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The Reprocessed LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:

• Scissor like design for opening and closing the instrument jaws and activating RF energy. . The mechanism must be held in the closed position during vessel sealing and cutting.
• . An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
• . A trigger for actuating the blade.

All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator.

The instrument is compatible with the Covidien ForceTriad Energy Platform and Valleylab FT10 Energy Platform.

The scope of the submission only includes the addition of a second reprocessing cycle to the previously cleared Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (K220411) and not the Covidien ForceTriad Energy Platform or Valleylab FT10 Energy Platform that are used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.

The provided text is a 510(k) summary for the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A). It describes the device, its intended use, comparison with predicate devices, and performance data. However, the document does NOT provide detailed acceptance criteria or the specific results of the studies in the format requested. While it lists types of tests performed, it does not specify quantitative acceptance criteria or the reported device performance against those criteria. It also does not explicitly mention sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC studies.

Therefore, many of the requested fields cannot be answered from the provided text. I will extract what information is available and state when information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several functional performance tests but does not explicitly state the quantitative acceptance criteria or the numerical reported device performance for each. It mentions "verification/comparative testing (to the predicate device)" and "evaluation of the device's performance and ability to seal and divide vessels from 1mm to 7mm, including burst pressure, maximum jaw temperature, device functionality, and functional attribute tests," suggesting that the reprocessed device performed comparably to the predicate or met general functional expectations for vessel sealing.

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

The document does not explicitly state the sample sizes for any of the test sets (bench, laboratory, or preclinical). It mentions "preclinical laboratory evaluations in an animal model," but does not specify the type or number of animals used. The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned.

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

Not applicable/Not provided. The studies described are primarily bench testing and animal model evaluations, which typically do not involve human expert interpretation for "ground truth" in the way a diagnostic imaging study would.

4. Adjudication method for the test set

Not applicable/Not provided. Adjudication methods are typically relevant for studies involving human interpretation where consensus or a tie-breaking mechanism is needed for ground truth. This was not such a study.

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. The device described is an electrosurgical sealer/divider and not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical instrument and requires human operation. The performance studies focused on the instrument's functional characteristics and its ability to achieve its intended effect (sealing vessels).

7. The type of ground truth used

For the bench and laboratory testing, the "ground truth" would be objective measurements and established engineering standards (e.g., force, temperature, burst pressure tolerances, electrical safety standards). For the preclinical animal studies, the "ground truth" would be physiological outcomes observed directly (e.g., successful hemostasis, measured thermal spread, histological analysis) compared against expected performance or predicate device performance.

8. The sample size for the training set

Not applicable. This device is a reprocessed surgical instrument, not a machine learning or AI algorithm, so there is no training set in that context. The "training" here refers to the process qualifications and validation of the reprocessing procedure itself.

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

Not applicable. See point 8.

Ask a specific question about this device

The Reprocessed LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:

• Scissor like design for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting.
• An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
• A trigger for actuating the blade.
  All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator.

The instrument is compatible with the Covidien ForceTriad Enerqy Platform and Valleylab FT10 Energy Platform.

The scope of the submission only includes the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider and not the Covidien ForceTriad Energy Platform or Valleylab FT10 Energy Platform that are used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.

This document is a 510(k) premarket notification for a reprocessed medical device, the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A). It demonstrates substantial equivalence to a predicate device.

Important Note: The provided document is for a reprocessed surgical instrument, not an AI-based diagnostic or therapeutic device. Therefore, the questions related to AI-specific criteria (such as multi-reader multi-case studies, expert consensus for ground truth, training set information, effects of AI assistance on human readers) are not applicable to this submission. The "acceptance criteria" discussed in this document refer to the performance of the reprocessed physical device, not an AI algorithm's performance against clinical endpoints.

Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not applicable:

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

The document does not present acceptance criteria and reported device performance in a formal table with specific numerical thresholds. Instead, it lists the types of tests conducted to demonstrate substantial equivalence to the predicate device. The general acceptance criterion for this 510(k) submission is that the reprocessed device performs "at least as safe and effective as the predicate" and "as well as the identified legally marketed predicate device."

