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The EnSeal PowerTip is an electrosurgical instrument for use with the EnSeal Universal electrosurgical generator. It is intended for use during open or faparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The cutting tip feature is intended for use in the dissection of tissue planes and the creation of enterotomies and gastrotomies.

The EnSeal PowerTip has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

EnSeal PowerTip with EnSeal Universal. The functionality of the devices are the same as the predicate devices.

The provided text indicates that the K081129 submission for the "EnSeal PowerTip with EnSeal Universal" is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting.

Therefore, the documentation does not contain the specific information requested in your prompt regarding acceptance criteria, a dedicated study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's what can be inferred from the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. The submission is a 510(k) for substantial equivalence. It does not present new acceptance criteria or clinical performance data in this format.

2. Sample size used for the test set and the data provenance:

• Not Applicable. No explicit "test set" in the context of a de novo clinical study is described. The device's safety and effectiveness are established by demonstrating functional similarities and preclinical testing in comparison to predicate devices.
• The provenance is "Preclinical laboratory (bench) and performance tests," suggesting in-house testing rather than human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Ground truth, in the sense of expert consensus on clinical outcomes, is not established or reported for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No adjudication method is mentioned as there is no described test set requiring one.

5. 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:

• Not Applicable. This is an electrosurgical instrument, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is an electrosurgical instrument, not an algorithm, so this concept does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable (in the clinical sense). For a 510(k) based on substantial equivalence, the "ground truth" essentially revolves around the performance characteristics of the predicate devices and whether the new device functions similarly and meets its design specifications during preclinical (bench) testing. The text states: "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications."

8. The sample size for the training set:

• Not Applicable. This is an electrosurgical instrument, not a learning algorithm or AI.

9. How the ground truth for the training set was established:

• Not Applicable. This is an electrosurgical instrument, not a learning algorithm or AI.

Summary based on the provided text:

The submission K081129 is a 510(k) for an electrosurgical instrument. Its approval is based on demonstrating substantial equivalence to existing predicate devices (e.g., K031133, K063195, K031079, K051644). The "study" proving the device met criteria was primarily preclinical laboratory (bench) and performance tests aimed at ensuring the device functions as intended and meets design specifications, consistent with the performance of its predicates. There are no detailed clinical study results, acceptance criteria tables, sample sizes for test sets, expert ground truth establishment, or AI-related metrics (like MRMC or standalone performance) reported in this summary.

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The EnSeal® Vessel Sealing and Hemostasis System is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open and laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The SurgRx EnSeal® Vessel Sealing and Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The EnSeal® Vessel Sealing and Hemostasis System is a bipolar electrosurgical instrument for use with an electrosurgical generator.

I apologize, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the EnSeal® Vessel Sealing and Hemostasis System. The document is a 510(k) clearance letter from the FDA, confirming the device's substantial equivalence to predicate devices and outlining its intended indications for use. It does not include details about specific performance metrics or clinical study data.

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The EnSeal™ PTC is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open and laparoscopic, general and gynerologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resetting, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

EnSeal™ PTC with ERBE VIO 300 D. The functionality of the device is the same as the predicate device.

The provided text is a 510(k) summary for the EnSeal™ PTC with ERBE VIO 300 D, an electrosurgical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study with specific acceptance criteria as one might see for novel AI/software devices. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment, as typically outlined for AI/ML device studies, is not present in this type of submission.

Here's an analysis based on the provided text, highlighting what is and is not available:

1. A table of acceptance criteria and the reported device performance

Explanation: In a 510(k) for an electrosurgical device like this, acceptance criteria would typically revolve around electrical safety, mechanical integrity, and functional performance (e.g., sealing strength, cut time, minimal thermal spread) compared to the predicate. However, these specific criteria and quantitative results are not detailed in this summary. The summary simply states that the tests "ensure the devices function as intended and meet design specifications."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified. The document only mentions "Preclinical laboratory (bench) and performance tests."
• Data Provenance: Not specified. The tests were "preclinical laboratory (bench)" tests, suggesting an in-house or contracted lab environment, but geographical origin is not mentioned. They would be considered prospective for the specific tests conducted.

