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The LigaSure XP Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw 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 such surgical specialties as colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, and so forth.

The LigaSure XP Maryland Jaw Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure XP Maryland Jaw Sealer/Divider for these procedures.

The proposed LigaSure™ XP Maryland Jaw Sealer/Divider is a sterile, single-use bipolar vessel sealer. It is labeled as prescription use only. The device connects to the Valleylab™ FT10 Electrosurgical Platform generator for tissue ligation. Energy is applied to tissue interposed between the nano-coated Maryland-style jaws creating a ligation. The jaws contain an independent cutting blade for division of tissue. A distinctive characteristic is the new continuous rotation capability of the jaws and shaft. The shaft is a common 5 mm diameter available in three lengths (23 cm, 37 cm, 44 cm) for various general surgical procedures in both open and minimally invasive (laparoscopic) approaches. The instrument body is a pistol grip design which can be used by right or left-handed users to access the controls. The new device is offered with two handle body designs, One-Step Sealing (LXMJ23S, LXMJ37S, LXMJ44S) or Latching Handle (LXMJ23L, LXMJ37L, LXMJ44).

The provided text does not contain information about the acceptance criteria and study proving a digital health device's performance. Instead, it describes a substantial equivalence determination for a surgical instrument, the LigaSure™ XP Maryland Jaw Sealer/Divider.

Therefore, many of the requested categories in your prompt, such as "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set," are not applicable to this medical device submission, which focuses on hardware and electrosurgical performance rather than an AI-powered diagnostic or assistive tool.

However, I can extract the relevant performance testing and acceptance criteria information that is present in the document for the LigaSure™ XP Maryland Jaw Sealer/Divider.

Here's the information structured to the best of my ability given the provided document:

Acceptance Criteria and Study for LigaSure™ XP Maryland Jaw Sealer/Divider

This submission details the substantial equivalence of an electrosurgical cutting and coagulation device, the LigaSure™ XP Maryland Jaw Sealer/Divider. The performance testing described focuses on various engineering, biological, and functional aspects of the surgical instrument, not on the performance of a digital health or AI device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test set (e.g., number of vessels, lymphatic segments, or animals).

• Provenance: The tests described (bench, animal) are laboratory-based performance studies, likely conducted by the manufacturer Covidien, llc. The document does not mention data provenance in terms of country of origin or whether human data was retrospective or prospective, as clinical trials for efficacy/safety in humans were not the primary evaluation method shown (literature review was used for clinical support).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for this device's performance would be objective measurements in engineering, biological models, and animal studies (e.g., burst pressure, hemostasis, thermal spread), not expert consensus on interpretations.

4. Adjudication method for the test set
This is not applicable and not provided. Performance outcomes are likely based on direct measurement against predefined physical/biological thresholds.

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
This is not applicable. This device is a surgical instrument, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a surgical instrument, not an algorithm.

7. The type of ground truth used
The "ground truth" for this device's performance is based on:

• Engineering standards (e.g., ISO, ASTM, IEC for sterilization, packaging, electrical safety).
• Biocompatibility standards (ISO 10993-1).
• Predefined physical and biological thresholds/measurements from ex vivo (vessel/lymphatic sealing/burst) and in vivo (hemostasis, thermal spread) studies.
• "Clinical literature studies were evaluated to further support the safety and effectiveness use of the proposed LigaSure™ XP Maryland Jaw Sealer/Divider indications for use." This implies that existing clinical evidence for similar devices and principles contributes to the overall justification, but no new clinical study data from the sponsor is explicitly referenced.

8. The sample size for the training set
This is not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established
This is not applicable.

Ask a specific question about this device

The 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, breast procedures, 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™ Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, coated, hand-held bipolar vessel sealing devices designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy.
A hemostat style body allows the user to open or close the instrument jaws during and cutting, with a single activation button incorporated into the body of the device.

The provided text describes the 510(k) summary for the "LigaSure™ Exact Dissector, Nano-coated" device (K202917). This submission is for an expanded indication for use (inclusion of breast procedures) for a device previously cleared under K173281. The central argument is that the device itself is unchanged from the predicate, and therefore, previously conducted studies and comparable literature support the expanded indication.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list acceptance criteria in a quantitative table format with corresponding reported device performance values. Instead, it refers to prior testing and literature as evidence of safety and effectiveness for a device that is mechanically and technologically identical to its predicate. The expanded indication for "breast procedures" is supported by showing that similar LigaSure™ devices have been successfully used in these procedures without new safety concerns.

The comparison table provided (page 5) focuses on technological characteristics for substantial equivalence to the predicate device, not on quantitative performance against pre-defined acceptance criteria for the new indication.

