(263 days)
The THUNDERBEAT hand instruments are intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
Seal & Cut mode:
The THUNDERBEAT hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general 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.
This mode is also indicated for open ENT procedures in adults for ligation (sealing and cutting) of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general 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 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.
This mode is also indicated for open ENT procedures in adults for sealing of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.
The THUNDERBEAT 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 hand instruments are intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
The THUNDERBEAT hand instruments are provided as sterile, single use devices. These are functional devices capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, dissecting. These instruments have been designed to seal and cut vessels up to and.including 7 mm in diameter, tissue bundles, and lymphatics for open, laparoscopic, open ENT and endoscopic procedures in surgery.
The provided text describes a 510(k) submission for the THUNDERBEAT hand instruments. This submission aims to demonstrate substantial equivalence to predicate devices and expand the Indications for Use. The information primarily focuses on performance testing rather than the detailed acceptance criteria and a standalone study with specific performance metrics against those criteria in a format directly requested by the prompt.
Therefore, many sections of your requested output cannot be directly extracted from the provided text. The document refers to "performance testing" being conducted but does not provide a table of acceptance criteria with corresponding device performance for a specific study. It also lacks details about sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, specific ground truth types for training/test sets, or training set sample size and ground truth establishment.
However, I can extract the types of performance tests conducted, which are often used to demonstrate that the device meets its intended use, even if the precise quantitative acceptance criteria and results are not explicitly listed in a comparative table.
Here's an attempt to populate the table and answer the questions based on the available information:
Acceptance Criteria and Device Performance
The document describes various performance tests conducted to support the expanded indications for use and marketing claims. While specific quantitative acceptance criteria or a direct comparison table are not provided, the tests aim to confirm the device's functional equivalence and safety.
| Acceptance Criteria (Implied from tests) | Reported Device Performance (Implied from "Confirmation Test," "Comparison") |
|---|---|
| Vessel Sealing & Cutting Performance (Ex-vivo) | Confirmed ("Performance Confirmation Test") |
| Cutting Performance on Blood Vessels and Mesentery (Ex-vivo) | Confirmed ("Cutting Performance Confirmation Test") |
| Sealing performance of SEAL & CUT mode | Confirmed ("Sealing performance of the THUNDERBEAT SEAL & CUT mode") |
| Sealing performance and characteristic of SEAL & CUT mode during activation | Confirmed ("Sealing performance and characteristic of the THUNDERBEAT SEAL & CUT mode during activation") |
| Comparison of dissecting performance vs. control devices | Demonstrated satisfactory comparative performance ("Comparison of dissecting performance between the THUNDERBEAT vs. Control devices") |
| Comparison of heating at grasping section vs. control devices | Demonstrated satisfactory comparative performance regarding heat ("A comparison of heating at the grasping section of THUNDERBEAT Hand Instruments vs. Control devices") |
| Histopathological confirmation of Sealing & Cutting/Sealing (Ex-vivo) | Confirmed ("Histopathological Confirmation Test on Blood Vessels") |
| In-vivo Sealing & Cutting and Sealing Performance (Porcine) | Confirmed ("THUNDERBEAT In-vivo Sealing & Cutting and Sealing Performance Confirmation Testing on Porcine Blood Vessels, Lymphatics and Tissue Bundles.") |
1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text for any of the performance tests.
- Data Provenance:
- Country of Origin: Not explicitly stated for each test. The applicant is from Japan, and the manufacturer is Aomori Olympus, Japan. The in-vivo animal test used "Porcine Blood Vessels, Lymphatics and Tissue Bundles," which could be from various locations.
- Retrospective or Prospective: Unclear. The tests are described as "Performance Confirmation Tests," which suggests prospective testing designed for this submission.
2. 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)
- Not specified in the provided text. The "Histopathological Confirmation Test" implies expert pathological analysis would have been used, but no details are given.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified in the provided text.
4. 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 MRMC study was mentioned. This device is an electrosurgical hand instrument, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a surgical instrument, not an algorithm, and is used with a human (surgeon) always in the loop. The performance tests evaluate the instrument's capabilities directly.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for sealing and cutting performance would likely be based on:
- Functional Observation: Successful cutting and sealing during bench and animal tests.
- Physical Measurement: Assessment of seal strength, thermal spread, cutting efficiency.
- Histopathology: For cellular and tissue-level confirmation of vessel sealing and tissue effects (explicitly mentioned: "Histopathological Confirmation Test on Blood Vessels").
- Biocompatibility Testing: Confirmed compliance to ISO-10993.
7. The sample size for the training set
- This concept of a "training set" is not applicable as the submission is for a physical medical device (surgical hand instrument), not an AI/ML algorithm.
8. How the ground truth for the training set was established
- Not applicable for a physical medical device.
§ 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.