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The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The P50 and P90 Electrodes when used with Mitek VAPR Electrosurgical Systems are intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The VAPR CP90 Electrodes when used with Mitek VAPR VUE Electrosurgical System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

The VAPR VUE Radiofrequency System is DePuy Mitek's next generation of VAPR Radiofrequency Systems. The system consists of a generator, wired or wireless footswitch and electrodes. The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes.

As with its predicate devices including the VAPR 3 generator, this electrosurgical system utilizes bipolar technology specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control.

The VAPR VUE system offers five output types of operation: Vaporization (ablation), Coagulation, CP Vaporization (ablation), Blended Vaporization (ablation and coagulation) and temperature control coagulation. All types are present in the predicate device (VAPR3 generator) except the CP Vaporization (ablation).

The VAPR P50 and P90 Electrodes are an addition to the family of LPS Electrodes. These Suction Electrodes are soft tissue ablation and coagulation devices intended for use with the VAPR Electrosurgical Systems. They extend the utility of the system by removing bubbles created during activation from the operating site.

The VAPR CP90 Electrodes are identical in technological characteristics as the P90 electrode only it is intended to be run only off the VAPR VUE platform at pre-determined default settings specific for the device. The CP90 with Handcontrols offers the integration of handcontrol capabilities via three buttons molded on the existing one-piece handles. Those buttons control ablation, coagulation and the generator mode functions.

The information provided describes the DePuy Mitek VAPR VUE Radiofrequency System and associated electrodes, which is a medical device for electrosurgical cutting and coagulation. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria or detailed reported device performance in terms of clinical metrics (e.g., success rates, complication rates, accuracy). Instead, it relies on demonstrating compliance with recognized electrical safety and software standards and asserting comparable RF performance.

The device's performance is generally stated as:

• RF Performance: "The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes."
• Safety and Performance Testing: "In addition safety and performance testing have been done to validate the performance and safety of the device. It has been demonstrated that these device modifications will not affect safety and effectiveness of the subject devices."
• Verification Testing: "Verification of the VAPR VUE System and Electrodes includes electrical, Safety and software and performance tests to show that the device meets its product Performance specifications over a range of operating conditions."

Acceptance Criteria (Implied by Standards & Equivalence):

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

The document does not specify sample sizes for "test sets" in the context of clinical performance or accuracy in a medical imaging or diagnostic sense. The testing mentioned (electrical, safety, software, performance) would typically involve engineering verification and validation on the device itself and its components, rather than patient data test sets.

• Test Set Sample Size: Not applicable/not specified in the provided text for clinical performance. The testing mentioned is for engineering verification and validation.
• Data Provenance: Not applicable, as no clinical/patient data test sets are described. The testing is device-centric.

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

This information is not provided because the submission explicitly states:

• "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance."
• Therefore, there were no "ground truth" derived from expert review of clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable as there were no clinical test sets requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device. The concept of "human readers improve with AI vs without AI assistance" is not relevant to this type of device.

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

• Not applicable. This is a hardware-based electrosurgical system, not an algorithm, and does not operate in a standalone diagnostic capacity.

7. The Type of Ground Truth Used

• No clinical grand truth was used. The "ground truth" for the device's performance is its compliance with engineering specifications, electrical safety standards, software standards, and its ability to achieve its intended physical effects (resection, ablation, coagulation) in laboratory or simulated environments, as demonstrated through non-clinical performance and safety testing.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ machine learning or AI that would require a "training set" of data.

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

• Not applicable. As no training set was used, no ground truth needed to be established for it.

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The Gyrus ACMI General Surgery Workstation is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.
The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.

