(72 days)
The Sonicision™ Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter.
The Sonicision™ Cordless Ultrasonic Dissector is a component of the Sonicision™ Cordless Ultrasonic Dissection Device, which is a hand-held surgical device consisting of three interdependent components that, when assembled, enable ultra high-frequency mechanical motion (ultrasonic energy) to transect, dissect, and coagulate tissue.
The dissector is a sterile, single-use component to which the Sonicision reusable generators and battery packs attach. This component contains features essential to the control and performance of the assembled device; such as the clamping jaw, active blade, speaker, two-stage energy button, rotation wheel, and jaw lever.
Four configurations are available, differing principally by shaft length. The lengths are 13 cm, 26 cm, 39 cm (cleared through K101797), and 48 cm; corresponding with catalog numbers SCD13, SCD26, SCD391/6, and SCD48, respectively.
The provided text describes a 510(k) premarket notification for the "Sonicision™ Cordless Ultrasonic Dissection Device" (K141371). This submission aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a standalone study with clinical outcomes.
Therefore, much of the requested information regarding acceptance criteria, device performance, ground truth, and study design elements like MRMC studies, sample sizes for test/training sets, and expert qualifications/adjudication methods typically associated with clinical performance studies validating a new AI/diagnostic device, cannot be found in this document.
This document focuses on bench testing and preclinical testing to demonstrate that the proposed device, despite having different shaft lengths, maintains the same safety and performance characteristics as its predicate device.
However, I can extract information related to the types of tests performed and what was demonstrated, which implicitly serve as a form of "acceptance criteria" for demonstrating substantial equivalence in this context.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide specific numerical acceptance criteria or performance values in a table format. Instead, it states that "All aspects were found to be identical" to the predicate device, implying that the performance of the new device (SCD13, SCD26, SCD48) matched that of the predicate (SCD391, SCD396) for the tested characteristics. The list below represents the areas of performance that were evaluated.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bench Testing - Electrical/Mechanical Characteristics: | |
| Basic safety and essential performance (AAMI ES60601-1:2005) | Conformance demonstrated (implicitly "identical" to predicate) |
| Electromagnetic compatibility (IEC 60601-1-2:2007) | Conformance demonstrated (implicitly "identical" to predicate) |
| Active blade displacement | Evaluated, found to be "identical" to predicate |
| Active blade frequency | Evaluated, found to be "identical" to predicate |
| Shaft deflection | Evaluated, found to be "identical" to predicate |
| Jaw clamping force | Evaluated, found to be "identical" to predicate |
| Packaging performance | Evaluated, found to be "identical" to predicate |
| System compatibility | Evaluated, found to be "identical" to predicate |
| Bench Testing - Performance Characteristics (excised porcine tissue): | |
| Burst pressures/hemostasis of isolated vessel up to 5mm diameter | Evaluated, found to be "identical" to predicate |
| Coagulation/Dissection speed | Evaluated, found to be "identical" to predicate |
| Temperature of the active blade and shaft | Evaluated, found to be "identical" to predicate |
| Preclinical Testing (device and human factors on tissue bundles and isolated vessels up to 5mm in diameter using porcine): | |
| Acute hemostasis | Evaluated, found to be "identical" to predicate |
| Thermal spread | Evaluated, found to be "identical" to predicate |
| Chronic hemostasis | Evaluated, found to be "identical" to predicate |
| Human factors and usability | Evaluated, found to be "identical" to predicate |
Key statement from the document: "All aspects were found to be identical, with the exception of the shaft length and measurement marks." And "The shaft-length differences were found to not affect safety or performance through design verification and validation testing..."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of numerical count for tissues or animals. The text mentions "excised porcine tissue" and "porcine" for preclinical testing, indicating animal tissue was used. No human data or specific number of tissue samples is provided.
- Data Provenance: Porcine (animal) tissue. The testing was described as "Bench testing" and "Preclinical testing." Given the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this type of submission. This document does not concern an AI/diagnostic device requiring expert consensus for ground truth. The "ground truth" for the performance evaluations would be objective measurements from the bench and preclinical tests (e.g., actual burst pressure, measured temperature, observed hemostasis).
4. Adjudication method for the test set
Not applicable. There's no indication of human expert adjudication for the performance results. The evaluations would rely on direct measurements and observations during testing.
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. This device is a surgical dissection device, not an imaging/diagnostic device that would involve human "readers" or an AI component in that capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (surgical instrument), not an algorithm or AI.
7. The type of ground truth used
The ground truth for the performance characteristics was derived from objective measurements during bench testing (e.g., active blade displacement, frequency, force, temperature, burst pressures) and observed physiological responses during preclinical testing on porcine tissue (e.g., hemostasis, thermal spread).
8. The sample size for the training set
Not applicable. The device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
N/A