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The Sonicision™ Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter.

The Sonicision™ Cordless Ultrasonic Dissector is a component of the Sonicision™ Cordless Ultrasonic Dissection Device, which is a hand-held surgical device consisting of three interdependent components that, when assembled, enable ultra high-frequency mechanical motion (ultrasonic energy) to transect, dissect, and coagulate tissue.

The dissector is a sterile, single-use component to which the Sonicision reusable generators and battery packs attach. This component contains features essential to the control and performance of the assembled device; such as the clamping jaw, active blade, speaker, two-stage energy button, rotation wheel, and jaw lever.

Four configurations are available, differing principally by shaft length. The lengths are 13 cm, 26 cm, 39 cm (cleared through K101797), and 48 cm; corresponding with catalog numbers SCD13, SCD26, SCD391/6, and SCD48, respectively.

The provided text describes a 510(k) premarket notification for the "Sonicision™ Cordless Ultrasonic Dissection Device" (K141371). This submission aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a standalone study with clinical outcomes.

Therefore, much of the requested information regarding acceptance criteria, device performance, ground truth, and study design elements like MRMC studies, sample sizes for test/training sets, and expert qualifications/adjudication methods typically associated with clinical performance studies validating a new AI/diagnostic device, cannot be found in this document.

This document focuses on bench testing and preclinical testing to demonstrate that the proposed device, despite having different shaft lengths, maintains the same safety and performance characteristics as its predicate device.

However, I can extract information related to the types of tests performed and what was demonstrated, which implicitly serve as a form of "acceptance criteria" for demonstrating substantial equivalence in this context.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria or performance values in a table format. Instead, it states that "All aspects were found to be identical" to the predicate device, implying that the performance of the new device (SCD13, SCD26, SCD48) matched that of the predicate (SCD391, SCD396) for the tested characteristics. The list below represents the areas of performance that were evaluated.

Key statement from the document: "All aspects were found to be identical, with the exception of the shaft length and measurement marks." And "The shaft-length differences were found to not affect safety or performance through design verification and validation testing..."

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

• Sample Size for Test Set: Not specified in terms of numerical count for tissues or animals. The text mentions "excised porcine tissue" and "porcine" for preclinical testing, indicating animal tissue was used. No human data or specific number of tissue samples is provided.
• Data Provenance: Porcine (animal) tissue. The testing was described as "Bench testing" and "Preclinical testing." Given the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer.

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

Not applicable to this type of submission. This document does not concern an AI/diagnostic device requiring expert consensus for ground truth. The "ground truth" for the performance evaluations would be objective measurements from the bench and preclinical tests (e.g., actual burst pressure, measured temperature, observed hemostasis).

4. Adjudication method for the test set

Not applicable. There's no indication of human expert adjudication for the performance results. The evaluations would rely on direct measurements and observations during testing.

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. This device is a surgical dissection device, not an imaging/diagnostic device that would involve human "readers" or an AI component in that capacity.

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

Not applicable. This is a medical device (surgical instrument), not an algorithm or AI.

7. The type of ground truth used

The ground truth for the performance characteristics was derived from objective measurements during bench testing (e.g., active blade displacement, frequency, force, temperature, burst pressures) and observed physiological responses during preclinical testing on porcine tissue (e.g., hemostasis, thermal spread).

8. The sample size for the training set

Not applicable. The device is not an AI/ML model that requires a training set.

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

Not applicable. No training set was used.

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The LigaSure™ 5 mm, Maryland Jaw, Open / Minimally Invasive Sealer/Dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of versels and lymphatics is desired. The instrument creates a seal by application of RF electrosirgical onergy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

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

The LigaSure 5 mm Maryland Jaw Sealer/Dividers can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

The LigaSure™ 5 mm Maryland Jaw Sealer/Divider One-step Sealing (LF17XX series) devices are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws without having to latch the lever, which includes a clicking mechanism that indicates to the user that the jaws are in the grasping zone, a button (switch) to activate the LigaSure™ mode by closing the handle against the button (switch) for vessel sealing, and a trigger to actuate an independent cutting blade.

