(88 days)
The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications would embody:
- ethmoidectomy/sphenoethmoidectomy .
- polypectomy .
- septoplasty and .
- procedures such as .
- antrostomy .
- endoscopic DCR .
- frontal sinus drill-out .
- frontal sinus trephination and irrigation .
- septal spurs removal .
- trans-spehnoidal procedures .
Nasopharyngeal/laryngeal procedures would comprise:
- adenoidectomy ●
- laryngeal lesion de-bulking ●
- laryngeal polypectomy .
- tracheal procedures ●
- . tonsillectomy
Head & Neck procedures would encompass:
- . soft tissue shaving
- rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
- removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
- acoustic neuroma removal .
Otology procedures would include:
- mastoidectomy .
- mastoidotomy .
The Diego Powered Dissector and Drill System Handpiece, cleared under 510(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter that will allow the Dissector blades and burs to be tracked in real time in the surgical field.
The provided text is a 510(k) summary for the Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece. This document is related to a medical device's regulatory review and does not contain information about acceptance criteria or a study proving device performance in the context of typical AI/software device evaluation.
The 510(k) is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the way an AI/software device would. The modifications described are about allowing the existing "Diego Powered Dissector and Drill System Handpiece" to integrate with BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri) through an adapter. This likely involves mechanical integration and compatibility, rather than a clinical performance study with statistical endpoints.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/software device is not present in this document.
Here's an attempt to answer based on the spirit of the request, highlighting what's missing in the context of your questions, and what can be inferred.
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria for device performance in terms of clinical accuracy or outcome metrics as would be seen for an AI/software device. Instead, the "acceptance criteria" for a 510(k) submission are largely based on demonstrating substantial equivalence to a predicate device, which implies that the modified device will perform as safely and effectively as the predicate.
The document implicitly "reports device performance" by stating its intended use and showing equivalence to predicate devices for navigation. The performance here is in terms of compatibility and retaining the function of the original dissector and drill system while integrating with image guidance.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence for a modified device) | Reported Device Performance (Implied by submission) |
|---|---|
| Device maintains existing safety and effectiveness. | The Diego™ Powered Dissector Handpiece continues to cut and remove bone and tissue as intended. |
| Device is compatible with specified predicate Image-Guided Surgery (IGS) Systems. | The modified handpiece accepts the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter, allowing real-time tracking. |
| Device supports the stated indications for use. | The device's intended use for various ENT, Head & Neck, and otoneurologic procedures remains supported by the original device's performance and now augmented by IGS. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/Not provided. This 510(k) submission does not describe a clinical performance study that would use a "test set" in the context of an AI/software device evaluation. The assessment is likely based on engineering verification and validation of the mechanical and functional integration with the IGS systems, rather than a statistical sample of patient data.
- Data Provenance: Not applicable/Not provided for a clinical "test set."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. There is no mention of a "test set" with expert ground truth in this submission, as it's not an AI/software device undergoing such a performance evaluation. The review for 510(k) is about substantial equivalence based on engineering, bench, and potentially pre-clinical (e.g., cadaveric) testing, and comparison to existing predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. As no clinical "test set" requiring expert ground truth or adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic or therapeutic guidance system that would typically undergo an MRMC study to show human reader improvement. The device itself is a surgical tool, and the modification enhances its guidance capabilities, but the submission doesn't include an MRMC study comparing surgeon performance with/without the image-guided assistance provided by this specific adapter.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a manual surgical tool that is guided by an image-guided surgery system. Its function inherently involves a human operator (the surgeon) and the image navigation system. There is no "algorithm only" component that would perform a task independently. The performance is the combined system's ability to track the instrument accurately.
7. Type of Ground Truth Used:
Not applicable in the context of an AI/software device's performance study. For a mechanical device, "ground truth" would relate to engineering specifications, e.g., the true position of the instrument as measured by highly accurate systems, or the physical dimensions and tolerances of the adapter. However, the submission does not detail these engineering verification methods beyond stating the intent to integrate with image-guided systems.
8. Sample Size for the Training Set:
Not applicable. This device is a mechanical surgical instrument; it does not utilize a "training set" for machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for this type of device.
Summary of what the document DOES provide:
- Device Description: A modified handpiece for the Diego™ Powered Dissector and Drill System, designed to accept adapters for BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri).
- Intended Use: Cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures, with specific examples listed.
- Predicate Devices: BrainLAB Kolibri IGS System (K014256) and BrainLAB Vectorvision2 IGS System (K003589). The modification makes the Gyrus ENT device "compatible" with these predicate image-guided systems.
- Regulatory Classification: Class II, Stereotaxic instrument (HAW).
- 510(k) Clearance: The document is the FDA's clearance letter, stating substantial equivalence to predicate devices, thus permitting marketing.
This 510(k) focuses on the mechanical and functional compatibility of a modified surgical instrument with existing image-guided navigation systems, rather than a new AI/software diagnostic or therapeutic device whose performance would be assessed with detailed statistical studies against clinical ground truth.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).