(115 days)
The Sonicision™ 7 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, and other open and endoscopic procedures. The device can be used to coagulate isolated vessels up to and including 7 mm in diameter, using the minimum mode. The device can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the maximum mode.
The Sonicision™ 7 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
The Sonicision™ reusable battery pack is a non-sterile, rechargeable, lithium-ion battery that provides power to compatible surgical devices. For full device indications for use, reference the indications for use statements of the compatible devices.
A functional Sonicision™ 7 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, (2) a user cleaned and sterilized reusable generator, and (3) a user cleaned and disinfected reusable battery. 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 tissue and to coagulate vessels up to and including 7 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 provided FDA 510(k) summary for the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device does not contain information about acceptance criteria for AI/ML performance, nor does it describe a study specifically proving the device meets AI/ML acceptance criteria. This document describes a medical device, not an AI/ML algorithm.
However, I can extract the performance data and comparisons that were provided for this medical device to demonstrate its substantial equivalence to predicate devices. This will address the general request for acceptance criteria and the study that proves the device meets them, but it will be in the context of a medical device, not an AI/ML algorithm.
Acceptance Criteria and Device Performance for Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device
The submission demonstrates substantial equivalence to predicate devices through various performance tests. The "acceptance criteria" here are implied by achieving comparable performance to the predicate devices or meeting recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Implied Acceptance Criterion (Comparable to Predicates / Standard Met) | Reported Device Performance (Sonicision™ 7) |
|---|---|---|
| Biocompatibility | No new materials introduced compared to the primary predicate (K180149), thus demonstrating similar biocompatibility. | Evidence presented in previously submitted primary predicate 510(k) [K180149]. The proposed device did not introduce any new materials, therefore, by inference, it met this criteria. |
| Software | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and IEC 62304:2015. | Software tested in accordance with the specified guidance. The software development process met the requirements of IEC 62304:2015. (Note: Software was modified to allow 7 mm coagulation using minimum mode, compared to the primary predicate's 5 mm coagulation. This implies the software changes met the safety and effectiveness criteria for the expanded capability.) |
| Electromagnetic Compatibility (EMC) | Meeting applicable requirements of IEC 60601-1-2, 4th edition. | The assembled device met the applicable requirements of IEC 60601-1-2, 4th edition. |
| Electrical Safety | Meeting applicable requirements of IEC 60601-1:2005/A1:2012, Edition 3.1. | The device met all applicable requirements of IEC 60601-1:2005/A1:2012, Edition 3.1. |
| Ex-vivo Burst Strength (Vessel Coagulation) | Comparable burst strength to the same type of blood vessels coagulated by predicate devices. This criterion is crucial for demonstrating effective hemostasis. | Ex-vivo burst testing showed that blood vessels coagulated by the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device had comparable burst strength to the same type of blood vessels coagulated by the predicates. (Specifically, the device is able to coagulate vessels up to and including 7 mm, an improvement over the primary predicate's 5 mm). |
| Ex-vivo Tissue Testing (Thermal Effects) | Maximum temperatures and cool down times of the active blade and shaft comparable to predicate devices after multiple activations on mesentery, implying acceptable thermal injury control. | Ex-vivo tissue testing showed that the maximum temperatures and cool down times of the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device's active blade and shaft were comparable to the maximum temperatures and cool down times of the predicate's active blade and shaft after multiple activations on mesentery. |
| Acute In-vivo Testing (Hemostasis & Lateral Thermal Spread) | Comparable rates of hemostasis and comparable lateral thermal spread to predicate devices, indicating equivalent immediate surgical performance. | Acute in-vivo testing showed that the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device and the predicates achieved comparable rates of hemostasis and comparable lateral thermal spread. |
| Chronic In-vivo Testing (Sustained Hemostasis) | Maintenance of hemostasis for at least 21 days for vessels up to and including 7 mm in diameter. This confirms long-term efficacy of vessel sealing. | Chronic in-vivo testing showed that vessels (up to and including 7 mm in diameter) coagulated by the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device maintain hemostasis for at least 21 days. |
| Human Factors | Meeting user needs and demonstrated ability for intended users to use the device safely and effectively in intended use environments. | Human factors activities demonstrated that the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device meets user needs and is able to be used for the intended users, intended use, and use environments. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the numerical sample sizes for each of the performance tests (e.g., how many vessels were tested in ex-vivo burst testing, how many animals in acute/chronic in-vivo studies). It only mentions "several bench and animal tests."
The data provenance (country of origin, retrospective/prospective) is not specified in this summary. These types of tests are typically prospective studies conducted by the device manufacturer or contracted labs.
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)
This device is a surgical instrument, not an AI/ML diagnostic tool requiring expert interpretation of images for ground truth. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense does not apply here. The "ground truth" or reference standards are established through direct measurements (e.g., burst pressure), histological analysis, and observed clinical outcomes in animal models. The experts involved would be qualified biomedical engineers, veterinarians, and possibly surgeons overseeing the animal studies, but their specific number and qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a medical device performance study, not an AI/ML algorithm evaluation with human readers.
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 a medical device performance study, not an AI/ML algorithm evaluation with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device performance study, not an AI/ML algorithm evaluation. While the device has "control software," its performance is evaluated in conjunction with the mechanical and ultrasonic components, as a complete system operated by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established through:
- Direct physical measurements: Ex-vivo burst pressure, temperature measurements.
- Biological observations: Visual assessment of hemostasis, measurement of lateral thermal spread.
- Pathology/Histology: Although not explicitly stated, chronic in-vivo studies often involve histological examination of tissue to confirm vessel sealing and assess tissue damage.
- Outcomes data: For the chronic in-vivo study, "maintaining hemostasis for at least 21 days" refers to an outcome measurement.
8. The sample size for the training set
Not applicable. This is a medical device and not an AI/ML algorithm. There is no "training set" in the context of machine learning. The device development involved engineering design, prototyping, and iterative testing, but not machine learning training.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML training set, there is no ground truth established for it.
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