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510(k) Data Aggregation
(345 days)
The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization may include laparoscopic, pelviscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as neurosurgical.
The AURORA Evacuator +Coag device is provided sterile, for single use only. It is a disposable, handheld, battery powered instrument that combines the ability to remove fluids and soft tissue, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site during minimally invasive surgical procedures. It consists of a wand and handle with connection ports for a bipolar electrode cable, vacuum source (for aspiration) and irrigation line. At the distal tip of the wand, a side aspiration window with an internally rotating whisk is provided to break up and aspirate soft tissue and fluids. The battery and motor that powers the whisk is contained in the device handle. Bipolar electrodes are located at the distal tip of the wand and can be activated to coagulate tissue when connected to an electrosurgical generator. When desired, an irrigation line may be connected to the handle and saline can be delivered to clear the surgical field as a procedural aid. Bipolar electrosurgical generator/cables, vacuum source, and irrigation source are not provided with the device. Prior to use, the device is to be connected to electrosurgical generator, external vacuum source (i.e. operating room suction) and irrigation source (i.e. drip). A green power indicator light is located on the top portion of the handle to show that power is available to the device. A suction control vent for the user to control vacuum pressure and a button for activating the whisk are located conveniently on the handle.
This document is a 510(k) Premarket Notification from the FDA regarding the AURORA Evacuator +Coag device. It describes the device, its intended use, and a comparison to predicate devices, and a summary of non-clinical testing. However, it does not contain information related to software or AI/ML components. Therefore, I cannot provide an answer based on the prompt's request for acceptance criteria and studies related to a device's AI/ML performance.
The document lacks the following information which are critical to answer your request:
- Acceptance criteria for AI/ML performance: The document details acceptance criteria for the physical device's performance (e.g., biocompatibility, electrical safety, sterilization, in-vitro verification, ex-vivo tissue studies), but not for any AI/ML components.
- Study that proves the device meets acceptance criteria for AI/ML: No studies related to AI/ML performance are mentioned.
- Sample size used for the test set and data provenance (AI/ML): Not applicable as no AI/ML component is discussed.
- Number of experts used to establish ground truth (AI/ML): Not applicable.
- Adjudication method (AI/ML): Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study (AI/ML): Not applicable.
- Standalone (algorithm only) performance study (AI/ML): Not applicable.
- Type of ground truth used (AI/ML): Not applicable.
- Sample size for the training set (AI/ML): Not applicable.
- How the ground truth for the training set was established (AI/ML): Not applicable.
Therefore, no table of acceptance criteria and reported device performance for an AI/ML component can be created from this document. The document focuses on regulatory approval for the physical medical device and its electrosurgical, aspiration, and irrigation functionalities.
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(57 days)
The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open.
The subject device, AURORA Evacuator +Coag, is provided sterile, for single use only. It is a disposable, handheld, battery powered instrument that combines the ability to remove fluids and soft tissue, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site during minimally invasive surgical procedures.
It consists of a wand and handle with connection ports for a bipolar electrode cable, vacuum source (for aspiration) and irrigation line. At the distal tip of the wand, a side aspiration window with an internally rotating whisk is provided to break up and aspirate soft tissue and fluids. The battery and motor that powers the whisk is contained in the device handle. Bipolar electrodes are located at the distal tip of the wand and can be activated to coagulate tissue when connected to an electrosurgical generator. When desired, an irrigation line may be connected to the handle and saline can be delivered to clear the surgical field as a procedural aid.
Bipolar electrosurgical generator/cables, vacuum source, and irrigation source are not provided with the device. Prior to use, the device is to be connected to electrosurgical generator, external vacuum source (i.e. operating room suction) and irrigation source (i.e. drip).
A green power indicator light is located on the top portion of the handle to show that power is available to the device. A suction control vent for the user to control vacuum pressure and a button for activating the whisk are located conveniently on the handle.
The provided text describes the AURORA Evacuator +Coag device, its indications for use, and a comparison to predicate and reference devices. It then lists a summary of non-clinical testing conducted to demonstrate its safety and effectiveness.
Here's an analysis of the text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a structured format. However, it describes several tests performed and states that the device was found to be "substantially equivalent" or demonstrated "comparable" effects.
Here's an interpretation of potential "acceptance criteria" and "reported device performance" based on the text:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility per ISO 10993-1 | Testing performed and results supported safe use (implied, as conclusion states "safe and effective use"). Specific tests conducted: Cytotoxicity (MEM Elution), Sensitization (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Materials Mediated Pyrogenicity. |
| Electrical Safety per IEC 60601-1 and IEC 60601-2-2 | Testing performed and results supported safe use (implied). |
| Emissions and Immunity per IEC 60601-1-2 | Testing performed and results supported safe use (implied). |
| Particulate Testing per USP | Testing performed and results supported safe use (implied). |
| Sterilization per ISO 11135-1 | Validated a Sterility Assurance Level (SAL) of 10-6. |
| Packaging and Shelf-life per ISTA 2A and ASTM F1980-16 | Testing performed and results supported safe use (implied). |
| Verification of product specifications (materials, bonds, physical, performance) | Verification performed and results supported safe use (implied). |
| Comparable thermal damage effect (coagulation zone) to predicate | Ex-vivo tissue studies (porcine heart, liver, and kidney) demonstrated comparable thermal damage effect (coagulation zone) when compared with the primary predicate under the same test parameters and conditions. |
| Comparable thermal damage as a function of temperature and time | Thermal damage as a function of temperature and time with the 3 tissue types supported comparability with the primary predicate. |
| Validation of product performance using surrogate soft tissue materials and fluids | Validation performed and results supported safe use (implied). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- For the ex-vivo tissue studies, the sample size is only specified as "porcine heart, liver, and kidney". The number of individual samples or replicates is not provided.
- For other tests like biocompatibility, electrical safety, etc., no specific sample sizes are mentioned.
- Data Provenance: The studies are described as "ex-vivo tissue studies" and "non-clinical testing." This implies laboratory-based testing rather than clinical data from human patients. There is no information regarding the country of origin of the data. Given it's non-clinical, the terms "retrospective" or "prospective" don't directly apply in the same way they would to human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish "ground truth" for the non-clinical tests. Non-clinical tests typically rely on standardized methods and measurements rather than expert consensus on subjective interpretations. For tests like thermal damage assessment, the ground truth would be based on scientific measurements and comparative analysis with a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information is provided about any adjudication methods. This is consistent with non-clinical testing where subjective expert interpretation and adjudication are generally not primary components.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was conducted or mentioned. The device is a surgical instrument (Electrosurgical Cutting and Coagulation Device and Accessories), not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The AURORA Evacuator +Coag is a physical medical device intended for surgical use. It is operated by a human and is not an algorithm. Therefore, "standalone" performance in the sense of an algorithm operating independently doesn't apply. Its performance is evaluated in conjunction with human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established by:
- Comparability to Predicate Device: For thermal damage, the ground truth was the established performance of the predicate device under the same conditions.
- Standardized Test Methods: For biocompatibility, electrical safety, sterilization, etc., the ground truth is defined by the specific parameters and requirements of the referenced ISO standards (e.g., ISO 10993-1, ISO 11135-1, IEC 60601 series, USP , ASTM F1980-16). These standards specify acceptable limits or methodologies.
- Physical and Performance Specifications: Internal product specifications verified through direct measurement.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm. The non-clinical studies described are for verification and validation of the device's physical and functional properties, not for training a model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.
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(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.
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