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510(k) Data Aggregation
(83 days)
MINI FORCEPS WITH HF, 3.5MM; MICRO FORCEPS WITH HF, 2MM
The forceps are used for grasping, manipulating and cutting as well as the dissection and biopsy of soft tissue/ organs under endoscopic control. The modular scissors can also be used for cutting of suture material. Minor hemorrhages can be coagulated using HF current, provided that products are marked accordingly. The modular forceps can be disassembled for easy cleaning and replacement.
The forceps with HF are part of the MICRO and MINI instrument set for laparoscopic microsurgery, particularly suitable for diagnostic, smaller interventions, outpatient, and pediatric laparoscopy. The instruments smaller diameter is less invasive and allows better cosmetic effects than bigger diameters. The forceps and scissors have comparable device materials as former R. Wolf devices. The dimensions are smaller for very minimal invasive laparoscopy. The design of the same, but miniaturized. The design of the handles is the same, but adapted to the smaller forceps. The modular forceps and scissors with 3.5 mm diameter can be disassembled into jaws with shaft and handle for easy cleaning and replacement. They have a Luer connector to rinse cavities and channels of the forceps with a cleaning gun while reprocessing. The jaws are rotatable with an adjustment knob at the handle.
Acceptance Criteria and Study for RICHARD WOLF MEDICAL INSTRUMENTS CORP. MINI and MICRO Forceps with HF
This document describes the acceptance criteria and the study conducted to demonstrate that the RICHARD WOLF MEDICAL INSTRUMENTS CORP. MINI and MICRO Forceps with HF devices meet these criteria, based on the provided 510(k) Summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No breakage of jaws or other instrument parts during use | "The Instruments have been tested to assure that there is no breakage of the jaws or other parts of the instrument." |
| No permanent deformation of forceps under normal use | "Mechanical load tests show that there is no permanent deformation of the forceps if used normally." |
| Functional performance maintained after steam sterilization | "The steam sterilization tests performed by Richard Wolf show that steam sterilization has no influence on the functional performance of the submitted devices when using the fractional method." |
| Safety and effectiveness when used according to instructions | "These devices are designed and tested to guarantee the safety and effectiveness when used according to the instructions manual." |
Note: The 510(k) summary does not explicitly state numerical acceptance limits for "no breakage," "no permanent deformation," or "no influence on functional performance." The statements indicate that these conditions were met qualitatively through testing.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the exact sample sizes (number of instruments tested) for the mechanical load tests or steam sterilization tests. It uses general phrasing like "The Instruments have been tested" and "Mechanical load tests show."
The data provenance is not explicitly stated in terms of country of origin, but the testing was "performed by Richard Wolf," implying internal testing by the manufacturer. The tests were likely retrospective laboratory tests on manufactured devices, rather than prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. The described tests are engineering and laboratory performance tests, not clinical evaluations requiring expert interpretation of ground truth in a diagnostic or clinical context. The "ground truth" here is the objective measurement of mechanical integrity and functional performance against defined engineering standards or internal specifications.
4. Adjudication Method for the Test Set
Not Applicable. As the tests are objective engineering assessments, there is no need for an adjudication method by experts. The results are based on direct measurement and observation of physical characteristics and functional outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided 510(k) summary explicitly states under Section 6.0, "Clinical Tests: No clinical tests performed." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not Applicable. This device is a surgical instrument (forceps), not an AI algorithm or a software-only device. Therefore, a standalone performance study for an algorithm is irrelevant. The performance evaluated relates to the physical and functional integrity of the instrument itself.
7. Type of Ground Truth Used
For the mechanical load tests, the "ground truth" would be the engineering specifications for acceptable deformation and breakage limits. For steam sterilization, the "ground truth" would be the pre-sterilization functional performance for comparison. These are objective engineering and performance standards, not expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
Not Applicable. This device is a physical surgical instrument. There is no AI algorithm involved, and therefore, no "training set" in the context of machine learning. The design and validation of this device do not involve machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As mentioned above, there is no AI algorithm or training set for this device.
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