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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.

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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 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.

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The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery.

The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery.

The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.

Not Found

This document is a 510(k) Pre-market Notification for a reprocessed medical device, the Green OR Reprocessed Aquamantys Bipolar Sealer. The submission aims to demonstrate substantial equivalence to the original, legally marketed predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists performance testing conducted to demonstrate substantial equivalence. These tests serve as the "acceptance criteria" for the reprocessed device to perform comparably to the original. The document states that the functional characteristics "have been evaluated and found to be equivalent to the predicate devices."

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

The document does not explicitly state the sample sizes used for each specific test. It broadly refers to "the functional characteristics of the subject devices have been evaluated." As this is a 510(k) for a reprocessed device, the data provenance would primarily be from laboratory testing conducted on the reprocessed units, comparing them against the specifications or performance of new, original devices (the predicates). There is no mention of clinical data or patient data (retrospective or prospective) in this summary.

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

This type of information (number and qualifications of experts) is typically associated with studies involving human interpretation or clinical outcomes, such as imaging diagnostic algorithms. For a device like a bipolar sealer undergoing functional and safety testing, the "ground truth" is established by objective engineering and laboratory standards and measurements, not expert human interpretation. Therefore, this information is not applicable or provided in this type of submission.

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

Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human experts in cases of subjective interpretation (e.g., radiology reads). Since the described tests are objective laboratory and engineering assessments of device performance (e.g., RF power output, residual protein), such an adjudication method is not relevant or applied.

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:

An MRMC comparative effectiveness study is used to evaluate the diagnostic performance of humans, often with and without AI assistance, on a set of cases. This device (a reprocessed bipolar sealer) is a surgical tool, not a diagnostic imaging device typically associated with human "readers" or AI assistance in a diagnostic context. Therefore, an MRMC study was not conducted, and effect sizes related to human reader improvement with AI assistance are not applicable.

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

This device is not an algorithm or an AI system, but a physical electrosurgical tool. Therefore, the concept of "standalone" performance for an algorithm is not applicable. The performance testing described (RF power, saline flow, cleaning, etc.) is the "standalone" performance of the reprocessed device itself.

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

For the specific tests listed (RF Power Output, Saline Flow Rate, Biocompatibility, Sterilization, Cleaning, Electrical Safety), the ground truth is established by objective, measurable engineering specifications, industry standards (e.g., IEC 60601-2-2), and validated test methods. For example, RF power output would be measured against the manufacturer's specified output range for a new device, and residual protein levels would be measured against established acceptance limits. It would not typically involve expert consensus, pathology, or outcomes data in the usual sense for this type of device and testing.

8. The sample size for the training set:

As this is a reprocessed physical medical device and not an AI/ML algorithm, the concept of a "training set" is not applicable. The device itself is manufactured/reprocessed and then tested, not "trained."

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

Since there is no "training set" for this device, this question is not applicable.

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The Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The Vein360 Endovenous RFA Catheter is a reprocessed single-use device (SUD) consisting of a molded handle with actuation switch, an integrated instrument cable, and a flexible catheter shaft with a radiofrequency (RF) heating element at the distal end. The catheter and integrated connection cable are provided sterile and meant for single patient use. The catheter's function is to provide thermal energy to the desired treatment site via RF heating of the heating element and to relay temperature back to the RF generator.

The Vein360 Endovenous RFA Catheter is subjected to reprocessing operations following the initial clinical use of the OEM predicate. These operations include cleaning, inspection, packaging and sterilization. After reprocessing, the Vein360 reprocessed Endovenous RFA Catheter retains substantially equivalent performance to that of the OEM predicate. The Vein360 reprocessed Endovenous RFA Catheter is reprocessed one (1) time.

Here's a breakdown of the acceptance criteria and study information for the Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly list quantitative "acceptance criteria" for the performance of the reprocessed device in a pass/fail-type table. Instead, it states that the device demonstrated "substantially equivalent performance" to the OEM predicate devices. The performance evaluation was focused on ensuring that reprocessing did not adversely affect form, fit, or function, and that the reprocessed device performed equivalently to the original.

However, based on the performance data section, we can infer the areas of evaluation and the general outcome:

2. Sample Size Used for the Test Set and Data Provenance

The documents do not specify a "test set" in the context of a clinical trial or a dataset for an AI model. This device is a reprocessed medical device, and its evaluation focused on non-clinical performance testing.

