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ArtiSeal Vessel Sealing System-ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on veins) up to and including 7 mm. It is indicated for use in general surgery.

The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.

ArtiSeal Vessel Sealing System - ArtiSeal Instruments

The ArtiSeal Vessel Sealing System - ArtiSeal invasive invasive instruments which are used with electrosurgical generator), intended to be used during laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels and tissue bundles is desired.

When activating the sealing button of ArtiSeal Vessel Sealing System-ArtiSeal instruments, the ArtiSeal Generator applies a high frequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation.

During a procedure with this product, the jaw opens, and jaw closes if the grip lever pulled. In addition, the jaw is also bent up, down, left, and right within a range of ±80° or more by moving the grip up, down, left, and tight, and the jaw can also turn 360° when rotating the grip.

ArtiSeal Vessel Sealing System - ArtiSeal Generator

The ArtiSeal Vessel Sealing System - ArtiSeal Generator supplies RF energy to the ArtiSeal Instruments. This energy supply device uses a touchscreen interface and features a unique instrument connecting the ArtiSeal Instrument. By connecting the connector on the ArtiSeal Instrument connection socket, the energy supply device can provide energy to the electrode.

The provided text describes a 510(k) premarket notification for the ArtiSeal Vessel Sealing System and outlines its indications for use and a summary of non-clinical/clinical tests. However, it does not contain detailed information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods in the manner typically presented for AI/ML device studies. The text focuses on establishing substantial equivalence to predicate electrosurgical devices through performance in animal studies rather than rigorous statistical evaluation of an AI component.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can and cannot be answered:

What can be extracted/inferred:

• Study Type: Non-clinical (animal) studies were conducted.
• Purpose of Study: "To evaluate the vessel sealing performance and tissue effects of ArtiSeal Instruments and ArtiSeal Generator. The evaluations included the device's ability to seal vessels of various sizes and types, its effect on tissue damage, as well as the device's safety and efficacy."
• Performance Metrics Mentioned (Qualitative): "complete vessel sealing was achieved without rebleeding as well as problematic macroscopic complications." "evaluation of sealing quality parameters such as tissue adhesion, transparency, desication, and damage to adjacent tissue."
• Ground Truth Type: Inferred to be a combination of direct observation in animal models and evaluation of sealing quality parameters.
• Data Provenance: Conducted in "pigs."

What cannot be extracted from the provided text:

• Table of acceptance criteria and reported device performance: The document only provides qualitative statements about performance, not a table of specific numerical acceptance criteria or results.
• Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document mentions "pigs" but no specific numbers for the sample size, nor details on the country of origin or whether it was retrospective/prospective.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrosurgical system, not an AI/ML-driven diagnostic or assistive tool for human readers.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no mention of a standalone algorithm component for diagnostic or interpretive purposes. The "automatic detection" and "safety and diagnostic functions" refer to hardware/firmware functions, not an AI algorithm generating standalone performance metrics.
• The sample size for the training set: Not mentioned (and likely not applicable in the context of an electrosurgical device without a distinct AI training phase for data interpretation).
• How the ground truth for the training set was established: Not mentioned.

Summary based on the provided text:

The provided document describes the clearance of an electrosurgical device, the ArtiSeal Vessel Sealing System. The "study" mentioned is a non-clinical (animal) evaluation to demonstrate the physical performance of the device in sealing and dividing vessels, and its safety. This is distinct from the type of performance study typically conducted for AI/ML-driven diagnostic devices, which would involve detailed metrics of sensitivity, specificity, AUC, and human reader performance with and without AI assistance.

Hypothetical Table (Illustrative, as data is not available in the text):

If this were an AI device, the table would look something like this, but the data below is purely illustrative of what would be present if the document contained AI study details and is NOT from the provided text:

In conclusion, based solely on the provided text, it is not possible to describe the acceptance criteria and study proving the device meets them in the context of an AI/ML device per your detailed request. The device in question is a traditional electrosurgical system, and the provided documentation focuses on its physical performance and safety in animal studies, not statistical validation of an AI algorithm against a specific set of rigorous metrics.

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The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:
Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas
Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

The device within the scope of this premarket notification is the optional CUSA® Electrosurgery Module (CEM) accessory that is intended to be used with the 23 kHz components of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The purpose of this submission is to modify the CEM nosecone accessory currently offered with CUSA Clarity to allow for connection with additional electrosurgical generators, to continue to provide electrosurgical capabilities to the user. The additional electrosurgical generators that the modified CEM Nosecone may be used with include the Medtronic FT10 (K191601), Medtronic FX8 (K181389), Erbe VIO 300D (K083452), and Erbe VIO 3 (K190823). Compatibility with the Medtronic Force FX (K143161) will be maintained as well.