The provided text describes a 510(k) summary for a medical device and outlines various tests performed to demonstrate its safety and effectiveness. However, it does not present a table of specific acceptance criteria with corresponding performance data. It also does not involve a study related to AI or human readers, as it is a physical surgical device.

Based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that evidence of safety and effectiveness was obtained from both bench and preclinical testing. While specific quantifiable acceptance criteria and their precise results are not explicitly listed in a table format, the document indicates that the device's performance was compared to predicate devices and found to be substantially equivalent.

Here's a breakdown of the types of tests performed:

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

The document does not explicitly state specific sample sizes for each test. It broadly mentions "bench and preclinical testing." It also does not specify the country of origin for the data or whether the studies were retrospective or prospective.

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

This information is not provided. Given that this is a physical electrosurgical device for which "ground truth" would be established through physical measurements, physiological responses, and potentially expert observation during preclinical studies (e.g., assessing hemostasis), the concept of "experts establishing ground truth for a test set" as described in the prompt (e.g., radiologists) is not directly applicable in the same way it would be for an AI-powered diagnostic device.

4. Adjudication Method for the Test Set

This information is not provided and would not typically be relevant for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are more commonly used in studies involving human interpretation of data, such as medical image analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human performance in diagnostic tasks, which is not applicable to this physical electrosurgical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is not applicable. The device is a physical electrosurgical instrument and does not involve an "algorithm only" component in the sense of a software-based diagnostic tool. The performance studies described are for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria appears to be established through:

• Physical measurements and engineering standards: For bench tests like blade return, jaw temperature, forces, and power curves. These would be compared against predefined specifications and industry standards (e.g., IEC 60601).
• Physiological outcomes in preclinical (animal) studies: For burst pressure, hemostasis, thermal spread, and the success of vessel/tissue bundle sealing and division. These outcomes would be assessed by observing the effects on biological tissue.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device development process described does not involve a "training set" in the context of machine learning (AI). The device's design and engineering are based on established principles and iterative development, not data-driven machine learning models.

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

This information is not provided and is not applicable for the reasons stated above (no AI training set).

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The Sonicision Sterilization Tray is intended to be used to encase and protect reusable battery packs and generators of the Sonicision system during sterilization and storage. The tray containing up to one generator and one battery pack (maximum load) can be used with the following models and pre-set (non-adjustable) cycles.

Maintenance of sterility of the content within the tray is based on demonstrated performance of the sterilization wrap or pouch used to encase the tray.

The Sonicision™ Sterilization Tray is intended to hold and protect Sonicision generators and battery packs during sterilization and storage, as indicated. It is comprised of a polysulfone base containing silicone inserts and a removable/latching polysulfone lid. The tray is reusable and provided to the customer in a non-sterile condition. Perforations on the lid and base permit exposure of the sterilant. Handles on the sides of the base facilitate transfer of the sterilized components, and the contoured inserts secure the contents within the tray.

The Sonicision™ Sterilization Tray does not contain gaskets, filters, or valves to act as a barrier to microorganisms during storage, handling, and transport. The tray containing its intended content (load) must be wrapped with an FDA-cleared STERRAD or STERIS V-PRO-compatible polypropylene sterilization wrap or pouched with an FDA-cleared STERRAD or STERIS V-PRO-compatible Tyvek® pouch (note: the wrap and pouch are not supplied by Covidien) and sterilized as instructed by the labeling.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