• Sample Size for Non-Clinical Tests:

  • Cleaning validation: Included "enumeration of clinical soil levels" to establish a worst-case basis for artificial test soil development. The validation involved using both clinical and artificial test soils, but specific sample sizes (e.g., number of catheters tested) are not provided.
  • Ex vivo tissue study: Performed in "three (3) tissue types" (muscle, liver, and kidney). The number of catheters or repetitions within this study is not specified.
  • For other tests (e.g., electrical, physical, mechanical), the number of units tested is not individually listed. The statement "extensive scope of performance tests executed to fully demonstrate substantial equivalence" suggests multiple units were likely tested for each parameter.

• Data Provenance: The studies were non-clinical, involving laboratory testing and ex vivo tissue studies. The ex vivo study was performed by an "independent laboratory." There is no mention of country of origin for any data or whether it was retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This evaluation did not involve a "test set" in the context of human expert review for ground truth, as it's a reprocessed device undergoing performance testing against its original, new counterpart.

4. Adjudication Method for the Test Set

Not applicable. There was no expert "adjudication" in the clinical sense for this type of performance evaluation.

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 an AI-powered diagnostic device, and therefore, no MRMC study or AI-assisted human reader improvement assessment was conducted.

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

Not applicable. This is a physical, reprocessed medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the reprocessed device's performance was established by comparing its performance directly to the OEM predicate devices. This comparison was based on:

• Physical specifications and dimensions.
• Electrical characteristics.
• Mechanical properties.
• Biocompatibility and sterilization standards.
• Results from validated cleaning processes.
• Direct comparison of ablative performance in ex vivo tissue models.

Essentially, the OEM predicate device's established performance served as the benchmark for "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this device.

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The 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 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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The Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The Reprocessed LigaSure Sealer/ Divider can be used on yessels (arteries, veins, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to. Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

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

The Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (LF4418) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LF4418 is designed for use with Covidien electrosurgical generators that include vessel sealing capability. The LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7mm.

The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

The following controls are located on the instrument handle:

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

All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator.

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

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

The scope of this submission only includes the reprocessed Covidien™ sealer/divider device and not the ForceTriad™ Energy Platform or Valleylab™ FT10 Energy Platform that are used to power the device or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generator or footswitch.

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

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

Acceptance Criteria and Device Performance

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

Study Details

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

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

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

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

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

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

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

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

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

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

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

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

7. The sample size for the training set:

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

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

   • Not applicable. There is no training set.

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The NES Reprocessed RF Stylet (RFS) is intended for use in vessel and tissue coagulation including:

• Treatment of incompetent (i.e. refluxing) perforator and tributaiy veins.

The NES Reprocessed RF Stylet (RFS) is a reprocessed VNUS RFS (510(k) # K052003). The device is a high frequency electrosurgical system designed for blood vessel and tissue coagulation in general surgical procedures. This device's energy source comes from a compatible and separately cleared Radiofrequency (RF) Generator. The device has been validated to be reprocessed a maximum of one time. The NES Reprocessed RF Stylet (RFS) is provided sterile (EtO) and is a single use, disposable device. The device is used in a healthcare facility. The device's function is to deliver RF energy to the desired treatment site and relay temperature and other information to the RF Generator. The device consists of one model. The device itself consists of the stylet shaft, handle and cable. A sharp is included with the device for patient insertion. The tip of the stylet serves to deliver the RF energy to the desired treatment site while the cable plugs into the RF generator (for power and relay temperature/other feedback). The tip, inner and outer lumen are the only patient-contacting parts. The patient-contacting material is as follows: AISI 304 SST and polyimide. All patient-contacting material has proven to be biocompatible. The non patient-contacting material is as follows: poly methyl methacrylate and polypropylene. The device is compatible with the separately cleared Radiofrequency (RF) Generator. The NES Reprocessed RF Stylet (RFS) is considered an external communicating device with circulating blood contact for a duration of less than 24 hours.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the NES Reprocessed RF Stylet (RFS), rather than an AI/ML powered device. As such, the information typically requested for AI/ML device studies (such as sample size for test/training sets, ground truth establishment with expert consensus, adjudication methods, or MRMC studies) is not applicable or provided in the document.

