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The SB Knife Jr2 is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47702, MD-47702L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current.

SB Knife Jr2 under application (Hereinafter "the Subject Device" is a single-patient use EtOsterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The Subject Device is designed to connect with Olympus and ERBE connectors and uses the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.

The Subject Device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1-6 and IEC 60601 2-18 by ISO 17025 accredited laboratory.

The Subject Device consists of two models as follows:

MD-47702 Working Length: 1970 mm
MD-47702L Working Length: 2320 mm

The provided text is a 510(k) summary for the SB Knife Jr2, a medical device. It does not contain the information typically found in a study proving a device meets specific acceptance criteria based on performance.

Specifically, the text describes:

• The device and its intended use.
• A comparison to a predicate device (SB Knife®).
• Differences between the subject device and the predicate device, particularly regarding type, shape, structure, presence of a rotating operation portion, and materials.
• Non-clinical testing performed (transportation, shelf-life, packaging, sterilization, electromagnetic compatibility, electrical safety, biocompatibility).
• A statement that clinical testing was not performed.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from the provided text. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through technological comparison and non-clinical performance, rather than providing a detailed study of the device's performance against pre-defined acceptance criteria for a new clinical claim or feature that requires such a study.

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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 Erbe APC 3 with accessories is intended to deliver argon gas for argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue when used in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and applicators or probes.

The Erbe Argon Plasma Coagulation Unit Model APC 3 is an APC unit for use in conjunction with an Erbe Electrosurgical Unit (ESU) compatible Model (currently Model VIO® 3). The APC 3 (as well as VIO 3) can be mounted/secured to a cart or on a ceiling mount using fastening sets, i.e. connecting cables and hardware. The APC 3 is connected to an argon gas source via a pressure reducer and connected to the VIO 3 which powers and controls the APC unit. The ESU further provides a touch-screen monitor (i.e., interactive display) with an onscreen tutorial, settings and operational information as well as safety features (i.e., audio and visual error system). When using the APC 3 together with the VIO 3, the user is offered various APC Modes as well as argon-supported Modes which can be adjusted by the physician via effect levels in order to achieve the desired tissue effect. The ESU VIO 3 provides the high-frequency (HF) current required for thermal coagulation. For argon plasma coagulation and ablation, the HF current is applied non-contact to the tissue to be coagulated through ionized and hence electrically conductive argon gas (argon plasma). The argon gas is ionized in the high-frequency electrical field between the electrode of the applicator and the tissue. For argon-assisted cutting, the ESU provides the regular cutting/coagulation Mode while the argon gas provided by the APC 3 circulates the active electrode. This application is with contact to tissue.

Applicators or probes connected to the APC 3 for coagulating tissue via argon plasma and/or for cutting tissue supported by argon gas may be activated via footswitches connected to the ESU or by use of applicators that have an activation finger switch.

The APC unit and its accessories (i.e. pressure reducer and fastening sets) are supplied non-sterile and are reusable. Cleaning and disinfections are provided in the APC user manual or notes on use of the involved accessory. The compatible applicators and probes are provided sterile as well as are single-use.

This document describes the Erbe Argon Plasma Coagulation Unit APC 3 with Accessories, and its substantial equivalence to a predicate device. It primarily focuses on the device's technological characteristics and safety standards rather than clinical performance or AI-driven improvements in human reading. Therefore, much of the requested information regarding AI acceptance criteria, clinical study specifics (sample size, expert involvement, MRMC studies, ground truth), and training set details for AI cannot be extracted from this document because it is about an electrosurgical device, not an AI/ML-driven diagnostic device.

Here's a breakdown of what can be extracted, and where limitations exist based on the provided text:

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

The document doesn't provide specific quantitative acceptance criteria or detailed performance metrics in a table format for clinical efficacy. Instead, it focuses on general safety, performance, and substantial equivalence to a predicate device based on technical specifications and adherence to recognized standards.

