(66 days)
The Sonicision™ Curved Jaw 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, 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 and including 5 mm in diameter.
The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
This is a bundled 510(k) that includes multiple individual component devices, as indicated in the table below.
A functional Sonicision™ Curved Jaw Cordless Ultrasonic Dissection device is assembled by the user within the operating room. The functional device is assembled from the following three components: (1) a sterile, single-use dissector (SCDAxx), (2) a user cleaned and sterilized reusable generator (SCGAA), and (3), a user cleaned and disinfected reusable battery (SCBA). There are four different lengths of sterile single-use dissectors to allow surgeons a range of options to meet the needs of each specific surgical case.
The assembled functional device is a hand-held, battery-powered device used to dissect through tissues and to coagulate vessels up to and including 5 mm in diameter. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy by pressing a button on the handpiece.
The 510(k) submission includes two accessories. The first is the Battery Insertion Guide (SCBIGA), a reusable, user-sterilized device that facilitates the assembly process.
The second accessory is a custom battery charger (CBCA). The charger is able to charge up to four SCBA batteries at a time. It provides the user with an indication of the charging progress. It also monitors battery health and the number of surgical uses the battery has gone through. It disables batteries that have reached end of life or that are out of specification.
This document is a 510(k) Premarket Notification for a medical device and therefore describes a device comparison study rather than a study aimed at proving a new AI/software-as-a-medical-device (SaMD) meets acceptance criteria. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to define and meet new performance acceptance criteria in the same way an AI/SaMD might.
However, based on the provided text, we can extract information regarding performance testing conducted to support the claim of substantial equivalence. I will frame the response by identifying what would traditionally be acceptance criteria for a new device and then describe the performance testing done in this 510(k) to demonstrate comparable performance to the predicate device.
Device: Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device
Study Purpose: To demonstrate substantial equivalence to the predicate device (Sonicision™ Cordless Ultrasonic Dissection Device family and accessories) by showing comparable performance.
The document does not explicitly state "acceptance criteria" in the traditional sense for a new device's performance benchmarks. Instead, the study aims to show that the proposed device performs comparably to the predicate device. The "acceptance criteria" can be inferred as performance that is not statistically or clinically meaningfully worse than the predicate device for key characteristics.
Here's how the information aligns with your requested format, interpreting "acceptance criteria" as "comparable performance to the predicate":
1. Table of Acceptance Criteria (Inferred as Demonstrating Comparability to Predicate) and Reported Device Performance
| Characteristic (Inferred Acceptance Criteria: Performance Comparable to Predicate) | Predicate Device Performance / Characteristic | Proposed Device (Sonicision Curved Jaw) Performance / Characteristic | Comment / Performance Result |
|---|---|---|---|
| Vessel Coagulation Diameter | Coagulate isolated vessels up to 5 mm in diameter. | Coagulate isolated vessels up to and including 5 mm in diameter. | Minor difference; "up to and including" 5mm. Supported by bench and pre-clinical testing. |
| Ex Vivo Burst Strength | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Blood vessels coagulated by the Sonicision Curved Jaw device had comparable burst strength to the same type of blood vessels coagulated by predicate Sonicision device. | Comparable performance. |
| Ex Vivo Tissue Temperature (Max Blade/Shaft Temp) | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Maximum temperature of the Sonicision Curved Jaw active blade and shaft were comparable to the maximum temperatures of the predicate Sonicision active blade and shaft after multiple activations on mesentery. | Comparable performance. |
| Acute In Vivo Hemostasis Rate | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Achieved comparable rates of hemostasis to the predicate Sonicision device family. | Comparable performance. |
| Acute In Vivo Lateral Thermal Spread | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Achieved comparable lateral thermal spread to the predicate Sonicision device family. | Comparable performance. |
| Chronic In Vivo Hemostasis Duration | (No explicit predicate value). | Vessels (up and including 5 mm) coagulated by the Sonicision Curved Jaw device family maintain hemostasis for at least 21 days. Surgical sites showed an expected healing response. | Meets user needs. |
| Human Factors/Usability | (No explicit predicate value, but implicitly, acceptable usability). | User interfaces and cleaning/sterilization instructions are suitable for intended user populations: OR staff (circulating nurses, surgical scrub nurses/technicians), surgeons (multiple specialties), and central processing technicians. | Validation demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test (e.g., number of vessels tested, number of mesentery activations). It broadly refers to "several bench and animal tests."
- Test Set Sample Size: Not specified quantitatively.
- Data Provenance: The tests are described as "ex vivo burst testing," "ex vivo tissue testing," "acute in vivo testing," and "chronic in vivo testing." This indicates the use of biological tissues (likely from animal models or perhaps excised human tissues, though species not specified) and live animal subjects for the in vivo studies. The country of origin of the data is not specified in the provided text. The studies would be considered prospective as they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The concept of "experts establishing ground truth" as typically seen in AI/SaMD studies (e.g., radiologists labeling images) is not directly applicable here. This is a medical device performance study.
- For Human Factors and Usability validation, the text mentions "Extensive human factors evaluation with operating room nurses and surgical technicians, surgeons, and central processing." While these are experts in their fields, their role is to evaluate usability rather than to establish a 'ground truth' in the diagnostic sense. The number of such participants is not specified.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1 consensus) are typically used for establishing ground truth in diagnostic studies (like image interpretation by multiple readers). This type of adjudication is not relevant to the performance tests conducted for this ultrasonic dissection device (e.g., burst strength, temperature measurement, hemostasis rates).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for AI applications where multiple human readers interpret patient cases, often with and without AI assistance, to measure diagnostic performance change. This document describes performance testing of a surgical device, not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is a surgical instrument operated by a human, not an AI algorithm performing a task without human intervention. The performance tests ("ex vivo," "in vivo") are of the device's physical performance in the hands of users or under simulated conditions, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" for this type of device performance study is established through highly controlled experimental measurements and observations:
- Quantitative Measurements: Burst strength, temperature, hemostasis rates, lateral thermal spread. These are direct physical measurements and observable outcomes from the bench and animal studies.
- Qualitative Observations: Healing responses in chronic in vivo testing, user feedback on usability. These are assessed based on established biological and usability criteria.
- The comparison is primarily against the performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a medical device performance study, not an AI/Machine Learning study involving training data sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied in this 510(k) submission.
N/A