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

• Test Set Description: The document states, "No design or specification changes are associated with the expanded indication of the LigaSure™ Exact Dissector, Nano-coated (LF2019) device." This implies that no new test set was generated specifically for this submission beyond what was previously submitted for K173281, as the device itself is unchanged.
• Data Provenance: The new expanded indication relies on "Clinical Literature Summary" for breast procedures. The literature pertains to "hemostat-style open LigaSure™ devices," which are similar to the subject device. The provenance of this literature would be varied (e.g., various countries of origin, likely retrospective and prospective studies published in medical journals). No specific sample size for a "test set" in the context of a new study for K202917 is mentioned.

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

Not applicable, as no new primary test set or ground truth establishment process is described for this 510(k) submission. The submission relies on previously established performance data from the predicate device (K173281) and findings from existing clinical literature.

4. Adjudication method for the test set

Not applicable, as no new primary test set or adjudication process is described for 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 instrument, not an AI-powered diagnostic or interpretive device.

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

Not applicable. This is a medical instrument, not an algorithm.

7. The type of ground truth used

The notion of "ground truth" as typically applied to diagnostic AI algorithms does not directly apply here. Instead, the submission relies on:

• Established Performance: Previous bench and animal studies (from K173281).
• Clinical Outcomes Data: From existing clinical literature on similar LigaSure™ devices in breast procedures, demonstrating "effective hemostasis, operative time, blood, thermal damage, and intraoperative and postoperative complications."

8. The sample size for the training set

Not applicable. The device is not an AI algorithm that requires a training set.

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

Not applicable. The device is not an AI algorithm that requires a training set.

Summary of Device Performance and Rationale for Acceptance:

The device (LigaSure™ Exact Dissector, Nano-coated) is being cleared for an expanded indication to include "breast procedures." The submission's core argument for acceptance is based on substantial equivalence to its own predicate device (also LigaSure™ Exact Dissector, Nano-coated, cleared under K173281) and a reference device (LigaSure™ Curved, Small Jaw, Open Sealer/Divider, K152286).

The key points are:

• Identical Device: The subject device is unchanged from its predicate in terms of intended use, design, performance, and technological characteristics. The only difference is the updated "indications for use" to include breast procedures.
• Prior Performance Data: Evidence of safety and effectiveness for the device's fundamental operation was presented in the original 510(k) (K173281), including:
  • Testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 (electrical safety, EMC)
  • Biocompatibility (ISO 10993-1)
  • Device functionality
  • Bench burst pressure
  • In vivo acute and chronic animal studies
• Clinical Literature Summary: To support the expanded indication for breast procedures, a review of clinical literature was conducted. This literature demonstrates that "hemostat-style open LigaSure™ devices" (including the reference device, which was the predicate for the original LigaSure Exact) have been successfully used in breast procedures. The outcomes reported (hemostasis, operative time, blood loss, thermal damage, complications) were consistent with other surgical procedures performed with LigaSure™ devices.
• Conclusion: The manufacturer concludes that, since the device itself is identical to its cleared predicate and literature supports the safe and effective use of similar LigaSure™ technology in breast procedures, no new safety issues are identified, and the device is suitable for the proposed expanded indications.

Ask a specific question about this device

The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries, veins, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

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 LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (LF1930T) device is a sterile, single-use, coated, hand-held bipolar vessel sealing device designed for use with a Covidien electrosurgical generator that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels (arteries, veins, pulmonary arteries, pulmonary veins), tissue bundles, and lymphatics clamped between the jaws using radio frequency (RF) energy. The LF1930T subject can also grasp tissue and perform blunt dissection during general surgical procedures (as indicated).

A hand actuated lever allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the handle. The proposed device has a 30cm length shaft and does not contain software.

The provided document is a 510(k) summary for the LigaSure™ Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (LF1930T). It details the device's technical characteristics, indications for use, and a comparison to predicate devices, along with performance data to support its substantial equivalence.

However, the document does not describe a study in the context of typical AI/ML device evaluations. This submission is for a traditional medical device (an electrosurgical instrument), and therefore the 'acceptance criteria' and 'study' described here are related to hardware performance, electrical safety, and animal studies, not statistical measures of algorithmic performance like accuracy, sensitivity, or specificity. There are no mentions of "test set," "training set," "ground truth experts," or an "AI/ML algorithm" in the provided text.

Therefore, many of the requested fields cannot be answered as they pertain to AI/ML device studies, which is not what this document describes.

Here's an attempt to fill in the table and information based on the provided text, while acknowledging the limitations for AI/ML specific questions:

1. Table of acceptance criteria and the reported device performance

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 applicable in the context of an AI/ML algorithm evaluation. For the acute and chronic animal studies, specific numbers of animals are not provided. The bench testing involved "validated and representative conditions," but specific sample sizes for vessel burst pressure or other tests are not detailed.
• Data Provenance:
  • Bench performance: Ex-vivo (likely animal tissue or synthetic models).
  • Animal Studies: Live animal subjects (acute and chronic). No country of origin is specified.
  • Study Design: These studies would be considered prospective for the specific tests performed.

