(229 days)
The THUNDERBEAT Type S hand instruments are intended to be used with the Ultrasonic Generator (USC-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer (TD-TB400).
Seal & Cut mode:
The THUNDERBEAT Type S hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc.), and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
Seal mode:
The THUNDERBEAT Type S hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc.), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
The THUNDERBEAT Type S hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The THUNDERBEAT Type S Hand Instruments is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
The THUNDERBEAT Type S Hand Instruments is provided as a sterile, single use device. It is a functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. This device has been designed to seal and cut vessels up to and including 7 mm in diameter, tissue bundles, and lymphatics.
This document is a 510(k) Summary for the THUNDERBEAT Type S Hand Instruments, which are electrosurgical cutting and coagulation devices. It compares the new device to a predicate device and provides performance testing summaries to demonstrate substantial equivalence.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
The document doesn't present specific numerical acceptance criteria in a table format with corresponding reported performance values explicitly labeled as "acceptance criteria met". Instead, it describes performance tests designed to compare the new device (THUNDERBEAT Type S) to a predicate device (THUNDERBEAT K132703) to demonstrate substantial equivalence. The implication is that the new device's performance results were "similar" or "demonstrated substantial equivalence" to the predicate, which serves as the de facto acceptance benchmark.
Here's a table based on the performance testing summarized, with the understanding that "acceptance criteria met" implies performance comparable/substantially equivalent to the predicate device. The document does not provide quantitative results for the performance tests, only that they were conducted.
| Acceptance Criteria (Implied: Performance Comparable/Substantially Equivalent to Predicate) | Reported Device Performance (Qualitative Summary) |
|---|---|
| Bench Testing: | |
| Ex-vivo Vessel Burst Pressure (vessel sealing performance) | Conducted on both subject and predicate devices to demonstrate vessel sealing performance. (Implied: Comparable performance to predicate). |
| Ex-vivo Cutting Performance (Cutting time) | Conducted on both subject and predicate devices to demonstrate cutting performance. (Implied: Comparable performance to predicate). |
| Max Temperature (inside/outside temperature at grasping section) | Conducted on both subject and predicate devices to demonstrate for the inside/outside temperature at the grasping section. (Implied: Comparable performance to predicate). |
| Grasping force (homogeneousness of grasping force) | Conducted on both subject and predicate devices to demonstrate homogeneousness of grasping force across the grasping section. (Implied: Comparable homogeneousness to predicate). |
| Durability of the coating on underside of probe tip | Conducted to confirm durability of coating on underside of probe tip after device output. (Implied: Acceptable durability). |
| Durability against twisting (torque when spark occurs) | Conducted on both subject and predicate devices to demonstrate torque when spark occurs between probe and jaw during activation. (Implied: Comparable durability to predicate). |
| Animal Testing: | |
| Chronic Animal Study (seal performance, thermal spread, healing degree for 7.0mm vessels, lymphatics, tissue bundles) | Conducted on both subject and predicate devices to confirm seal performance, thermal spread, and healing degree. (Implied: Acceptable and comparable performance to predicate). |
| Acute Animal Study (seal performance, thermal spread, degeneration degree for 7.0mm vessels, lymphatics, tissue bundles) | Conducted on both subject and predicate devices to confirm seal performance, thermal spread, and degeneration degree. (Implied: Acceptable and comparable performance to predicate). |
| Biocompatibility Testing: | Compliance with ISO-10993 series. |
| Sterilization: | Compliance with ISO11135:2014. |
| Shelf Life: | Three-year shelf life. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document mentions ex-vivo and animal studies using porcine models. However, it does not specify the sample sizes (e.g., number of vessels, number of animals) used for these tests. The data provenance is described as:
- Country of origin: Not explicitly mentioned for the data itself, but the manufacturer and associated entities are in Japan and Massachusetts, USA. The animal studies were likely conducted in a research facility.
- Retrospective or prospective: The studies described (bench and animal testing) are inherently prospective in nature, as they involve actively conducting tests with the devices.
3. Number of Experts and Qualifications for Ground Truth
This type of submission for an electrosurgical device does not typically involve human expert interpretation of images or data for ground truth establishment in the same way an AI-powered diagnostic device would. The "ground truth" for the performance tests (e.g., burst pressure, cutting time, temperature, seal performance, thermal spread, healing) would be established by objective measurements and observations conducted by trained personnel using standardized protocols, rather than expert consensus on a subjective measure. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as seen in AI/imaging studies is not directly applicable here.
4. Adjudication Method for the Test Set
As the ground truth is based on objective measurements and observations, an adjudication method like 2+1 or 3+1 (common in image interpretation studies) is not applicable. The data would likely be collected and analyzed according to predefined statistical methods and quality control procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices assisting human readers in diagnostic tasks (e.g., radiologists interpreting images). The THUNDERBEAT device is a surgical instrument, not a diagnostic AI system, so an MRMC study would be irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This question is highly relevant for AI/software devices. The THUNDERBEAT is a physical electrosurgical device; it does not have a standalone "algorithm only" performance that would be evaluated in this context. Its performance is always in the context of its physical operation.
7. The Type of Ground Truth Used
The ground truth for the performance testing was based on objective measurements and observations from ex-vivo (e.g., porcine blood vessels, mesentery) and in-vivo (porcine animal studies) experiments. This includes quantifiable measures like burst pressure, cutting time, temperatures, grasping force, torque, and qualitative assessments of seal performance, thermal spread, and healing observed in animal models. It is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on the direct results of the physical and biological tests.
8. The Sample Size for the Training Set
This device does not involve machine learning or AI algorithms that require a "training set" in the computational sense. Therefore, the concept of a "training set" and its sample size is not applicable. The device's design and manufacturing are based on conventional engineering principles and testing, not AI model training.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for an AI algorithm, this question is not applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.