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The ArthroCare Dermal Electrosurgery System and ConMed Hyfrecator are intended for use in dermatologic surgical procedures to remove soft tissue and to control bleeding.

The ArthroCare Dermal Electrosurgery System is comprised of three components: the Dermal Handpiece with Cable unit, the disposable Dermal Handpiece Tip, and an electrosurgical generator called the Controller. The Dermal Handpiece Tip attaches to the distal end of the Dermal Handpiece and Cable. The proximal end of the Dermal Handpiece and Cable unit connects to the Controller. The Dermal Handpiece Tip is provided in a variety of models, ranging in diameters from 0.5 mm to 2.5 mm with the distal tip of the dermal Handpiece as straight or bent at angles up to 90 degrees. The distal tip is configured with multi-electrodes. The Dermal Handpiece Tip is supplied sterile and intended for single patient use. The Dermal Handpiece and Cable unit are designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller. The ArthroCare Dermal Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.

This document is a Premarket Notification (510(k) Summary) for a medical device (ArthroCare Dermal Electrosurgery System), not a study evaluating its performance against acceptance criteria. Therefore, most of the information requested in your prompt (such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance) is not present in the provided text.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance against specific acceptance criteria through a study.

Here's what can be extracted from the provided text in relation to your questions:

• Acceptance Criteria and Reported Device Performance: This information is not provided in the 510(k) summary. The document asserts "substantial equivalence" based on design, principle of operation, materials, and intended use, rather than reporting performance metrics against specific criteria.
• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no performance study is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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/software-based interpretive system.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an electrosurgical unit, not an algorithm.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Essentially, the provided text describes a medical device and claims its substantial equivalence to existing devices, but it does not detail any studies with acceptance criteria or performance metrics.

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The ArthroCare Urologic Multi-electrode Electrosurgery System is a high frequency electrosurgical device intended for use in general urological surgery to resect soft tissue and provide hemostasis.

The ArthroCare Urologic Multi-electrode Electrosurgery System is a high frequency electrosurgical device. The System is comprised of three components: the UroWand, the UroWand Cable, and the Controller. The UroWand, UroWand Cable and the Controller are virtually identical to the ArthroCare Probe, Probe Cable and Controller determined substantially equivalent in K943450 for the ArthroCare Arthroscopic Electrosurgery System. The technology is also substantially equivalent to that of the ArthroCare Bipolar Loop Electrode System (K955531). The bipolar design of the ArthroCare UroWand incorporates the return electrode into the shaft of the device. The ArthroCare UroWand is designed to be operated in a physiological saline environment.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ArthroCare Urologic Multi-electrode Electrosurgery System:

Summary of Acceptance Criteria and Supporting Study for ArthroCare Urologic Multi-electrode Electrosurgery System (K961069)

The provided document describes a premarket notification (510(k)) for the ArthroCare Urologic Multi-electrode Electrosurgery System. As such, the approach to "acceptance criteria" and "study" is focused on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics with a dedicated clinical trial for a novel device.

The core acceptance criterion is substantial equivalence to existing legally marketed predicate devices in terms of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criterion | Reported Device Performance (as demonstrated by comparison to predicates) |
| :------------------- | :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Safety: | |
| - Patient Ground Pad Requirement | Not Required: Bipolar design incorporates return electrode into the shaft, eliminating the need for a patient ground pad (unlike monopolar predicates). This is an improvement over predicates, implying enhanced safety by reducing risks associated with ground pads. |
| - Operating Environment | Physiological Saline Environment: Designed to operate in physiological saline, which is different from predicate products that require non-conductive environments (sterile water or glycine). This difference is presented as an advantage allowing equivalent efficacy with less power, implying no compromise in safety due to the new environment. |
| - Material Safety | Identical Materials: Materials used are identical to those of the ArthroCare Arthroscopic Electrosurgery System (K943450) and ArthroCare Bipolar Loop Electrode System (K955531). Predicate devices use stainless or titanium. This demonstrates established material safety. |
| - General Safety Standards | Meets Applicable Safety Requirements: The ArthroCare System meets applicable domestic and international safety requirements and standards. |
| Effectiveness: | |
| - Resection of Soft Tissue | Equivalent Performance (Bench & Animal Studies), Similar Depth of Alteration (Animal Studies):

• Bench Testing: Demonstrated equivalent performance characteristics between the ArthroCare UroWand and predicate electrosurgical devices (ACMI Circon, Olympus America). This suggests equivalent ability to resect tissue.
• In Vivo Arthroscopic Animal Studies: Demonstrated that the depth of soft tissue alteration with the ArthroCare Arthroscopy System (virtually identical to the urological system) is similar to that of a standard monopolar electrosurgery device. This indicates equivalent tissue manipulation capability. |
  | - Hemostasis | Not explicitly detailed, but implied by 'equivalent performance characteristics' and 'substantial equivalence' to devices that provide hemostasis in urological surgery. Predicate devices are described as effective in "resecting soft tissue and provide hemostasis" The ArthroCare System is stated to be "intended for use in general urological surgery to resect soft tissue and provide hemostasis," assuming similar effectiveness to predicates. |

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

• Test Set Sample Size: Not explicitly stated/quantified in terms of a specific number of cases or subjects.
  • Bench Testing: Implied to involve a comparison of device performance characteristics against predicate devices. The number of tests or specific samples is not provided.
  • In vivo Arthroscopic Animal Studies: Involved "animal studies," but the number of animals or specific experimental setup for the "test set" is not detailed.
• Data Provenance:
  • Bench Testing: Presumably conducted by ArthroCare Corporation.
  • In vivo Arthroscopic Animal Studies: Conducted as "animal studies," likely a controlled laboratory setting.
  • Retrospective/Prospective: The document doesn't specify if the animal studies were prospective (designed specifically for this submission) or if it leverages retrospective data. Given the context of a 510(k) submission, new testing is often performed.

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

• This information is not applicable in this context. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices. The studies (bench and animal) are designed to show that the new device performs similarly to these known, safe, and effective predicates, not to establish a new ground truth based on expert consensus for a novel condition. Independent experts are not mentioned in relation to establishing ground truth for the device's performance.

4. Adjudication Method for the Test Set

• This is not applicable. There's no mention of human-reviewed test sets or adjudication processes in the way one would define it for diagnostic or screening device studies. The "adjudication" is essentially the comparison of performance against established predicate device characteristics.

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

• No, an MRMC comparative effectiveness study was not done. The document describes bench testing and animal studies comparing the device to existing technology, not human reader performance with or without AI assistance.

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

• This question is not applicable as the device is an electrosurgical system, not an AI algorithm. Its performance is inherent to its physical and functional design, not an AI model.

7. The Type of Ground Truth Used

• The "ground truth" implicitly used for comparison is the demonstrated safety and effectiveness of the legally marketed predicate devices (e.g., electrosurgery devices by Circon ACMI, Karl Storz, Olympus America).
  • For safety, this refers to their known history of safe use and compliance with standards.
  • For effectiveness, it refers to their known ability to "resect soft tissue and provide hemostasis" in urological procedures.
• The studies (bench and animal) then serve to demonstrate the ArthroCare system performs equivalently against this established "ground truth" of the predicates.

8. The Sample Size for the Training Set

• This information is not applicable. This is a hardware medical device submission; there is no "training set" in the context of machine learning or AI.

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

• This information is not applicable for the same reasons as #8.

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