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

Not applicable. This device is not an AI/ML diagnostic or prognostic tool. Ground truth would be defined by direct physical measurements, observations by veterinary surgeons/pathologists in animal studies, and engineering specifications. The document does not specify expert qualifications beyond the implicit expertise required to conduct and interpret these types of pre-clinical studies.

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

Not applicable. This concept applies to human reader consensus for AI ground truth, which is not relevant here. Decisions about performance in animal studies or bench testing would be based on objective criteria and measurements, likely by a single investigator or team, with standard scientific peer review implicit in the process, but not a formal adjudication akin to expert consensus for image interpretation.

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 a surgical instrument, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed as it is irrelevant to the device's function. The study compares the performance of the new device to predicate (existing) devices.

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

Not applicable. This device is a manual electrosurgical instrument requiring human operation. "Standalone" performance in this context would refer to the device's inherent mechanical and electrical function. The "Bench Performance Testing" and "Animal Studies" serve this purpose by evaluating the device's function on its own or in the hands of trained users without comparison to an AI.

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

For the various studies:

• Electrical Safety & EMC: Ground truth established directly from standardized tests and measurements against published limits (e.g., IEC standards).
• Bench Performance: Ground truth established through engineering specifications, direct physical measurements (e.g., burst pressure), and functional tests against design inputs.
• Acute Animal Study: Ground truth based on direct observation of sealing performance and histological assessment of lateral thermal spread.
• Chronic Animal Study: Ground truth based on animal survival, direct observation of hemostasis, and potentially post-mortem pathological examination of sealed vessels.
• Human Factors: Ground truth based on observing user interaction against safety protocols and effectiveness criteria defined by usability engineering principles.

8. The sample size for the training set

Not applicable. This refers to AI/ML model training, which is not described.

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

Not applicable. This refers to AI/ML model training, which is not described.

Ask a specific question about this device

The 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 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, 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 LigaSure™ Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, coated, hand-held bipolar vessel sealing devices designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. A hemostat style body allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the device.

The provided text describes a 510(k) premarket notification for the LigaSure Exact Dissector, Nano-coated device, seeking to demonstrate its substantial equivalence to a predicate device. This type of submission generally relies on performance testing rather than extensive clinical studies to prove safety and effectiveness.

Here's an analysis of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative manner for specific performance metrics with predefined thresholds. Instead, the "acceptance criteria" are implied to be achieving performance comparable to the predicate device, demonstrating safety, and meeting relevant electrical safety, EMC, and biocompatibility standards. The reported device performance is presented as successfully meeting these implied criteria.

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

The document provides the following information:

• Ex-vivo Vessel Burst Pressure: "excised fresh porcine renal arteries and lymphatics" were used. The exact number of vessels or samples is not specified. Data provenance is porcine (animal origin).
• Acute Animal Study: "a porcine" was used. The exact number of animals is not specified, but the use of "a porcine" suggests it might have been a small number, possibly one or a few. Data provenance is porcine (animal origin) and acute (short-term observation).
• Chronic Animal Study: "All animals" (plural) survived 21 days. The exact number of animals is not specified, but it was a cohort observed over 21 days (chronic). Data provenance is porcine (animal origin).

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

This information is not provided in the document. The studies conducted (ex-vivo and in vivo animal studies) are preclinical in nature and typically involve researchers and veterinary professionals evaluating outcomes based on physiological measurements, histological analysis, and observed healing, rather than a "ground truth" established by human expert readers in the context of interpretation, like in imaging studies.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data to establish a consensus ground truth. Since this submission relies on preclinical animal and ex-vivo studies, an adjudication method in this sense is not applicable and therefore not mentioned. The evaluation of outcomes would have been based on objective measurements and observations by the study investigators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." MRMC studies inherently involve human readers and clinical cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is typically relevant for AI/ML-driven devices. The LigaSure Exact Dissector is a physical electrosurgical instrument. Therefore, the concept of "standalone performance" of an algorithm without human-in-the-loop is not applicable. The device's performance is intrinsically tied to its use by a human surgeon.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the methods used to assess the device's performance and safety. It appears to be a combination of:

• Objective Physiological Measurements: Ex-vivo burst pressure to assess seal strength.
• Direct Observation and Macroscopic Assessment: During acute and chronic animal studies, including observations of hemostasis, healing, and presence/absence of major complications.
• Histological Analysis: Implied by the evaluation of "lateral thermal damage" and "healing" in animal studies, suggesting microscopic examination of tissue.
• Compliance with Standards: Verification against biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-2-2), and EMC (IEC 60601-1-2) standards.

8. The Sample Size for the Training Set

This question is typically relevant for AI/ML devices. Since the LigaSure Exact Dissector is a physical electrosurgical device, there is no "training set" in the machine learning sense. The device's design and manufacturing rely on engineering principles, materials science, and verified production processes, not on data-driven model training.

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

As there is no "training set" for this type of medical device, this question is not applicable.