Acceptance Criteria (Implied from the document):

• Safety: Adherence to electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• Performance: Ability to deliver argon gas for argon plasma coagulation, ablation, and argon-assisted cutting as intended. This is assessed through "Output/Mode Comparison," "Tissue Testing," and "Capacitive Coupling" as listed in the "Performance Evaluations/Testing" section.
• Usability: Conformance to usability engineering standards (e.g., IEC 62366, IEC 60601-1-6).
• Compatibility: Operation with compatible Erbe VIO Electrosurgical Generators (ESU) and specific applicators/probes.
• Substantial Equivalence: Demonstrating that the new device has "essentially the same principles of operation, technological characteristics, as well as performance characteristics as the predicate APC unit."

Reported Device Performance:
The document states that "Validation and verification activities in design control that includes testing/certification to designated standards (including electrical safety standards) and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate." However, specific numerical performance data (e.g., coagulation efficacy rates, ablation depth measurements, cutting speeds) are not provided. The "Output/Mode Comparison" and "Tissue Testing" are mentioned as performance evaluations, but their results are summarized qualitatively as proving substantial equivalence.

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

This document describes a medical device (an electrosurgical unit), not an AI/ML diagnostic algorithm tested on a dataset of patient data. Therefore, the concepts of "test set sample size" and "data provenance" in the context of clinical/imaging data are not applicable here. The testing involves engineering and performance validation of the device itself, rather than testing on a retrospective or prospective clinical dataset.

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 an AI/ML diagnostic device requiring expert annotation of medical images or data to establish ground truth for a test set. The validation is technical and engineering-focused.

4. Adjudication method for the test set

Not applicable. As this is not a diagnostic device involving human interpretation of data, there is no need for adjudication of readings.

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 not an AI-assisted diagnostic tool, so an MRMC study and
assessment of human reader improvement with AI assistance is irrelevant.

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

Not applicable. This is not an algorithm. It is a hardware medical device.

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

The "ground truth" for this device's performance evaluation is based on engineering standards, physical measurements, and comparison to the predicate device's established performance characteristics. It relies on:

• Compliance with recognized consensus standards: e.g., electrical safety, electromagnetic compatibility, usability (IEC, ISO standards listed).
• Physical (in-vitro/bench) testing: "Output/Mode Comparison," "Tissue Testing," "Capacitive Coupling." These tests would compare the device's output and tissue effects to specifications and the predicate.
• Functional verification: Ensuring the device operates as intended when connected to compatible components.

It does not involve "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not an AI/ML system that requires a "training set" of data.

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

Not applicable. See point 8.

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The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The Erbe ESU Model VIO® 3 with Accessories is an electrosurgical unit for the delivery of high frequency (HF) electrical current to cut and/or coagulate tissue via various universal instruments (e.g., electrodes, etc.).

The provided document pertains to a 510(k) premarket notification for a medical device, the Erbe ESU Model VIO® 3 with Accessories. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance acceptance criteria through clinical studies in the same way a PMA or a de novo submission might.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or how ground truth for training sets was established. These details would typically be found in clinical study reports or more extensive technical documentation, which are not part of this 510(k) summary.

Instead, the document highlights:

• Intended Use: "The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue."
• Substantial Equivalence: The submission claims the device is substantially equivalent to the predicate device, Erbe ESU Model VIO® 300 D with Accessories (K083452).
• Verification/Validation Activities: These activities focused on meeting recognized standards, including electrical safety (e.g., IEC 60601 series), software lifecycle (IEC 62304), usability (IEC 62366, IEC 60601-1-6), sterilization information (IEC 17664, AAMI ST81), and biological evaluation (ISO 10993-1).
• Performance Evaluations/Testing:
  • Output/Mode Comparison
  • Tissue Testing
  • Contact Quality Monitoring (CQM)
  • Capacitive Coupling (per Standard Number 60601-2-2)
  • Accessory Testing

These performance evaluations were likely bench or pre-clinical tests designed to show that the device performs as intended and similarly to the predicate device, but the specifics of acceptance criteria for these tests and their results in a tabular format are not provided in this summary.

In summary, the document does not provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as such detailed performance data is generally not part of a 510(k) summary that focuses on substantial equivalence.

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