3. 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)

• Number of Experts: Not applicable/Not specified. This type of device performance testing does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging AI algorithm would. Device performance is measured by objective metrics (e.g., burst pressure, temperature).
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus ground truth in studies involving human interpretation (e.g., reviewing medical images). This is a physical device, and its performance is measured mechanically and electrically, not through human consensus on a diagnosis.

5. 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

• MRMC Study: No. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Study: The device itself is "standalone" in its electrosurgical function, but the context of "standalone performance" typically refers to an algorithm's performance without human intervention. This device performs its function directly. Therefore, this question is not fully applicable in the context of an AI/ML algorithm. The "Preclinical laboratory (bench) and performance tests" assess the device's inherent function, which could be considered its standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For electrosurgical devices, "ground truth" is established through engineering and scientific principles. Examples might include:
  • Physical measurements: Tensile strength of sealed vessels, burst pressure, impedance, power output.
  • Histopathology: To assess thermal damage zones in sealed tissue (though not mentioned in the summary).
  • Objective functional assessments: Such as sealing time, cutting efficacy, and lack of electrical leakage.
    The summary does not detail the specific ground truth metrics but states tests were performed to ensure it "function[s] as intended and meet[s] design specifications."

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not applicable. As there is no training set for an AI/ML model, this question does not apply.

Study Description:

The study proving the device meets its "acceptance criteria" (which are generally implied to be equivalent performance to the predicate) is described as "Preclinical laboratory (bench) and performance tests." The conclusion drawn from these tests is that the device "function[s] as intended and meet[s] design specifications" and is "safe and effective and substantially equivalent to the predicate device." The study's focus was on demonstrating substantial equivalence to the previously cleared devices (EnSeal™ Vessel Sealing and Hemostasis System # K031133, and the ERBE VIO ESU, Model VIO 300 D, # K060484 and EnSeal PTC # K061526). This type of submission relies on comparative analysis of technological characteristics and performance data, rather than establishing de novo safety and effectiveness through a comprehensive multi-site clinical trial with specific performance endpoints often seen for novel therapeutic or diagnostic devices.

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The EnSeal™ PTC Tissue Sealing Device of the EnSeal™ Vessel Sealing and Hemostasis system is a bipolar electrosurgical instrument for use with a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

EnSeal™ PTC Tissue Sealing Device. The functionality of the device is the same as the predicate device. The EnSeal™ electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.

The provided text describes a 510(k) premarket notification for the EnSeal™ PTC Tissue Sealing Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical study data with acceptance criteria and detailed performance metrics as would be found in a PMA.

Therefore, the input does not contain the kind of detailed information about acceptance criteria and a study proving those criteria that your request anticipates for a medical device with an AI component or complex performance claims requiring extensive clinical validation. The document states "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." and "The EnSeal™ PTC Tissue Sealing Device is equivalent to the predicate device based on results of design validation." This suggests that the studies performed were primarily bench testing and design validation to show the new device operates similarly to the predicate, not a clinical trial with specific performance targets against a ground truth.

Given the available information, I cannot complete most of the requested fields. Here's what I can extract and what is missing:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the format of a table with specific thresholds (e.g., sensitivity > X%, specificity > Y%). It broadly states that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." This implies that the acceptance criteria were likely related to engineering specifications and functional equivalence to the predicate device, but these are not enumerated. The reported performance is a general statement of "design validation" demonstrating equivalence.

2. Sample size used for the test set and the data provenance

The document mentions "Preclinical laboratory (bench) and performance tests" but does not specify the sample size for these tests. There's no mention of a "test set" in the context of patient data, data provenance (country of origin), or whether the data was retrospective or prospective, as this device uses bench testing for clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The clearance is based on bench testing and design validation against engineering specifications and predicate device performance, not clinical interpretation against a ground truth established by experts.

4. Adjudication method for the test set

Not applicable. There's no mention of a "test set" requiring adjudication in the context of this 510(k) submission.

5. 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

Not applicable. This device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm; it's a physical surgical tool.

7. The type of ground truth used

The "ground truth" for this submission would be defined by engineering standards, functional specifications, and the performance characteristics of the predicate device, demonstrated through bench testing. It does not involve expert consensus, pathology, or outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there's no training set, there's no ground truth to establish for it in this context.

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The EnSeal™ PTC TRIO of the EnSeal™ Vessel Sealing and Hemostasis system is a bioolar electrosurgical instrument for use with a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

EnSeal™ Vessel Sealing and Hemostasis System. The functionality of the System is the same as the predicate device.