Ask a specific question about this device

The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation 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 gerry and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

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 LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated (LF19XX) devices are sterile, single-use, coated, hand-held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy.

A hand actuated lever allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the handle. The proposed devices come in three shaft lengths (23, 37, and 44 cm) and do not contain software.

This document, a 510(k) summary for the LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated, does not describe a study involving an AI/ML algorithm or human readers. Instead, it focuses on demonstrating substantial equivalence to a predicate device through pre-clinical performance data, primarily related to the physical and functional characteristics of an electrosurgical device.

Therefore, many of the requested details regarding AI/ML-specific study design (such as data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details) are not applicable to the information provided in this 510(k) summary.

However, I can extract the acceptance criteria as demonstrated by the device performance tests outlined in the document, which primarily focus on a traditional medical device's safety and efficacy.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not applicable:

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

The document doesn't present explicit numerical "acceptance criteria" in a table format with corresponding "reported device performance" in the same way one might for an AI/ML model's metrics (e.g., sensitivity/specificity thresholds). Instead, it lists types of performance tests conducted and generally states that the device "performed as expected" or "demonstrated that the subject devices are as safe and effective as the predicate devices."

Implied Acceptance Criteria and Reported Performance (based on tests conducted):

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

• Test Set Sample Size:
  • Ex-vivo Vessel Burst Pressure: "excised fresh porcine renal arteries and lymphatics" (Number not specified)
  • Acute Animal Study: "porcine underwent various procedures" (Number not specified)
  • Chronic Animal Study: "All animals" (Number not specified, but this refers to a continuous assessment over 21 days on the animals used in the chronic study).
• Data Provenance:
  • The animal studies indicate data from in vivo porcine models, which are animal data, not human patient data.
  • The ex-vivo studies indicate in vitro data using excised porcine tissue.
  • The document does not specify a country of origin for the data, but the submitter is based in Boulder, CO, USA.
• Retrospective or Prospective: These are laboratory/pre-clinical studies, so the terms "retrospective" or "prospective" as applied to clinical trials are not directly applicable. They were conducted specifically for this submission.

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

• Not Applicable. This device is a physical electrosurgical instrument, not an AI/ML diagnostic device requiring expert interpretation of images or patient data to establish "ground truth." The "ground truth" for its performance is established through direct measurements (e.g., burst pressure), physiological outcomes (e.g., hemostasis in animal models), and adherence to safety standards.

4. Adjudication method for the test set:

• Not Applicable. See point 3. The outcomes are objective measurements or direct observations in animal models.

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. This product is an electrosurgical device, not an image analysis or diagnostic AI/ML system. Therefore, MRMC studies involving human readers are not relevant.

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

• Not Applicable. No algorithm is involved in the operation of this device.

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

• For this electrosurgical device, the "ground truth" is established by:
  • Physical and Electrical Standards: Adherence to defined industry and regulatory standards (e.g., ISO 10993-1, ANSI AAMI ES 60601-1, IEC 60601-2-2, IEC 60601-1-2) for material properties and electrical safety.
  • Direct Objective Measurement: Mechanical properties (jaw force, gap), electrical characteristics (resistance, capacitance, inductance).
  • Physiological Outcomes in Animal Models: Successful vessel sealing (demonstrated by burst pressure, lack of acute bleeding, chronic hemostasis) and acceptable thermal damage in live porcine models.
  • Functional Performance: The device's ability to ligate, divide, grasp, and perform blunt dissection as intended.

8. The sample size for the training set:

• Not Applicable. No AI/ML model with a "training set" is described for this device.

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

• Not Applicable. No AI/ML model or training set.

In summary, the provided document details the pre-clinical validation of a traditional electrosurgical device, not an AI/ML-enabled medical device. Therefore, the information pertains to physical, electrical, and biological performance characteristics rather than data-driven AI model performance metrics.

Ask a specific question about this device

The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation 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 such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc.

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 LigaSure™ Blunt Tip Sealer/Divider, Nano-coated (LF18XX) devices are sterile, single-use, coated, hand-held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. The proposed devices come in three shaft lengths 23 cm (LF1823), 37 cm (LF1837), and 44 cm (LF1844). A hand actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do not contain software.

Here's a breakdown of the acceptance criteria and study information for the Ligasure Blunt Tip, Sealer/Divider, Nano-coated (K162941) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that various tests were conducted to demonstrate "equivalent performance" or that the devices "performed as expected" or "similarly" to the predicate devices. The acceptance criteria for each test inherently relate to achieving this equivalence or expected performance.

