(375 days)
The MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 is indicated for soft-tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ear, nose and throat [ENT]), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.
MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9 (originally manufactured by Ethicon Endo-Surgery). Following clinical use, the instruments are cleaned, refurbished, tested, inspected, packaged, sterilized with ethylene oxide and returned to the user facility by MEDISISS for an additional clinical use.
This document, K124033, describes a 510(k) premarket notification for the MEDISISS Reprocessed Harmonic FOCUS Curved Shears FCS9. This is a reprocessing submission, meaning the device is a reprocessed version of an existing device (Ethicon Endo-Surgery Harmonic FOCUS Shears).
The acceptance criteria and the study proving the device meets them are described in terms of "Performance Testing" to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Tests) | Reported Device Performance (as stated in the document) |
|---|---|
| Grasping/Pull Force | Evaluated and found substantially equivalent |
| Cutting Effectiveness / Functionality | Evaluated and found substantially equivalent |
| Drop Test | Evaluated and found substantially equivalent |
| Device Integrity | Evaluated and found substantially equivalent |
| Cutting/Coagulation Evaluation for a Prolonged Period of Time | Evaluated and found substantially equivalent |
| Thermal Analysis Characterization | Evaluated and found substantially equivalent |
| Tissue Sticking: Simulated Use | Evaluated and found substantially equivalent |
| IEC 60601-1 (Electrical Safety Standard) | Evaluated and found substantially equivalent |
| Cleaning (o protein, carbohydrate, hemoglobin, and endotoxins) | Evaluated and found substantially equivalent |
| Biocompatibility (o cytotoxicity, sensitization, irritation, and acute systemic toxicity) | Evaluated and found substantially equivalent |
| Performance Qualification | Evaluated and found substantially equivalent |
| Sterilization and Stability | Evaluated and found substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the performance tests.
The document does not specify the data provenance (e.g., country of origin, retrospective/prospective). It only states that the device is reprocessed and returned to the user facility, implying data would be generated from testing reprocessed units.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies listed are likely laboratory-based performance tests rather than clinical studies requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. The performance tests described do not suggest a need for an adjudication method in the context of human expert review.
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
This information is not applicable. The device is a surgical instrument (reprocessed shears), not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical surgical instrument and does not involve an algorithm.
7. The Type of Ground Truth Used
For performance testing (e.g., cutting effectiveness, pull force, thermal analysis), the "ground truth" would be established by objective measurements against predefined engineering specifications and criteria, ensuring the reprocessed device performs comparably to the original predicate device. For biocompatibility and cleaning, the ground truth would be established by laboratory analyses (e.g., measuring residual protein/endotoxins) against established safety limits. The document does not explicitly state the specific thresholds or methodologies for these "ground truths," only that evaluation led to a conclusion of substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable/not provided. Since this is a physical medical device (reprocessed surgical tool) and not an AI/machine learning algorithm, there is no "training set" in the conventional sense. The "training" for the reprocessing process would involve establishing and validating the cleaning, refurbishment, and sterilization protocols, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided as there is no "training set" for an algorithm. For the reprocessing methods, the "ground truth" for validating the cleaning, refurbishment, and sterilization processes would be established through scientific evidence and adherence to recognized standards (e.g., AAMI standards for sterilization, FDA guidance for reprocessing), demonstrating that the reprocessed device meets the same safety and performance requirements as a new device.
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