The provided 510(k) summary for the EnSeal™ PTC TRIO of the EnSeal™ Vessel Sealing & Hemostasis System does not contain sufficient information to fulfill all aspects of your request regarding acceptance criteria and a detailed study.

Here's what can be extracted based on the provided text, and where information is missing:

Missing Information:
The document primarily focuses on establishing substantial equivalence to a predicate device based on the functionality of the system and preclinical laboratory (bench) and performance tests. It does not detail specific acceptance criteria with numerical targets or comprehensive clinical study results. There is no mention of a test set, ground truth experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details. This is typical for a 510(k) submission that relies on substantial equivalence to a predicate device for safety and effectiveness, rather than a de novo or PMA submission requiring extensive clinical trial data detailing explicit performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information (Based on available text):

2. Sample size used for the test set and the data provenance:

• Not explicitly stated. The document refers to "Preclinical laboratory (bench) and performance tests" and "design validation" without providing details on specific sample sizes for these tests or the origin of any data used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not mentioned. The submission describes device testing (likely in a lab/bench setting), not a study requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method for the test set:

• Not applicable / Not mentioned. This type of adjudication is typically for clinical or diagnostic accuracy studies, which are not detailed here.

5. 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. An MRMC study is not mentioned. This device is an electrosurgical instrument, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is an electrosurgical instrument for human use, not an algorithm.

7. The type of ground truth used:

• Not applicable / Not mentioned. For bench and performance tests of a surgical instrument, "ground truth" would likely relate to objective measurements of sealing strength, cut efficacy, temperature profiles, etc., against predefined engineering or performance specifications. The document states "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications."

8. The sample size for the training set:

• Not applicable / Not mentioned. This is not a machine learning or AI device that would typically involve a "training set."

9. How the ground truth for the training set was established:

• Not applicable / Not mentioned. See point 8.

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The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including unlake polluding and reconstructive, bowel resections, hysterectomies, cholecysted, theracter, plactions and resolunts, bowel resedunts. edbacialysis contrasses in the secures, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

EnSeal™ Vessel Sealing & Hemostasis System. The functionality of the System is the same as the predicate device. The EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.

The medical device in question is the SurgRx EnSeal Vessel Sealing & Hemostasis System.

1. Acceptance Criteria and Reported Device Performance:

The document mentions that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." However, no specific quantitative acceptance criteria or their corresponding performance results are provided in the extracted text. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against pre-defined thresholds.

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

The document does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "Preclinical laboratory (bench) and performance tests."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not specify the number of experts used and their qualifications for establishing ground truth for any test set.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence to a predicate device.

6. Standalone (Algorithm Only) Performance:

This device is an electrosurgical instrument system, not an AI-powered algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable.

7. Type of Ground Truth Used:

The document implies that the ground truth for "design validation" was based on the "function as intended" and "meet design specifications." This suggests a bench test and performance test-driven ground truth, likely based on engineering specifications and direct observation of the device's physical performance (e.g., ability to seal vessels of a certain size, cutting capabilities). It is not pathology, outcomes data, or expert consensus in a diagnostic sense.

8. Sample Size for the Training Set:

This device is not an AI/ML algorithm that requires a training set. Therefore, this question is not applicable.

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

This device is not an AI/ML algorithm that requires a training set. Therefore, this question is not applicable.

Summary of the Study:

The study performed was a design validation using "Preclinical laboratory (bench) and performance tests." The primary objective was to demonstrate substantial equivalence to a predicate device (EnSeal™ Vessel Sealing and Hemostasis System # K061526). The document concludes that "The EnSeal System is equivalent to the predicate device based on results of design validation." It is implied that the device met its design specifications and performed as intended in these preclinical tests, thus satisfying the requirement for substantial equivalence. No detailed analytical study with quantitative acceptance criteria, specific test data, or statistical analysis against the predicate device is provided in the summary.

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The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It is intended for use during open or laparoscopic general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, colorectal, urologic procedures, Nissen fundoplication, hysterectomies, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection in the same instrument can be used on tissue of any amount that will fit in the jaws of the instruments.

The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

EnSeal™ Vessel Sealing and Hemostasis System. The functionality and components of the System are the same as the Predicate Device.

