(80 days)
The Harmonic Scalpel Shears Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic and other open and endoscopic procedures.
The Harmonic Scalpel 5 mm Instruments with Protective Sleeve is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 10cm Sharp Curved Blade instruments are 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, plastic, gynecologic, and thoracic surgery.
The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to be used 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, plastic, gynecologic, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 5 mm Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel Blades and Shears are ultrasonic surgical instruments for the cutting and coagulation of soft tissue incisions when bleeding control and minimal thermal injury are desired. The device system has three essential parts: the generator/ footswitch, the hand piece and the instruments, which are available in various lengths shapes and types. The selection of the appropriate instrument is a matter of surgeon preference.
The provided 510(k) summary for the Ethicon Harmonic Scalpel Blades and Shears does not include information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for a diagnostic AI/ML device.
This 510(k) pertains to a surgical instrument, not a diagnostic AI/ML device. The "Performance Data" section explicitly states: "A clinical literature search was performed to show the use of the devices in plastic surgery." This indicates that the regulatory submission relied on existing clinical evidence for similar devices and the proven safety and effectiveness of the underlying technology, rather than new performance studies with specific statistical endpoints and acceptance criteria as would be required for an AI/ML diagnostic.
Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable to this particular device submission.
Here's a breakdown of what can be extracted and what is not applicable based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The submission does not define specific performance metrics with acceptance criteria (e.g., sensitivity, specificity, AUC) for the device. The "performance" is implicitly related to its intended surgical function (cutting and coagulation with minimal thermal injury and bleeding control), which is demonstrated through established clinical practice and existing literature for the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There was no specific "test set" in the context of a diagnostic performance study. The "Performance Data" section refers to a "clinical literature search." The "sample size" would therefore be the aggregate patient population across the studies identified in that literature, but specific numbers and provenance are not provided as it's not a de novo study.
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 was no "test set" requiring ground truth established by experts in the context of a diagnostic evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There was no test set or adjudication process for diagnostic performance.
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 a surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No explicit ground truth was established for a performance study. The "ground truth" for the device's efficacy is based on established surgical outcomes and clinical experience with ultrasonic surgical instruments, as demonstrated by the literature search.
8. The sample size for the training set
- Not Applicable. This device is a physical surgical instrument, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for this device.
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