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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 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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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 specialities 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 (LF1623, LF1644) devices are sterile (EtO), single-use, 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 open and minimally invasive general surgical procedures (as indicated) using radio frequency (RF) energy. 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.

This document describes the testing and performance of the LigaSure™ Blunt Tip Sealer/Divider. However, it does not contain explicit "acceptance criteria" presented as quantitative thresholds that the device must meet, nor does it present the "reported device performance" in a structured table directly compared to such criteria for many of the tests.

Instead, the document primarily focuses on verifying that the new shaft lengths of the LigaSure™ Blunt Tip Sealer/Divider devices perform as expected and are substantially equivalent to the predicate device (LigaSure™ Blunt Tip Laparoscopic Sealer/Divider). The studies described are for demonstrating this equivalence and safety, rather than proving performance against specific pre-defined quantitative acceptance criteria in a format typical for AI/software device evaluation.

Here's an attempt to extract and present the information you requested, highlighting where specific details are missing for this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for most of the tests in a table, nor does it provide specific numerical performance results for the device against such criteria. Instead, it generally states that tests were conducted and the device "performs as expected" or "met the predefined acceptance criteria" (for the animal study), or that it has a "safety and effectiveness profile that is similar to the predicate device."

Study Details:

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

   • Biocompatibility: Not specified beyond "patient-contacting materials" being tested.
   • Electrical Safety & EMC: Not specified.
   • Mechanical/Functional Testing: Not specified.
   • Ex-vivo Vessel Burst Pressure: "excised fresh porcine renal, pulmonary arteries, and lymphatics." The number of samples/vessels is not specified.
   • Acute Animal Study: "one female pig" was used.
   • Chronic Animal Study: Not applicable to a new study; results from K130744 were carried over due to device similarity.
   • Human Factors and Usability: "representative users" were used, but the number is not specified.
   • Data Provenance:
     • Ex-vivo: Porcine tissue.
     • Acute Animal Study: Porcine.
     • Other tests (Mechanical, Electrical, Biocompatibility): Likely conducted in a laboratory setting (in-house or contracted).
     • All studies are prospective for the K142929 submission.

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

   • This question is more pertinent to diagnostic AI devices. For this electrosurgical device, "ground truth" would be established through direct physical measurements, observation of physiological responses (e.g., hemostasis), or pathological evaluation, rather than human expert interpretation of images/data.
   • Acute Animal Study: "Macroscopic and histological evaluation of the tissue that was sealed and divided" was performed. These evaluations would typically be done by veterinary pathologists or trained researchers, but their number and specific qualifications are not detailed in this summary.

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

   • Not applicable in the context of this device's testing. Ground truth for performance (e.g., burst pressure, hemostasis, thermal damage) is determined by direct physical measurement, observation, or histological analysis, not by human reader consensus/adjudication.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use the AI as an aid. The LigaSure™ Blunt Tip Sealer/Divider is a surgical tool, not a diagnostic AI system.

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

   • The device itself is a hand-held surgical instrument requiring human operation. It does not contain an "algorithm" in the sense of an AI or diagnostic software that could perform "standalone." Its performance is always in the context of human use. The document explicitly states, "The proposed devices do not contain software."

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

   • Biocompatibility: Laboratory testing results based on established international standards.
   • Electrical Safety & EMC: Measurements against specified standard limits.
   • Mechanical/Functional Testing: Direct physical measurements (e.g., force, gap, resistance).
   • Ex-vivo Vessel Burst Pressure: Measured burst pressure values of sealed vessels.
   • Acute Animal Study: Direct observation of hemostasis and pathological evaluation (macroscopic and histological) of tissue for thermal damage.
   • Human Factors and Usability: Observational studies of user interaction and performance of tasks.

7. The sample size for the training set:

   • The LigaSure™ Blunt Tip Sealer/Divider is a hardware electrosurgical device, not an AI or software algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design is based on engineering principles and prior validated predicate devices.

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

   • As there is no training set for an AI/software algorithm, this question is not applicable. The functional performance of the device's design is established through engineering design, material science, and testing as described.

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