(132 days)
The INTELLIO SHIFT System is indicated for:
- Resection of soft and osseous tissues .
- . Resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during the following arthroscopic and orthopedic procedures:
| Arthroscopic | | |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Location | Ablation/Debridement | Excision/Resection |
| All Joints (Hip,
Knee, Shoulder,
Wrist, Ankle,
Elbow) | Articular Cartilage Bursectomy Chondroplasty Fascia Ligament Scar Tissue Soft Tissue Synovectomy Tendon | Articular Labrum Capsule Cysts Ligament Loose Bodies Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon |
| Hip | N/A | Acetabular Labrum |
| Knee | ACL/PCL Notchplasty | Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release Meniscal Cystectomy Meniscectomy Villusectomy |
| Shoulder | Subacromial Decompression Acromioplasty | Frozen Shoulder Release Glenoid Labrum |
| Wrist | N/A | Triangular Fibrocartilage (TFCC) |
| Orthopedic | | |
| Hemostasis (via coagulation) of soft tissue and bone | | |
The INTELLIO SHIFT System combines two previously cleared technologies into one system. The INTELLIO SHIFT System is composed of (1) a controller that combines the radio frequency coblation/coagulation technology of the previously cleared (K210423) WEREWOLF+ COBLATION System with the mechanical resection technology of the previously cleared (K062849) DYONICS POWER II Control System and (2) a wired foot pedal that controls these two technologies. The INTELLIO SHIFT System utilizes the same technologies as the predicates and matches the performance requirements of the WEREWOLF+ and DYONICS POWER II controllers. The INTELLIO SHIFT System allows the user to select and operate two established resection technologies using the same device: Mechanical Resection (MR) for cutting and tissue removal, and Bipolar Radio Frequency (RF) for coblation/coagulation. The INTELLIO SHIFT System is compatible with various accessories including RF coblation/coagulation Wands, a Mechanical Resection Motor Drive Unit Handpiece, and a wired foot pedal. The INTELLIO SHIFT System interfaces with a handpiece Motor Drive Unit (MDU) shaver, to provide mechanical cutting and tissue removal. The INTELLIO SHIFT System interfaces with RF Wands to utilize bipolar RF technology for the resection, ablation, and coagulation of tissues and hemostasis of blood vessels in various arthroscopic, and orthopedic procedures. Additionally, the INTELLIO SHIFT System can be interfaced directly with 510K cleared fluid management systems. INTELLIO SHIFT provides an optional interface for the INTELLIO Connected Tower, which is composed of Smith and Nephew equipment typically used in arthroscopic or orthopedic surgical procedures and stored near each other on a single cart. While the INTELLIO SHIFT System provides options to healthcare professionals to use both Mechanical Resection and Coblation/Coagulation through the same device and within the same surgery, these technologies cannot be used at the exact same time.
The INTELLIO SHIFT System is an electrosurgical cutting and coagulation device. The provided text, however, is a 510(k) summary for FDA clearance and does not include a clinical study with acceptance criteria and reported device performance directly comparable to the format requested.
The summary focuses on demonstrating substantial equivalence to existing predicate devices (WEREWOLF+ COBLATION System and DYONICS POWER II Control System) through a comparison of intended use, indications for use, and general/technical characteristics, along with non-clinical performance data.
Here's an attempt to extract and present the information based on the provided text, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) summary predicated on substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined target performance metrics for a novel clinical study. Instead, the "acceptance criteria" for clearance are that the new device's characteristics and performance are "at least as safe and effective as the predicates" and that any differences do "not raise any new questions of safety and efficacy." The "reported device performance" is essentially the device demonstrating it meets these equivalence criteria through non-clinical testing.
| Acceptance Criteria (Implicit for 510(k) Clearance) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Functional Equivalence | The INTELLIO SHIFT System provides Radiofrequency Resection, Ablation, Coagulation, and Mechanical Resection (MR), combining the functionalities of the primary (WEREWOLF+ COBLATION System: Radiofrequency Resection, Ablation, Coagulation) and reference (DYONICS POWER II Control System: Mechanical Resection) predicate devices. |
| Mechanical Resection Performance | Bench tests for Mechanical Resection Performance passed all established acceptance criteria. |
| Mechanical Resection Reliability | Bench tests for Mechanical Resection Reliability passed all established acceptance criteria. |
| Software Automation Verification | Bench tests for Software Automation Verification passed all established acceptance criteria. |
| Disconnection Force Testing, RF Wands | Bench tests passed all established acceptance criteria. |
| Motor Drive Unit and Foot Pedal Pull Force Verification | Bench tests passed all established acceptance criteria. |
| Fluid Control Module Verification | Bench tests passed all established acceptance criteria. |
| Environmental Performance | Bench tests for Storage Environmental Verification, Environmental Operation Verification, and Foot Pedal Environmental Operation Verification passed all established acceptance criteria. |
| Packaging Design Verification for Controller | Bench tests passed all established acceptance criteria. |
| Audible Notifications, Reset, and Power Cycling | Bench tests passed all established acceptance criteria. |
| Design Verification Physical characteristics | Bench tests passed all established acceptance criteria. |
| Electrical Safety and EMC Compliance | EMI/EMC Testing (IEC 60601-1-2) and Electrical Safety Testing (IEC 60601-1, IEC 60601-1-8, IEC 60601-2-2, IEC 60601-1-9) were submitted and passed. |
| Cybersecurity Posture | "The cybersecurity posture of the INTELLIO SHIFT System Software has been comprehensively assessed. The known cybersecurity risks have been identified and the proper mitigations and controls have been identified." |
| No New Questions of Safety and Efficacy compared to Predicates | The submission concludes that "any differences in technological characteristics of the predicates do not raise any new questions of safety and efficacy and (2) the proposed device is at least as safe and effective as the predicates." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a clinical study with human subjects that would have a "test set" in the context of AI performance evaluation. The "tests" mentioned are non-clinical bench tests. Therefore, information on sample size for a human-data test set or its provenance (country of origin, retrospective/prospective) is not applicable or available in this document.
3. Number of Experts Used to Establish Ground Truth and Qualifications
As there is no clinical study involving human data or expert review mentioned, this information is not applicable to this 510(k) summary.
4. Adjudication Method
This is not applicable as no expert review or adjudication of a test set is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or described in this 510(k) summary. The device discussed is a surgical tool, not an AI-assisted diagnostic or interpretation system for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The device is a physical electrosurgical system with software control. It is designed to be used with a human operator (surgeon). Therefore, the concept of a "standalone algorithm only" performance test is not applicable in the AI sense. The software's performance is verified through automated verification, electrical safety, and other non-clinical tests as part of the overall system's safety and effectiveness.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" would be established by engineering specifications, safety standards (e.g., IEC 60601), and the expected performance parameters derived from the predicate devices. For instance, for electrical safety, the ground truth is adherence to the specified voltage, current, and power limits as defined by the standards. For mechanical resection performance, it would be the ability to cut specific tissue analogs within predefined parameters. No pathology or outcomes data is mentioned in relation to testing for this 510(k).
8. The Sample Size for the Training Set
This is not applicable as the document does not describe an AI/machine learning model that undergoes a "training set." The software is designed and verified, not "trained" in the typical ML sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable because there is no mention of a training set for an AI/machine learning model.
§ 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.