Here's a summary of the performance tests conducted, implying the "reported device performance" met the equivalence standard for each:

Acceptance Criteria (Implied: Performance comparable to or equivalent to the predicate device for safe and effective use)

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

• Sample Size: The document does not specify exact numerical sample sizes for each test conducted (e.g., number of devices tested for each functional performance metric, number of animals in preclinical studies). It generally refers to "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model."
• Data Provenance: The tests were conducted by Stryker Sustainability Solutions, a U.S. company. The data would primarily originate from their internal testing facilities. The nature of the testing (bench, in-vitro, and animal studies) is prospective for the purpose of this 510(k) submission.

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)

• Not Applicable: This pertains to an AI/imaging device. For this reprocessed surgical instrument, "ground truth" is established through engineering and performance testing against predefined mechanical, electrical, and functional specifications, as well as comparative performance in an animal model. There is no concept of expert human image interpretation or "ground truth" in the AI sense for this device.

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

• Not Applicable: This pertains to an AI/imaging device where human readers might disagree. For a physical device, testing involves quantitative measurements and observations against specifications. Any discrepancies would be handled through standard engineering quality control and retesting protocols, not through expert adjudication in a clinical reading context.

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 specific to AI devices and their impact on human reading performance. This document is for a reprocessed surgical instrument.

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

• Not Applicable: This is specific to AI algorithms. This is a physical surgical device.

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

For this physical device, the "ground truth" is based on:

• Engineering Specifications and Benchmarking: Mechanical properties (e.g., force, angles, excursion), electrical properties, and material integrity tested against established standards and the performance of the predicate device.
• Physiological Performance in Animal Models: "Thermal spread and the ability to achieve hemostasis of vessels" in an animal model serve as a form of "ground truth" for the device's functional performance in a biological system, compared to the expected performance of new devices or the predicate.

There is no "expert consensus" or "pathology" as "ground truth" in the context of clinical endpoints for an AI system.

8. The sample size for the training set

• Not Applicable: This question relates to AI model training. This document is about a reprocessed physical device, which does not have a "training set" in the machine learning sense. The device is re-manufactured and tested, not "trained."

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

• Not Applicable: As above, this pertains to AI model training.

Ask a specific question about this device

The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open Sealer/Divide LF1212A is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgical specialties as urologic, thoracic, plastic and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures. Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectory, and tonsillectorny) for ligation and division of vessels, lymphatiss and tissue bundles 2 - 3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Medline ReNewal Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open general surgical procedures. Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue. The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a hand switch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line. The 10-foot cord, cable connector, and generator are not reprocessed by Medline ReNewal.

The provided text is a summary of a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider LF1212A.

The key aspect of this document is demonstrating substantial equivalence to an existing predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The study's purpose is not to prove the device meets pre-defined clinical acceptance criteria for a novel functionality, but rather to show that the reprocessed device performs as safely and effectively as the original, legally marketed device.

Therefore, the "acceptance criteria" here largely refer to demonstrating performance consistent with the predicate device across various functional and safety aspects.

Here's an analysis of the acceptance criteria and the study, based on the provided text, while acknowledging that a 510(k) summary often provides high-level information without deep specifics on study methodologies:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a reprocessed device, the "acceptance criteria" are generally that the reprocessed device performs equivalently to the original device. The "reported device performance" is the demonstration through various tests that this equivalence is met.

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

The document does not specify the exact sample sizes for each of the performance tests (e.g., number of devices tested for electrical safety, number of tissue samples for histopathology). It only lists the types of tests performed.

The data provenance is not explicitly stated in terms of country of origin. However, the FDA 510(k) submission process typically requires data generated in accordance with Good Laboratory Practice (GLP) or similar standards. Given it's a US FDA submission, it's highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The data is retrospective in the sense that the predicate device's performance already exists, and the reprocessed device is being compared against it. New prospective testing is done on the reprocessed devices.

