(56 days)
The AURORA Evacuator is a powered instrument with a handpiece intended for removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/ Otolaryngological.
The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures. The AURORA Evacuator consists of a stainless-steel suction wand connected to a plastic handle. The stainless-steel suction wand is configured with an aspiration window, near its distal end, for fluid and soft tissue to enter. Internal to the suction wand is a shaft with a whisk-shaped configuration at its distal end. The whisk-shaped configuration is aligned with the aspiration window. The proximal end of the shaft is connected to a battery powered motor in the handle. The interior of the plastic handle contains the battery powered motor, batteries, electrical circuitry and the suction tubing. The suction tubing connects the stainless-steel suction wand to operating room vacuum. On the exterior of the handle is a tear-dropped shaped vent for user control of vacuum strength, a green light that illuminates when power is available, and a button for user activation of the motor. The AURORA Evacuator is shipped in a non-functional state that requires removal of a pull tab from the handle to initiate power to the device. There are three (3) configurations of the AURORA Evacuator; AURORA Evacuator -13, AURORA Evacuator -10 and AURORA Evacuator -7. All configurations are fabricated from the same materials and electrical components. The only difference among the configurations is the working length of the wand component. The wand working lengths are 13cm, 10cm, and 7cm, respectively.
The provided text is a 510(k) premarket notification for the "AURORA Evacuator" device. It outlines the device's intended use, design, and comparison to predicate devices, along with a summary of the conducted testing. However, it does not include specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or similar quantitative measures for medical devices that rely on diagnostic or interpretative capabilities) nor detailed study results proving a device meets such criteria if they were for a diagnostic or AI-driven device.
The "AURORA Evacuator" is described as a powered surgical instrument for tissue and fluid removal, not a diagnostic device or an AI-powered system that requires high-level performance metrics based on data analysis or image interpretation. The testing summarized is primarily related to safety, biocompatibility, electrical safety, manufacturing quality, and basic operational verification (e.g., rotational speeds, duration of use), which are typical for surgical tools.
Therefore, many of the requested items (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable or not present in this document because the device is a physical surgical tool and not a diagnostic or AI-driven system.
Nonetheless, I can extract the relevant information regarding the device's validation:
Acceptance Criteria and Study for the AURORA Evacuator
Based on the provided document, the "acceptance criteria" are implicitly tied to the safety and functionality standards for a surgical instrument, and the "study" refers to the verification and validation (V&V) testing performed to demonstrate substantial equivalence to predicate devices and satisfy regulatory requirements.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a surgical tool and not a diagnostic or AI device, the "acceptance criteria" are not presented as numerical thresholds for performance metrics like sensitivity or accuracy. Instead, they are met through adherence to established standards and successful completion of specific tests demonstrating safety, functionality, and manufacturing quality. The "reported device performance" is the successful completion of these tests.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity | Successful (Implied, as submission states safe and effective use shown) |
| Electrical Safety | IEC 60601-1 and IEC 60529-1 | Successful (Implied) |
| Emissions & Immunity | IEC 60601-1-2 | Successful (Implied) |
| Particulate Testing | USP 36 | Successful (Implied) |
| Sterilization | ISO 11135-1 (SAL of 10^-6^) | Validated (Implied) |
| Packaging & Shelf-life | ISTA 2A and ASTM F1980 | Successful (Implied) |
| Product Specifications | Materials, multiple bonds evaluations, physical characteristics, audible characteristics, rotational speeds, duration of use, operational temperatures | Verified (Implied) |
| Product Performance | Use with surrogate soft tissue and fluid materials | Validated (Implied) |
| Substantial Equivalence | Comparison to Predicate Device (NICO Myriad) for vacuum source, energy source, and tissue cutting mechanism | Results show no new or different questions of safety and effectiveness. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document does not specify quantitative sample sizes for each test (e.g., how many units were tested for electrical safety or how many batches for sterilization). The testing appears to follow standard medical device V&V protocols, which typically involve testing a statistically representative sample of manufactured units or materials.
- Data Provenance: Not explicitly stated regarding country of origin or whether retrospective/prospective. The testing would have been conducted in a controlled lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This device is a surgical instrument. The "ground truth" for its performance is determined by meeting engineering specifications, safety standards, and functional requirements, not by expert interpretation of data like in diagnostic imaging.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments (e.g., image interpretation). For a surgical tool, performance is determined by objective physical and electrical measurements, and adherence to standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic or AI-assisted interpretation, where human readers interact with image data. This device is a physical surgical tool and does not involve human readers interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. The AURORA Evacuator is a physical device operated by a human, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. Its performance is inherent to its mechanical and electrical function.
7. The Type of Ground Truth Used
- The "ground truth" for this device's validation is adherence to engineering specifications, established biocompatibility standards (ISO 10993-1), electrical safety standards (IEC 60601-1, IEC 60529-1, IEC 60601-1-2), sterilization standards (ISO 11135-1), packaging/shelf-life standards (ISTA 2A, ASTM F1980), and functional performance verification using surrogate materials. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8, there is no "training set" for this type of 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.