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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."

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The THUNDERBEAT hand instruments are intended to be used for open, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect.

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), coasping, 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 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.

The THUNDERBEAT hand instruments have not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The THUNDERBEAT Type X 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 Type X Hand Instruments are provided as a sterile, single use devices. Type X devices are functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. These devices have been designed to seal and cut vessels up to and including 7 mm in diameter, tissue bundles, and lymphatics.

The provided document describes the safety and performance testing for the THUNDERBEAT Type X Hand Instruments, comparing them to a predicate device (K132703) to establish substantial equivalence. However, it does not explicitly state specific acceptance criteria in terms of numerical thresholds for performance metrics. Instead, it focuses on demonstrating comparable performance to the predicate device.

Given the information provided, here's an attempt to structure an answer, making assumptions where explicit numerical criteria are missing:

Acceptance Criteria and Study for THUNDERBEAT Type X Hand Instruments

The THUNDERBEAT Type X Hand Instruments demonstrated substantial equivalence to the predicate device (THUNDERBEAT Hand Instruments cleared under K132703) through a series of performance tests. The acceptance criteria were implicitly based on demonstrating performance that is equivalent or superior to the predicate device, or within acceptable safety margins for the intended use. While explicit numerical acceptance criteria are not provided in the document, the studies aimed to show comparable performance in key areas.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

The document does not explicitly state the exact sample sizes (number of vessels, resections, or animals) for the ex-vivo and in-vivo studies.

• Ex-vivo Vessel Burst Pressure: Porcine blood vessels.
• Ex-vivo Cutting Performance: Porcine mesentery.
• Chronic Animal Study: Porcine animals.
• Acute Animal Study: Porcine animals.

All these studies represent retrospective data collected specifically for the purpose of this submission. The country of origin for the data is implied to be from the manufacturer (Olympus Medical Systems Corp. in Japan, and Aomori Olympus in Japan, with the submitter Gyrus ACMI, Inc. in the US facilitating the submission). However, the specific location where the animal studies were conducted is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a surgical instrument (electrosurgical cutting and coagulation device), not an AI/diagnostic device that requires expert adjudication for ground truth. The "ground truth" for performance is established through objective physical measurements (like burst pressure, cutting time) and biological outcomes in animal models (seal maintenance, thermal spread, healing).

4. Adjudication Method for Test Set

Not applicable. As noted above, this device does not involve human interpretation of outputs that would require an adjudication method like 2+1 or 3+1. Performance is measured objectively.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a surgical instrument. MRMC studies are typically used for diagnostic or imaging AI devices to assess the impact on human reader performance.

6. Standalone Performance

The "standalone performance" of the device is precisely what the ex-vivo and in-vivo animal studies evaluated. These tests assess the direct performance of the instrument on biological tissue without human-in-the-loop performance considerations (beyond the operator performing the procedure as intended). The performance metrics described in Section 1 above (burst pressure, cutting time, seal maintenance, thermal spread, healing, degeneration) represent the standalone performance of the device.

7. Type of Ground Truth Used

The ground truth for the performance studies was based on:

• Objective physiological measurements: Ex-vivo burst pressure of vessels, ex-vivo cutting time.
• Pathological and observational outcomes in animal models: Seal maintenance rates, thermal spread, degree of healing progression, degree of degeneration observed in porcine tissue. These would typically be assessed by veterinary pathologists or trained researchers.
• Biocompatibility testing: Standardized laboratory tests adhering to ISO 10993.
• Sterilization and stability testing: Standardized laboratory tests adhering to ISO 11135 and other stability protocols.

8. Sample Size for the Training Set

Not applicable. This is a medical device (surgical instrument), not an AI/machine learning model, so there is no "training set." The performance testing described (bench and animal studies) serves as the validation set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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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.

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.

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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

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.

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.

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