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

• Biocompatibility: Not specified.
• Electrical Safety and EMC: Not specified.
• Mechanical/Functional Testing: Not specified.
• Ex-vivo Vessel Burst Pressure: Not specified, but involved "excised fresh porcine renal arteries and lymphatics." This suggests in vitro testing using animal tissue. Data provenance is therefore in vitro (animal tissue).
• Acute Animal Study: Not specified, but involved "porcine" subjects. This is a prospective animal study. Data provenance is in vivo (animal).
• Chronic Animal Study: Not specified, but involved "animals" that survived 21 days post-op (implying a controlled in vivo study). Data provenance is in vivo (animal).

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

There is no mention of human experts being used to establish ground truth for any of the performance tests. The evaluation appears to be based on objective measurements and experimental outcomes (e.g., burst pressure, thermal damage assessment, hemostasis over time).

4. Adjudication Method for the Test Set

Not applicable, as no human readers or subjective assessments requiring adjudication are described for establishing ground truth in the performance tests.

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 instrument, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC studies or human reader improvement with AI are relevant. The 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

Not applicable. This device is not an algorithm, but a physical electrosurgical instrument. Its performance is inherent to its hardware and function, not software.

7. The Type of Ground Truth Used

• Biocompatibility: Established through standardized in vitro tests according to ISO 10993-1.
• Electrical Safety and EMC: Established through compliance with specific electrical and EMC standards.
• Mechanical/Functional Testing: Established through objective measurements against design specifications.
• Ex-vivo Vessel Burst Pressure: Established through direct measurement of burst pressure in ex-vivo animal tissue samples.
• Acute Animal Study: Established through direct observation and measurement of sealing performance and lateral thermal damage in in vivo animal models.
• Chronic Animal Study: Established through direct observation of animal survival and maintenance of hemostasis over 21 days in in vivo animal models.

8. The Sample Size for the Training Set

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

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

The LigaSure™ Retractable L-Hook Laparoscopic Sealer/Divider is a 5mm bipolar/monopolar electrosurgical instrument intended for use in minimally invasive 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 7mm in diameter. The monopolar L-Hook can be used to dissect through tissue planes and to create enterotomies or gastrotomies.

It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, colorectal, bariatric, and gynecologic. Procedures may include, but are not limited to gastric bypass, hysterectomy, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, oophorectomy, etc.

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™ Retractable L-Hook Laparoscopic Sealer/Divider is a 5mm sterile, single-use, hand-held bipolar electrosureical 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 general procedures (as indicated) and monopolar capabilities to electrically dissect through tissue planes and to create openings in bowel (enterotomies) and stomach (gastrotomies). 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 new device will be provided EO sterilized with a 5mm diameter shaft, in shaft lengths of 37 cm and 44 cm with a fine curved jaw featuring an extendable and retractable monopolar L-Hook. The proposed devices do not contain software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LigaSure™ Ret retractable L-Hook Laparoscopic Sealer Divider:

The document provided is a 510(k) Summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria against a defined performance target. Therefore, the information provided does not directly outline "acceptance criteria" in the way one might see for a novel device with specific performance metrics to meet. Instead, the study aims to show that the new device performs similarly to the predicate devices.

However, based on the performance data presented, we can infer the intent of the testing and the outcomes that demonstrate substantial equivalence.

Here's an attempt to structure the information based on the requested categories, keeping in mind the nature of a 510(k) submission:

Acceptance Criteria and Study for LigaSure™ Retractable L-Hook Laparoscopic Sealer Divider

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit "acceptance criteria" are not stated. The studies aim to demonstrate performance that is "similar" to or "as expected" and "conforms to requirements defined in related design inputs and subsequent product specifications," thereby supporting substantial equivalence to the predicate devices.

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

• Sample Size for Test Set: Specific numerical sample sizes for each test are not provided in this summary. The studies are described as "ex-vivo" and "in-vivo acute" using "porcine models" for many performance tests. A "Chronic Hemostasis Porcine study" was also conducted.
• Data Provenance: The animal studies (porcine models) indicate the data is from pre-clinical studies. The country of origin for the animal studies is not specified in this document. Given Covidien (now Medtronic) is a US-based company with a facility in Boulder, Colorado, it is plausible the pre-clinical studies were conducted in the US or a region with similar regulatory and ethical standards. All studies mentioned appear to be prospective as they are specifically conducted to evaluate the new device.

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

This type of study does not typically involve "experts" in the sense of clinical reviewers establishing ground truth for a test set. Instead:

• For Biocompatibility, Electrical Safety, EMC, Mechanical/Functional Testing: Compliance is assessed against established international standards (e.g., ISO 10993-1, IEC 60601 series) by qualified testing personnel and laboratories.
• For Animal Studies (e.g., renal burst pressure, lymphatic sealing, hemostasis, thermal spread, enterotomy, chronic hemostasis): The "ground truth" or evaluative metrics are physiological measurements (e.g., burst pressure, thermal spread measurements, successful hemostasis, proper enterotomy formation) as assessed by trained researchers, veterinarians, and possibly pathologists involved in the pre-clinical studies. The exact number of individuals or their specific qualifications (e.g., DVM, Ph.D. in physiology, toxicologist) are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations, often in clinical imaging or diagnostic studies. This document describes pre-clinical engineering and animal studies with objective or semi-objective measurements. Therefore, an "adjudication method" in that sense is not applicable or described for this type of testing. The results would be based on direct measurements and observations during the experiments, recorded and analyzed by the research team.

