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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:

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

The provided text is a 510(k) summary for the ArthroCare System 15000, an electrosurgical device. It outlines the device description, predicate devices, and intended use. However, it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria in terms of analytical or clinical performance (e.g., sensitivity, specificity, accuracy, concordance rates).

The summary states: "The modified ArthroCare System 15000, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This indicates that the regulatory clearance was based on demonstrating substantial equivalence to a previously cleared predicate device (K090393), rather than the presentation of a new study with explicit performance acceptance criteria and results.

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

Here's a breakdown of why each point cannot be fulfilled based on the given text:

1. A table of acceptance criteria and the reported device performance: Not available. The document focuses on substantial equivalence to a predicate device, not on specific performance metrics with acceptance criteria.
2. Sample sized used for the test set and the data provenance: No test set information is provided as no new clinical or analytical study with a test set is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication 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 applicable. The device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an electrosurgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no specific performance study requiring ground truth is detailed.
8. The sample size for the training set: Not applicable, as no algorithmic training is involved.
9. How the ground truth for the training set was established: Not applicable, as no algorithmic training is involved.

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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 System 12000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare System 12000 is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.

The provided text is for a 510(k) premarket notification for a medical device called the "ArthroCare System 12000." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical study for an AI/ML-driven diagnostic device.

Therefore, the requested information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document.

Here's why and what the document does state:

• No Acceptance Criteria or Performance Metrics: The 510(k) summary for the ArthroCare System 12000, an electrosurgical device, does not contain a table of acceptance criteria or reported device performance metrics in the way one would see for an AI/ML diagnostic. Its purpose is to demonstrate that it is as safe and effective as a previously approved device.
• Substantial Equivalence, Not De Novo Performance: The core of this 510(k) is "Substantial Equivalence" to a predicate device (ArthroCare® System K032504). This means that the device manufacturer is asserting that their new device is similar enough in intended use, technology, safety, and effectiveness to a device already on the market.
• Performance Testing Mentioned, but Details Absent: The document states, "Additionally, performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare System 12000 to the predicate device." However, it does not provide details about this performance testing, such as specific metrics, sample sizes, data provenance, ground truth, or expert involvement. It simply concludes that the testing "demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use."
• No AI/ML Component: The ArthroCare System 12000 is described as a "bipolar, high frequency, electrosurgical generator... intended to be used with a family of disposable, bipolar, single use Wands." This is a physical and electrical medical device, not an AI/ML-driven diagnostic or assistive system. Therefore, concepts like "AI assistance," "standalone algorithm performance," "training set," and "test set" in the context of AI are irrelevant.

In summary, the provided text does not contain the information required to populate the table or answer the specific questions about acceptance criteria and study design for an AI/ML diagnostic device. It's a regulatory document for a traditional electrosurgical device seeking market clearance through substantial equivalence.

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

The ArthroCare System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

This document is a 510(k) summary for the ArthroCare System, an electrosurgical device. It details the device's intended use, its substantial equivalence to a predicate device, and confirms that modifications do not significantly affect safety or efficacy. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets specific acceptance criteria related to its performance metrics.

The document discusses:

• Device Description: A bipolar, high-frequency electrosurgical system comprising a Controller, disposable Wands, and a reusable Patient Cable.
• Intended Uses: Resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in various arthroscopic and orthopedic procedures across multiple joints.
• Substantial Equivalence: The current submission (K032504) proposes modifications to performance specifications, dimensional specifications, and labeling of an already cleared device (K030551). It explicitly states that "The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare System remain the same as in the predicate cleared 510(k)." The document concludes that the modifications are not substantial and do not significantly affect safety or efficacy.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria and a study demonstrating the device meets those criteria. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures.

The ArthroCare Electrosurgery System is a bipolar, high frequency electrosurgical System designed for use in general surgical procedures where ablation and resection of soft tissue and coagulation of blood vessels is desired. The System consists of three components: an electrosugical generator called the Controller, the reusable Cable, and the disposable Wand. The Controller utilizes radio frequency (RF) energy as a power source. RF energy is delivered to the patient via the Cable and the Wand. The Cable is designed to connect the Controller to the Wand for patient treatment. The single use, sterile Wand is the patient contacting component of the System, and is available with suction and/or irrigation. The Wand can be configured with single or multiple electrodes. The ArthroCare Electrosurgery System uses bipolar technology in the design of the Wand, eliminating the need for a patient contacting dispersive pad used in monopolar devices.

This document is a 510(k) summary for a medical device modification, not a study report. It states that the device's substantial equivalence is based on the fact that modifications to the ArthroCare Electrosurgery System's Wands "are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device." Therefore, it does not contain specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria in the way a clinical or performance study would.

Instead, the submission for K992972 is a Special 510(k) for modifications to an already cleared device (K971532). It claims substantial equivalence to the predicate device because the technology, principle of operation, and intended use remain the same.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted directly from this document.

Here's what can be gathered, addressing your points where possible:

1. A table of acceptance criteria and the reported device performance:
   This information is not provided in the document. The submission asserts that the modifications do not significantly affect safety or efficacy, implying that the modified device's performance is still within the acceptable range of the original cleared device. No new performance metrics or acceptance criteria are defined or reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not applicable/Not provided. This document does not describe a performance or clinical study with a test set.

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/Not provided. This document does not describe a performance or clinical study requiring ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable/Not provided. This document does not describe a performance or clinical study with a test set.

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 electrosurgery system, not an AI-assisted diagnostic tool leveraging human readers. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is an electrosurgery system and does not involve an algorithm for standalone performance evaluation in the described context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable/Not provided. As there is no described performance study, there is no ground truth data. The submission relies on demonstrating that modifications do not change the fundamental safety and efficacy established for the predicate device.

8. The sample size for the training set:
   Not applicable/Not provided. This document does not describe a performance study involving a training set.

9. How the ground truth for the training set was established:
   Not applicable/Not provided. As there is no training set described, there is no ground truth established for it.

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