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510(k) Data Aggregation
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.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety & Electromagnetic Compatibility (EMC) | In accordance with IEC 60601-2-2 and 60601-1-2. (The reprocessed device meets these standards, implying equivalence to the predicate which would also meet these standards). |
| Simulated Use | Evaluated and found equivalent to the predicate devices. This implies the reprocessed devices perform as expected during simulated surgical procedures. |
| Device Integrity | Evaluated and found equivalent to the predicate devices. This suggests the physical and structural integrity of the reprocessed devices is maintained. |
| Blade Trigger Advance/Return | Evaluated and found equivalent to the predicate devices. The cutting mechanism functions correctly. |
| Activation Button Device Recognition | Evaluated and found equivalent to the predicate devices. The device properly interacts with the associated electrosurgical generators. |
| Thermal Analysis Characterization | Evaluated and found equivalent to the predicate devices. The reprocessed device's thermal performance (e.g., heat generation during use) is comparable to the predicate. |
| Tissue Sticking | Evaluated and found equivalent to the predicate devices. The reprocessed device minimizes tissue sticking during use, similar to the predicate. |
| Burst Pressure | Evaluated and found equivalent to the predicate devices. This likely refers to the strength of the seal created by the device on vessels, demonstrating its ability to occlude vessels effectively, comparable to the predicate. |
| Histopathology | Evaluated and found equivalent to the predicate devices. This suggests the tissue effects (e.g., thermal damage, seal quality) produced by the reprocessed device are similar to those of the predicate. |
| Seal Quality | Evaluated and found equivalent to the predicate devices. This is a direct measure of the effectiveness of the device in sealing vessels, confirming it performs comparably to the predicate. |
| Cleaning: Protein, and Carbohydrates (Residuals After Reprocessing) | Evaluated and found equivalent to the predicate devices. This confirms the reprocessing methods effectively remove biological contaminants to a safe level, meeting the standards necessary for a reprocessed device. (Though "equivalent to the predicate" is stated, for cleaning, the acceptance is typically passing a defined threshold for residuals, implying the reprocessed devices meet these thresholds). |
| Biocompatibility: Cytotoxicity, Sensitization, Irritation, Pyrogenicity, and Acute Systemic Toxicity | Evaluated and found equivalent to the predicate devices. This indicates that the materials and reprocessing do not induce adverse biological responses, meeting established biocompatibility standards. (Similar to cleaning, "equivalent to the predicate" here means meeting the same biological safety standards of a new device). |
| Performance Qualification | Evaluated and found equivalent to the predicate devices. This generally refers to verification that the manufacturing process consistently produces device that meets specifications. |
| Sterilization Validation | Evaluated and found equivalent to the predicate devices. This confirms the sterilization process effectively renders the reprocessed devices sterile to an acceptable sterility assurance level (SAL). |
| Product Stability | Evaluated and found equivalent to the predicate devices. This assesses the device's ability to maintain its safety and performance characteristics over its shelf life. |
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.
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(59 days)
The BiZact™ device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
The tissue fusion function of the device can be used on vessels (arteries and veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It is also indicated for adult ENT procedures, including tonsillectomy for the ligation and division of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.
The BiZact™ device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use for these procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a sterile, single use, hand-held electrosurgical device that incorporates RF tissue fusion technology for a desired tissue effect when used with the ForceTriad Energy Platform (K051644, K070162, K102913, and K110268), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (K143654), or the Valleylab FT10 Energy Platform (K151649, K170170) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider attaches to a compatible electrosurgical generator with a 10 foot cord containing a proprietary connector. The generator is able to identify the BiZact™ device via the RFID tag embedded in the connector (Valleylab LS10 LS Series single Channel Vessel Sealing Generator and Valleylab FT10 Electrosurgical Platform) or with a barcode on the connector (ForceTriad). The generator delivers energy to the device using a defined algorithm that adjusts the generator output as a function of the electrical resistance of the combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.
The provided document is a 510(k) premarket notification for a medical device (BiZact Tonsillectomy Device) and does not contain information about an AI/ML-based device or its performance criteria related to AI/ML tasks.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device's performance. The document focuses on the substantial equivalence of a physical electrosurgical device to a predicate device, based on mechanical, electrical, functional, biocompatibility, sterilization, and animal (ex-vivo/in-vivo) studies.
The request asks for:
- Table of acceptance criteria and reported device performance (for AI/ML): Not applicable, as this is not an AI/ML device. The document summarizes various engineering and biological tests, but not specific AI performance metrics like sensitivity, specificity, or AUC.