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

For a device like this, "ground truth" isn't typically established by expert consensus in the way it would be for an AI diagnostic algorithm. Instead, it's established by:

• Engineering specifications and regulatory standards: These define acceptable performance ranges (e.g., electrical parameters, burst pressure requirements, cleanliness levels).
• Predicate device's established performance: The predicate device, already on the market, sets the benchmark for equivalent performance.
• Scientific and clinical literature: Informing what constitutes safe and effective tissue sealing and cutting.
• Pathology results: For tests like histopathology, a qualified pathologist would interpret the tissue samples, but this is part of the test result generation, not "ground truth" establishment in the AI sense.

The document does not mention the number or qualifications of experts establishing ground truth in the context of an AI study. However, the evaluation of the various tests would be performed by qualified personnel (e.g., engineers, microbiologists, toxicologists, pathologists) relevant to each specific test.

4. Adjudication Method for the Test Set

Not applicable in the context of a 510(k) for a reprocessed surgical instrument. Adjudication methods like "2+1" or "3+1" are characteristic of studies establishing ground truth for diagnostic AI, especially in image interpretation, where multiple human readers resolve discrepancies. Here, objective measurements and comparisons to established standards and predicate performance are used.

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 diagnostic AI tools where human readers interpret images or data, and the AI's impact on their performance (with or without AI assistance) is evaluated. This 510(k) is for a physical surgical instrument, not a diagnostic AI.

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

Not applicable. This device is not an algorithm. It's a physical electrosurgical instrument that is used by a human surgeon. The performance tests evaluate the instrument's physical and functional capabilities, which are inherently "standalone" in the sense that the instrument itself is being tested, but always within the context of its intended use by a human.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device is multifactorial:

• Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The reprocessed device must demonstrate equivalent performance across all tested parameters.
• Industry Standards and Regulatory Requirements: Technical standards (e.g., IEC 60601 series for electrical safety) and FDA regulations set minimum acceptable performance and safety thresholds.
• Objective Measurements: Laboratory tests yield objective data (e.g., electrical resistance, burst pressure, protein levels, cell viability) that can be directly compared against specified limits or predicate device data.
• Pathology: For histopathology, the ground truth would be the pathological assessment of tissue effects.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or corresponding ground truth to establish.

Ask a specific question about this device

The LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The LigaSure™ Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue.

The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a handswitch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line.

The purpose of this submission is to propose the use of an alternate dot material for the LigaSure Curved, Small Jaw, Open Sealer/Divider devices (K141153). There have been no prior submissions for the proposed change. The proposed devices do not contain software.

This document is a 510(k) summary for a medical device called the "LigaSure™ Curved, Small Jaw, Open Sealer/Divider (LF1212A)". This submission is for a modification to an existing device, specifically changing the material of ceramic spacers and adding an etched wetting ring feature. Therefore, the information provided focuses on demonstrating that the modified device is substantially equivalent to the predicate device and that the changes do not negatively impact its safety or performance.

The document does not describe a study involving AI, human readers, or a typical diagnostic device's acceptance criteria like sensitivity, specificity, or AUC. Instead, it describes hardware device performance criteria based on engineering specifications and safety standards.

Here's an analysis of the provided text in relation to the requested information, acknowledging that many requested points are not directly applicable due to the nature of this particular device submission (a modification to a non-AI surgical instrument):

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the format typically seen for AI/diagnostic devices (e.g., sensitivity/specificity thresholds). Instead, it states that "design verification testing... confirmed the continued conformance to applicable technical design specifications and performance requirements". These performance requirements are listed as:

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

The document does not specify a "test set" in the context of data for an AI algorithm. The device is a surgical instrument, and testing involves physical evaluation and engineering measurements. The document states "design verification testing", which implies a set of physical devices were tested. However, the exact sample size (number of devices or tests performed) is not provided. No data provenance related to "country of origin for data" is relevant here, nor is retrospective or prospective as it's not a data-driven model.

