(29 days)
The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels.
The Ultracision Instruments are indicated for soft tissue inclaions when bleeding control and minimal thermal injury are desired. The instruments aan be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels.
The Ultracision Hand Piece is the hand-held component of the Ultracision Instrumentation. The instrument is for cutting and coagulating soft tissues.
This document (K990430) is a 510(k) premarket notification for a medical device called the "Ultracision® Harmonic Scalpel® Hand Piece." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information typically requested for acceptance criteria and device performance.
Therefore, many of the requested fields cannot be filled.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "All studies demonstrated satisfactory performance in the areas of cutting, coagulation and ease of use." (Quantitative details, specific metrics, or thresholds are not provided.) |
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.
- Data Provenance: Not specified. (The submitting company is Ethicon Endo-Surgery, Inc., Cincinnati, OH, USA, but this doesn't confirm the data's origin.)
- Retrospective or Prospective: Not specified.
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 as no details on expert review or ground truth establishment for a test set are provided. The device testing appears to be functional performance testing, not diagnostic accuracy testing that would require expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for the type of device testing described.
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 is not an AI/diagnostic device; it's a surgical instrument. An MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical sense for diagnostic devices. The "ground truth" for a surgical instrument's performance would be the direct measurement of its physical properties and effects (e.g., cutting efficacy, coagulation depth, thermal spread). The document states "Testing was performed to ensure the device performs as intended" but doesn't detail the methodology for establishing ground truth for these performance aspects.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/machine learning model.
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