- Sample size for test set and data provenance: The document mentions "fresh porcine renal arteries" for burst pressure, "porcine model" for lymphatic and acute hemostasis studies, and a "chronic hemostasis porcine study." It does not specify sample sizes in terms of number of cases for these animal studies beyond indicating they were sufficient for verification. Data provenance is "porcine model" (animal data), which is prospective in the context of these experiments. There is no human patient data test set for AI.
- Number of experts and qualifications for ground truth: Not applicable for an AI/ML device. Ground truth in this context would be physical measurements, biological response, or pathological findings from the animal studies, not expert consensus on AI outputs.
- Adjudication method: Not applicable for an AI/ML device.
- MRMC comparative effectiveness study: Not applicable, as there's no AI component or human reader interaction with AI.
- Standalone AI performance: Not applicable.
- Type of ground truth: For the physical device, it's based on physiological and pathological outcomes in animal models (e.g., vessel burst pressure, acute hemostasis, lymphatic sealing, lateral thermal spread over time).
- Sample size for training set: Not applicable, as there is no AI training set.
- How ground truth for training set was established: Not applicable.
In summary, the provided document describes a medical device clearance for an electrosurgical tool, not an AI/ML device. Therefore, none of the requested information pertaining to AI/ML acceptance criteria and performance studies can be found or inferred from the text.
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(213 days)
The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open Sealer/Divide 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 LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general 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, parotidectory, and tonsillectorny) for ligation and division of vessels, lymphatiss 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 Medline ReNewal Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open general surgical procedures. Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue. The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a hand switch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line. The 10-foot cord, cable connector, and generator are not reprocessed by Medline ReNewal.
The provided text is a summary of a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider LF1212A.
The key aspect of this document is demonstrating substantial equivalence to an existing predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The study's purpose is not to prove the device meets pre-defined clinical acceptance criteria for a novel functionality, but rather to show that the reprocessed device performs as safely and effectively as the original, legally marketed device.
Therefore, the "acceptance criteria" here largely refer to demonstrating performance consistent with the predicate device across various functional and safety aspects.
Here's an analysis of the acceptance criteria and the study, based on the provided text, while acknowledging that a 510(k) summary often provides high-level information without deep specifics on study methodologies:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a reprocessed device, the "acceptance criteria" are generally that the reprocessed device performs equivalently to the original device. The "reported device performance" is the demonstration through various tests that this equivalence is met.
| Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Electrical Safety and Electromagnetic Compatibility | Found equivalent to predicate devices based on tests in accordance with IEC 60601-2-2 and 60601-1-2. |
| Simulated Use | Functional characteristics evaluated, found equivalent. (Specific metrics not detailed, but implies comparison to predicate performance during simulated surgical scenarios). |
| Device Integrity | Functional characteristics evaluated, found equivalent. (Implies structural soundness and resistance to failure under expected conditions). |
| Blade Trigger Advance/Return | Functional characteristics evaluated, found equivalent. (Implies smooth and reliable operation of the cutting mechanism). |
| Activation Button Device Recognition | Functional characteristics evaluated, found equivalent. (Ensures proper interaction with the electrosurgical generator). |
| Thermal Analysis Characterization | Functional characteristics evaluated, found equivalent. (Ensures thermal spread remains within acceptable limits, comparable to the predicate). |
| Tissue Sticking | Functional characteristics evaluated, found equivalent. (Ensures minimal sticking to tissue, similar to the predicate, for ease of use and reduced collateral damage). |
| Blade Sharpness | Functional characteristics evaluated, found equivalent. (Ensures effective cutting performance comparative to the predicate). |
| Transient Cooling Analysis Burst Pressure | Functional characteristics evaluated, found equivalent. (Likely assesses the integrity and strength of the sealed vessels under pressure after the sealing cycle, comparing to the predicate). |
| Histopathology | Functional characteristics evaluated, found equivalent. (Examines tissue changes at a microscopic level after sealing, comparing the reprocessed device's effect to the predicate's). |
| Seal Quality | Functional characteristics evaluated, found equivalent. (Directly assesses the effectiveness of the vessel sealing functionality, likely through metrics like burst pressure, tensile strength, or visual inspection, against predicate performance). |
| Cleaning (Protein, Carbohydrates, Endotoxin) | Demonstrated effective cleaning to acceptable levels. (Ensures removal of biological contaminants from previous use). |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute Systemic Toxicity) | Demonstrated acceptable levels for all listed parameters. (Ensures the device materials, after reprocessing, do not elicit harmful biological responses). |
| Sterilization Validation | Demonstrated effective sterilization. (Ensures the device is sterile when provided for use). |
| Product Stability | Demonstrated. (Ensures the device maintains its performance and safety over its shelf life after reprocessing). |
| Intended Use / Indications for Use | The reprocessed device shares the identical Intended Use and Indications for Use as the predicate device. The only difference is the manufacturer of the specific device, and that one is "reprocessed." |
| Technological Characteristics | The technological characteristics and fundamental scientific technology of the proposed device are identical to the predicate device. Both use bipolar energy to seal and divide vessels up to and including 7mm. Both are designed for use with the ForceTriad Electrosurgical Generator running software version 3.40 or higher. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each of the performance tests (e.g., number of devices tested for electrical safety, number of tissue samples for histopathology). It only lists the types of tests performed.