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)

This question is not applicable. The device is a surgical instrument, not an AI diagnostic tool. "Ground truth" for this device is based on objective engineering specifications and international safety standards, not expert consensus on medical images or diagnoses. The "truth" is whether the physical properties and performance characteristics of the instrument meet defined regulatory and design standards.

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

This question is not applicable as there is no "test set" in the context of medical images or diagnoses requiring adjudication by experts.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument and does not involve AI or human readers for diagnostic interpretation. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

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

This question is not applicable as the device does not contain an AI algorithm. The document explicitly states: "The proposed devices do not contain software."

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

The "ground truth" for this device's performance is established by engineering specifications, international safety standards (ISO, IEC), and design verification requirements. For example, "renal burst pressure" testing has an objective, measurable outcome that is compared against a predefined standard for acceptable sealing strength.

8. The sample size for the training set

This question is not applicable as the device does not involve an AI algorithm or a training set.

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

This question is not applicable as the device does not involve an AI algorithm or a training set.

Ask a specific question about this device

The LigaSure™ Curved, Small Jaw, Open Sealer / Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad™ energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and lymphatics is performed, such as urologic, thoracic, plastic, and reconstructive; and including such procedures as bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, etc.

The device is also indicated for open ENT procedures in adults (thyroidectorny, radical neck dissection, parotidectorny, and tonsillectorny) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The LigaSure™ Curved, Small Jaw, Open Sealer/Divider is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). The ForceTriad's tissue-fusion (LigaSure) mode delivers precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion, and has been designed to produce minimal sticking, charring, or thermal spread to adjacent tissue.

LigaSure instruments attach to the generator with a ten-foot containing a "smart" connector. This connector functions as a unique product identifier for device-specific recognition by the generator. The Curved, Small Jaw, Open Sealer/Divider instrument is designed to be both ergonomic and intuitive for the user. Its hemostat-style body and symmetrically placed controls facilitate handling by both left and righthanded users, and its small, curved jaws maximize visibility and access when the instrument is used in confined surgical spaces.

Ring handles function to allow the user to grasp tissue by opening and closing the jaws of the instrument. The interior surfaces of the jaws contain the electrodes, which serve to ligate by delivering energy to the grasped tissue. RF energy can be activated by the user in two ways: (1) through the use of a single button incorporated into the handle body or (2) through the use of a footswitch attached to the generator. A cutting mechanism functions to mechanically divide tissue following tissue fusion. It consists of a stainless steel blade and is controlled by the user through a trigger located on the handle body.

The device in question is the LigaSure™ Curved, Small Jaw, Open Sealer / Divider (LF1212) by Covidien, a bipolar electrosurgical instrument. The purpose of this submission (K113572) is to expand its indications for use to include ENT procedures and remove a warning regarding specific surgical procedures requiring precision. There are no physical changes to the device itself; the design remains the same as its predicate (K102470).

This 510(k) summary does not use a typical "acceptance criteria" table in the form of specific numerical thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing various performance characteristics. For a device like an electrosurgical instrument, "acceptance criteria" are implicitly met if its performance is comparable to or better than previously cleared, substantially equivalent devices, particularly regarding safety and effectiveness.

Here's an interpretation of the performance data and how it addresses the 'acceptance criteria' in the context of substantial equivalence:

1. Table of "Acceptance Criteria" (interpreted as performance comparison to predicates) and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to predicates) is a preclinical bench and animal testing study combined with usability studies and a clinical literature review.

2. Sample Size and Data Provenance (for test set, relevant for bench/animal testing and usability):

• Preclinical Bench Testing (Burst Pressure & Thermal Profile): The document states "Preclinical comparative bench testing... was conducted." It does not specify the exact sample size for isolated vessels or the number of activations for thermal profile tests. The data provenance is implied to be laboratory testing conducted by Covidien.
• Animal Testing (Thermal Spread): The document states "Animal Testing: The mean thermal spread of the subject device was shown to be comparable to the predicates for all vessel sizes evaluated." It does not specify the number of animals or the number of vessel seals performed. The data provenance is likely internal animal studies conducted by Covidien.
• Usability / Human Factors: "These studies consisted of several formative and one summative study." It does not specify the number of users (sample size) for these studies. The data provenance is internal usability studies.

