. How the ground truth for the training set was established

• Not applicable.

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