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510(k) Data Aggregation
(224 days)
SureTek Reprocessed Electrosurgical Electrodes are intended for use during general, arthroscopic and endoscopic surgery for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels.
Devices are monopolar and bipolar electrosurgical electrodes designed for ablation, resection and coagulation of soft tissue. Instruments consist of one or more distal electrodes, an insulated shaft, and a proximal handle with electrical connections to a compatible electrosurgical unit. Monopolar instruments require concurrent use of a compatible return electrode. Models have varying electrode configurations and tip angles. Some models are equipped with suction tubing for continuous cooling of the ablation site and aspiration of fluids/debris during use. Reprocessed electrodes have equivalent technological characteristics as the predicate devices, i.e. device design, dimensions, energy delivery and system compatibility are unchanged during reprocessing. Device materials are identical with the exception of shaft insulation, which may be replaced with a comparable heat shrink material.
The SureTek Medical 510(k) summary provided does not contain the specific type of acceptance criteria and associated study details that would typically be found for a medical imaging AI device. Instead, this document describes the reprocessed electrosurgical electrodes and focuses on demonstrating substantial equivalence to predicate devices for safety and performance in a manufacturing context.
Therefore, I cannot extract the information required concerning an AI device study. The provided text outlines:
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Acceptance Criteria & Device Performance: The document states that "Simulated-use testing of instruments following maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices." This is a broad statement regarding functional equivalence but lacks specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would be expected for an AI device. The other listed testing (insulation, cleaning, packaging, sterility, biocompatibility) are related to manufacturing and safety standards, not AI performance.
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Sample Size, Data Provenance: Not applicable in this context as no AI study is described. The "sample" here refers to reprocessed medical devices, not patient data.
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Number of Experts, Qualifications: Not applicable.
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Adjudication Method: Not applicable.
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MRMC Comparative Effectiveness Study: Not applicable.
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Standalone Performance: The closest analogous information is the "Simulated-use testing" which compares the reprocessed devices directly to new, unused devices. This is a standalone comparison for the physical device's function.
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Type of Ground Truth: For the reprocessed electrosurgical electrodes, the "ground truth" seems to be the performance of new, unused devices as the benchmark for "substantial equivalence."
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Sample Size for Training Set: Not applicable, as this is not an AI model.
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How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided SureTek Medical 510(k) summary is for reprocessed electrosurgical electrodes and details performance testing related to manufacturing, safety, and functional equivalence to predicate devices, rather than an AI device's clinical performance study.
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(7 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Performance specifications not significantly altered | Performance is consistent with predicate devices |
| Safety not significantly affected | Safety profile is consistent with predicate devices |
| Efficacy not significantly affected | Efficacy is consistent with predicate devices |
| Indications for Use remain the same | Indications for Use are identical to predicate devices |
| Technology remains the same | Technology is identical to predicate devices |
| Principle of operation remains the same | Principle of operation is identical to predicate devices |
| Sterilization parameters remain the same | Sterilization parameters are identical to predicate devices |
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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