All these studies appear to be prospective in nature, as they were conducted specifically for this submission to compare the device against predicates or assess usability. The country of origin for the data is not explicitly stated but is presumed to be the United States, given the submitter's location and the FDA submission.

3. Number of Experts and Qualifications (for establishing ground truth for the test set):

• Bench and Animal Testing: The establishment of ground truth for metrics like burst pressure, thermal profile, and thermal spread typically relies on objective physical measurements and established scientific methodologies, not expert consensus in the human interpretation sense. Therefore, the "experts" would be the scientists and engineers conducting and analyzing these objective tests, following standardized protocols. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, as this is not a diagnostic device.
• Usability Studies: "Usability was evaluated with users... in the ENT space." These users are the "experts" in terms of operating the device. While their specific qualifications (e.g., "surgeon with X years of experience") are not detailed, it can be inferred that they were medical professionals (surgeons or surgical assistants) experienced in surgical procedures, likely ENT specialists given the mention of "ENT space." No specific number of experts for "ground truth setting" is given in the context of interpretation of results, as the usability studies themselves generate the data.
• Clinical Literature Review: An "assessment of published clinical literature" was performed. This implies medical experts (likely regulatory affairs personnel or medical scientists within Covidien) evaluated existing peer-reviewed studies. No specific number or qualifications of these reviewers are provided.

4. Adjudication Method (for the test set):

Since the "acceptance criteria" are based on objective physical measurements (burst pressure, thermal profile, thermal spread) and directly observed usability, rather than subjective interpretations by multiple experts, a formal "adjudication method" like 2+1 or 3+1 for resolving discrepancies in expert opinions is not applicable or described. The results of bench and animal tests are typically analyzed statistically. Usability studies involve observations and feedback, rather than adjudication of 'ground truth'.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and would not be applicable for this type of device (a surgical instrument). MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess changes in diagnostic accuracy or efficiency. This device is a surgical tool, not an image interpretation or diagnostic aid. Therefore, no effect size of human readers improving with AI assistance is reported.

6. Standalone (Algorithm Only) Performance:

No, a standalone performance study (algorithm only without human-in-the-loop) was not done and is not applicable for this device. This device is a manual surgical instrument that requires a human operator for its function; it does not contain a standalone algorithm in the sense of AI performing a task independently. The "algorithm" here refers to the energy delivery system within the ForceTriad™ platform, which is always used with the human-controlled instrument.

7. Type of Ground Truth Used:

• Bench Test (Burst Pressure, Thermal Profile): The ground truth is based on objective physical measurements using scientific equipment and standardized test methods (e.g., pressure gauges, temperature probes).
• Animal Testing (Thermal Spread): Ground truth is based on objective pathological assessment of tissue sections (histology) or direct macroscopic measurements of the thermal damage zone in animal models.
• Usability Studies: Ground truth is based on observed user performance, task completion, and user feedback in simulated environments, assessed against predefined safety and performance metrics.
• Clinical Literature: The "ground truth" for clinical safety and effectiveness in ENT procedures is derived from the published outcomes data and expert consensus within the scientific and medical literature.

8. Sample Size for the Training Set:

This device is a hardware surgical instrument, not a machine learning or AI algorithm in the typical sense that would require a "training set" for model development. The "ForceTriad™ energy platform (generator)" delivers energy, and its design would be based on engineering principles and previous device experience, not statistical learning from a "training set" of data. Therefore, the concept of a "training set" and its sample size is not applicable or addressed in this submission.

9. How Ground Truth for Training Set Was Established:

As there is no "training set" in the context of a machine learning model, the question of how its ground truth was established is not applicable. The device's 'training' or development is based on engineering design, preclinical testing, and iterative improvements, not a data-driven model training process.

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