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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 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 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 researcines, 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 & 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 provided 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System (K061526) states that preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications. The submission then concludes that the system is equivalent to its predicate device based on these design validation results.

However, the summary does not provide specific details about the acceptance criteria or the study that "proves the device meets the acceptance criteria" in the format of the requested table and detailed analysis. This type of information is typically considered proprietary and is not fully disclosed in a public 510(k) summary. The summary focuses on establishing substantial equivalence to a predicate device (K031133) rather than presenting a detailed performance study with explicit acceptance criteria and results.

Therefore, I cannot fully complete the requested table and analysis due to the limited information available in the provided document.

Here's what can be inferred and what is missing:

Inferred Information from the 510(k) Summary

The summary indicates that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." This implies that the device was evaluated for its ability to cut and seal vessels, grasp and dissect tissue effectively and safely, similar to its predicate device.

Missing Information - Cannot be Extracted from the Provided Document

1. Table of Acceptance Criteria and Reported Device Performance

Reason for missing information: The 510(k) summary did not disclose the specific quantifiable acceptance criteria or the detailed results of the performance tests. It broadly states that tests were done to "meet design specifications."

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

Reason for missing information: The document does not specify the sample size (e.g., number of vessels, tissues, or animals tested) used in the preclinical laboratory and performance tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

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

Reason for missing information: The document does not mention the involvement of experts for establishing ground truth, as this type of preclinical testing typically involves engineers and researchers evaluating physical performance rather than clinical expert consensus.

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

Reason for missing information: This is not applicable to the preclinical bench and performance tests described. Adjudication methods are typically used in clinical studies involving human readers or evaluators.

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

Reason for missing information: This information is not relevant to the device described. The EnSeal system is an electrosurgical instrument, not an AI-powered diagnostic or assistive technology for human readers.

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

Reason for missing information: This is not applicable. The EnSeal system is a medical device requiring direct human operation, not a standalone algorithm.

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

Reason for missing information: For preclinical bench testing of an electrosurgical device, the "ground truth" would typically be established by objective measurements against engineering specifications and validated experimental methods (e.g., bursting pressure measurements for seals, microscopic analysis of tissue effects, temperature readings). The document does not specify these methods.

8. The sample size for the training set

Reason for missing information: Not applicable to this type of device. "Training set" is a concept used in machine learning and AI development, not for the validation of an electrosurgical instrument in the manner described. The device's design is based on engineering principles and previous predicate device experience, not a "training set" in the AI sense.

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

Reason for missing information: Not applicable for the same reason as point 8.

In summary, the provided 510(k) summary states that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications," leading to the conclusion of substantial equivalence. However, it explicitly lacks the granular detail regarding acceptance criteria, sample sizes, expert involvement, and specific performance results that would be needed to fulfill the request.

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