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

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and 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 Remanufactured LigaSure Exact Dissector Without Nano-coating (LF2019) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:
. Scissor like design for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting.
. An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
. A trigger for actuating the blade.

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

For the LF2019, the Original Manufacturer applies a non-stick coating the jaws of the device to reduce tissue sticking. When remanufacturing the LF2019, Stryker Sustainability Solutions will not apply a non-stick coating to the jaws of the device.

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

The scope of the submission only includes the addition of a second reprocessing cycle to the previously cleared Remanufactured LigaSure Exact Dissector Without Nano-coating (K220481) and not the Covidien Valleylab FT10 Energy Platform that is used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.

The provided text is a 510(k) summary for a remanufactured medical device, the LigaSure Exact Dissector. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics. As such, the information needed to fully answer your request regarding specific acceptance criteria values and detailed study methodology and results is not present in the given text.

However, I can extract and infer some information based on the typical content of a 510(k) summary and the general nature of medical device premarket notifications.

Here's a breakdown of what can and cannot be answered from the provided text:

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

The document lists various tests performed but does not provide specific numerical acceptance criteria or the quantitative results achieved for each. For example, it lists "Burst Pressure" as a test, but doesn't say "acceptance criteria: >X mmHg, reported performance: Y mmHg."

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

• Sample Size for Test Set: Not specified in the document for any of the performance tests.
• Data Provenance: The studies were conducted by Stryker Sustainability Solutions, a company based in Tempe, Arizona, USA. The nature of the studies (bench, laboratory, and preclinical animal model) suggests they were prospective, specifically designed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable in this context. The device is a surgical instrument, not an AI diagnostic tool. Ground truth in this context would generally refer to objective physical measurements (like burst pressure, temperature, force) and clinical observations in an animal model, not expert interpretation of diagnostic data.

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

Not applicable for a physical medical device performance study. Adjudication methods like 2+1 or 3+1 are typically used in AI/diagnostic studies where there's an element of human interpretation that needs to be resolved.

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

Not applicable. This is a physical surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable.

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

The "ground truth" for this type of device performance study would be:

• Objective physical measurements: Electrical safety parameters, electrosurgical compatibility (IEC standards), mechanical forces (blade actuation, clamp arm force, jaw clamp force), geometrical measurements (jaw opening angle, blade excursion), and in-vitro performance (burst pressure, maximum jaw temperature).
• Preclinical animal model observations: Direct observation of hemostasis, thermal spread, and absence of adverse events (acute and chronic survival studies).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set. The term "training set" is relevant for AI/machine learning.

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

Not applicable.

Summary of available information related to performance:

The document states that the following tests were conducted:

• Biocompatibility
• Validation of Reprocessing
• Sterilization
• Electrical Safety and Electromagnetic Compatibility: In accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
• Functional Performance Tests:
  • Blade Trigger Actuation Force
  • Clamp Arm Closing and Seal Button Force
  • Clamp Arm Opening Force
  • Clamp Arm Deflection
  • Jaw Clamp Force
  • Blade Excursion
  • Jaw Opening Angle
  • Burst Pressure (evaluated ability to seal and divide vessels from 1mm to 7mm)
  • Maximum Jaw Temperature
  • Device Reliability
  • Functional Attribute Testing
  • Generator Software Compatibility
• Preclinical laboratory evaluations in an animal model: Acute and chronic survival studies to evaluate thermal spread and ability to achieve hemostasis of vessels.

Conclusion stated: "The results of bench testing and preclinical laboratory evaluations demonstrate that the Remanufactured LigaSure Exact Dissector Without Nano-coating is at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device as described herein."

In essence, the document confirms that various performance tests were performed and demonstrated that the remanufactured device is "at least as safe and effective" as the predicate, which is the standard for 510(k) clearances. However, it does not disclose the specific quantitative acceptance criteria or the detailed numerical results from these tests.

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

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

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

The Remanufactured LigaSure Exact Dissector. Without Nano-coating (LF2019) is a bipolar electrosurgical instrument intended for use in open surqical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:

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

For the LF2019, the Original Manufacturer applies a non-stick coating the jaws of the device to reduce tissue sticking. When remanufacturing the LF2019, Stryker Sustainability Solutions will not apply a non-stick coating to the iaws of the device.

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

The scope of the submission only includes the Remanufactured LigaSure Exact Dissector. Without Nano-coating and not the Valleylab FT10 Energy Platform that is used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess, remanufacture, or market the generators or footswitch.

The provided text describes the acceptance criteria and the study conducted for the Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019). Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for each test with numerical thresholds. However, it states that the device was evaluated against the predicate device and that the results "demonstrate that the Remanufactured LigaSure Exact Dissector, Without Nano-coating is at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device."

Therefore, the implicit acceptance criteria are that the remanufactured device performs comparably to the predicate device in the specified tests, particularly regarding safety and effectiveness.

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

• Sample Size: The document does not specify the exact sample size for each bench test or the number of animals used in the preclinical studies. It generally refers to "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model."
• Data Provenance: The document does not provide details on the country of origin of the data. The studies appear to be prospective as they were conducted specifically to demonstrate the performance of the remanufactured device.

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

This information is not provided in the document. The studies described are primarily performance and comparative tests against a predicate device, rather than subjective evaluations requiring expert consensus for ground truth.

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

This information is not applicable/not provided. The performance data described are objective measurements (e.g., forces, temperatures, burst pressure) or observations in animal models that do not typically involve an adjudication method by multiple human readers.

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. The device described is a surgical instrument (Electrosurgical Cutting and Coagulation Device), not an AI-powered diagnostic or imaging tool. Therefore, an MRMC study related to human reader
improvement with AI is irrelevant to this device.

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

This is not applicable. The device is a physical surgical instrument; it is not an algorithm, and its performance inherently involves human-in-the-loop operation.

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

The "ground truth" for the tests appears to be based on:

• Predicate Device Performance: The primary method for establishing effectiveness is comparison against the legally marketed predicate device (LigaSure Exact Dissector, Nano-coated LF2019, K173281). The remanufactured device needed to perform "as well as" the predicate.
• Established Engineering and Medical Standards: Compliance with electrical safety and electromagnetic compatibility (IEC 60601 series).
• Direct Physical Measurements: For functional performance tests (e.g., force, temperature, burst pressure).
• Biological Outcomes: In the animal model, the ground truth would be the observed hemostasis and thermal spread characteristics.

8. The sample size for the training set:

This is not applicable. The device is a remanufactured physical instrument, not an AI model that requires a training set.

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

This is not applicable as there is no training set for this type of device.

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