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