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The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:

Knee

1. Meniscectomy
2. Lateral Release
3. Chondroplasty
4. Synovectomy
5. ACL Debridement
6. Plica Removal
7. Meniscal Cystectomy

Ankle

1. Fracture Debridement
2. Excision of Scar Tissue
3. Synovectomy
4. Chondroplasty

Wrist

1. Synovectomy
2. Cartiledge Debridement
3. Fracture Debridement

Shoulder

1. Labral Tear Resection
2. Synovectomy
3. Excision of Scar Tissue
4. Acromioplasty
5. Bursectomy
6. Subacromial Decompression
7. Chondroplasty

Elbow

1. Synovectomy
2. Tendon Debridement
3. Chondroplasty

The Ablator Electrode is packaged in a kit containing an Electrode, pencil, and a Ablator electrosurgical dispersive pad. The electrode will also be individually. The electrode is connected sold to an electrosurgical generator via the electrosurgical pencil.

This document is a 510(k) summary for the Linvatec Ablator Electrode, submitted to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and outlining the device's intended use.

Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data analysis, particularly regarding AI/algorithm performance. The testing mentioned in this document is simply to prove safety and effectiveness for substantial equivalence, not to quantify specific performance metrics for an AI device.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving a device meets them with the provided input. This is not an AI/algorithm-enabled medical device submission.

However, I will address each point based on the information that would typically be present in such a submission if it were for an AI/algorithm device, noting its absence here.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable.
This document describes a conventional electrosurgical electrode, not an AI-powered device. Therefore, there are no specific numerical acceptance criteria for algorithm performance (e.g., sensitivity, specificity, AUC) or reported performance metrics against such criteria. The "performance" mentioned relates to the physical device's safety and effectiveness in its intended surgical applications, typically demonstrated through engineering tests, biocompatibility, and comparison to predicates.

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

Not applicable.
No "test set" in the context of AI/algorithm evaluation is mentioned. The document references "Testing has been done to prove safety and effectiveness of the devices" but provides no details on the nature of this testing, sample sizes, or data provenance.

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

Not applicable.
No "experts" for establishing ground truth of an imaging or diagnostic dataset are mentioned. Ground truth derivation is not relevant for this type of conventional surgical device.

4. Adjudication Method for the Test Set

Not applicable.
No adjudication method is mentioned as there is no test set or ground truth determination in the context of an AI/algorithm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable.
No MRMC study was conducted. This device is not an AI-assisted diagnostic or interpretative tool for human readers.

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

Not applicable.
There is no standalone algorithm performance to measure, as this is a physical medical device.

7. The Type of Ground Truth Used

Not applicable.
No ground truth is used for this device as it is not an AI/algorithm-enabled device.

8. The Sample Size for the Training Set

Not applicable.
No training set is mentioned as there is no AI/algorithm in this device.

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

Not applicable.
No ground truth for a training set is established, as there is no AI/algorithm in this device.

Summary of the Document's Contents Regarding "Performance":

The document focuses on:

• Device Description: The Ablator Electrode is packaged in a kit, connected to an electrosurgical generator via a pencil, and sold individually.
• Intended Use: General surgical use for resection, ablation, excision of soft tissue, hemostasis, and coagulation in various arthroscopic procedures (knee, ankle, wrist, shoulder, elbow).
• Substantial Equivalence: The key regulatory pathway chosen. The device is claimed to be substantially equivalent in design, function, and intended use to existing predicate devices: ESA Electrodes (Linvatec), ArthroCare® Electrosurgery System 2000 (ArthroCare), and VAPR™ (Mitek Products).
• Safety and Effectiveness: The document states, "Testing has been done to prove safety and effectiveness of the devices." However, it does not provide details of these tests, specific performance metrics, or acceptance criteria. This "testing" is typically non-clinical (e.g., electrical safety, biocompatibility, mechanical strength), and comparison to predicate devices, rather than clinical trials with defined performance endpoints.

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