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

   • Sterilization Efficacy: The trays were loaded with the "intended maximum load (one reusable battery pack and one reusable generator)." The number of trays or replicates is not explicitly stated, but the mention of "the sterilization trays were either wrapped... or pouched" implies multiple test items. The biological indicator used was Geobacillus stearothermophilus. The data provenance is from non-clinical performance studies conducted by Covidien. The location of the testing is not specified, but it's internal company testing supporting a US FDA submission.
   • Sterilant Residuals: "Three runs of loaded (one battery pack and one generator), wrapped, or pouched Sonicision trays placed in STERRAD or STERIS systems." Testing of the reference predicate tray involved "at least one run." Provenance is also internal non-clinical testing.
   • Use Life (Material Compatibility): The study involved "repeatedly (340 cycles)" of reprocessing the tray. This implies testing on at least one (and likely more) trays. Provenance is internal non-clinical testing.
   • Biocompatibility: "Test samples were prepared in accordance with ISO 10993-12:2007, Part 12: Sample Preparation and Reference Materials." The Sonicision Sterilization Tray was exposed to "two full cycles (as indicated) of the STERRAD and STERIS systems." "All biocompatibility assays were performed on neat extracts." The specific number of samples or replicates is not explicitly given, but the methodology suggests controlled lab-based testing. Provenance is internal non-clinical testing.
   • Mechanical/Bench: The text does not explicitly state the sample size for mechanical testing beyond "The Sonicision Sterilization Tray was evaluated." Provenance is internal non-clinical testing.

   All studies appear to be prospective in nature, designed specifically to test the device's performance against defined criteria. The origin is internal non-clinical testing for the purpose of a 510(k) submission to the US FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The studies described are non-clinical performance studies involving laboratory testing, not human expert evaluations of clinical data. Therefore, this question is not applicable in the context of this submission. The "ground truth" for these tests comes from established scientific and engineering principles, accepted standards (e.g., AAMI ST77, ISO 10993), and the documented efficacy of sterilization methods and biological indicators.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. The studies are non-clinical, laboratory-based performance tests, not clinical evaluations requiring expert adjudication.

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:
   Not applicable. This device is a medical device accessory (sterilization tray), not an AI-assisted diagnostic or imaging device used by human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This device is a physical medical device accessory, not an algorithm. The performance described is "standalone" in the sense that the tray's performance is measured directly through physical and biological tests without human intervention in the performance aspect, but rather human designers and users are integral to its intended use and reprocessing.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For these non-clinical studies, the "ground truth" is established by:

   • Sterilization Efficacy: Gold standard biological indicators (Geobacillus stearothermophilus) and their known reduction kinetics represent the ground truth for microbial inactivation.
   • Sterilant Residuals: Chemical analytical methods (UV/VIS spectroscopy) with established reference values from predicate devices.
   • Use Life (Material Compatibility) & Mechanical/Bench: Adherence to material specifications, functional performance requirements, and conformity to recognized industry standards (AAMI ST77).
   • Biocompatibility: In vitro cytotoxicity assays conforming to ISO 10993-5, where the absence of cytotoxic effects is the ground truth.

7. The sample size for the training set:
   Not applicable. This is a physical medical device accessory, not an AI/ML-based device that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this device.

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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:

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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The LigaSure™ Curved, Small Jaw, Open Sealer / Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad™ energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and lymphatics is performed, such as urologic, thoracic, plastic, and reconstructive; and including such procedures as bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, etc.

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

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

The LigaSure™ Curved, Small Jaw, Open Sealer/Divider is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). The ForceTriad's tissue-fusion (LigaSure) mode delivers precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion, and has been designed to produce minimal sticking, charring, or thermal spread to adjacent tissue.

LigaSure instruments attach to the generator with a ten-foot containing a "smart" connector. This connector functions as a unique product identifier for device-specific recognition by the generator. The Curved, Small Jaw, Open Sealer/Divider instrument is designed to be both ergonomic and intuitive for the user. Its hemostat-style body and symmetrically placed controls facilitate handling by both left and righthanded users, and its small, curved jaws maximize visibility and access when the instrument is used in confined surgical spaces.

Ring handles function to allow the user to grasp tissue by opening and closing the jaws of the instrument. The interior surfaces of the jaws contain the electrodes, which serve to ligate by delivering energy to the grasped tissue. RF energy can be activated by the user in two ways: (1) through the use of a single button incorporated into the handle body or (2) through the use of a footswitch attached to the generator. A cutting mechanism functions to mechanically divide tissue following tissue fusion. It consists of a stainless steel blade and is controlled by the user through a trigger located on the handle body.

