(98 days)
The TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch is indicated for debridement, resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Procedure | Body Structure as Described Below |
|---|---|
| Fasciotomy | Foot |
| Synovectomy | Foot |
| Tendonotomy | Knee, Wrist, Elbow, Ankle, Shoulder, Foot |
| Rotator Cuff Tendonotomy | Shoulder |
| Capsulotomy | Foot |
The TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch (Topaz EZ IFS) is a bipolar, sterile, high frequency electrosurgical device, which consists of a distal electrode tip composed of tungsten, an alumina ceramic spacer, stainless steel shaft, saline irrigation tubing and a molded handle with an integrated single finger switch used to activate the Wand. The handle connects proximally to the radiofrequency Controller via an electrical cable. The Topaz EZ IFS is only compatible with the ArthroCare Quantum Controllers.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the TOPAZ® EZ Microdebrider Coblation® Wand with Integrated Finger Switch:
1. Table of Acceptance Criteria and Reported Device Performance:
| Testing Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Verification Testing | Performance within established testing specifications, demonstrating substantial equivalence to the predicate device. | Both the Topaz EZ IFS and predicate device had substantially equivalent testing specifications and both performed within acceptance criteria. Results support substantial equivalence. |
| • Visual Inspection | Implicit: Meet visual specifications, no defects. | Performed within acceptance criteria. |
| • Dimensional Inspection | Implicit: Meet dimensional specifications. | Performed within acceptance criteria. |
| • Hi-Pot Testing | Implicit: Meet electrical insulation and dielectric strength requirements. | Performed within acceptance criteria. |
| • Electrical Impedance | Implicit: Meet specified electrical impedance values. | Performed within acceptance criteria. |
| • Saline Flow Rate | Implicit: Meet specified saline flow rates. | Performed within acceptance criteria. |
| • Controller Ablation Set Points | Implicit: Respond correctly to controller ablation set points. | Performed within acceptance criteria. |
| • Finger Switch Actuation Testing | Implicit: Finger switch functions reliably and as intended. | Performed within acceptance criteria. |
| • Ablation Testing | Implicit: Achieve expected ablation performance. | Performed within acceptance criteria. |
| • Shaft Stiffness | Implicit: Meet specified stiffness requirements. | Performed within acceptance criteria. |
| • Axial Compression Force Testing | Implicit: Withstand specified axial compression forces. | Performed within acceptance criteria. |
| Biocompatibility Testing | No adverse biological reactions (cytotoxicity, sensitization, maximization). | The Topaz EZ IFS and the predicate device are biocompatible. Results support substantial equivalence. |
| • Cytotoxicity | No cytotoxic effects. | Biocompatible. |
| • Sensitization | No sensitization reactions. | Biocompatible. |
| • Maximization | No maximization reactions. | Biocompatible. |
| Electrical Safety Testing (IEC 60601-2-2:2009) | Meet all acceptance criteria detailed in IEC 60601-2-2:2009 (e.g., patient protection from electrical shock, electromagnetic compatibility, insulation). | The Topaz EZ IFS and the predicate device met all acceptance criteria in accordance with IEC 60601-2-2: 2009. Results support substantial equivalence. |
2. Sample Size for the Test Set and Data Provenance:
The document describes non-clinical performance testing to support substantial equivalence. It does not explicitly state the sample sizes for each specific test (e.g., how many wands were used for ablation testing or shaft stiffness tests). It also does not specify the provenance of "data" in the sense of patient data, as the tests are non-clinical, mechanical, and electrical in nature.
The changes are largely related to materials and manufacturing, and the data provenance for such tests would typically be laboratory-based (e.g., in-house testing at ArthroCare Corporation), rather than geo-specific or patient-derived. The study is not based on human or animal subjects, but on the device's physical and electrical characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
Not applicable. The "ground truth" for non-clinical performance and safety testing (e.g., dimensions, electrical impedance, biocompatibility) is established by engineering specifications, international standards (like IEC 60601-2-2:2009), and material science principles, not by human expert interpretation of results in the way it would be for a diagnostic AI.
4. Adjudication Method for the Test Set:
Not applicable. As this is not a diagnostic or interpretative study involving human readers, there is no adjudication method used. The results are quantitative measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and an AI might assist or replace them. The TOPAZ® EZ Microdebrider Coblation® Wand is a surgical tool, and its efficacy is evaluated through non-clinical performance, safety, and substantial equivalence to a predicate device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. This concept is not applicable as the device is a physical surgical tool, not an algorithm. The performance described is inherently "standalone" in the sense that the device's functional characteristics (e.g., ablation, electrical safety) are tested on their own.
7. Type of Ground Truth Used:
The ground truth used for these non-clinical tests is based on:
- Engineering Specifications: Designed dimensions, material properties, electrical characteristics.
- Performance Requirements: Defined operational parameters (e.g., saline flow rate, ablation efficacy).
- International Standards: e.g., IEC 60601-2-2:2009 for electrical safety.
- Biocompatibility Standards: Standards for assessing biological reactions to materials.
- Predicate Device Performance: The predicate device's established performance serves as a benchmark for demonstrating substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data for learning. Its design and manufacturing process are based on engineering principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.