Search Results

The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.

Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw Type X 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, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.

Seal mode:
The THUNDERBEAT Open Fine Jaw Type X 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, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.

The THUNDERBEAT Open Fine Jaw Type X hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.

The THUNDERBEAT Open Fine Jaw Type X hand instrument is provided as a sterile, single use device. The subject device is 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 device also has been designed for open ENT procedures in adults.

Based on the provided text, the device in question is the THUNDERBEAT Open Fine Jaw Type X hand instrument, an electrosurgical cutting and coagulation device. The document is an FDA 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial to establish novel effectiveness.

Therefore, the study described here is primarily a bench and animal testing study to support the substantial equivalence claim, especially concerning design modifications and an expanded indication. It is not an AI/Medical Imaging device, so many of the requested elements (like MRMC study, expert judgment for image ground truth, training set information) are not applicable.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance:

The document doesn't explicitly list "acceptance criteria" in a typical table format with quantitative thresholds for each performance metric, as might be seen for a novel device. Instead, the performance testing was conducted to demonstrate equivalence to the predicate device and ensure safety and effectiveness despite modifications and expanded indications. The "acceptance criteria" can be inferred as meeting the performance standards of the predicate device and showing no new safety concerns.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Study Purpose):

The document concludes that the "THUNDERBEAT Open Fine Jaw Type X hand instrument is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness." This statement implies that the device met the (implicit) acceptance criteria for demonstrating equivalence.

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Bench Testing:
     • Ex-vivo Vessel Burst Pressure: Tested on "porcine blood vessels" for both subject and predicate devices. No specific quantitative sample size is provided (e.g., number of vessels).
     • Ex Vivo Testing for Temperature-time History: Tested on "both the subject and predicate devices." No specific sample size provided.
   • Animal Test (In-vivo):
     • Chronic Animal Study: Conducted using "porcine/Beagle Dogs" for both subject and predicate devices. No specific number of animals or instances is provided.
     • Acute Animal Study: Conducted using "porcine/Beagle Dogs" for both subject and predicate devices. No specific number of animals or instances is provided.
   • Data Provenance: The animal studies use "porcine/Beagle Dogs," implying controlled animal laboratory environments. The ex-vivo testing uses "porcine blood vessels."
   • Retrospective or Prospective: These are prospective, controlled laboratory and animal studies designed specifically for this submission.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not Applicable: This is not a study involving human expert interpretation (e.g., radiologists reading images). Ground truth is established through direct physiological measurements (burst pressure, temperature, direct observation of tissue effects in animals).

3. Adjudication Method for the Test Set:

   • Not Applicable: Not applicable as it's not an expert-based subjective assessment. The "ground truth" is derived from quantitative measurements and histological/gross pathology observation in animal models.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No: This type of study (MRMC, human readers with/without AI assistance) is typically performed for AI-powered diagnostic devices (e.g., for medical imaging). This is a surgical instrument, and its performance is evaluated via direct physical and biological effects.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • No: This concept applies to AI algorithms. The device itself is a surgical instrument. Its "performance" is its direct mechanical and energy-delivery function. The testing described (bench and animal) is effectively "standalone" performance relative to its predicate, but the term does not apply in the context of AI.

6. The Type of Ground Truth Used:

   • Physiological/Biological Outcomes and Direct Measurement:
     • Ex-vivo: Vessel burst pressure, temperature distribution, thermal damage.
     • In-vivo (Animal): Seal maintenance rates, thermal spread, degree of healing progression, degree of degeneration.
     • Biocompatibility: Compliance with ISO-10993 standards.
     • Sterilization & Shelf Life: Compliance with relevant standards and FDA guidance.
   • The "ground truth" is established through direct observation, measurement, and pathological analysis in controlled experimental settings.

7. The Sample Size for the Training Set:

   • Not Applicable: This device does not involve machine learning or AI that would require a "training set."

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable: This device does not involve machine learning or AI that would require a "training set" or "ground truth for training."

Ask a specific question about this device

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.

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.

Ask a specific question about this device