The CUSA Clarity 23kHz Expanded CEM Nosecone has the same intended use and technological characteristics as the predicate CUSA Clarity 23 kHz CEM Nosecone (K190180). The subject CEM nosecone will continue to allow the surgeon to apply immediate electrosurgical coagulation to bleeding tissue at the surgical site, with the same handpiece assembly that is removing unwanted tissue.

The provided text describes the CUSA Clarity Ultrasonic Surgical Aspirator System, specifically focusing on a modified CEM nosecone accessory for the 23 kHz components. This submission is a 510(k) premarket notification claiming substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes various non-clinical tests undertaken to ensure the safety and efficacy of the device and its substantial equivalence to the predicate.

The reported device performance is broadly stated as:

• "Testing was determined successful and supports the conclusion that all product specifications and design inputs have been met."
• "The results of the non-clinical testing indicate that the intended use of the device, fundamental scientific technology, and performance of the CUSA Clarity 23 kHz Expanded CEM Nosecone is substantially equivalent to the predicate device."

Therefore, a table of quantitative acceptance criteria and specific reported device performance cannot be generated from the provided text. The information indicates that all tests were passed and specifications met, implying the device performed within acceptable limits.

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

The document describes non-clinical testing but does not specify a "test set" in terms of subject or patient data. The tests are focused on device characteristics rather than clinical outcomes with a patient population.

• Sample size for test set: Not applicable in the context of device performance testing described. The tests are on the device itself (e.g., handpiece life, functionality, mechanical properties).
• Data provenance: Not applicable in the context of patient data. The provenance is from internal testing conducted by Integra LifeSciences Corporation. There is no mention of country of origin for data related to clinical or patient studies, as none were performed. The tests are prospective as they were conducted as part of the submission process.

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

• Number of experts: Not applicable. The "ground truth" for the non-clinical tests is established by engineering specifications, recognized standards (FDA guidance documents, ISO standards for biocompatibility, EMC, and electrical safety), and comparison to the predicate device's established performance.
• Qualifications of experts: Not specified as a separate set of experts for ground truth. However, the development and testing would have been overseen by Integra LifeSciences Corporation's engineering and regulatory teams.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. The testing described is objective device performance (e.g., sterilization, biocompatibility, electrical safety, mechanical, thermal effects). Success or failure is determined by meeting predefined engineering specifications and regulatory standards, not by an adjudication process between human experts on a specific outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC study: No. The document explicitly states: "No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate device."
• Effect size of human readers with/without AI assistance: Not applicable, as no MRMC study or study involving human readers with or without AI assistance was conducted. The device is a surgical aspirator system, not an AI diagnostic tool.

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

• Standalone study: Not applicable. The CUSA Clarity Ultrasonic Surgical Aspirator System is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is based on:

• Established engineering specifications and design inputs: Ensuring the device functions as intended.
• Compliance with FDA guidance documents and recognized standards: Such as those for sterilization, biocompatibility, EMC, electrical safety, thermal effects, and capacitive coupling.
• Substantial equivalence to the legally marketed predicate device (CUSA® Clarity Ultrasonic Surgical Aspirator System K190180): This implies that the predicate's established safety and effectiveness profile serves as a benchmark for the new component.

8. The Sample Size for the Training Set

• Sample size for training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is assessed through traditional engineering and regulatory compliance testing.

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

• How ground truth for training set was established: Not applicable, as there is no training set for this type of device.

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The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.

The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The Valleylab™ FT10 Energy Platform (VLFT10GEN) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion and vessel-sealing applications (LigaSure vessel-sealing function), and cardiac ablation. It is a combination of a full-featured general-surgery electrosurgical unit, a bipolar vessel sealing system, and an ablation unit. The monopolar and bipolar sections, including the LigaSure section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery. The LigaSure vessel-sealing section of the system provides power for vessel sealing. The cardiac ablation feature of the device is only available when used with compatible Cardioblate™ instruments.

The VLFT10GEN is used in hospitals and other health care facilities where surgical procedures are carried out.

The VLFT10GEN can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10GEN connects to electrical mains and operates at an input line frequency of 47-63 Hz.

This FDA 510(k) summary does not contain the information requested for a detailed description of acceptance criteria and a study proving a device meets them.