The data provenance is not explicitly stated in terms of country of origin. However, the FDA 510(k) submission process typically requires data generated in accordance with Good Laboratory Practice (GLP) or similar standards. Given it's a US FDA submission, it's highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The data is retrospective in the sense that the predicate device's performance already exists, and the reprocessed device is being compared against it. New prospective testing is done on the reprocessed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For a device like this, "ground truth" isn't typically established by expert consensus in the way it would be for an AI diagnostic algorithm. Instead, it's established by:
- Engineering specifications and regulatory standards: These define acceptable performance ranges (e.g., electrical parameters, burst pressure requirements, cleanliness levels).
- Predicate device's established performance: The predicate device, already on the market, sets the benchmark for equivalent performance.
- Scientific and clinical literature: Informing what constitutes safe and effective tissue sealing and cutting.
- Pathology results: For tests like histopathology, a qualified pathologist would interpret the tissue samples, but this is part of the test result generation, not "ground truth" establishment in the AI sense.
The document does not mention the number or qualifications of experts establishing ground truth in the context of an AI study. However, the evaluation of the various tests would be performed by qualified personnel (e.g., engineers, microbiologists, toxicologists, pathologists) relevant to each specific test.
4. Adjudication Method for the Test Set
Not applicable in the context of a 510(k) for a reprocessed surgical instrument. Adjudication methods like "2+1" or "3+1" are characteristic of studies establishing ground truth for diagnostic AI, especially in image interpretation, where multiple human readers resolve discrepancies. Here, objective measurements and comparisons to established standards and predicate performance are used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers interpret images or data, and the AI's impact on their performance (with or without AI assistance) is evaluated. This 510(k) is for a physical surgical instrument, not a diagnostic AI.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. It's a physical electrosurgical instrument that is used by a human surgeon. The performance tests evaluate the instrument's physical and functional capabilities, which are inherently "standalone" in the sense that the instrument itself is being tested, but always within the context of its intended use by a human.
7. The Type of Ground Truth Used
The "ground truth" for this reprocessed device is multifactorial:
- Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The reprocessed device must demonstrate equivalent performance across all tested parameters.
- Industry Standards and Regulatory Requirements: Technical standards (e.g., IEC 60601 series for electrical safety) and FDA regulations set minimum acceptable performance and safety thresholds.
- Objective Measurements: Laboratory tests yield objective data (e.g., electrical resistance, burst pressure, protein levels, cell viability) that can be directly compared against specified limits or predicate device data.
- Pathology: For histopathology, the ground truth would be the pathological assessment of tissue effects.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or corresponding ground truth to establish.
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(125 days)
The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.
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 reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7 mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's' tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol-grip-style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left- and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10-foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device -specific recognition by the generator. The 10-foot cord, cable connector, and ForceTriad are not reprocessed by Medline ReNewal.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (Model LF4318). This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Covidien LigaSure Impact LF4318).
Here's an analysis of the acceptance criteria and the study information, extracting what's available from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds for each test, nor does it provide a direct numerical "reported device performance" against such criteria. Instead, it states that the functional characteristics "have been evaluated and found to be equivalent to the predicate devices based on the following tests."
