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The Reprocessed 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 Reprocessed LigaSure Sealer/ Divider can be used on yessels (arteries, veins, 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, 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 Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (LF4418) 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 LF4418 is designed for use with Covidien electrosurgical generators that include vessel sealing capability. The LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7mm.

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 instrument handle:

• A lever for opening and closing the instrument iaws. The mechanism incorporates a latch to . hold the jaws in the closed position during vessel sealing and cutting.
• . An activation button for generator power to initiate vessel sealing.
• A triager for actuating the cutter. ●
• . A knob to rotate the instrument jaws.

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 attaches to the compatible electrosurgical generator via a cord with a cable connector that identifies the instrument type to the generator.

For the LF4418, the Original Manufacturer applies a non-stick coating to the jaws of the device to reduce tissue sticking. When reprocessing the LF4418, Stryker Sustainability Solutions will not apply a non-stick coating to the iaws of the device.

The scope of this submission only includes the reprocessed Covidien™ sealer/divider device and not the 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 generator or footswitch.

This submission describes the reprocessing of a LigaSure Impact surgical device, not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects like training sets, ground truth establishment for training data, expert adjudication, multi-reader multi-case studies, and standalone algorithm performance are not applicable to this document. The provided text primarily focuses on bench and laboratory testing, as well as preclinical animal studies.

Here's an analysis of the provided text based on the applicable criteria:

Acceptance Criteria and Device Performance

The general acceptance criteria are implied to be that the reprocessed device is "as safe and effective as the predicate and operate as originally intended." The specific quantitative acceptance criteria are not explicitly detailed in numerical thresholds. However, the performance data section lists the types of tests conducted to demonstrate this equivalence.

Study Details

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

   • Sample Size: The document does not specify the exact number of devices or animal subjects used in the various tests.
   • Data Provenance: The testing was "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model." No country of origin for the data is specified, but it can be inferred to be conducted by Styker Sustainability Solutions or its contracted labs. The data is prospective as it was generated specifically for this submission.

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

   • This is not applicable to this type of device and testing. The "ground truth" for the functional tests is objective measurements (e.g., burst pressure, temperature) and observation of physical outcomes (e.g., successful sealing, coagulation, cutting). For animal studies, the "ground truth" would be observed physiological outcomes and histological analysis conducted by veterinary pathologists or similar experts, though their number and qualifications are not specified.

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

   • Not applicable/specified. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement among reviewers. The tests described are primarily objective physical and functional tests.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, this is a reprocessed surgical instrument, not an AI/ML-powered device. Therefore, an MRMC study and AI-related effect sizes are not applicable.

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

   • No, this is a reprocessed surgical instrument. Standalone algorithm performance is not applicable.

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

   • The ground truth used for the functional and preclinical tests is based on objective physical measurements (e.g., burst pressure, maximum jaw temperature), adherence to engineering standards (e.g., IEC 60601 series), and observed physiological outcomes (e.g., achievement of hemostasis, thermal spread evaluation) in animal models, likely supported by pathology or histological analysis in the animal studies.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable. There is no training set.

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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.

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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.

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