The document is a regulatory approval letter for the Valleylab FT10 Energy Platform, indicating its substantial equivalence to a predicate device. It describes the device, its intended use, and general performance characteristics, but it explicitly states that no clinical performance data was relied upon for this premarket submission.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to the performance evaluation of a device through specific studies, which this summary confirms were not clinically focused.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document describes general performance characteristics and compliance with standards (e.g., thermal spread, system functionality, electrical safety, usability), but it does not list specific quantitative acceptance criteria or corresponding reported device performance metrics in a table format.

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

• Cannot be provided. The document mentions "ex vivo testing using porcine tissue" for thermal spread, but it does not specify the sample size for this testing (e.g., number of porcine tissue samples). It also does not mention the country of origin of the data or whether it was retrospective or prospective.

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)

• Cannot be provided. Since no clinical performance study involving human interpretation or "ground truth" establishment is detailed, this information is not available.

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

• Cannot be provided. Similar to point 3, without a clinical performance study involving multiple human readers and ground truth, there is no adjudication method described.

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

• Cannot be provided. The document does not mention any MRMC study, AI assistance, or human reader improvement. The device described is an electrosurgical generator, not an AI-powered diagnostic tool.

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

• Cannot be provided. The device is an electrosurgical generator; the concept of "standalone algorithm performance" is not applicable in the context presented.

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

• Cannot be provided. No clinical "ground truth" is discussed for the performance evaluation in this document. The "ground truth" for the ex vivo testing would likely relate to objective measurements of thermal spread in the tissue samples, but the methodology is not detailed.

8. The sample size for the training set

• Cannot be provided. The document discusses software verification and validation, but it does not mention a "training set" in the context of an AI/ML algorithm or a similar data-driven model. The software testing mentioned is for embedded device software, not a learning algorithm.

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

• Cannot be provided. As there is no mention of a "training set," this information is not applicable.

In summary, the provided document focuses on regulatory clearance based on substantial equivalence and non-clinical verification and validation activities (e.g., bench testing, software testing, electrical safety). It explicitly states that clinical performance data was not used for this submission, which means the detailed information about acceptance criteria, specific study designs, sample sizes, and ground truth methodologies (especially as they relate to human or AI performance) is absent.

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The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles and lymphatics is desired.

The tissue fusion function of the device can be used on veins) and lymphatics up to and including 3mm diameter. The BiZact device is indicated for use in open general surgical procedures.

It is also indicated for adult and adolescent ENT procedures (12 years of age and above), 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 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 (ForceTriad), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (VLLS10GEN), or the Valleylab™ FT10 Energy Platform (VLFT10GEN) 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 can identify the BiZact™ device via the RFID tag embedded in the connector (VLLS10GEN and VLFT10GEN) 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 tissue. The combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.

Based on the provided text, the device in question is the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A). This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.

The core of this submission is not about a new AI/ML device with acceptance criteria for algorithm performance. Instead, it's about a medical device (an electrosurgical instrument) that is seeking to expand its Indications for Use to include an adolescent population (12-21 years of age), building upon its previous clearance for adults (22+ years of age).

Therefore, many of the questions about AI/ML specific studies (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of device and submission.

Here's an attempt to address the relevant points based on the provided text, and to explicitly state when information is not available or not applicable for this device type:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not describe acceptance criteria in the typical sense for an AI/ML device's algorithmic performance. Instead, it demonstrates continued acceptable performance and substantial equivalence to a predicate device. The "acceptance criteria" here are implicitly tied to the safety and performance standards relevant to electrosurgical devices.

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

• Sample Size: Not explicitly stated for specific tests. The "Performance Testing" section mentions "bench tissue - burst testing (renal artery and lymph)" and "in-vivo - acute (hemostasis, thermal spread) and chronic (hemostasis)". The sample sizes for these tests are not provided in this summary.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory/bench and animal (in-vivo) testing rather than human clinical trials for this 510(k) submission. The "Clinical Literature Summary" refers to existing literature, but its provenance is not detailed.

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

• Not Applicable. This is not a study requiring expert ground truth for classification or interpretation, as it's a physical medical device. The "Clinical Literature Summary" likely relies on the expertise of the medical community as a whole.

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

• Not Applicable. This is not a diagnostic device with interpretative tasks requiring adjudication.

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

• Not Applicable. This is not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an AI/ML algorithm.

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

As it's not an AI/ML device, the concept of "ground truth" as it applies to diagnostic algorithms is not relevant. For the physical device, performance is evaluated against engineering specifications, physiological measurements (e.g., burst pressure, thermal spread), and clinical outcomes (e.g., hemostasis). The "Clinical Literature Summary" relies on existing medical literature regarding tonsillectomy procedures in different age groups.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device with a training set.

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

• Not Applicable. This is not an AI/ML device with a training set.

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