The acceptance criteria and the study proving the device meets these criteria are focused on demonstrating that the reprocessed device is substantially equivalent to its predicate device and maintains its safety and effectiveness.

Here's a breakdown of the provided information, framed within the context of a reprocessed medical device:

1. A 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)

The document does not specify exact sample sizes (e.g., number of devices reprocessed and tested) for each of the performance tests. The testing appears to be conducted on reprocessed devices themselves, rather than clinical patient data. The provenance of the data is implicit in that it comes from testing conducted by Northeast Scientific, Inc. as part of their 510(k) submission. No specific country of origin for the data or whether it was retrospective or prospective is mentioned, but given it's a device reprocessing validation, it would be laboratory-based testing.

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)

For the "Design Validation" section, it is stated that the evaluation was done by "a user and expert of the device." The specific number (one or more) is not definitively stated, nor are their exact qualifications beyond "user and expert." This is not a ground truth establishment in the AI/ML sense, but rather a usability and design review.

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

No adjudication method is relevant or described, as this is laboratory testing of a reprocessed medical device's physical and functional properties, not an interpretative task requiring consensus among experts.

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 an AI/ML powered device, so no MRMC study was conducted or is relevant.

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

This is not an AI/ML powered device, so no standalone algorithm performance was assessed.

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

The "ground truth" for this device is its physical and functional performance, as measured against established engineering and biocompatibility standards for medical devices, as well as comparison to the original (predicate) device's specifications. For example, for biocompatibility, the "ground truth" is that the device does not cause adverse biological reactions, confirmed by passing specific biological tests. For functional performance, the "ground truth" is that the device successfully performs its intended function without errors.

8. The sample size for the training set

This is not an AI/ML powered device; therefore, there is no "training set."

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

Not applicable, as this is not an AI/ML powered device and therefore there is no training set or associated ground truth establishment in that context.

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The Reprocessed DePuy Mitek Ablation Wands for use with the VAPR Electrosurgical System are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

Reprocessed DePuy Mitek Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed DePuy Mitek Ablation Wand. It does not contain information about an AI/machine learning device, nor does it provide the detailed specifics about acceptance criteria involving performance metrics like accuracy, sensitivity, or specificity, or the methodology for a multi-reader multi-case (MRMC) study.

The document discusses the substantial equivalence of the reprocessed device to its original (OEM) predicate devices based on various performance tests conducted to ensure that the reprocessing activities did not affect the form or function of the device and that it performs as well as the original, new device.

Therefore, many of the requested details about acceptance criteria and study methodology for an AI/ML device, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.

However, I can extract the acceptance criteria and performance data for this reprocessed medical device as presented in the document:

Acceptance Criteria and Device Performance for Reprocessed DePuy Mitek Ablation Wand

The acceptance criteria are implicitly defined by demonstrating that the reprocessed device performs equivalently to the original, new device in various tests. The study's goal was to prove substantial equivalence, meaning the reprocessed device is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates "side by side" testing with predicate devices. Specific sample sizes for each test are not provided. The data provenance is presumed to be from the manufacturer's internal testing facilities, as is typical for 510(k) submissions, but a specific country of origin for the data generation or whether it was retrospective/prospective is not mentioned. Given the nature of benchtop testing, it would be prospective.

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

Not applicable. The "ground truth" for this reprocessed device relates to its physical, functional, and electrical performance compared to a new, predicate device, not to diagnostic interpretation requiring expert consensus. Performance is measured against engineering specifications and industry standards.

4. Adjudication method for the test set

Not applicable. Performance testing for this device does not involve human interpretation requiring adjudication.

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 medical device, not an AI/machine learning diagnostic aid.

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

Not applicable. This is a physical medical device, not an algorithm. Its performance is measured directly through benchtop tests.

7. The type of ground truth used

The "ground truth" for this device is based on engineering specifications, established performance standards, and comparison to the performance of the new, predicate device. For cleaning, it refers to the absence of residues. For functional performance, it's the measured performance (e.g., thermal effects, bending, drop) being equivalent to the predicate. For biocompatibility, it's meeting ISO standards.

8. The sample size for the training set

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

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

Not applicable. This is not an AI/machine learning device.

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