The device in question is the LigaSure™ Curved, Small Jaw, Open Sealer / Divider (LF1212) by Covidien, a bipolar electrosurgical instrument. The purpose of this submission (K113572) is to expand its indications for use to include ENT procedures and remove a warning regarding specific surgical procedures requiring precision. There are no physical changes to the device itself; the design remains the same as its predicate (K102470).

This 510(k) summary does not use a typical "acceptance criteria" table in the form of specific numerical thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing various performance characteristics. For a device like an electrosurgical instrument, "acceptance criteria" are implicitly met if its performance is comparable to or better than previously cleared, substantially equivalent devices, particularly regarding safety and effectiveness.

Here's an interpretation of the performance data and how it addresses the 'acceptance criteria' in the context of substantial equivalence:

1. Table of "Acceptance Criteria" (interpreted as performance comparison to predicates) and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to predicates) is a preclinical bench and animal testing study combined with usability studies and a clinical literature review.

2. Sample Size and Data Provenance (for test set, relevant for bench/animal testing and usability):

• Preclinical Bench Testing (Burst Pressure & Thermal Profile): The document states "Preclinical comparative bench testing... was conducted." It does not specify the exact sample size for isolated vessels or the number of activations for thermal profile tests. The data provenance is implied to be laboratory testing conducted by Covidien.
• Animal Testing (Thermal Spread): The document states "Animal Testing: The mean thermal spread of the subject device was shown to be comparable to the predicates for all vessel sizes evaluated." It does not specify the number of animals or the number of vessel seals performed. The data provenance is likely internal animal studies conducted by Covidien.
• Usability / Human Factors: "These studies consisted of several formative and one summative study." It does not specify the number of users (sample size) for these studies. The data provenance is internal usability studies.

All these studies appear to be prospective in nature, as they were conducted specifically for this submission to compare the device against predicates or assess usability. The country of origin for the data is not explicitly stated but is presumed to be the United States, given the submitter's location and the FDA submission.

3. Number of Experts and Qualifications (for establishing ground truth for the test set):

• Bench and Animal Testing: The establishment of ground truth for metrics like burst pressure, thermal profile, and thermal spread typically relies on objective physical measurements and established scientific methodologies, not expert consensus in the human interpretation sense. Therefore, the "experts" would be the scientists and engineers conducting and analyzing these objective tests, following standardized protocols. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, as this is not a diagnostic device.
• Usability Studies: "Usability was evaluated with users... in the ENT space." These users are the "experts" in terms of operating the device. While their specific qualifications (e.g., "surgeon with X years of experience") are not detailed, it can be inferred that they were medical professionals (surgeons or surgical assistants) experienced in surgical procedures, likely ENT specialists given the mention of "ENT space." No specific number of experts for "ground truth setting" is given in the context of interpretation of results, as the usability studies themselves generate the data.
• Clinical Literature Review: An "assessment of published clinical literature" was performed. This implies medical experts (likely regulatory affairs personnel or medical scientists within Covidien) evaluated existing peer-reviewed studies. No specific number or qualifications of these reviewers are provided.

4. Adjudication Method (for the test set):

Since the "acceptance criteria" are based on objective physical measurements (burst pressure, thermal profile, thermal spread) and directly observed usability, rather than subjective interpretations by multiple experts, a formal "adjudication method" like 2+1 or 3+1 for resolving discrepancies in expert opinions is not applicable or described. The results of bench and animal tests are typically analyzed statistically. Usability studies involve observations and feedback, rather than adjudication of 'ground truth'.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and would not be applicable for this type of device (a surgical instrument). MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess changes in diagnostic accuracy or efficiency. This device is a surgical tool, not an image interpretation or diagnostic aid. Therefore, no effect size of human readers improving with AI assistance is reported.

6. Standalone (Algorithm Only) Performance:

No, a standalone performance study (algorithm only without human-in-the-loop) was not done and is not applicable for this device. This device is a manual surgical instrument that requires a human operator for its function; it does not contain a standalone algorithm in the sense of AI performing a task independently. The "algorithm" here refers to the energy delivery system within the ForceTriad™ platform, which is always used with the human-controlled instrument.

