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The Medline ReNewal Reprocessed ArthroWands models ASHA 4250-01; ASH 4250-01; ASHA 2530-01; ASHA 3730-01; ASHA 4830-01; and ASH 4830-01 and Medline ReNewal Reprocessed Smith & Nephew Dyonics model 72202140 ablation wands 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 (knee); acromioplasty (shoulder); articular cartilage (all joints); bursectomy (all joints); chondroplasty (all joints); fascia (all joints); notchplasty (knee); scar tissue (all joints); soft tissue (all joints);subacromial decompression (shoulder); synovectomy (all joints); and tendon (all joints).

Excision and Resection: acetabular labrum (hip); articular labrum (all joints); capsular release (knee); cartilage flaps (knee); cysts (all joints); discoid meniscus (knee); frozen shoulder); glenoidale labrum (shoulder); lateral release (knee); ligament (all joints); loose bodies (all joints); meniscal cystectomy (knee); meniscectomy (knee); plica removal (all joints); soft tissue (all joints); synovial membrane (all joints); tendon (all joints); triangular fibrocartilage (TFCC); (wrist); and villusectomy (knee). Coagulation: ACL/PCL (knee); articular cartilage (all joints); carpal ligaments (wrist); glenohumeral capsule (shoulder); ligament (all joints); medial retinaculum (knee); rotator cuff (shoulder); tendon (all joints) and wrist tendons (wrist).

Ablation wands are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic procedures, including knee, shoulder, ankle, hip, elbow, and wrist joints. The device is powered by a separate generator. The generator is not included in the scope of the study and will not be reprocessed.

This document is a 510(k) premarket notification for reprocessed electrosurgical cutting and coagulation devices. It details the substantial equivalence determination made by the FDA. The document does not describe the acceptance criteria and study for a medical device's performance in the context of AI/ML or clinical efficacy, but rather focuses on the substantial equivalence of reprocessed medical devices to predicate devices.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods (as typically applied to AI/ML device evaluations) are not applicable to this type of submission.

However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence for the reprocessed devices:

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

The document describes various performance tests conducted to demonstrate equivalence to the predicate devices. It doesn't present a table of specific acceptance criteria values alongside reported device performance values in the way one would for a novel device's clinical efficacy. Instead, it lists the types of tests performed and states that the devices were "found to be equivalent."

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for each of the performance tests listed. The data provenance is implied to be from laboratory testing performed by Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) as part of their reprocessing validation, conducted in the United States. It's retrospective in the sense that the studies are conducted after the reprocessing process is established.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. For reprocessed devices, "ground truth" refers to the original device's performance characteristics. Equivalence testing compares the reprocessed device to the original (predicate) specifications, not human expert interpretation.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments. The tests described are objective engineering and performance validations.

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. This document concerns reprocessed electrosurgical tools, not AI/ML-assisted diagnostic or interpretive devices. No MRMC studies were conducted.

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

This information is not applicable. This document does not describe an AI/ML algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the established performance specifications and safety profiles of the original, legally marketed predicate devices. The reprocessed devices are evaluated against these known characteristics to demonstrate that they perform "as good as" the original devices.

8. The sample size for the training set:

This information is not applicable. There is no "training set" in the context of validating reprocessed physical medical devices.

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

This information is not applicable. As there is no training set, there is no ground truth to establish for it in this context.

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The ArthroCare System 15000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare System 15000 consists of a bipolar, high frequency, electrosurgical generator called the Controller, a family of disposable, bipolar, single use Wands and Foot Control.

This document describes the ArthroCare® System 15000, an electrosurgical device for arthroscopic and orthopedic procedures. However, the provided text does not contain any information regarding acceptance criteria or the results of a study designed to prove the device meets specific acceptance criteria.

The document is a 510(k) summary for premarket notification to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical or performance study with detailed metrics.

Therefore, I cannot provide the requested information in the format requested. The document primarily discusses the device description, intended uses, and asserts substantial equivalence to predicate devices based on a comparison of specifications and "performance testing" without detailing the nature, methods, or results of this testing.

There is no information in the provided text to fulfill the following requirements of your request:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance metrics are detailed.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not 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 mentioned; this device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned; this is an electrosurgical device, not an algorithm.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document states: "Additionally, performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare System 15000 to the predicate device. The performance testing and device comparison demonstrated that the subject devices are substantially equivalent to the predicate devices, and is safe and effective for its intended use." This is a general statement and does not provide the detailed information requested about acceptance criteria or study specifics.

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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 a medical device (ArthroCare ArthroWands). It is not a study about an AI/ML device. Therefore, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria, device performance, study types (MRMC, standalone), sample sizes, ground truth establishment, or expert qualifications in the context of an AI/ML study.

The document primarily states that the proposed modifications to the ArthroCare ArthroWands are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." It asserts substantial equivalence to a predicate device (K082980) based on unchanged indications for use, technology, principles of operation, and sterilization parameters, with only material specification changes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from an AI/ML study, nor any of the other requested details related to such a study, because the provided text does not describe an AI/ML product or performance study.

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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 document is a 510(k) summary for the ArthroCare ArthroWands, a medical device for electrosurgical cutting and coagulation. It's a regulatory submission to the FDA, not a study report. Therefore, it does not contain information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as it would for an AI/ML device study.