The provided text is a 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System. It states that the device is a modification of a previously cleared device (K031133) and does not require additional performance testing because the modification does not affect the system's performance. Therefore, typical acceptance criteria and a study demonstrating performance against those criteria, as one might find for a novel device, are not detailed in this document.

However, based on the information provided, we can deduce some aspects and limitations regarding "acceptance criteria" and "study."

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The submission states: "This modification does not affect performance of the System. Additional performance testing not required." This implies that the device is expected to meet the same performance criteria as its predicate device (K031133), but those specific criteria are not listed here.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. As "additional performance testing not required," there would likely not have been a new test set for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided.

4. Adjudication Method for the Test Set

This information is not provided.

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

A MRMC study was not performed or mentioned in this document. The submission focuses on substantial equivalence based on the predicate device's performance, not comparative effectiveness with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable as the device is an electrosurgical system, not an AI algorithm.

7. Type of Ground Truth Used

Not explicitly stated for this submission. For the original predicate device, performance would typically be evaluated against established biological, surgical, or engineering outcomes relevant to vessel sealing and hemostasis (e.g., burst pressure, thermal spread, tissue effect).

8. Sample Size for the Training Set

Not applicable as this is not an AI/ML device requiring a training set.

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

Not applicable.

Summary derived from the document:

The core "acceptance criterion" for this specific 510(k) submission (K050671) is substantial equivalence to the predicate device (K031133). The "study" that proves the device meets this "acceptance criterion" is the design validation that demonstrated the modification did not alter the existing system's performance.

From the text:

• Acceptance Criterion: Substantial equivalence to the predicate device (EnSeal™ Vessel Sealing and Hemostasis System # K031133), based on the functionality and components remaining the same. The implicit performance criteria are those established for the original predicate device.
• Study Proving Acceptance: "Results of design validation." The document explicitly states: "This modification does not affect performance of the System. Additional performance testing not required." This implies that the design validation assessed that the changes did not negatively impact the previously established performance of the predicate device.

The document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive new performance studies if the changes are minor or do not impact core functionality.

Ask a specific question about this device

The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

The RF-60 generator/controller which is used in conjunction with the EnSeal System. The functionality and remaining components of the System are the same.

The provided 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System (K043008) does not include detailed acceptance criteria or a specific study designed to prove the device meets such criteria.

Instead, the submission relies on the concept of substantial equivalence to a predicate device (EnSeal™ Vessel Sealing and Hemostasis System # K031133). The performance data section broadly states:

"Preclinical laboratory (bench & live animal studies) and performance tests were executed to ensure the devices function as intended and meet design specifications."

This phrasing indicates that internal testing was conducted, but it doesn't provide the level of detail requested in the prompt regarding specific acceptance criteria and the study design to evaluate them.

Therefore, I cannot provide the requested information in the table or answer most of the follow-up questions because the necessary details are not present in the provided document.

However, I can extract what is explicitly stated:

Information Not Available in the Provided Document:

• A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence rather than explicit performance benchmarks for this specific device.
• Sample size used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method: Not provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not explicitly stated for bench or animal studies beyond "function as intended and meet design specifications."
• The sample size for the training set: Not applicable/not provided. This is a medical device, not a machine learning model with a training set.
• How the ground truth for the training set was established: Not applicable/not provided.

Information that can be inferred or is broadly stated:

• Study Type: Preclinical laboratory (bench & live animal studies) and performance tests. These are internal validation studies, not typically large-scale clinical trials with human subjects for product clearance in this context.
• Purpose of Studies: "to ensure the devices function as intended and meet design specifications." This broadly implies that the "acceptance criteria" were the device's design specifications for functionality and safety.
• Conclusion: "The EnSeal System is equivalent to the predicate devices based on results of design validation." and "We believe that the RF-60 generator/controller used in conjunction with the EnSeal devices is safe and effective and substantially equivalent to the predicate devices."

In summary, the 510(k) submission describes a reliance on the existing predicate device's safety and effectiveness, supported by internal "preclinical laboratory (bench & live animal studies) and performance tests" to demonstrate that the functionality and design specifications of the new component (RF-60 generator/controller) are met and maintain substantial equivalence. Specific, quantifiable acceptance criteria and detailed study designs for those criteria are not part of this public summary.

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