(242 days)
The THUNDERBEAT Open Fine Jaw hand instrument is 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 Open Fine Jaw hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has 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 procedure in adults (thyroidectomy, parotidectomy, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has 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 procedure in adults (thyroidectomy, parotidectomy, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw hand instrument has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.
- 1 It should be extended appropriately depending on the operation situation.
The THUNDERBEAT Open Fine Jaw TB-0009OF is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).
The THUNDERBEAT Open Fine Jaw TB-0009OF 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 for open, open ENT procedures in surgery.
This document is a 510(k) premarket notification for the "THUNDERBEAT Open Fine Jaw TB-0009OF" device, an electrosurgical cutting and coagulation device. The document describes various non-clinical (bench and animal) tests conducted to demonstrate substantial equivalence to predicate devices, but no clinical studies or studies involving human readers and AI assistance are mentioned.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it pertains to AI-driven diagnostic or interpretative devices, which this is not.
Here's what can be extracted based on the provided text, primarily focusing on the device's technical and non-clinical evaluations:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several non-clinical tests (bench and animal) with their objectives. However, specific numerical acceptance criteria (e.g., minimum burst pressure for vessel seals) and the exact quantitative reported performance metrics from these tests are not provided in this summary. The summary only states the objective of each test.
| Test Code | Objective | Implied Acceptance Criterion | Summary of Reported Performance (Qualitative) |
|---|---|---|---|
| #A1 | To confirm the sealing & cutting and sealing performances of THUNDERBEAT Open Fine Jaw. | Performance is comparable/sufficient for intended use. | Not explicitly stated; implied as meeting the objective for substantial equivalence. |
| #A2 | To compare the sealing & cutting performance of the THUNDERBEAT Open Fine Jaw with the conventional bipolar device. | Performance is comparable to conventional bipolar devices. | Not explicitly stated; implied as meeting the objective for substantial equivalence. |
| #B1 | To compare the cutting performance of THUNDERBEAT Open Fine Jaw with those of THUNDERBEAT, conventional bipolar and ultrasonic devices. | Performance is comparable to predicate and conventional devices. | Not explicitly stated; implied as meeting the objective for substantial equivalence. |
| #Fb1 | To verify the sealing performance and characteristics of THUNDERBEAT Open Fine Jaw during SEAL&CUT mode output compared with a conventional ultrasonic device. | Sealing performance and characteristics are comparable. | Not explicitly stated; implied as meeting the objective for substantial equivalence. |
| #Fb2 | To verify the characteristics of THUNDERBEAT Open Fine Jaw during SEAL&CUT mode output compared with a conventional ultrasonic device. | Characteristics are comparable. | Not explicitly stated; implied as meeting the objective for substantial equivalence. |
| #H | To confirm grasping and dissection performance of the THUNDERBEAT Open Fine Jaw by comparison with the control devices. | Grasping and dissection performance is comparable to control devices. | Not explicitly stated; implied as meeting the objective for substantial equivalence. |
| #I/J | To compare maximum temperature and cooling time of the grasping section of the THUNDERBEAT Open Fine Jaw and the control devices. | Temperature/cooling time are within acceptable ranges and comparable. | Not explicitly stated; implied as meeting the objective for substantial equivalence. |
| #L | To compare subject device to predicate device regarding evenness of grasping force across grasping section. | Grasping force evenness is comparable to predicate device. | Not explicitly stated; implied as meeting the objective for substantial equivalence. |
| #D | To confirm the performance of THUNDERBEAT Open Fine Jaw on blood vessels up to 7.0 mm in diameter, lymphatics and tissue bundles, and its safety on blood vessels up to 7.0 mm in diameter and tissue bundles with blood vessels and lymphatics by comparing the seal achievement rate, thermal spread, degree of degeneration and seal achievement with those yielded. | Acceptable seal achievement rate, thermal spread, and degree of degeneration, comparable to predicate or established norms. | Not explicitly stated; implied as demonstrating performance and safety. |
| #Ca | To confirm the performance of THUNDERBEAT Open Fine Jaw on blood vessels up to 7.0 mm in diameter, lymphatics and tissue bundles by comparing the seal achievement and maintenance rates with those yielded. | Acceptable seal achievement and maintenance rates. | Not explicitly stated; implied as demonstrating performance. |
| #G | To confirm the safety and performance of THUNDERBEAT Open Fine Jaw when utilized during ENT procedures including thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy. | Acceptable safety and performance for ENT procedures. | Not explicitly stated; implied as demonstrating safety and performance. |
| #M | To confirm the safety and performance of THUNDERBEAT Open Fine Jaw when utilized during ENT procedures... The thermal spread and the acute tissue response... were evaluated in comparison with the control devices. | Acceptable thermal spread and acute tissue response, comparable to control devices. | Not explicitly stated; implied as demonstrating safety and performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Tests (Ex-vivo): Specific sample sizes for ex-vivo vessel and tissue tests (#A1, #A2, #B1, #Fb1, #Fb2, #H, #I/J, #L) are not provided in this summary. The provenance is implied to be laboratory-controlled settings.
- Animal Tests (In-vivo):
- For performance testing M and G: Canine animal model was used. Specific number of animals not stated.
- For performance testing Ca and D: Porcine animal models were used. Specific number of animals not stated.
- Data Provenance: Laboratory animal models.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This document describes non-clinical performance testing of a surgical device. It does not involve human interpretation of medical images or data that would typically require "experts to establish ground truth" related to diagnostic accuracy, as is common in AI/ML device submissions. The "ground truth" for the device's performance would be the direct physical measurement and observation of its interaction with tissue and vessels in the described bench and animal models.
4. Adjudication Method for the Test Set
- Not applicable in the context of this device and the tests described. Adjudication methods are typically used for disagreements among human readers or for establishing consensus in clinical interpretations. The reported tests are objective measurements of device performance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document explicitly states: "Clinical testing using the subject device itself was not conducted." The submission focuses on non-clinical data and comparison to predicate devices, not human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is a hardware surgical device, not an algorithm or AI.
7. The Type of Ground Truth Used
- For the non-clinical tests (bench and animal studies), the "ground truth" refers to direct physical measurements and observations of the device's performance on tissues and vessels, such as:
- Measurement of seal achievement rate.
- Measurement of thermal spread.
- Assessment of tissue degeneration.
- Comparison of cutting performance and characteristics.
- Measurement of grasping force distribution.
- Measurement of maximum temperature and cooling time.
- Pathological examination of animal tissue responses.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set. The device's design and manufacturing process are validated through engineering and non-clinical performance testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.