The currently marketed Gyrus ACMI General Surgery Workstation is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) or PlasmaCision (PC) waveform. The generator face includes two sockets that allow a range of hand pieces to be utilized in a dry field environment, although only one socket may be active at any given time.
The Gyrus ACMI General Surgery Workstation General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a resistor located in the hand piece connector plug. This ensures that only the allowable range of waveform output and power level can only be applied to the instrument irrespective of the output socket. Accessories presently provided with the Gyrus ACMI General Surgery Workstation include a power cable and a foot switch. It should be noted that this footswitch is also used with the Gyrus ACMI SuperPulse generator (cleared under K031085).
This Special 510(k) proposes the addition of a new optional accessory, the Dual Footswitch Connector Cable. The Dual Footswitch Connector Cable allows for easier use of the Gyrus ACMI General Surgery Workstation when multiple surgeons are present. This is achieved by allowing the connection and use of two footswitches on the same generator. The indications for use, principles of operation, energy waveform outputs, and accessories of the Gyrus ACMI General Surgery Workstation with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI General Surgery Workstation.

The provided text is a 510(k) summary for the Gyrus ACMI General Surgery Workstation. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain information about:

• Specific acceptance criteria in a quantitative or qualitative table format.
• A study designed to "prove" the device meets acceptance criteria, beyond the claim of substantial equivalence.
• Sample sizes for test sets or training sets.
• Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth.

The document primarily focuses on regulatory approval based on equivalence, not on a detailed performance study with specific metrics. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred and explicitly stated:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is a Special 510(k) for an accessory, focusing on substantial equivalence rather than a new clinical study.

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)
This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. This device is an electrosurgical workstation, not an AI or imaging device, so an MRMC study would not be relevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This is not an algorithm-only device. The submission is for a physical medical device and an accessory.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. Given this is a 510(k) for an electrosurgical device accessory, the "truth" is typically established through engineering bench testing and comparison to the predicate device's established performance, rather than clinical ground truth as might be seen for diagnostic devices.

8. The sample size for the training set
This information is not provided in the document.

9. How the ground truth for the training set was established
This information is not provided in the document.

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The Gyrus ACMI PKS Plasma Morcellator is intended for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical procedures, laparoscopic urological procedures, and laparoscopic gynecologic procedures.

The Gyrus ACMI PKS Plasma Morcellator consists of two main elements: a Morcellator that includes a cutting shaft and handle with an integrated electrical cable that connects to a Gyrus Medical generator; and a Grasper that passes through the hollow shaft of the Morcellator, to grasp tissue and retract it toward the cutting element on the Morcellator shaft tip. An obturator may also be used to assist in the introduction of the device in laparoscopic procedures, and like the grasper, is positioned through the shaft of the Morcellator tube when being utilized

The provided text describes a 510(k) submission for the Gyrus ACMI PKS Plasma Morcellator, focusing on substantial equivalence to predicate devices rather than detailed performance studies with specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.

However, I can provide what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document states: "During design verification, the performance of the PKS Plasma Morcellator was compared against the known performance characteristics of the predicate Gynecare Laparoscopic Morcellator using the bipolar tissue cutting technology of the predicate Gyrus PlasmaCision Laparoscopic Spatula. Testing demonstrated that the performance requirements were met, and that the PKS Plasma Morcellator exhibited comparable performance characteristics to both the predicate care Laparoscopic Morcellator and predicate Gyrus PlasmaCision Laparoscopic Spatula."

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The study described is a "design verification" which compared the new device against predicate devices' known characteristics, implying bench testing and comparison, not clinical trials with human subjects or specific data sets with provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study described does not appear to involve human experts establishing ground truth in the context of diagnostic or interpretive tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. The study described does not appear to involve adjudication of expert 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:
This information is not provided in the document. This is a medical device (morcellator) and not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a medical instrument (morcellator), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" implicitly used for comparison was the "known performance characteristics" of the predicate devices. This would likely stem from previously established performance data, design specifications, and clinical experience with those predicate devices. Formal "ground truth" in the sense of pathology or outcomes data from a prospective study specifically for this device comparison is not mentioned.

8. The sample size for the training set:
This information is not provided in the document. This device does not use machine learning, so a "training set" is not relevant.

9. How the ground truth for the training set was established:
This information is not applicable as the device does not use machine learning, so there is no training set.

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