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

No, an MRMC comparative effectiveness study was not conducted. This is a pre-clinical submission for substantial equivalence based on engineering, bench, and animal testing. There is no human reader component in the studies described.

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

This device is an electrosurgical instrument, not an AI algorithm. Therefore, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable. The device inherently requires a human operator to function. The "standalone" performance here refers to the device's functional performance in isolation from a clinical human context, which is what the bench and animal tests aim to assess (e.g., the device's ability to seal a vessel, its thermal spread, its electrical safety).

7. Type of Ground Truth Used

• Bench Testing (Biocompatibility, Electrical Safety, EMC, Mechanical/Functional): Ground truth is established by referencing international standards, internal design specifications, and objective measurement validation.
• Animal Studies (Ex-vivo Renal Burst Pressure, Ex-Vivo / Lymphatic, In-Vivo Acute, Ex-vivo Monopolar Thermal Effect, In-Vivo Acute Enterotomy, Chronic Animal Study): Ground truth is based on physiological measurements and observations from the animal models, such as burst pressure readings, histological evaluation of thermal spread, visual confirmation of hemostasis, successful tissue dissection/formation, and pathological examination (if conducted for chronic studies).

8. Sample Size for the Training Set

This document describes pre-clinical testing for a physical medical device. It does not involve a "training set" in the context of machine learning or AI algorithms. The design and development of the device might involve internal testing iterations, but a formal "training set" as understood in AI/ML is not part of this type of submission.

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

As there is no "training set" mentioned or applicable in the context of this device and submission, this question is not applicable.

Ask a specific question about this device

The 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, veins, pulmonary arteries, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

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 Impact™ Curved, Large Jaw. Open Sealer/Divider, Nano-coated (LF4418) is a sterile, single-use, coated, hand-held bipolar vessel sealing device designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, pulmonary arteries/veins, and lymphatics during open general surgical procedures (as indicated). A hand actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do not contain software.

The provided text describes a 510(k) premarket notification for a medical device, the LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than to independently prove safety and effectiveness against specific acceptance criteria. Therefore, the document does not contain a typical "acceptance criteria" table with reported device performance metrics in the way one might expect for a de novo device.

Instead, the submission focuses on demonstrating that the new device, which has a non-stick coating added to its jaws, performs comparably to its predicate device (LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider without the nano-coating) across various performance aspects. The "acceptance criteria" here are implicitly that the new device should not introduce new safety or effectiveness concerns and should perform at least as well as the predicate.

Here's an attempt to structure the information based on the provided text, while acknowledging the limitations of a 510(k) submission not explicitly stating quantifiable acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, explicit quantitative acceptance criteria for each test are not provided in the document. The acceptance criterion is implicitly that the subject device (with nano-coating) should perform comparably to the predicate device (without nano-coating) and not raise new safety or effectiveness questions.

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

The document does not explicitly delineate what constitutes a "test set" in the context of device approval, as various tests are performed. However, for the animal studies:

• Acute Animal Study: Two female porcine were used.
• Chronic Animal Study: Five animals (porcine, based on prior mention of porcine tissue) were used.
• Ex-vivo Vessel Burst Pressure and Thermal Profile: "Excised fresh porcine renal, pulmonary arteries, and lymphatics" and "porcine tissue" were used, respectively. The sample size for these ex-vivo/bench tests is not specified.
• Data Provenance: The origin of the animal and tissue data is preclinical testing (animal and ex-vivo studies). The document does not specify the country of origin, but it is typically conducted by or for the manufacturer, Covidien, based in Boulder, Colorado, USA. The data is prospective with respect to the tests conducted for this submission.

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

The document does not specify the number or qualifications of experts used to establish "ground truth" for the preclinical test results.
For the animal studies, "macroscopic and histological evaluation" was performed. This implies assessment by veterinary pathologists or similar experts, but their number and specific qualifications are not mentioned. In a 510(k) submission for a device of this nature, the ground truth for performance characteristics (like burst pressure, thermal damage, hemostasis) is typically established through objective measurements and accepted scientific and histopathological evaluation methodologies rather than subjective expert consensus, as might be the case for image-based diagnostic AI.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set. This type of adjudication is typically relevant for studies involving human interpretation (e.g., medical image reading), which is not the primary focus of the performance tests for this electrosurgical device. The evaluation of test results (e.g., burst pressure measurements, histological findings) is based on objective criteria and standard scientific/pathological assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an electrosurgical instrument, not a diagnostic imaging device that involves human interpretation of medical cases. Comparative effectiveness was demonstrated through preclinical performance testing between the subject device and the predicate device. 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 to this device. The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated is a physical electrosurgical instrument operated by a human surgeon; it does not contain an algorithm or AI that operates in a "standalone" or "human-in-the-loop" fashion. The device description explicitly states: "The proposed devices do not contain software."

