(251 days)
The Solero Microwave Tissue Ablation (MTA) System is indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not indicated for cardiac use.
The Solero Microwave Tissue Ablation (MTA) System and Accessories is a software-controlled, microwave generator with an integrated peristaltic pump that surgically ablates soft tissue through sterile applicators. It is used to deliver microwave energy into soft tissue for the purpose of microwave ablation.
The Solero MTA Generator is distributed with a main power cable and a footswitch, which may be used as an alternate means of controlling microwave activation in place of the microwave button on the front of the generator. Power is delivered through the disposable Solero Applicator which are provided separately. The Solero Applicator is a surgically invasive, sterile single patient use device used to thermally ablate targeted soft tissue. The probe is specifically designed to deliver microwave energy at a frequency of 2.45 GHz from its distal end into soft tissue. A chilled saline source is required to maintain the Solero Applicators at an appropriate temperature.
The Solero MTA System includes an optional accessory, the Solero MTA Cart, that is used to assist transport of the Solero Generator, and to provide a resting surface during operation and storage.
The provided text describes a 510(k) premarket notification for the Solero Microwave Tissue Ablation (MTA) System and Accessories. This notification seeks to demonstrate substantial equivalence to an existing predicate device, primarily due to manufacturing improvements and minor accessory additions, rather than a new clinical indication or significant technological change requiring extensive new performance studies against clinical endpoints.
Therefore, the information typically found in a clinical study evaluating a diagnostic AI device is largely absent here. This document pertains to an electrosurgical cutting and coagulation device, not an AI or diagnostic device that would have acceptance criteria based on classifications (sensitivity, specificity, AUROC, etc.). The "performance data" discussed relates to engineering and bench testing, as well as an animal study for ablation size comparison.
However, I can extract and structure the information that is present, aligning it as closely as possible to your requested format, and explicitly noting where the requested information is not applicable or not provided in the document.
Explanation of Applicability:
The questions asked (1 through 9) are highly specific to the evaluation of AI-powered diagnostic devices, often involving complex statistical analysis of classification performance, human reader studies, and ground truth establishment from medical experts or pathology. The Solero MTA System is a surgical device for tissue ablation, and its evaluation strategy focuses on safety, electrical compatibility, biocompatibility, and demonstration of equivalent physical performance (like ablation size) to a predicate device after minor design changes. Therefore, many of your requested points are not directly addressed or are not relevant to this type of device submission.
Acceptance Criteria and Device Performance (Solero Microwave Tissue Ablation (MTA) System and Accessories)
Given the nature of the device (a surgical tissue ablation system) and the 510(k) submission which focuses on substantial equivalence due to manufacturing changes, the "acceptance criteria" and "reported device performance" are primarily related to engineering specifications, safety standards, and comparative performance to the predicate device in an ex-vivo model. There are no clinical performance metrics like sensitivity, specificity, or AUROC for this type of device as it's not a diagnostic AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion / Test Area | Acceptance Standard / Requirement | Reported Device Performance (Solero MTA System) |
|---|---|---|
| I. Engineering & Safety | ||
| Flow Rate | Conforms to specified design and performance requirements. | Met all specified design and performance requirements. |
| Power Output | Conforms to specified design and performance requirements. | Met all specified design and performance requirements. |
| Tensile Testing | Conforms to specified design and performance requirements. | Met all specified design and performance requirements. |
| Coolant Temperature | Conforms to specified design and performance requirements. | Met all specified design and performance requirements. |
| Ablations (System Function) | Conforms to specified design and performance requirements. | Met all specified design and performance requirements. |
| Leak Testing | Conforms to specified design and performance requirements. | Met all specified design and performance requirements. |
| Dielectric Strength | Conforms to specified design and performance requirements. | Met all specified design and performance requirements. |
| Pump Compatibility | Conforms to specified design and performance requirements. | Met all specified design and performance requirements. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-6. | Evaluated against and compliant with cited IEC standards. |
| Software Life Cycle | Compliance with IEC 62304. | Evaluated against and compliant with IEC 62304. |
| Usability Engineering | Compliance with IEC 62366-1. | Evaluated against and compliant with IEC 62366-1. |
| II. Biocompatibility | Compliance with ISO 10993 (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Hemolysis). | Acceptable results for all required tests on the Solero MTA Applicator (patient-contacting part). Generator and Cart require no biocompatibility testing (non-patient contact). |
| III. Sterilization | Suitability of sterile packaging to protect device and ensure sterility; integrity and distribution cycle. | Testing confirmed packaging integrity, sterility (via EO), and distribution cycle robustness against extreme conditions, maintaining sterility and integrity within stated shelf life. |
| IV. Ablation Performance (Ex-Vivo) | Ablation size measurements comparable to predicate device. | The Solero MTA System created ablations consistently in ex-vivo bovine liver. Measurements of ablation size (length, width, and volume) were comparable to the predicate device at minimum, medium, and maximum energy settings. This demonstrates equivalent performance to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Description: The primary "test set" for performance evaluation was an ex-vivo bovine liver model.
- Sample Size: For the ex-vivo animal study, ablations were performed at three energy settings (minimum, medium, maximum). Each setting was performed a minimum of three (3) separate times. This means a minimum of 9 ablations in total for both the test device and the predicate device for comparison.
- Data Provenance: The study was conducted by AngioDynamics, presumably in the USA. The data is prospective for this ex-vivo study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable in the context of this device submission. For a tissue ablation device, "ground truth" for the ex-vivo study would typically involve direct physical measurement of the ablated tissue, not expert interpretation or consensus on diagnostic findings. The document does not specify who performed the measurements or their qualifications, as it's an engineering and animal model study rather than a clinical expert study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This specific type of adjudication method is used in diagnostic studies (especially AI-assisted ones) to resolve discrepancies in expert interpretation of medical images or data. For an ex-vivo physical measurement study, such a method is not relevant.
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 done. This device is a surgical tool, not a diagnostic AI system or an AI-assisted diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not relevant or applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The Solero MTA System is not a standalone algorithm. It is a physical device operated by a human surgeon. While it has software controls, its "performance" is the physical ablation of tissue, not an algorithmic output like a diagnostic reading.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the ex-vivo animal study: The "ground truth" was direct physical measurement of ablation size (length, width, and volume) in the bovine liver tissue. This is objective measurement rather than expert consensus, pathology, or outcomes data, which are typically found in clinical studies or diagnostic evaluations.
- For engineering/safety tests: Ground truth is defined by the objective pass/fail criteria of the respective engineering and safety standards (e.g., specific voltage/current ranges, leak rates, resistance to tensile forces, biological responses in biocompatibility tests).
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm that undergoes a "training phase" with a dataset in the way a machine learning model does. The device's design is based on engineering principles and validated through testing, not iterative learning from a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply here.
§ 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.