(246 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 is a softwarecontrolled, microwave generator with an integrated peristaltic pump that surgically ablates soft tissue through sterile applicators. The system may be used during open procedures for the ablation of soft tissue.
The Solero 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. A chilled saline source is required to maintain the Solero Applicators at an appropriate temperature.
The provided text describes a 510(k) premarket notification for the Solero Microwave Tissue Ablation (MTA) System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in the way clinical studies for algorithms typically would.
However, I can extract information related to the device's technical specifications and the safety and performance testing conducted. It's important to note that the term "acceptance criteria" here refers to the performance specifications the device aims to meet to be considered substantially equivalent to existing devices, and the "study" is the testing outlined to demonstrate this equivalence.
Here's an attempt to structure the requested information based on the provided text, recognizing that it's not a typical algorithm performance study report:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerically defined thresholds in a table format for performance metrics like sensitivity, specificity, accuracy, etc., as one would find for an AI diagnostic device. Instead, it describes compliance with design controls and recognized standards, and functional characteristics compared to predicate devices. The "reported device performance" is primarily qualitative, aiming to show similar functionality and safety.
| Feature / Performance Area | Acceptance Criteria (Implied / Stated Goal) | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Ablation Size and Duration | Near spherical volumes, scalable to approximately 4 cm diameter in ≤ 6 minutes (similar to predicate). | Achieves Near spherical volumes, scalable to approximately 4 cm diameter in ≤ 6 minutes. |
| Tip Puncture Force | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Flexural Tip Strength | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Removal Force | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Flow Rate | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Bag Spike | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Cartridge Connection Force | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Cartridge Alignment | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Device Recognition | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Power Output | 60 to 140 watts in 20 watt increments (matches predicate). | Achieves 60 to 140 watts in 20 watt increments. |
| Shaft to Applicator Tip Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Handle to Shaft Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Umbilical to Handle Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Umbilical to Cartridge Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Pump Tubing to Cartridge Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Pump Tubing to Bag Spike Tensile | Meets predetermined performance specifications. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Saline Temperature | Temperatures below 48°C (Coolant warning at 38°C, alarm/termination at 48°C) (similar to predicate). | Achieves Temperatures below 48°C, alerts user when coolant begins to become warm (38°C), and alarm will sound and microwave energy delivery will terminate when coolant in tip reaches 48°C. |
| Multiple Ablations | Demonstrates ability to perform multiple ablations as intended. | Test conducted. (Result: demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Track Ablation | Characterizes ablation track. | Test conducted. |
| Temperature Control | Maintains prescribed temperature ranges/limits. | Test conducted. (Result: Demonstrated effective temperature control, specifically with the 48°C cutoff). |
| Dielectric Strength | Meets electrical safety criteria. | Test conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements and conformance to IEC 60601-1-2). |
| Cartridge Connection / Attachment / Removal Force | Meets predetermined performance specifications for secure and easy handling. | Tests conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Generator Hardware Testing | Meets functional and safety requirements for generator hardware. | Test conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Complex Programmable Logic Device | Meets functional and safety requirements. | Test conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Reliability Testing | Demonstrates reliable operation over intended lifespan. | Test conducted. (Result: Demonstrated meeting predetermined performance specifications as part of design control requirements). |
| Safety in Animal Studies | Similar safety profile to predicate devices, without unexpected adverse events (assessed from animal behavior, ECG's, etc.). | Two GLP compliant animal studies performed, assessing animal behavior, ECG's, respiration rates, and temperature. The devices' safety at highest power (140W) and time (6 minutes) was specifically evaluated and compared to the predicate, demonstrating substantial equivalence in safety. |
| Performance in Animal Studies | Similar performance characteristics to predicate devices, particularly in ablation efficacy. | Two GLP compliant animal studies performed, establishing substantial equivalence to the predicate and reference devices, and assessing fundamental operational characteristics. The study aimed to support recommended ablation settings. |
| Human Factors | Usable and safe for intended users and use environments. | Simulated Use / Human Factors Testing conducted to evaluate the application of the system. (Result: No specific findings or acceptance criteria for human factors are detailed, but the testing was performed to ensure usability). |
| Electrical Safety (IEC 60601-1) | Conforms to IEC 60601-1 standards. | Conformance testing to IEC 60601-1 "Medical Electrical Equipment – Part 1: General Requirements for Safety" was completed. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Conforms to IEC 60601-1-2 standards. | Conformance testing to IEC 60601-1-2 "Medical Electrical Equipment – Part 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard Electro Magnetic Compatibility - Requirements and Test" was completed. |
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: The document describes "verification and validation activities" and "performance characterization" using:
- Three different ex-vivo tissues: bovine liver, porcine kidney, and porcine lung.
- Two GLP compliant animal studies: one to evaluate substantial equivalence and fundamental operational characteristics, and a second to specifically compare safety and performance at high power/time in an acute porcine model during open surgical procedure.
- Sample Size: The exact number of tissue samples or animals used in these studies is not specified in the provided text.
- Data Provenance:
- Ex-vivo tissue: "bovine liver, porcine kidney, and porcine lung." (origin not specified)
- Animal studies: Prospective, specifically "two GLP compliant animal studies were performed." "Porcine model" for the second study. (Country of origin not specified).
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)
This device is not an AI algorithm requiring expert ground truth labeling in the typical sense for diagnostic or prognostic tasks. The "ground truth" for this device's performance would be the direct measurement of ablation size, temperature, electrical parameters, and physiological responses (e.g., animal behavior, ECGs) in the animal models, along with successful completion of functional tests.
Therefore, the concept of "experts establishing ground truth" as applied to AI studies is not directly applicable here. The expertise required would be in veterinary care, pathology (for assessing ablation zones post-mortem), and engineering for device measurement and analysis as part of GLP studies. The document does not specify the number or qualifications of such experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 consensus are typically used for establishing ground truth from expert interpretations in AI diagnostic studies. This is not applicable to the type of device and testing described (functional, electrical, ex-vivo, and animal studies). The results are based on objective measurements and observations within a GLP (Good Laboratory Practice) framework, which implies rigorous, standardized methodology and data recording.
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, a multi-reader, multi-case comparative effectiveness study with human readers and AI assistance was not done. This device is a medical instrument (Microwave Tissue Ablation System), not an AI-powered diagnostic or assistive tool for human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question generally applies to AI algorithms. The Solero Microwave Tissue Ablation System is a physical medical device. The "performance" being evaluated is the device's ability to ablate tissue, its safety characteristics, and its compliance with electrical and mechanical standards. These are inherently "standalone" in the sense that they describe the device's intrinsic function, but not in the context of an "algorithm only" performance. The device does have software control, described as "software-controlled, microwave generator," and "complex programmable logic device" testing was done, which would evaluate the software's performance as part of the overall system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for evaluating this device's performance includes:
- Direct physical measurements: Puncture force, flexural strength, flow rates, tensile strengths, power output, temperatures, and dielectric strength.
- Pathology: For ex-vivo tissue and animal studies, the dimensions and characteristics of the ablated tissue volumes would be assessed pathologically post-procedure.
- Physiological data: In animal studies, this included animal behavior, ECGs, respiration rates, and temperature.
- Compliance with standards: Verification that the device meets the specifications outlined in recognized standards like IEC 60601-1 and IEC 60601-1-2.
8. The sample size for the training set
This question is relevant for machine learning algorithms. The provided document concerns a physical medical device. There is no mention of a "training set" in the context of an algorithm being developed or trained.
9. How the ground truth for the training set was established
As there is no mention of a "training set", this question is not applicable.
§ 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.