(81 days)
The UltraCision Harmonic Scalpel 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, gynecological 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 UltraCision Harmonic Scalpel is an ultrasonically activated surgical blade with a protective sleeve. These instruments are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.
The provided document is a 510(k) summary for the Ethicon Endo-Surgery UltraCision® Harmonic Scalpel® Blades with Protective Sleeve. This document describes a medical device, and the information requested pertains to the evaluation of AI/ML-based medical devices. Therefore, much of the requested information regarding AI-specific criteria (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.
However, I can extract the information related to the device's performance evaluation as described within the context of a traditional medical device submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Satisfactory cutting | Demonstrated satisfactory performance in cutting. |
| Satisfactory coagulation | Demonstrated satisfactory performance in coagulation. |
| Satisfactory performance for expanded indication | The clinical information demonstrated satisfactory performance for the expanded indication. |
Explanation: The document does not explicitly state numerical acceptance criteria. Instead, it uses qualitative terms like "satisfactory performance." The device is deemed to have met these criteria as it received substantial equivalence.
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 for Test Set: Not specified. The document refers to "bench testing and animal studies" and "clinical information," but no sample sizes for these studies are provided.
- Data Provenance: Not specified. The studies are generalized as "bench testing and animal studies" and "clinical information." It's common for such studies to be conducted internally or by contract research organizations, but specific details like country of origin or whether they were retrospective/prospective are not given.
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/not specified. For this type of traditional medical device (surgical scalpel), "ground truth" as it relates to expert review of output like images or diagnoses is not relevant. The performance is assessed through direct observation, measurement, and clinical outcomes during the studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified. Adjudication methods are typically relevant for studies where subjective interpretation or classification of data (like medical images) is involved.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a physical surgical device, not an AI/ML-based diagnostic or assistive software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a surgical instrument that requires direct human operation. It is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The implicit "ground truth" for this device would be established through direct observation of cutting and coagulation efficacy and safety endpoints in bench testing, animal studies, and clinical observations/outcomes during the use of the device. This is more akin to direct performance measurement rather than establishing a "ground truth" for classification or diagnosis.
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
N/A