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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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The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

The provided document, K030551, is a 510(k) Pre-market Notification for the ArthroCare ArthroWands. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies with reported performance metrics.

Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics for the device itself (as if it were a novel device undergoing clinical efficacy trials) is not present in this document. The document primarily attests that the modifications to the ArthroWands do not significantly affect safety or efficacy compared to the previously cleared predicate device (K020557).

Here's an breakdown based on the available information:

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

This document does not contain a table of acceptance criteria or reported device performance in the way one would expect for a de novo submission or a clinical trial report. The "acceptance criteria" here is implicitly "substantial equivalence" to the predicate device. The performance is assessed through the unchanged indications for use and principle of operation.

2. Sample size 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. As a 510(k) for modifications to a predicate device, it likely relies on non-clinical testing (e.g., bench testing for dimensional changes, material compatibility) and a comparison to the established safety and efficacy of the predicate device, rather than a clinical "test set" in the traditional sense.

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 applicable/not provided. The document does not describe a clinical study requiring ground truth established by experts.

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

This information is not applicable/not provided. There is no description of a clinical test set requiring adjudication.

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 applicable/not provided. This device is an electrosurgical tool, not an AI-powered diagnostic imaging device.

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

This information is not applicable/not provided. This is an electrosurgical device, not an algorithm.

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

This information is not applicable/not provided. The assessment relies on substantial equivalence to the predicate device, which would have had its own methods of demonstrating safety and effectiveness originally (likely through a combination of non-clinical and potentially some clinical data, but not detailed here).

8. The sample size for the training set

This information is not applicable/not provided. This document does not describe a machine learning algorithm requiring a training set.

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

This information is not applicable/not provided. No training set is mentioned as this device is not an AI/ML product.

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The Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.

The Wands are bipolar, single use, high frequency electrosurgical device designed for specific indications.

The provided document is a 510(k) Summary for the ArthroCare Electrosurgery Wands, which details a modification in material for an already cleared device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with acceptance criteria for device performance.

Therefore, the information typically requested regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this specific submission.

The document states:
"The proposed modification in material is not a substantial change or modification, and does not significantly affect the safety or efficacy of the devices." (page 1)

And confirms:
"The indications for use, technology, principle of operation, design, performance and dimensional specifications, labeling, packaging, and sterilization parameters of the ArthroCare Electrosurgery Wands remain the same as in the predicate cleared 510(k)." (page 1)

This means that the device's performance characteristics (and any associated acceptance criteria) were established and accepted during the clearance of the predicate device (K020622). This 510(k) is specifically for a material change, not a new device requiring new performance data.

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The Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.

The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications.

The provided document is a 510(k) summary for ArthroCare Electrosurgery Wands. It discusses a special 510(k) submission for modifications to a previously cleared device (K014222). The key aspect of this submission is that the modified specifications, materials, and labeling are not substantial and do not significantly affect the safety or efficacy of the devices, and thus the device is considered substantially equivalent to its predicate.

Crucially, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data analysis, such as sensitivity, specificity, or accuracy metrics often associated with AI/ML devices.

This document is a regulatory submission for an electrosurgical device, not an AI/ML diagnostic tool. Therefore, the questions related to clinical study design for AI/ML devices (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to the information contained within this 510(k) summary.

The summary states: "The Electrosurgery System modified Wands, as described in this submission, are substantially equivalent to the predicate, unmodified Wands. The proposed modifications in dimensional and performance specifications, materials, and labeling are not substantial and do not significantly affect the safety or efficacy of the devices." This statement serves as the "proof" that the device meets acceptance criteria, implying that it continues to perform as safely and effectively as the predicate device because the changes are not substantial.

Therefore, I cannot populate the table or answer most of the questions as the document does not provide this type of information.

Here's what I can infer from the document regarding the general nature of this submission:

1. A table of acceptance criteria and the reported device performance:
   The document asserts "substantial equivalence" to a predicate device (K014222) due to "modifications in dimensional and performance specifications, materials, and labeling [that] are not substantial and do not significantly affect the safety or efficacy of the devices." This implies that the 'acceptance criteria' are met by demonstrating that the modified device performs identically or insignificantly differently from the predicate device, whose performance would have been established during its original clearance. No specific quantitative performance metrics (e.g., in terms of cutting efficiency, coagulation time, tissue damage) or acceptance thresholds for these metrics are provided in this summary.

2. Sample sizes used for the test set and the data provenance: Not applicable. This document does not describe a clinical study in the context of an AI/ML device to establish performance metrics against a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

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: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a regulatory clearance document for an electrosurgical device based on substantial equivalence, not a performance study report for an AI/ML medical device.

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