7. Type of Ground Truth Used:

• Bench Test (Burst Pressure, Thermal Profile): The ground truth is based on objective physical measurements using scientific equipment and standardized test methods (e.g., pressure gauges, temperature probes).
• Animal Testing (Thermal Spread): Ground truth is based on objective pathological assessment of tissue sections (histology) or direct macroscopic measurements of the thermal damage zone in animal models.
• Usability Studies: Ground truth is based on observed user performance, task completion, and user feedback in simulated environments, assessed against predefined safety and performance metrics.
• Clinical Literature: The "ground truth" for clinical safety and effectiveness in ENT procedures is derived from the published outcomes data and expert consensus within the scientific and medical literature.

8. Sample Size for the Training Set:

This device is a hardware surgical instrument, not a machine learning or AI algorithm in the typical sense that would require a "training set" for model development. The "ForceTriad™ energy platform (generator)" delivers energy, and its design would be based on engineering principles and previous device experience, not statistical learning from a "training set" of data. Therefore, the concept of a "training set" and its sample size is not applicable or addressed in this submission.

9. How Ground Truth for Training Set Was Established:

As there is no "training set" in the context of a machine learning model, the question of how its ground truth was established is not applicable. The device's 'training' or development is based on engineering design, preclinical testing, and iterative improvements, not a data-driven model training process.

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The indications for use include general (including urologic, thoracic, plastic and reconstructive, arthroscopic), laparoscopic, and gynecologic procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal). laparoscopic cholesystectomies, laparoscopically assisted vaqinal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesilysis, oophorectomy, etc. Vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) 7mm and smaller in diameter, and bundles as large as will fit in the jaws of the devices can be sealed with the LigaSure™ vessel sealing (tissue fusion) output.

The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and LigaSure™ vessel sealing outputs. The generator is an electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ForceTriad™ Electrosurgical Generator:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "No clinical testing was conducted." Therefore, there is no test set in the traditional sense of patient data. The evaluation was based on non-clinical testing, including software validation and bench testing. The provenance of this non-clinical test data is not specified in terms of country of origin, but it is implied to be internal testing by the manufacturer (Covidien). The testing itself would be considered prospective for the specific software change being evaluated.

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

As no clinical testing was performed and the evaluation focused on software and bench testing, there were no "experts" in the sense of clinical professionals establishing a ground truth on patient data. The ground truth for the non-clinical tests would have been established by engineering and quality assurance personnel, likely using predefined specifications and expected outputs for the software and hardware interfaces. Their specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set with human assessment was utilized. The "ground truth" for the non-clinical tests would have been determined through objective measurements and comparisons against technical specifications, not through a consensus-based adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states, "No clinical testing was conducted." Therefore, there is no information about the effect size of human readers with vs. without AI assistance. This submission focuses on a software change for integration, not on a new diagnostic or interpretative AI feature.

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

This device is an electrosurgical generator, which is inherently a human-in-the-loop device. However, the specific software change being evaluated (allowing the generator to interface with an Integrated OR system) was likely tested in a standalone manner relative to its function of communication. The bench testing and software validation would assess the algorithm's ability to correctly interface and transmit data without direct human intervention once configured, but the overall device always requires human operation. The document doesn't explicitly describe a "standalone performance" study in the context of an AI algorithm making decisions, as this is not an AI-driven diagnostic device.

7. The Type of Ground Truth Used:

The ground truth used for this submission was primarily technical specifications and expected system behavior. For software validation, this would involve comparing actual software outputs against designed functional requirements. For bench testing, it would involve verifying that the device communicated correctly with the simulated and actual Olympus EndoAlpha system according to predefined communication protocols and interface standards.

