(27 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 with an exiting vacuum tube. A barb connector at the end of the exiting vacuum tube is intended to connect to operating room suction.
The 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 rotatable shaft with wire loops. The wire loops are aligned with the aspiration window and are intended to physically break-up soft tissue. The rotatable shaft is connected to a battery powered motor.
The motor and batteries are housed in the ergonomically designed handle. A green power indicator light is located on the top portion of the handle to show that power is available to the device. The handle also contains a suction control vent for user vacuum control and a motor control button for user activation of the rotating wire loops.
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.
Based on the provided text, the device in question is the AURORA Evacuator, a powered instrument designed for the removal of soft tissue and fluids during surgical procedures. The submission is for market clearance of modifications to the device, specifically a product line extension to include larger diameter suction wands.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based only on the provided text:
Important Note: The provided document is a 510(k) premarket notification letter and summary, not a detailed study report. Therefore, specific performance statistics, detailed acceptance criteria for each test, sample sizes for many tests, and the intricacies of ground truth establishment (especially for human-in-the-loop studies) are not fully disclosed in this summary. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with precisely defined acceptance criteria and statistical outcomes for a novel AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of precise quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or effect sizes, which are typically found for AI/ML device performance. Instead, the "acceptance" is focused on demonstrating substantial equivalence to a predicate device by showing that modifications (larger diameter wands) do not introduce new questions of safety or effectiveness and improve certain performance aspects.
The performance demonstration is primarily through a summary of various verification and validation (V&V) testing, rather than a comparative effectiveness study in the typical AI/MRMC sense.
| Test Category / Performance Aspect | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Safety & Biocompatibility | Compliance with ISO 10993-1 | Adopted from predicate; materials identical, thus considered compliant. |
| Electrical Safety & Enclosure | Compliance with IEC 60601-1 and IEC 60529-1 | Adopted from predicate; electrical configuration unchanged, thus considered compliant. |
| Emissions & Immunity | Compliance with IEC 60601-1-2 | Adopted from predicate; electrical configuration unchanged, thus considered compliant. |
| Particulate Testing | Compliance with USP 36 | Adopted from predicate; no change to configuration except wand diameter, thus considered compliant. |
| Sterilization | SAL of 10⁻⁶ (per ISO 11135-1) | Adopted from predicate; considered compliant. |
| Packaging & Shelf-life | Compliance with ISTA 2A and ASTM F1980 | Adopted from predicate; no changes to packaging, thus considered compliant. |
| Product Specifications | Meet predefined specifications (e.g., material, bonds, physical chars, audible, rotational speeds, duration of use, operational temp) | Verification testing conducted; implied meeting of specifications. Specific values not provided. |
| Product Performance (Aspiration) | Effective and safe removal of soft tissue and fluids. Faster aspiration rate is a positive attribute. | Validation using surrogate materials shows faster aspiration rates with larger diameter wands compared to predicate, without new safety/effectiveness concerns. |
| Tissue Break-up Performance | Mechanical break-up of soft tissue within the wand. | Described mechanism and functionality of rotating wire loops; implied effective break-up. No comparative performance data against predicate for this specific function provided. |
| Overall Equivalence | Substantially equivalent to predicate based on intended use, design, materials, principle of operation, and characteristics. | Determined to be substantially equivalent by the submitter. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set (for performance validation): The document mentions "Validation of product performance using surrogate soft tissue materials and surrogate fluid material." It does not specify the sample size (e.g., number of tests, volume of material, duration of tests) for this validation.
- Data Provenance: Not explicitly stated, but given it's for a US FDA submission by a US company (Irvine, CA), the testing was likely conducted in a controlled lab environment. It is retrospective in the sense that the test results are being summarized for a submission. There is no mention of prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of study (for a mechanical aspiration device, not an AI/ML diagnostic) does not typically involve human expert ground truth establishment in the way an AI diagnostic imaging device would. The "ground truth" for the performance validation would be directly measured physical parameters (e.g., aspiration rate, tissue removal effectiveness) using standardized methods and surrogate materials, verified by engineers or lab technicians. There is no mention of a panel of qualified experts (e.g., radiologists) for adjudication or establishing ground truth for perception-based tasks.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study involving human reader interpretation or perception for which adjudication methods (like 2+1, 3+1) would be used. The "truth" is established by physical measurement and engineering principles.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic imaging, where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure improvement in diagnostic performance. The AURORA Evacuator is a surgical instrument; its performance and safety are primarily evaluated through engineering and bench testing, not human reader interpretation of images.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not an AI/ML algorithm-driven device, so the concept of "standalone performance" (algorithm only) doesn't directly apply in the typical sense of AI diagnostics. However, the "validation of product performance" using surrogate materials could be considered analogous to a standalone performance evaluation of the device's mechanical capabilities independent of a specific surgical procedure. The device's operation is independent of human interpretation tasks.
7. The Type of Ground Truth Used
The ground truth for the "Validation of product performance" was established using "surrogate soft tissue materials and surrogate fluid material." This implies a controlled, measurable laboratory setup where the characteristics of the removed material and the speed of removal can be objectively quantified. This is a form of physical measurement/bench testing ground truth.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a mechanical surgical instrument.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no "training set" or corresponding ground truth establishment in that context.
§ 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.