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests was established through:

• Objective Measurements: For electrical safety, EMC, mechanical/functional tests (e.g., jaw force, resistance), and ex-vivo burst pressure.
• Biological/Pathological Evaluation: For biocompatibility tests (e.g., cytotoxicity, sensitization), thermal profile assessment (using porcine tissue), and animal study outcomes (macroscopic and histological evaluation of tissue for sealing performance, lateral thermal damage, and chronic hemostasis).

There is no pathology used in the sense of diagnosing a disease from a biopsy, but rather in the sense of macroscopic and microscopic evaluation of tissue changes as a result of the device's action. Outcomes data in the animal studies included survival and maintenance of chronic hemostasis.

8. The Sample Size for the Training Set

This question is not applicable to this device. As noted previously, the device does not contain software or AI components that would require a "training set."

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

This question is not applicable to this device, as there is no training set.

Ask a specific question about this device

The LigaSure Sealer/Divider, comprised of a single use electrode and a reusable clamp, is intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

The LigaSure Electrode is a single use component that attaches to the LigaSure Clamp. After assembly, 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, reconstructive, and gynecologic . Procedures may include, but are not limited to, bowel resections, hysterectomy, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

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 LigaSure Clamp is a reusable handpiece to which the LigaSure Electrode attaches. Refer to the labeling of the compatible electrode for specific indications.

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 Jaw, Open Sealer/Divider (LF3225, LF3225C) is a hand-held bipolar electrosurgical vessel sealing device intended for use with compatible Covidien generators that include LigaSure™ vessel sealing capabilities to ligate (seal) and divide (cut) blood vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). It is composed of a reusable hemostat-style clamp and a sterile single-use electrode.

The device creates a seal by application of RF electrosurgical energy delivered from the compatible Covidien generators to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the instrument to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charing, and thermal spread to adjacent tissue. Once the seal cycle is complete, surgeon actuates a blade within the electrode of the instrument to divide the tissue along the seal line. The proposed device does not contain software.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device, the LigaSure™ Curved Jaw, Open Sealer/Divider Electrode (LF3225) and LigaSure™ Curved Jaw Open Reusable Clamp (LF3225C). The document confirms the device's substantial equivalence to predicate devices and lists the types of verification and validation activities performed. However, it does not provide specific acceptance criteria or detailed results of these studies in a format that allows for a direct comparison table of acceptance criteria vs. device performance, or details on sample sizes, ground truth establishment, or human-in-the-loop studies as requested.

Here's a breakdown of the information that can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly available in the provided document. The document states that "Verification and validation activities were successfully completed and establish that the LigaSure™ Curved Jaw, Open Sealer/Divider performs as intended and is substantially equivalent to its predicates." It lists types of testing conducted but does not provide specific metrics, acceptance thresholds, or reported performance values for those criteria. For example, it mentions "thermal effects and vessel sealing capabilities" but without quantified criteria or results.

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

This information is not explicitly available in the provided document.

• Sample Size: The document mentions "Ex vivo and in vivo testing using porcine tissue and a porcine model" but does not specify the number of samples, vessels, or animals used in these tests.
• Data Provenance: The testing was conducted using "porcine tissue and a porcine model." The country of origin for the data is not specified, but the applicant's address is in Shanghai, China, and Covidien is a global company. The studies are inferred to be prospective experimental studies given their nature (ex vivo and in vivo testing).

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

This information is not explicitly available in the provided document. The document describes engineering, functional, and biological testing, typically overseen by engineers, scientists, and veterinarians/surgeons, but it does not specify the role or number of "experts" in establishing ground truth for a test set in the way this question implies (e.g., for image analysis or diagnostic accuracy).

4. Adjudication Method for the Test Set

This information is not explicitly available in the provided document. Given the nature of the device (electrosurgical vessel sealing), "adjudication" methods like "2+1, 3+1" commonly seen in diagnostic device studies are not relevant or described. Performance would typically be assessed by objective measurements (e.g., burst pressure, thermal spread, seal integrity) performed by testing personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

This information is not applicable/not available. The device is an electrosurgical tool, not a diagnostic imaging or AI device that relies on "human readers." Therefore, an MRMC comparative effectiveness study is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not available. The device is a physical electrosurgical tool, not an algorithm. Its performance is inherently tied to its use by a human (surgeon) but its "standalone" performance would refer to its inherent functional capabilities, which were assessed through engineering, functional, and preclinical studies. These studies implicitly evaluate the device's performance independent of the variables introduced by individual human technique, focusing on the device's physical and biological effects. The document states, "The proposed device does not contain software." Thus, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth for this type of device performance would be based on:

• Physical/Engineering Metrics: Measured properties like electrical performance, mechanical integrity, precise temperature readings, and sealing capabilities (e.g., burst pressure, seal quality, tissue necrosis).
• Biological Outcomes: Direct observation of tissue effects in ex vivo and in vivo models, such as thermal spread, complete tissue fusion, absence of bleeding, and histological analysis of sealed vessels. This can be considered a form of pathology/histology and direct outcomes data from preclinical models.

