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The ArthroCare Irrigation Pump is an accessory, supplied separately, that can be used with the following Electrosurgery Systems for the referenced indications:

• The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and . coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
• The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.

The Irrigation Pump is an accessory that may be used with ArthroCare's Electrosurgery Systems. The Irrigation Pump consists of the Irrigation Pump and Flow Control Cable. The ArthroCare Irrigation Pump is designed to automate the flow of conductive media during soft tissue ablation and coagulation where conductive media must be delivered to the treatment site.

The provided text describes a 510(k) premarket notification for the ArthroCare Irrigation Pump. It states that the submission is a "Special 510(k)" proposing a "modification in the performance specifications, ergonomic user interface, and labeling for the ArthroCare Flow Control Unit." It also explicitly mentions that "The indications for use and principal of operation remain the same as in the originally cleared 510(k)."

Given this information, the study described is a performance modification study rather than a de novo effectiveness study for a new device. Therefore, the focus is on demonstrating that the modified device's performance is equivalent to the predicate device, not necessarily on meeting specific clinical acceptance criteria or conducting extensive clinical trials as would be required for a new therapeutic or diagnostic device.

Based on the provided text, there is no information about acceptance criteria or a study that typically measures a device's performance against such criteria using patient data, ground truth, expert opinions, or statistical metrics like sensitivity, specificity, or MRMC studies. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on modifications to performance specifications, user interface, and labeling, rather than presenting a detailed clinical or diagnostic performance study.

Therefore, most of the requested information cannot be extracted from the provided document.

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

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

• Cannot be provided. The document describes a Special 510(k) for modifications to an existing device, focusing on "performance specifications, ergonomic user interface, and labeling." It does not specify new quantitative acceptance criteria or report performance data against such criteria in the context of clinical outcomes or diagnostic accuracy. The "performance specifications" being modified would likely refer to engineering or functional specifications (e.g., flow rate, pressure, durability) rather than clinical performance metrics.

2. Sample size 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 does not describe a clinical test set or data provenance.

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. The concept of "ground truth" established by experts for a test set is not applicable to the information given, as no such clinical study is described.

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

• Cannot be provided. No test set or adjudication method is mentioned.

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. This is an irrigation pump, not a diagnostic or AI-assisted device. Therefore, an MRMC study is not relevant, and no information on human reader improvement with or without AI is present.

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

• Cannot be provided. This is an irrigation pump and does not involve algorithms or AI for standalone performance.

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

• Cannot be provided. No clinical ground truth is described.

8. The sample size for the training set:

• Cannot be provided. This device does not involve a training set as would be used for AI or machine learning.

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

• Cannot be provided. Not applicable.

Summary of available information:

• Device: ArthroCare Irrigation Pump
• Type of Submission: Special 510(k)
• Purpose of Submission: Modification in "performance specifications, ergonomic user interface, and labeling" for the ArthroCare Flow Control Unit (predicate K001904).
• Key Statement: "The indications for use and principal of operation remain the same as in the originally cleared 510(k)."

This document primarily serves to demonstrate that the modified device remains "substantially equivalent" to its predicate, rather than detailing a study against specific clinical performance acceptance criteria.

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