8. The Sample Size for the Training Set:

Not applicable. This submission is for a software modification to an existing device for interoperability. There is no mention of a machine learning or artificial intelligence component that would require a "training set" in the traditional sense. The software development process would involve iterative testing and debugging, but not a distinct training set for an AI model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no training set in the context of machine learning. The "ground truth" for the software development and validation would have been based on the functional specifications and design documents for the integration with the Olympus EndoAlpha endosurgery system, established by Covidien's engineering team.

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The Sonicision™ Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter.

The Sonicision™ Cordless Ultrasonic Dissection Device is a hand-held surgical device consisting of three interdependent components that, when assembled, enable ultra high-frequency mechanical motion (ultrasonic energy) to transect, dissect, and coagulate tissue. The Sonicision device is designed to be both ergonomic and intuitive for the user. It can coagulate vessels up to and including 5 mm in diameter and is designed to be inserted and extracted through a compatible 5 mm trocar, when used endoscopically/laparoscopically. A unique characteristic of the device is that it functions without the need for external power cords and transducer cables. Sonicision generators and batteries are prepared by the facility and attached to the dissector (disposable component). When assembled, electrical power supplied by the battery pack is available to be converted to ultrasonic energy in the generator. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy through the use of a two-stage button. The system is comprised of single-use and reusable components.

The provided text describes the 510(k) summary for the Sonicision™ Cordless Ultrasonic Dissection Device. It details the device's description, intended use, and technological/performance characteristics, along with a summary of non-clinical/preclinical performance. However, it does not contain specific acceptance criteria tables nor comparative study results with human readers or standalone algorithm performance as requested in the prompt. The information provided is primarily for demonstrating substantial equivalence to predicate devices, focusing on design features and non-clinical testing.

Therefore, many of the requested details cannot be extracted from the provided document.

Here's a summary of what can be extracted and what cannot:

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

The document describes various performance aspects that were evaluated to demonstrate substantial equivalence, but it does not present them in a formal table with specific acceptance criteria (e.g., "burst pressure > X mmHg") and corresponding reported values. Instead, it states that the device "performs at least as well as (not inferior to) the predicate ultrasonic device."

• Evaluated areas: Active blade displacement, frequency, grasping and pulling force, shaft deflection, distal seal leakage, button activation force, jaw clamping force, temperature, isolated vessel burst pressures/hemostasis, coagulation and dissection speed, qualitative ratings of sealed tissue, thermal spread, and enterotomy formation speed and hemostasis.
• Performance Outcome: "performs at least as well as (not inferior to) the predicate ultrasonic device (Harmonic ACE36E)"

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

• Sample Size for Test Set: Not specified for individual tests. The preclinical studies used "porcine" models.
• Data Provenance: Porcine (animal) studies for preclinical evaluations. The document does not specify a country of origin for the studies.
• Retrospective or Prospective: These were primarily prospective preclinical studies using animal models.

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. The "ground truth" here is based on objective measurements and observations in bench and animal studies (e.g., vessel burst pressure, tissue integrity), not on expert interpretations of medical images or data.

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

Not applicable. This type of adjudication method is used for establishing ground truth in expert-based studies, which is not what was performed here.

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

Not applicable. This device is a surgical instrument, not an AI diagnostic tool. No MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is a physical surgical device, not an algorithm. Performance was evaluated in non-clinical, preclinical (bench/animal), and usability studies, which involve the device in operation.

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

The "ground truth" in this context was established through:

• Objective measurements in non-clinical (electrical/mechanical/functional) testing: e.g., direct measurements of active blade displacement, frequency, forces, leakage.
• Preclinical (bench tissue/animal) evaluations: using direct observation, measurement, and histological assessment of tissue effects (e.g., isolated vessel burst pressures, coagulation speed, thermal spread, enterotomy formation).

8. The sample size for the training set:

Not applicable. The device is not an AI algorithm that requires a training set. Its development and validation are based on engineering design, material science, and physical testing.

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

Not applicable, as there is no training set for an AI algorithm.

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The LigaSure™ Curved, Small Jav, Open Sealer/Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad™ energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and lymphatics is performed, such as urologic, thoracic, plastic, and reconstructive; and including such procedures as bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, etc.

