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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: Ablation and Debridement (ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Facia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Excision and Resection (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoidale Labrum, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons).

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

The provided 510(k) summary for the ArthroCare ArthroWands is a submission that proposes modifications in the materials specification of a previously cleared device (K082323). This is a "Special 510(k)" submission.

For Special 510(k)s, substantial equivalence is claimed when design or manufacturing changes are made to a manufacturer's own legally marketed device, and the changes do not significantly affect the safety or effectiveness of the device. Therefore, the "study" demonstrating that the device meets acceptance criteria is typically a demonstration that the new materials do not negatively impact the performance of the device or pose new safety risks, rather than a clinical performance study against specific acceptance criteria. The existing performance of the predicate device is assumed to be acceptable.

Based on the provided text, the specific details regarding acceptance criteria and a study proving performance as one might expect for a de novo device or a traditional 510(k) for a novel device are not explicitly stated in this summary. Instead, the document focuses on demonstrating that the modifications do not change the safety and effectiveness relative to the predicate.

Here's how to interpret the request in the context of this Special 510(k):

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

Since this is a Special 510(k) for material changes, there are no new performance acceptance criteria outlined. The acceptance criterion is effectively that the device's performance, safety, and effectiveness remain unchanged from the predicate device despite the material specification modifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical "test set" or clinical data provenance. The assessment for a Special 510(k) regarding material changes typically involves bench testing, biocompatibility testing, and potentially some limited non-clinical performance testing to ensure the new materials meet specifications and do not negatively impact the device. The specific sample sizes for such engineering or materials tests are not provided in this summary.

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)

Not applicable. The submission is about material changes and relies on bench and non-clinical testing, not expert-adjudicated clinical data.

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

Not applicable, as no clinical test set requiring expert adjudication is described.

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. This device is an electrosurgical tool, not an AI-powered diagnostic device.

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

Not applicable. This device is an electrosurgical tool, not a standalone algorithm.

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

For a Special 510(k) involving material changes, the "ground truth" would be established specifications and standards for the materials themselves (e.g., biocompatibility standards, mechanical property specifications, electrical performance safety standards). The summary does not detail the specific standards or how compliance was achieved.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

Summary of the Study Proving Device Meets Acceptance Criteria (as per the Special 510(k) context):

The "study" in this context is the design control process and testing performed by ArthroCare Corporation to ensure that the proposed material changes do not affect the safety or efficacy of the ArthroWands. The document states:

"The proposed modifications in the materials is not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."

This statement serves as the conclusion of their internal assessment and testing (e.g., bench testing, biocompatibility, electrical safety, performance testing specific to the material change) that would have been conducted to demonstrate continued substantial equivalence to the predicate device K082323. The 510(k) summary itself does not provide the detailed results or methodology of these tests, but rather asserts their outcome. The FDA's clearance (K082980) indicates that they reviewed this assessment and agreed with the manufacturer's conclusion.

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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.

This 510(k) summary does not contain information on acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document describes modifications to the ArthroCare ArthroWands, which were previously cleared, and asserts that these modifications are not substantial and do not significantly affect safety or efficacy. The review is for "substantial equivalence" to a predicate device, not for specific performance metrics based on new studies.

Therefore, the requested information cannot be extracted from the provided text.

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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.

This is a 510(k) premarket notification for electrosurgical devices (ArthroCare® ArthroWands®). The document states that the proposed modifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices; therefore, no new studies were conducted. The device is found to be substantially equivalent to previously cleared predicate devices (K020557 and K033584).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or performance metrics derived from new testing are provided in this special 510(k). The basis for clearance is substantial equivalence to predicate devices. The document explicitly states: "The proposed modifications in the performance specifications, labeling, and packaging configuration are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."

Therefore, the "acceptance criteria" here is that the modified device's performance remains consistent with, and not significantly worse than, the predicate devices cleared under K020557 and K033584, for which presumably performance data would have been submitted at that time.

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

No new test set was used for a study comparing the modified device's performance directly. This submission relies on the established performance of its predicate devices.

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

Not applicable, as no new clinical or performance test set was evaluated.

4. Adjudication Method for the Test Set

Not applicable, as no new test set was evaluated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention any MRMC study. The device is an electrosurgical tool, which typically undergoes performance testing (e.g., power output, tissue effects) rather than MRMC studies.

6. Standalone Performance Study (Algorithm Only)

No. This is a physical electrosurgical device, not an AI algorithm.

7. Type of Ground Truth Used

Not applicable, as no new performance claims, clinical data, or "ground truth" establishment are presented for the modified device beyond its substantial equivalence to predicates.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

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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 text is a 510(k) summary for the ArthroCare ArthroWands, an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to a predicate device (K032504) rather than presenting a study proving that the device meets specific acceptance criteria through performance validation.

Therefore, many of the requested details about acceptance criteria, the study design, sample sizes, expert involvement, and ground truth are not present in this document.

Here's the breakdown of what can and cannot be extracted from the provided text:

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

• Not present. The document explicitly states: "The proposed modifications in materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This implies that no new performance testing was conducted against new acceptance criteria. Instead, the device's performance is assumed to be equivalent to the predicate device due to the nature of the modifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not present. No specific test set or associated data is described as part of this 510(k) submission, as it relies on substantial equivalence to the predicate device.

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)

• Not present. Ground truth establishment is not relevant in this context because no performance study on a test set is described.

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

• Not present. No test set or related adjudication process 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

• Not present. This document discusses an electrosurgical device, not an AI-assisted diagnostic tool.

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

• Not present. This is not an algorithm, but a medical device.

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

• Not present. No ground truth is established for a new performance study.

8. The sample size for the training set

• Not present. This is not a machine learning or AI device that would involve a training set.

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

• Not present. Not applicable.

Summary of the document's content relevant to performance and equivalence:

• Basis for Equivalence: The submission is a "Special 510(k)" proposing "modifications in materials for the ArthroCare ArthroWands."
• Key Statement on Equivalence: "The proposed modifications in materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This means that the manufacturer is asserting that the changes are minor enough that new specific performance testing isn't required to assure safety and effectiveness, as the device is considered substantially equivalent to its predicate.
• Predicate Device: ArthroCare® System (K032504), cleared on August 21, 2003.
• Attributes Remaining the Same: "The indications for use, technology, principle of operation, packaging, sterilization parameters, and labeling of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)."

In essence, this 510(k) relies on the premise that because the changes are only material modifications and do not alter the fundamental operation or intended use, the device inherently meets its (unchanged) performance expectations, which were previously established for the predicate device. No new "acceptance criteria" or a new "study proving device meets acceptance criteria" are detailed in this specific document.

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