(90 days)
The UltraCision 5mm LaparoSonic® Hook Blades and UltraCision HS2 Blade 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 and thoracic surgery, including the mobilization of the Internal Mammary Artery (IMA).
The UltraCision 5mm LaparoSonic® Hook Blade instruments are two styles of sterile, single patient use instruments consisting of a titanium blade with a non-removable sheath. The two styles consist of a Sharp Hook and Dissecting Hook. The working lengths are approximately 32 cm.
The UltraCision HS2 Blade is a sharp hook and has a working length of approximately 10 cm. The system consists of a blade affixed with a sheath, a hand piece, blade adaptor, blade wrench, generator, foot switch and cart.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ethicon Endo-Surgery, Inc. UltraCision devices:
This document is a 510(k) summary for the UltraCision 5mm LaparoSonic® Hook Blades and UltraCision HS2 Blade. It describes the device's substantial equivalence to a predicate device rather than presenting a novel clinical study with detailed acceptance criteria and performance metrics for a new AI-powered device. Therefore, many of the requested elements (like sample sizes, expert qualifications, MRMC studies, standalone performance, training sets, etc.) are not applicable or not provided in this type of regulatory submission.
The core of this submission is to demonstrate "substantial equivalence" to a previously cleared device, meaning its safety and effectiveness are similar to the predicate, rather than proving performance against specific clinical benchmarks like an AI model would.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, formal acceptance criteria in the sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) are not explicitly stated. The "acceptance criteria" are implicitly met by demonstrating that the new device performs acceptably and is as safe and effective as the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acceptable performance in cutting soft tissue | Demonstrated acceptable performance in cutting. |
| Acceptable performance in blunt tissue dissection | Demonstrated acceptable performance in blunt tissue dissection. |
| Acceptable performance in coagulation | Demonstrated acceptable performance in coagulation. |
| Functionality in the mobilization of the Internal Mammary Artery | Demonstrated acceptable performance in the mobilization of the IMA. |
| Device can be used as designed. | Studies demonstrated acceptable performance. |
| Technological characteristics are the same as the Predicate Device | Confirmed: "The technological characteristics of the New Devices are the same as the Predicate Device." |
| Same ultrasonic characteristics as a method of activation | Confirmed: "The same ultrasonic characteristics remain as a method of activation." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document refers to "pre-clinical laboratory evaluations" but does not detail the number of samples or tests conducted.
- Data Provenance: Not specified, but generally, pre-clinical lab evaluations would be conducted in a controlled lab setting, likely in the country of manufacture (e.g., USA, where Ethicon is based). The studies were retrospective in the sense that they evaluated the device's performance, but not in the context of analyzing previously collected patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. As this involves pre-clinical lab evaluations of physical device performance (cutting, coagulation), the "experts" would likely be engineers, technicians, or surgeons involved in product development and testing, rather than clinical experts establishing a medical "ground truth" on patient data.
4. Adjudication Method for the Test Set
- Not applicable. This type of pre-clinical bench testing does not involve adjudication as would be found in clinical or AI performance studies where multiple readers interpret images or data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not done. This document focuses on the direct performance of the surgical instrument itself in pre-clinical settings, not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical surgical instrument, not an algorithm or AI system. Its performance ("standalone") is how it functions mechanically and ultrasonically in lab evaluations. The "pre-clinical laboratory evaluations" are essentially the standalone performance tests for this medical device.
7. The Type of Ground Truth Used
- The "ground truth" was established based on direct observation and measurement of physical effects (cutting, blunt dissection, coagulation, and IMA mobilization) in pre-clinical laboratory settings. This would involve objective assessment of tissue effects, speed, and consistency, rather than medical "ground truth" derived from patient outcomes, pathology, or expert consensus on clinical data.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device does not involve a "training set" or its associated ground truth establishment.
In summary: The provided document is a 510(k) summary focused on demonstrating the substantial equivalence of a surgical device to a predicate device based on its technological characteristics and acceptable performance in pre-clinical laboratory evaluations. It does not contain the detailed information typically associated with complex AI or clinical diagnostic device studies involving specific acceptance criteria measured against clinical ground truths, reader studies, or training/test sets.
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