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The reprocessed vessel sealer/dividers are intended for use in general and gynecological laparoscopic surgical procedures where ligation and division of vessels and lymph is desired.

Indications for use include general laparoscopic procedures including urologic, vascular, thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectory, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The reprocessed vessel sealer/dividers can be used to on vessels and lymphatics up to and including 7 mm, and tissue bundles.

The reprocessed vessel sealer is a sterile, hand-held bipolar RF electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during laparoscopic general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting.

The provided text describes a 510(k) premarket notification for a reprocessed vessel sealer, focusing on its substantial equivalence to a predicate device. The information details functional and safety testing to support this claim, rather than a clinical study evaluating AI performance or human reader improvements. Therefore, some of the requested information regarding AI-specific assessments (like MRMC studies, standalone AI performance, or training set details) will not be present in this document.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of "acceptance criteria" alongside specific "reported device performance" values for each criterion in a quantitative format as one might expect for a typical diagnostic device study. Instead, it lists the types of tests performed and generally states that the device performs "as originally intended."

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

The document states: "Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics." It does not specify the exact sample size for any of the test sets (e.g., number of devices used for burst pressure, thermal spread, or fatigue testing).

The data provenance is from non-clinical tests performed by SterilMed, Inc. (and Libra Medical Inc. for contact purposes). This is a manufacturer's submission for regulatory approval, implying the data was generated internally for this purpose. The country of origin for the testing would presumably be the country of the manufacturing/testing facility, which is stated as "11400 73rd Avenue North Maple Grove, MN 55369" (USA). The testing is retrospective in the sense that it's performed on batches of reprocessed devices to demonstrate consistent quality and performance.

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 type of device (a reprocessed surgical instrument) is established through engineering and scientific performance testing against defined physical and electrical standards, not through expert clinical consensus as would be common for diagnostic or AI-driven devices.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) where experts may disagree, requiring a method to reach a consensus "ground truth." For engineering performance tests, the results are quantitative and objective, not subject to expert disagreement requiring adjudication in this 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

No, an MRMC comparative effectiveness study was not done. This submission is for a reprocessed electrosurgical device, not an AI-based diagnostic tool or system that assists human readers.

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

No, a standalone algorithm-only performance study was not done. This device does not involve an algorithm or AI.

7. The type of ground truth used

The ground truth used for this device is based on engineering standards, physical measurements, and compliance with predicate device performance characteristics. This includes:

• Pre-defined physical and electrical specifications (e.g., IEC 60601-2-2 for electrical safety).
• Validation against established protocols for cleaning, sterilization, packaging, and shelf-life (e.g., ISO 11135, USP , ISO 10993-7, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-07).
• Functional performance benchmarks, such as vessel seal burst pressure, thermal spread, and mechanical integrity, designed to demonstrate equivalence to the original (predicate) device's intended performance.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/machine learning device, so there is no "training set."

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

This information is not applicable and not provided for the same reason as point 8.

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The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5 mm Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

The LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during laparoscopic general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting.

The provided document is a 510(k) Summary for a medical device, the LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo safety and effectiveness through a traditional clinical study with explicitly defined acceptance criteria and statistical analysis as one might find for a novel device.

Therefore, the information requested regarding acceptance criteria, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic or AI-driven device is largely not applicable in the context of this 510(k) submission for a surgical instrument.

However, I can extract the relevant information from the document to address the spirit of your request within the confines of what is provided:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a surgical device like this, "acceptance criteria" are typically demonstrated through successful completion of specified engineering, mechanical, and preclinical tests, showing that the modified device performs comparably to the predicate device and meets safety standards. The document doesn't list specific numerical acceptance criteria for each test, but it states that the device "operated as intended and is as safe and effective as the predicate device."

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

• Sample Size for Test Set: Not explicitly stated as "test set" in the context of a diagnostic study. For mechanical and preclinical testing, the number of samples or animals used for each specific test is not detailed in the summary.
• Data Provenance: The testing was conducted by Covidien, the device manufacturer. The document does not specify the country of origin for the data (e.g., where animal studies were conducted if applicable) or if it's retrospective or prospective. Given the nature of a 510(k), it would be prospective testing specifically for this submission.

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

• Not Applicable. This is a surgical instrument and a 510(k) submission, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set in the conventional sense. The "ground truth" is established through the physical and physiological performance observed in bench and preclinical (animal) tests.

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

• Not Applicable. This is not a diagnostic study requiring human adjudication for interpretation of results. The results of the mechanical and preclinical tests are objective measurements or observations of device 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 study is for a surgical instrument, not an AI-assisted diagnostic tool. No human reader performance improvement with or without AI assistance was evaluated.

