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The High Frequency (HF) device is intended exclusively for the generation of electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations.

The ARC 400 (REF: 900-400) is an electrosurgical device. It generates high frequency (HF) electrical current for the purpose of cutting (e.g. removing tissue) or coagulating (e.g. control bleeding) human tissue. It is used with compatible bipolar instruments (e.g. K953509) or with monopolar instruments (e.g. K982743) in combination with a neutral electrode (e.g. K173877). The ARC 400 offers 34 modes that represent four main categories: monopolar cutting (12 modes), monopolar coagulation (9 modes), bipolar cutting (4 modes) and bipolar coagulation (9 modes).

Here's a breakdown of the acceptance criteria and the study information for the ARC 400 Electrosurgical Unit, based on the provided document.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific clinical acceptance criteria in the way an AI/ML device might. Therefore, the "acceptance criteria" here are generally performance specifications that align with the predicate device and established standards.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of specific numerical "acceptance criteria" for clinical performance, this device demonstrates substantial equivalence by matching or exceeding the technological characteristics and performance of its predicate device, the AUTOCON III 400. The "reported device performance" are the specifications of the ARC 400.

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

This document describes non-clinical performance testing for an electrosurgical unit, not an AI/ML device. Therefore, the concept of a "test set" for clinical data or image data isn't directly applicable in the same way. The testing involves engineering and performance validations, such as:

• Electrical safety testing: ES 60601-1 / 19-4
• Electromagnetic Compatibility testing: IEC 60601-1-2 / 19-8
• Particular requirements for the basic safety and essential performance of high frequency surgical equipment: IEC 60601-2-2 / 6-389
• Performance testing: Applicable parts of FDA Guidance Document "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" May 2016
• Usability testing: IEC 62366 / 5-114

The "sample size" would refer to the number of devices tested or the number of test runs conducted within these engineering and performance evaluations. The document does not specify these exact numbers.

Data provenance (country of origin, retrospective/prospective) is not applicable here as the tests are non-clinical engineering and performance tests, not clinical data collection.

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

This information is not provided and is not typically relevant for the type of non-clinical testing described for an electrosurgical unit. The "ground truth" for these tests is defined by established engineering standards and specifications.

4. Adjudication Method for the Test Set

This information is not provided and is not typically relevant for the type of non-clinical testing described.

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. This type of study is relevant for evaluating human reader performance, particularly with AI assistance, which is not applicable to this electrosurgical unit.

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

Not Applicable. This is an electrosurgical unit, not an AI algorithm. Its performance is intrinsically "standalone" in the sense that it generates electrical current based on user settings, but it is not an algorithm that performs diagnostic or assistive tasks.

7. The Type of Ground Truth Used

The "ground truth" for the ARC 400 is based on established engineering standards, international and national recognized standards (e.g., IEC 60601 series), and the performance specifications of the legally marketed predicate device (AUTOCON III 400). The device is tested to ensure it meets these defined technical parameters.

8. The Sample Size for the Training Set

Not Applicable. This is an electrosurgical unit, not an AI/ML device that requires a training set.

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

Not Applicable. As explained above, this device does not utilize a training set in the context of AI/ML.

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Disposable neutral electrodes are self-adhesive, ready-to-use and single-use products and are an accessory for HF surgery in monopolar applications. The electrical circuit between the patient and the HF generator on the passive side.

BOWA Neutral Electrodes for adults, children and neonates provide a safe return path for electrosurgical current. The electrode consists of a conductive adhesive area surrounded by a non-conductive border adhesive. The conductive area is split in longitudinal or circumferential direction which enables a quicker detection of disconnection. The electrode backing is fluid resistant. The neutral electrode is single-use only, disposable, and non-sterile. The electrodes are supplied with or without a pre-attached cable. For the non-pre-corded electrodes, a reusable cable is available as accessory.

The provided document describes the FDA 510(k) premarket notification for BOWA Neutral Electrodes, which are accessories for electrosurgical cutting and coagulation devices. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria for AI-related functions.

Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using an AI/ML context (e.g., accuracy, sensitivity, specificity) is not present in this document.

This document is for an electrosurgical accessory and its 510(k) submission primarily relies on:

• Comparison to predicate devices: Highlighting similarities in intended use, indications for use, principles of operation, and technological characteristics.
• Non-clinical performance data: This includes compliance with established electrical safety and biocompatibility standards (e.g., IEC 60601-2-2, ISO 10993-1, ISO 10993-5, ISO 10993-10), shelf-life testing, and reprocessing testing for consumable accessories.

There is no mention of AI/ML components, diagnostic performance metrics (accuracy, sensitivity, specificity), test sets, training sets, ground truth establishment by experts, or MRMC studies.

In summary, this document does not contain the information needed to address the prompt's specific requirements concerning acceptance criteria and study details for an AI-powered device.

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