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The ArthroCare ENT Plasma Wands are indicated for ablation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

• · Adenoidectomy
• Cysts
• · Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• · Myringotomy with Effective Hemorrhage Control
• · Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal/Laryngeal Indications including Tracheal Polypectomy, and Laryngeal Lesion Debulking
• Neck Mass
• · Papilloma Keloids
• · Submucosal Palatal Shrinkage
• Submucosal Tissue Shrinkage
• · Tonsillectomy (including palatine tonsils)
• · Traditional Uvulopalatoplasty (RAUP)
• Tumors
• · Tissue in the Uvula/Soft Palate for the Treatment Of Snoring

The ArthroCare ENT Plasma Wands are bipolar, high frequency electrosurgical devices designed for use in otorhinolaryngology (ENT) surgery. The Wands consists of a single or multiple active electrode(s) located on the distal end of the shaft, a suction line, a saline line, and an injection molded, medical grade plastic handle with integrated cable at the proximal end of the wand. A cable connector is attached to the end of the cable, which connects the wand directly to the ArthroCare Coblator II Controller (CII Controller). The EVac 70 Xtra and PROcise XP Wands with Integrated Cable (EVac 70 Xtra and PROcise XP Wands) are a part of the ENT Plasma Wand family previously cleared under 510(k) K070374 for a change in indications; the integrated cable design was first cleared under 510(k) K033257.

Consistent with the predicate cleared under 510(k) K070374, the ENT Plasma Wands are only compatible with the CII Controller. The controller is designed to deliver radiofrequency energy to the active electrode(s) at the distal end of the wand. Each Wand is designed for soft tissue procedures where tissue resection, ablation, coagulation, and hemostasis are desired. The Wands are provided sterile, and are intended for single use.

This 510(k) seeks clearance for the following changes:

• 트 Addition of an Electronic Use-Limiting (EUL) feature to the integrated cable which will limit the re-use of these single-use disposable Wands.
• 트 A change in the design of the cable connector which mates with the Controller.
• 트 Implementation of Ethylene Oxide (EO) sterilization in lieu of e-Beam sterilization.

This document does not contain the detailed acceptance criteria or a study that precisely defines performance metrics with specific numerical targets. Instead, it is a 510(k) premarket notification summary for a medical device (ArthroCare ENT Plasma Wands) that seeks to establish substantial equivalence to a predicate device.

The core of this submission is to demonstrate that the modified device (EVac 70 Xtra and PROcise XP Wands with Integrated Cable) is as safe and effective as the previously cleared predicate device (ENT Plasma Wands, K070374), despite some minor changes.

Here's an attempt to extract and infer the information based on the provided text, while acknowledging that many specific details requested are not present in this type of FDA submission summary:

Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide specific numerical acceptance criteria. Instead, it states that various tests "met the required specifications" or "perform as intended" or are "substantially equivalent."

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

• Sample Size: Not explicitly stated for specific tests. The performance data section vaguely mentions "animal tissue" for ablation and coagulation testing.
• Data Provenance: "Animal tissue" is mentioned, implying in vivo or ex vivo animal studies. The country of origin is not specified but is implicitly within the scope of ArthroCare Corporation's operations (Austin, TX, USA). The studies are prospective in the sense that they were conducted for this 510(k) submission to demonstrate the equivalence of the modified device.

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

Not applicable. This document describes bench testing and animal tissue testing (likely performed by engineers/scientists), not studies requiring human expert adjudication of clinical outcomes or images for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was primarily bench and animal tissue testing, not a study requiring human adjudication.

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

No. This type of study is not mentioned as it is not typically required for a 510(k) submission seeking substantial equivalence for minor device modifications, especially when clinical data is explicitly stated as "not required."

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

Not applicable. This device is a medical instrument (electrosurgical wand), not an AI algorithm. Its performance is inherent in its physical and functional characteristics.

7. The Type of Ground Truth Used

For the ablation and coagulation testing (the closest thing to a performance evaluation of its intended effect), the "ground truth" seems to be the observable tissue effects in animal tissue, which were then compared to the effects produced by the predicate device. The fundamental assumption is that if the new device produces similar tissue effects, it is equivalent.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is a physical medical device and not an AI/machine learning system.

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

Not applicable. No training set was used.

