(88 days)
The UltraCision 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, gynecologic, and thoracic surgery.
The UltraCision instruments are hand-held instruments which cut and coagulate soft tissue when attached to the ultrasonic hand piece and generator.
The provided text is a summary of a 510(k) premarket notification for the UltraCision Harmonic Scalpel Sharp Curved Blade. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics as might be found for novel devices or software.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and the reported device performance: This document primarily states that "Preclinical testing was performed to ensure that the devices perform as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." It does not provide specific quantitative acceptance criteria or detailed performance data.
- Sample size used for the test set and the data provenance: No information on test set sample sizes or data provenance (country of origin, retrospective/prospective) is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not a study involving human-labeled ground truth for a diagnostic AI.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device, not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI algorithm.
- The type of ground truth used: The "ground truth" here is implied by the successful outcomes of the bench and animal studies, confirming performance in cutting and coagulation, rather than an expert-determined or pathology-confirmed ground truth for a diagnostic task.
- The sample size for the training set: Not applicable, as this is a medical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The document states that preclinical testing was performed, including bench and animal studies, to ensure the device performs as intended. The conclusion of these studies was that they "demonstrated satisfactory performance in cutting and coagulation." This indicates a qualitative acceptance criterion of "satisfactory performance" in these two key functions. However, specific quantitative metrics or detailed results are not provided in this summary. The basis for marketing approval is "substantial equivalence" to predicate devices, and the performance testing supports this claim.
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