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

• Standalone Performance: The "standalone performance" of the device is implicitly demonstrated through the bench and preclinical testing where the device is operated according to its intended use and evaluated against performance metrics. The device itself is an electrosurgical instrument operated by a surgeon, not an algorithm.

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

• Ground Truth: For this type of device, the "ground truth" is based on the objective physical and biological performance characteristics, verified through:
  • Compliance with recognized electrical safety standards (IEC 60601-1, IEC 60601-2-2).
  • Quantitative mechanical measurements (e.g., jaw force, burst pressure).
  • Qualitative and quantitative observations in preclinical (animal) studies of vessel sealing, hemostasis, and tissue division.
  • The predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that uses a "training set." The device is a physical surgical instrument.

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

• Not Applicable. As there is no training set for an AI model, there is no ground truth established for it in this context.

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The LigaSure 5mm. Blunt tip. Laparoscopic Sealer- Divider is a bipolar electrosurgical instrument intended for use the ForceTriad Generator in general and gynecologic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5mm Blunt tip Laparoscopic Sealer-Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.

The LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider is a multifunctional electrosurgical instrument for use with the ForceTriad™ generator when performing laparoscopic surgery. The instrument is capable of sealing vessels and lymphatics, dividing tissue (including vessels) clamped between the jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. The following controls are located on the instrument handle: A lever for opening and closing the instrument jaws. The mechanism incorporates a latch to hold the jaws in the closed position during vessel sealing and cutting. An activation button for generator power to initiate vessel sealing. A trigger for actuating the cutter. The cutter can only be actuated when the jaws are closed and latched. A knob to rotate the instrument jaws. The jaws can rotate 179 degrees to facilitate surgeon access and visibility. All controls can be operated with either the right or left hand. Vessel scaling can be initiated using the activation button, or utilizing a footswitch connected to the generator. The instrument attaches to the ForceTriad generator via a ten foot cord with a "Smart" connector that identifies the instrument type to the generator. The instrument is supplied sterile for single use.

The provided text is a 510(k) summary for the LigaSure 5mm Blunt Tip Laparoscopic Sealer-Divider. It describes the device, its intended use, and states that non-clinical testing was performed, but no specific acceptance criteria or detailed study results are provided in the document. The summary only generally states that "The data obtained showed that the device is substantially equivalent to the predicate and meets the safety and effectiveness criteria," without listing criteria or performance metrics. Furthermore, it explicitly states, "No clinical testing was conducted."

Therefore, I cannot fulfill all parts of your request with the given information.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• The document does not provide a table of acceptance criteria or specific reported device performance metrics that can be accurately tabulated. It only states that the device "meets design specifications" and "meets the safety and effectiveness criteria."

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

• Sample Size: Not specified. The document mentions "ex-vivo tissue studies" and "in-vivo tissue studies (porcine and canine model)" but does not detail the number of samples or animals used.
• Data Provenance: The studies were non-clinical, involving ex-vivo and in-vivo (porcine and canine model) tissue studies. The country of origin for these studies is not specified, but the applicant's address is Boulder, CO, USA. The studies were retrospective, as they were conducted to support a Special 510(k) for a modified device.

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

• Not applicable. As this was non-clinical testing (ex-vivo and in-vivo animal models), the concept of "experts establishing ground truth" in the context of clinical interpretation of data (e.g., radiologist consensus) is not relevant. The ground truth would likely be established through physical measurements, histological analysis, and observed physiological outcomes in the animal models, rather than expert interpretation of images or clinical assessments.

4. Adjudication method for the test set

• Not applicable. Given that the testing was non-clinical and did not involve human interpretation of results requiring adjudication (like image analysis in a clinical study), an adjudication method is not described or relevant.

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

• No. An MRMC study was not done. This device is a surgical instrument, not an AI-assisted diagnostic or interpretive tool that would involve human readers or AI assistance in that context.

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

• Not applicable. This device is a manual surgical instrument. The concept of an "algorithm only" or "human-in-the-loop performance" does not apply to its function.

7. The type of ground truth used

• Non-clinical (Ex-vivo/In-vivo observations): Ground truth would have been established through direct measurements, histological examination of sealed tissues, observation of immediate and delayed physiological effects in live animal models (e.g., vessel patency, bursting strength, thermal spread), and technical performance assessment against design specifications.

8. The sample size for the training set

• Not applicable. This device is a physical surgical instrument, not an AI or machine learning model that requires a "training set."

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

• Not applicable. As above, there is no training set for this type of device.

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