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™ Curved, Small Jaw, Open Sealer/Divider is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). The ForceTriad's tissue-fusion (LigaSure) mode delivers precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion, and has been designed to produce minimal sticking, charring, or thermal spread to adjacent tissue. LigaSure instruments attach to the generator with a ten-foot containing a "smart" connector. This connector functions as a unique product identifier for device-specific recognition by the generator. The Curved, Small Jaw, Open Sealer/Divider instrument is designed to be both ergonomic and intuitive for the user. Its hemostat-style body and symmetrically placed controls facilitate handling by both left and righthanded users, and its small, curved jaws maximize visibility and access when the instrument is used in confined surgical spaces. Ring handles function to allow the user to grasp tissue by opening and closing the jaws of the instrument. The interior surfaces of the jaws contain the electrodes, which serve to ligate by delivering energy to the grasped tissue. RF energy can be activated by the user in two ways: (1) through the use of a single button incorporated into the handle body or (2) through the use of a footswitch attached to the generator. A cutting mechanism functions to mechanically divide tissue following tissue fusion. It consists of a stainless steel blade and is controlled by the user through a trigger located on the handle body.

The submission describes the device's technological and performance characteristics compared to predicate devices, drawing upon non-clinical (electrical/mechanical/functional) performance testing, preclinical (bench tissue/animal) evaluations, and usability studies to demonstrate substantial equivalence. It does not provide explicit "acceptance criteria" for novel performance metrics nor a "study that proves the device meets the acceptance criteria" in the format of a clinical trial with pre-defined endpoints and statistical analysis. Instead, it relies on comparative testing to known predicate devices and established safety standards.

Here's a breakdown of the requested information based on the provided text, indicating where information is not explicitly stated or is not applicable in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" as pass/fail thresholds for novel performance metrics in a tabular format. Instead, it demonstrates substantial equivalence through comparative performance testing to predicate devices and compliance with relevant safety standards. The "reported device performance" is qualitative and comparative for most aspects.

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

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of a clinical study. The evaluations involved various bench testing samples, excised porcine renal and pulmonary arteries, porcine and ovine models (for in vivo acute studies), and a porcine model (for in vivo chronic studies). The specific number of each type of sample/animal used is not detailed.
• Data Provenance:
  • In vitro: Excised porcine renal and pulmonary arteries.
  • In vivo: Porcine and ovine models.
  • Usability: "Simulated operating environments" with "users."
  • The origin (e.g., country) of these animal models or where the usability studies were conducted is not specified. All studies are preclinical/non-clinical, not human clinical data, so the retrospective/prospective distinction for human subjects is not directly applicable.

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

Not applicable in the context of this 510(k) submission. Ground truth for performance (e.g., burst pressure, thermal spread, healing) was established through objective measurements in bench and animal studies, not through expert human interpretation of images or other data typically requiring adjudicated ground truth. Usability studies involved "users," but these are for evaluating human factors, not for establishing diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical imaging studies where multiple human readers interpret data. The evaluations here are based on objective physical measurements and animal model outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers of medical images. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical electrosurgical instrument. It operates with a human user in the loop. The "standalone" concept refers to algorithms performing diagnostic tasks without human intervention, which is not relevant here.

7. The Type of Ground Truth Used

• Objective Measurements: For electrical, mechanical, and functional performance (e.g., jaw temperature, force, power curves).
• Biological Endpoints in Animal Models: For preclinical evaluations, the ground truth was based on measurable biological outcomes such as:
  • Isolated vessel burst pressures/hemostasis
  • Ligation (sealing) speed
  • Division (cutting) performance
  • Overall hemostasis
  • Overall activation time
  • Overall grasping performance
  • Lateral thermal damage
  • Chronic hemostasis and healing over a 21-day survival period.

8. The Sample Size for the Training Set

Not applicable. This device did not involve machine learning or AI that would require a "training set" for an algorithm. The development and testing focused on engineering, materials science, and preclinical biological performance.

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

Not applicable, as no training set for an algorithm was used.

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