This submission is for a traditional medical device (electrosurgical device), where "acceptance criteria" and "study" are typically evaluated through bench testing, animal studies, and potentially human clinical trials to demonstrate safety and effectiveness for its intended use, often compared to existing predicate devices. The document explicitly states:

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

This indicates that the device is a modification of an already cleared predicate device (K071963 and other 510(k)s), and the basis for its substantial equivalence is that these modifications do not change the fundamental safety or efficacy. Therefore, a new, extensive study proving "device meets acceptance criteria" in the context of AI/ML performance metrics would not be included here.

In summary, the provided text does not contain the information requested based on the nature of a 510(k) submission for a non-AI/ML 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:
Ablation and Debridement: ACL/PCL (Knee), Acromioplasty (Shoulder), Articular Cartilage (All Joints), Bursectomy (All Joints), Chondroplasty (All Joints), Facia (All Joints), Ligament (All Joints), Notchplasty (Knee), Scar Tissue (All Joints), Soft Tissue (All Joints), Subacromial Decompression (Shoulder), Synovectomy (All Joints), Tendon (All Joints).
Excision and Resection: Acetabular Labrum (Hip), Articular Labrum (All Joints), Capsule (All Joints), Capsular Release (Knee), Cartilage Flaps (Knee), Cysts (All Joints), Discoid Meniscus (Knee), Frozen Shoulder Release (Shoulder), Glenoidale Labrum (Shoulder), Lateral Release (Knee), Ligament (All Joints), Loose Bodies (All Joints), Meniscal Cystectomy (Knee), Plica Removal (All Joints), Scar Tissue (All Joints), Soft Tissue (All Joints), Synovial Membrane (All Joints), Tendon (All Joints), Triangular Fibrocartilage (TFCC) (Wrist), Villusectomy (Knee).
Coagulation: ACL/PCL (Knee), Articular Cartilage (All Joints), Carpal Ligaments (Wrist), Glenohumeral Capsule (Shoulder), Ligament (All Joints), Medial Retinaculum (Knee), Rotator Cuff (Shoulder), Tendon (All Joints), Wrist Tendons (Wrist).

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

The provided text describes a 510(k) summary for the ArthroCare ArthroWands. However, it does not contain any information about acceptance criteria, device performance metrics, or details of a study (such as sample sizes, ground truth establishment, or expert involvement) that proves the device meets specific criteria.

The document states that the ArthroCare ArthroWands are substantially equivalent to predicate devices (K070958 and K040338). The current submission (K071963) is a Special 510(k) for modifications in performance specifications and labeling, noting that "The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)s." It explicitly states, "The proposed modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices."

Therefore, based solely on the provided text, I cannot fill out the requested information about acceptance criteria or a study proving those criteria are met. The FDA's determination of substantial equivalence implies that the device is deemed safe and effective because it is similar to devices already legally marketed, rather than through a new, comprehensive performance study outlined in this document.

To briefly address each point based on the absence of information:

1. A table of acceptance criteria and the reported device performance: Not provided. The document relies on substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance: Not provided. No specific test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 is 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 applicable. This is an electrosurgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not applicable; not a machine learning device.
9. How the ground truth for the training set was established: Not applicable; not a 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.

This document is a 510(k) summary for a medical device (ArthroCare ArthroWands) and does not contain the acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical validation reports for AI/CADe devices.

Instead, this document is focused on demonstrating substantial equivalence to a previously cleared predicate device for a modification in material. The relevant sections state:

• "This Special 510(k) proposes modifications in material for the ArthroCare ArthroWands, which were previously cleared in K052686 (October 5, 2005). The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)s."
• "The modified ArthroCare ArthroWands, as described in this Special 510(k), are substantially equivalent to the predicate device. The proposed modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because it is not present in the provided text. The document's purpose is to show that a material change does not alter the device's safety or effectiveness, not to present a new performance study.

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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:

| Arthroscopic and Orthopedic Procedures | Joint Specific or All
Joints (ankle, elbow,
hip, knee, shoulder, and
wrist) |
|----------------------------------------|--------------------------------------------------------------------------------------|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| • Bursectomy | All Joints |
| • Chondroplasty | All Joints |
| • Facia | All Joints |
| • Ligament | All Joints |
| • Notchplasty | Knee |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Subacromial Decompression | Shoulder |
| • Synovectomy | All Joints |
| • Tendon | All Joints |
| Excision and Resection | |
| • Acetabular Labrum | Hip |
| • Articular Labrum | All Joints |
| • Capsule | All Joints |
| • Capsular Release | Knee |
| • Cartilage Flaps | Knee |
| • Cysts | All Joints |
| • Discoid Meniscus | Knee |
| • Frozen Shoulder Release | Shoulder |
| • Glenoidale Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • Meniscal Cystectomy | Knee |
| • Meniscectomy | Knee |
| Continued | |
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
| • Plica Removal | All Joints |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Synovial Membrane | All Joints |
| • Tendon | All Joints |
| • Triangular Fibrocartilage (TFCC) | Wrist |
| • Villusectomy | Knee |
| Coagulation | |
| • ACL/PCL | Knee |
| • Articular Cartilage | All Joints |
| • Carpal Ligaments | Wrist |
| • Glenohumeral Capsule | Shoulder |
| • Ligament | All Joints |
| • Medial Retinaculum | Knee |
| • Rotator Cuff | Shoulder |
| • Tendon | All Joints |
| • Wrist Tendons | Wrist |

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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