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The ArthroCare ENT Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

• Adenoidectomy
• Cysts
• Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• Myringotomy with Effective Hemorrhage Control
• Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
• Neck Mass
• Papilloma Keloids
• Submucosal Palatal Shrinkage
• Submucosal Tissue Shrinkage
• Tonsillectomy
• Traditional Uvulopalatoplasty (RAUP)
• Tumors
• Tissue in the Uvula/Soft Palate for the Treatment of Snoring

The ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in otorhinolaryngology (ENT) surgery.

The provided text is a 510(k) premarket notification for a medical device (ArthroCare® ENT Plasma Wands) and does not describe a study that conducted testing with associated acceptance criteria. Instead, it describes a "Special 510(k)" submission for a material modification to a previously cleared device.

The key points from the text related to performance, acceptance criteria, and studies are:

• Substantial Equivalence: The document states that the modified ArthroCare ENT Plasma Wands are "substantially equivalent" to a predicate device (K033257). This is a regulatory pathway and not a performance study demonstrating new acceptance criteria.
• No new performance criteria: The submission explicitly states: "The indications for use, technology, principle of operation, dimensional specifications, performance specifications, labeling and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)."
• No new study presented: Because the performance specifications are stated to be the same, and the modification is primarily material, the document does not present a new study with acceptance criteria to demonstrate device performance. It relies on the substantial equivalence to the previously cleared device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this specific document, as those types of studies were not included in this Special 510(k) submission.

Summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or specific reported device performance data from a new study. It asserts that the "performance specifications... remain the same as in the predicate cleared 510(k)" (K033257).

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

Not applicable. No new test set data is presented as part of this Special 510(k) submission.

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

Not applicable. No new test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No new test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC comparative effectiveness study.

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

Not applicable. This device is an electrosurgical wand; it is not an AI algorithm.

7. The Type of Ground Truth Used

Not applicable. No new study requiring ground truth is described.

8. The Sample Size for the Training Set

Not applicable. This device is an electrosurgical wand; there is no AI algorithm with a training set discussed.

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

Not applicable. There is no training set discussed.

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SureTek Reprocessed Electrosurgical Electrodes are intended for use during general, arthroscopic and endoscopic surgery for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels.

Devices are monopolar and bipolar electrosurgical electrodes designed for ablation, resection and coagulation of soft tissue. Instruments consist of one or more distal electrodes, an insulated shaft, and a proximal handle with electrical connections to a compatible electrosurgical unit. Monopolar instruments require concurrent use of a compatible return electrode. Models have varying electrode configurations and tip angles. Some models are equipped with suction tubing for continuous cooling of the ablation site and aspiration of fluids/debris during use. Reprocessed electrodes have equivalent technological characteristics as the predicate devices, i.e. device design, dimensions, energy delivery and system compatibility are unchanged during reprocessing. Device materials are identical with the exception of shaft insulation, which may be replaced with a comparable heat shrink material.

The SureTek Medical 510(k) summary provided does not contain the specific type of acceptance criteria and associated study details that would typically be found for a medical imaging AI device. Instead, this document describes the reprocessed electrosurgical electrodes and focuses on demonstrating substantial equivalence to predicate devices for safety and performance in a manufacturing context.

Therefore, I cannot extract the information required concerning an AI device study. The provided text outlines:

1. Acceptance Criteria & Device Performance: The document states that "Simulated-use testing of instruments following maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices." This is a broad statement regarding functional equivalence but lacks specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would be expected for an AI device. The other listed testing (insulation, cleaning, packaging, sterility, biocompatibility) are related to manufacturing and safety standards, not AI performance.

2. Sample Size, Data Provenance: Not applicable in this context as no AI study is described. The "sample" here refers to reprocessed medical devices, not patient data.

3. Number of Experts, Qualifications: Not applicable.

4. Adjudication Method: Not applicable.

5. MRMC Comparative Effectiveness Study: Not applicable.

6. Standalone Performance: The closest analogous information is the "Simulated-use testing" which compares the reprocessed devices directly to new, unused devices. This is a standalone comparison for the physical device's function.

7. Type of Ground Truth: For the reprocessed electrosurgical electrodes, the "ground truth" seems to be the performance of new, unused devices as the benchmark for "substantial equivalence."

8. Sample Size for Training Set: Not applicable, as this is not an AI model.

9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided SureTek Medical 510(k) summary is for reprocessed electrosurgical electrodes and details performance testing related to manufacturing, safety, and functional equivalence to predicate devices, rather than an AI device's clinical performance study.

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