8. The Sample Size for the Training Set

This information is not applicable/not available. Since the device is a physical electrosurgical tool and not an AI or machine learning algorithm, there is no "training set" in the computational sense. The "training" to develop and refine such a device would be part of its engineering design and iterative testing process.

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

This information is not applicable/not available for the same reasons as point 8.

Ask a specific question about this device

The LigaSure Advance Sealer/Divider is a bipolar/monopolar electrosurgical instrument intended for use in minimally invasive surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Advance Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. The instrument can be used to dissect through tissue planes and to create enterotomies or gastrotomies.

It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, colorectal, bariatric, and gynecologic. Procedures may include, but are not limited to, gastric bypass, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

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™ Advance Monopolar Tip Sealer/Divider, Pistol Grip is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during minimally invasive general surgical procedures. The device uses radio frequency (RF) energy to seal vessels, tissue bundles, and lymphatics. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to activate bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to active a blade, which divides the tissue along the seal line.

The LigaSure Advance Sealer/Divider also includes a tip that can deliver monopolar energybased dissection and creation of gastrotomies and enterotomies (openings in the stomach or bowel).

The provided document is a 510(k) premarket notification for a medical device, not a study report detailing specific acceptance criteria and their fulfillment. Therefore, the requested information, particularly quantitative data on acceptance criteria and study results, is not present in the given text.

The document discusses the substantial equivalence of the "LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip" (the subject device) to a predicate device (LigaSure Advance family cleared under K063195). It primarily focuses on the regulatory submission process and the justification for substantial equivalence based on similar indications for use, technological characteristics, and performance data from bench and preclinical testing.

Here's a breakdown of what can be gleaned, and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This specific table is not provided. The document mentions general areas of testing but does not quantify acceptance criteria or specific performance metrics.

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

This information is not provided. The document refers to "bench and preclinical testing" but gives no details about the sample sizes for these tests or the data provenance.

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

This information is not provided. Given that the testing mentioned is primarily "bench and preclinical," it's unlikely that human experts were used to establish a "ground truth" in the way radiologists establish ground truth for image interpretation.

4. Adjudication Method

This information is not provided.

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

No MRMC study is mentioned. The device is an electrosurgical instrument, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm is mentioned, as this is a physical medical device, not an algorithm. The "performance" mentioned refers to the physical characteristics and function of the electrosurgical instrument.

7. Type of Ground Truth Used

The concept of "ground truth" in the context of expert consensus, pathology, or outcomes data, as typically applied to diagnostic devices or AI, does not directly apply here. For this electrosurgical device, the "performance" data would likely be based on:

• Bench Testing: Measurements of physical properties, power output, sealing capabilities on surrogate materials, thermal spread, etc.
• Preclinical Testing: In vivo observations in animal models related to sealing vessels, achieving hemostasis, and thermal effects.
• Renal artery burst pressure: This is a specific performance metric indicating the strength of the seal.

The document states:

• "Supporting data were obtained from both bench and preclinical testing to support substantial equivalence include:" followed by bullet points.
• "Preclinical testing for this device includes: Sealing and dividing vessels and tissue bundles up to and including 7 mm, Ability to achieve hemostasis of tissue and vessels, Thermal spread measurements."
• "Comparative test results showed that the current design performs very similarly to the original design."

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI algorithm that requires a "training set."

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

This information is not applicable, as there is no training set for an AI algorithm.

Summary of Available Information from the Provided Text:

• Device: LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip
• Purpose: Ligation and division of vessels, tissue bundles, and lymphatics in minimally invasive surgical procedures. Can be used on vessels up to 7mm. Also provides monopolar energy for dissection and creating enterotomies/gastrotomies.
• Context: 510(k) submission for substantial equivalence to a legally marketed predicate device (LigaSure Advance family, K063195).
• Performance Data Mentioned (General):
  • Bench testing (IEC 60601-1, IEC 60601-2-2)
  • Biocompatibility (ISO 10993-1)
  • Sterilization cycle validation (Ethylene oxide)
  • Renal artery burst pressure
  • Preclinical testing (sealing/dividing vessels/tissue bundles up to 7mm, hemostasis, thermal spread measurements)
• Conclusion on Performance: "Comparative test results showed that the current design performs very similarly to the original design."

To answer your request comprehensively, a detailed study report or clinical trial documentation for the LigaSure Advance device would be required, which is beyond the scope of this 510(k) summary.

Ask a specific question about this device