However, we can infer the type of performance evaluation conducted:
| Test Type | Implied Acceptance Criteria (Inferred from "found to be equivalent") | Reported Device Performance (Inferred from "found to be equivalent") |
|---|---|---|
| Electrical Safety and EMC (IEC 60601-1, 60601-1-2) | Compliance with international standards for electrical safety and electromagnetic compatibility. | Compliant (equivalent to predicate). |
| Simulated Use | Performance under simulated surgical conditions comparable to the predicate device. | Equivalent to predicate. |
| Device Integrity | Structural and functional soundness comparable to the predicate device. | Equivalent to predicate. |
| Blade Trigger Advance/Return | Proper functioning of the cutting blade mechanism. | Equivalent to predicate. |
| Shaft Knob Rotation | Proper functioning of the shaft rotation. | Equivalent to predicate. |
| Device Recognition | Correct recognition by the associated energy platform (ForceTriad). | Equivalent to predicate. |
| Thermal Analysis Characterization | Thermal profile during use comparable to the predicate device. | Equivalent to predicate. |
| Handle Locking | Proper functioning of the handle locking mechanism. | Equivalent to predicate. |
| Burst Pressure | Vessel sealing strength (burst pressure) comparable to the predicate device. | Equivalent to predicate. |
| Histopathology | Tissue effect (e.g., seal quality, thermal spread) comparable to the predicate device. | Equivalent to predicate. |
| Seal Quality | Quality of vessel seals comparable to the predicate device. | Equivalent to predicate. |
| Tissue Sticking | Degree of tissue sticking to the device comparable to the predicate device. | Equivalent to predicate. |
| Cleaning: Protein, Carbohydrates | Effectiveness of cleaning process to remove biological contaminants to accepted levels. | Met (implied by "equivalent"). |
| Biocompatibility: Sensitization, Irritation | No adverse biological reactions (sensitization, irritation) when in contact with tissues, comparable to predicate. | Met (implied by "equivalent"). |
| Biocompatibility: Pyrogenicity | Absence of fever-inducing substances (pyrogens) to accepted levels. | Met (implied by "equivalent"). |
| Biocompatibility: Acute Systemic Toxicity | Absence of acute toxic effects, comparable to predicate. | Met (implied by "equivalent"). |
| Performance Qualification | Overall functional performance meeting specified requirements. | Met (implied by "equivalent"). |
| Sterilization Validation | Sterility assurance level (SAL) achieved and maintained. | Met (implied by "equivalent"). |
| Product Stability | Device maintaining its characteristics over shelf life. | Met (implied by "equivalent"). |
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 the sample size for any of the tests conducted.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the testing). The nature of the tests (e.g., simulated use, burst pressure, histopathology, cleaning, biocompatibility) suggests they are prospective bench and lab-based studies, rather than clinical data.
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)
The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as this type of preclinical testing typically relies on predefined material properties and functional parameters rather than expert interpretation of complex clinical data. For histopathology, it would typically be a pathologist, but no specifics are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. This is generally not relevant for the types of bench and lab tests listed.
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 MRMC study was performed or described. The device is a reprocessed electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This section is for AI/software devices. The device is a physical electrosurgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be established through:
- Physical and electrical measurements: For electrical safety, device integrity, blade function, shaft rotation, handle locking, device recognition.
- Material and mechanical properties standards: For burst pressure, product stability.
- Microscopic evaluation/laboratory analysis: For histopathology (tissue effect), seal quality, tissue sticking, cleaning (protein, carbohydrates).
- Standardized biological assays: For biocompatibility (sensitization, irritation, pyrogenicity, acute systemic toxicity).
- Sterility testing: For sterilization validation.
These are objective measurements and standardized tests designed to demonstrate equivalence to the predicate device's established performance specifications.
8. The sample size for the training set
Not applicable. This device is a physical instrument, not a machine learning model that requires a training set. The term "training set" would not apply here.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriad™ energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies. Nissen fundoplication, colectorny, adhesiolysis, oophorectorny, etc. The LigaSure Impact LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7mm and tissue bundles.
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 Impact™, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol grip style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10 foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device-specific recognition by the generator.
The provided text is a 510(k) summary for a medical device (LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider) and does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically assessed for AI/software devices.
Instead, it describes the performance testing undertaken to demonstrate substantial equivalence to predicate devices, which is the regulatory pathway for this type of medical device. Therefore, I cannot extract the information required by your prompt as it pertains to AI/software acceptance criteria and studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size).
However, I can extract the information provided about the device's performance testing for its 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of numeric acceptance criteria and corresponding performance metrics in the way your prompt expects for AI/software. Instead, the performance is described qualitatively in the "Performance" section:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Testing | Involved safety and performance testing in accordance with IEC 60601-1 and IEC 60601-2-2. |
| Verification/Comparative Testing | Performed against predicate devices. |
| Bench Testing | Evaluation of the device's performance and ability to seal and divide vessels up to 7mm. |
| Pre-clinical Testing | Performed both acute and chronic testing. Evaluated thermal spread and ability to achieve hemostasis of tissue and vessels in a variety of simulated clinical settings. Confirmed that the LF4318 is as safe and effective as the predicate devices and operated as intended. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively. The text only mentions "extensive functional, bench and pre-clinical testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for this kind of hardware device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a surgical instrument, not an AI/software device requiring expert-established ground truth on a dataset. Performance was evaluated through engineering tests and pre-clinical studies.
4. Adjudication method for the test set:
Not applicable.
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 hardware surgical instrument, not an AI system.
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:
For this device, "ground truth" would be established through physical measurements (e.g., sealing strength, thermal spread, hemostasis) and direct observation in pre-clinical studies, rather than expert labels on data.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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