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The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surqical 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 in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectomy) for ligation and division of vessels. Ivmphatics 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 Medline ReNewal Remanufactured LigaSure Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, handle-held bipolar vessel sealing device 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 the 510(k) summary for the Medline ReNewal Reprocessed LigaSure Exact Dissector, a remanufactured surgical instrument, not an AI-powered diagnostic device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "test set," "ground truth," "experts," "adjudication," "MRMC study," and "training set" as typically applied to AI/ML diagnostic devices, are not applicable in this context.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of functional characteristics, materials, and technological aspects.

Here's how to reframe the information based on the provided text for a non-AI medical device:

The device under review is the Medline ReNewal Remanufactured LigaSure Exact Dissector, without Nano-coating (LF2019). This is a reprocessed version of a legally marketed predicate device. The "acceptance criteria" in this context refer to demonstrating that the reprocessed device performs equivalently to the original and meets necessary safety and functional standards.

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

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

The document summarizes testing categories but does not provide specific sample sizes or provenance information for each test performed (e.g., how many devices were tested for functional performance or biocompatibility). This level of detail is typically found in the full 510(k) submission, not the summary document.

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

This concept is not applicable for a reprocessed surgical instrument. The assessment is based on quantifiable engineering and biological tests, not expert interpretation of diagnostic images or clinical scenarios.

4. Adjudication method for the test set:

Not applicable. Testing involves objective measurements and predefined pass/fail criteria for mechanical and biological performance.

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 reprocessed surgical instrument, not an AI-powered diagnostic tool.

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

Not applicable. This is a physical surgical instrument.

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

For this type of device, "ground truth" is established through:

• Engineering specifications and performance standards: The device must meet predefined mechanical, electrical, and functional parameters.
• Biological safety standards: Biocompatibility testing compares material responses to established safe limits.
• Sterilization efficacy standards: Validation ensures a specified sterility assurance level (SAL).
• Comparison to predicate device performance: The reprocessed device is expected to perform comparably to the original during functional tests.

8. The sample size for the training set:

Not applicable. There is no "training set" for a reprocessed surgical instrument.

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

Not applicable.

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication method for the test set

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

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

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

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

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

7. The type of ground truth used

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

8. The sample size for the training set

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

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

Not applicable. See point 8.

Ask a specific question about this device

The 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.

Ask a specific question about this device

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 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.

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Not Applicable: This is specific to AI devices and their impact on human reading performance. This document is for a reprocessed surgical instrument.

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

Ask a specific question about this device

The 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.

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The Medline ReNewal Reprocessed LigaSure Maryland Jaw 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, 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 Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open and minimally invasive general surgical procedures using radio frequency (RF) energy. 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 initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to activate a knife, which divides the tissue along the seal line.

The request is for information on the acceptance criteria and study proving device performance for the Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737, and LF1744), as detailed in the FDA 510(k) summary K182588.

Based on the provided document, the device is a reprocessed version of a legally marketed predicate device. The submission primarily focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers with 510(k) K141153) through performance testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the functional characteristics of the proposed reprocessed devices have been evaluated and found to be equivalent to the predicate devices. The acceptance criteria are implied to be that the reprocessed device performs comparably to the new predicate device across various tests.

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

The document does not specify the exact sample sizes used for each of the performance tests. It broadly states "The functional characteristics of the proposed devices have been evaluated..." without providing numerical details for the test sets.

The data provenance is not explicitly stated in terms of country of origin. Given it is an FDA submission for a device manufactured by "Surgical Instrument Service and Savings Inc (dba Medline ReNewal)" and the predicate is from "Covidien," it can be inferred that the testing and data would be primarily from the United States, following U.S. regulatory guidelines. The data is retrospective in the sense that it relies on established standards and comparisons to an already legally marketed predicate device, rather than a novel prospective clinical trial for the reprocessed device's primary effectiveness.

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

The document does not mention the use of experts to establish ground truth for this type of device comparison study. The tests listed are primarily engineering and laboratory-based performance evaluations (e.g., electrical, mechanical, material, and in-vitro or ex-vivo tissue property tests). For biocompatibility and histopathology, qualified laboratories and pathologists would perform the evaluations, but their specific number and qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical outcomes or interpretations by multiple readers/experts. The testing involves objective measurements against established engineering and biological standards.

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 not a study involving AI or human readers for diagnostic interpretation. It is a performance evaluation of a reprocessed surgical instrument.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance evaluation of this reprocessed device is established by:

• Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers, K141153). The reprocessed device is deemed substantially equivalent if its performance matches or falls within acceptable ranges compared to the predicate.
• Industry Standards: Compliance with international and national standards (e.g., IEC 60601 series for electrical safety, ISO standards for biocompatibility and sterilization, and internal performance specifications), which represent a form of accepted "ground truth" for device safety and performance.
• Laboratory-based measurements: Objective measurements of physical, chemical, and biological properties through various tests (e.g., burst pressure, protein residuals, cytotoxicity).
• Histopathology: Evaluation of tissue effects, performed by qualified personnel (likely pathologists), forms a 'ground truth' for tissue interaction.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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 Reprocessed 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 Covidien™ LigaSure™ 5 mm Maryland Jaw Sealer/Divider (LF1723, LF1737, LF1744) is a bipolar electrosurgical instrument intended for use in minimally invasive or 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 outer diameter of the instrument shaft is 5 mm with a working length of 23 cm, 37 cm, or 44 cm.

The provided text describes the regulatory clearance for reprocessed LigaSure Maryland Jaw Sealer/Divider devices and includes information about the performance testing conducted. However, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria, particularly for AI/machine learning devices.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent for many of your points:

1. Table of acceptance criteria and the reported device performance:

The document mentions that "bench testing involved evaluation of the device's performance and ability to seal and divide vessels up to 7mm, including: burst pressure, maximum jaw temperature, device functionality, device reliability, and generator compatibility." It also states, "The results of the evaluations demonstrate that the Reprocessed LigaSure Maryland Jaw Sealer/Divider effectively cut and coagulated vessels up to and including 7mm in diameter."

However, specific numerical acceptance criteria (e.g., "burst pressure must be greater than X mmHg") and concrete performance data (e.g., "average burst pressure was Y mmHg") are not provided in the text.

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