(71 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 when connected with 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 a medical device (Solero Microwave Tissue Ablation (MTA) System and Accessories) that underwent a software modification. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the validation of these software changes, rather than a clinical study evaluating the device's efficacy in ablating tissue.
Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:
Nature of the Device Modification and its Impact on the Study:
The core of this 510(k) submission is a software modification. The text explicitly states:
- "The purpose of this submission is to introduce into commercial distribution a modification to the Solero MTA System software..."
- "The primary purpose of the software update is to mitigate risk of boot up failure."
- "The results of this Risk Analysis activity determined the proposed software correction did not present any new risks or modify an existing risk."
- "These changes did not affect the materials, manufacturing, design, biocompatibility/sterilization, technical characteristics, functionality, performance, usability, or indication for use of the previously cleared device (K162449)."
Given this context, the "acceptance criteria" and "study" are focused on verifying that the software changes are effective, do not introduce new risks, and maintain the existing performance of the device. There is no large-scale clinical efficacy study described, as the changes are deemed not to impact the fundamental therapeutic function.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the acceptance criteria relate to the proper functioning of the software changes and the continued safe and effective operation of the device as previously cleared.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Text) | Reported Device Performance and Evidence |
|---|---|---|
| Software Functionality (Boot-up Fallback) | The device's software should have a robust boot-up process, including a backup copy of the software to prevent corruption-related boot failure. | "a correction related to software becoming corrupted during loading... a back-up copy of the identical software can load." "The board support software was validated to ensure proper function of the bootloader." "All testing completed successfully." |
| Software Functionality (Language Management) | Correct display and management of languages; inclusion of Finnish language. | "minor software changes were made to correct displayed languages and include Finnish language within the system." "Regression testing was performed to confirm language translations..." "All testing completed successfully." |
| Risk Mitigation (Software) | The software changes should not introduce any new risks or modify existing risks. | "The results of this Risk Analysis activity determined the proposed software correction did not present any new risks or modify an existing risk. The software modification does not necessitate a new or modified risk control measure." (Based on Risk Analysis activity). |
| Maintain Existing Device Performance (Power Output) | The software changes should not adversely affect the device's technical characteristics, specifically its power output. | "Regression testing was performed to... evaluate power output." "All testing completed successfully." "Results from regression testing included power output testing to ensure that the changes did not create any unintended issues in the operation of the system overall." |
| Compliance with Relevant Standards (Electrical Safety) | The device must continue to meet relevant electrical safety and performance standards. | Evaluated against: |
- IEC-60601-1: 2006/03/09 (R2012), Ed 3.0 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
- IEC 60601-1-2:2014/02/25 Ed.4 (Medical Electrical Equipment - Electromagnetic Compatibility)
- IEC 60601-1-6 2013/10/29 Ed: 3.1 (Medical Electrical Equipment - Usability)
(Implied successful testing, as submission was cleared). |
| Compliance with Relevant Standards (Software Lifecycle)| Software development and testing must comply with medical device software lifecycle standards. | "software testing was conducted in compliance with IEC 62304 2006/05/09 Ed: 1 Medical Device Software - Software Lifecycle Process." |
| No Impact on Core Device Characteristics | The software changes should not impact materials, manufacturing, design, biocompatibility/sterilization, technical characteristics, functionality, usability, or indications for use. | "The changes did not affect the materials, manufacturing, design, biocompatibility/sterilization, technical characteristics, functionality, performance, usability, or indication for use of the previously cleared device (K162449)." (Stated explicitly, supported by focused testing on software and power output). Biocompatibility and Sterilization specifically mentioned as "no impact" due to changes being solely software related. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for "tests" or "test sets" in the context of clinical data. The testing described is verification and validation (V&V) of software changes and system performance, not a clinical trial with patient data. It refers to "executing tests" and "regression testing." It's likely that these tests involved a sufficient number of runs or configurations to cover the changed software functions and ensure no adverse effects on power output.
- Data Provenance: Not applicable in the context of clinical data for this submission. The "data" refers to the results of internal engineering and software V&V testing. The document does not mention the country of origin of data or whether it was retrospective or prospective, as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. The "ground truth" for the software modifications and performance checks is based on engineering specifications, software requirements, and established performance parameters (e.g., power output specifications defined during the original device development). There is no mention of human experts establishing ground truth in the context of interpreting medical images or clinical outcomes for this specific submission, as it's a software update to an existing device.
- Qualifications of Experts: N/A, as above.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies for resolving discrepancies in expert interpretations of medical data. For software verification and validation, test results are compared against defined acceptance criteria (pass/fail for specific tests) rather than adjudicated by multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No. An MRMC study is a clinical study design often used for evaluating the effectiveness of AI systems in diagnostic imaging by comparing performance with and without AI assistance across multiple readers and cases. This submission is for a software update to a microwave tissue ablation system, not a diagnostic imaging AI, and the changes are not related to diagnostic utility.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable in the context of typical AI diagnostic algorithms. The device itself is an electrosurgical device; its "performance" is about delivering microwave energy. The software enables the function of the device. The "standalone performance" was evaluated through the various verification and validation tests to ensure the software properly controls the hardware and that the power output remains as specified.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for this software modification related to boot-up, language, and power output was based on:
- Defined software requirements and specifications: For the boot-up process (e.g., successful boot, automatic switch to backup), and language display.
- Engineering specifications and regulatory standards: For power output (i.e., the power output must remain within specified tolerances as per the original device's cleared performance) and compliance with electrical safety and software lifecycle standards.
- Risk Analysis: To confirm no new risks were introduced.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This is not a machine learning/AI model that requires training data in the traditional sense. The software changes are programming fixes and additions, not an algorithm learned from data.
9. How the Ground Truth for the Training Set was established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for a machine learning algorithm. The "ground truth" for the software development refers to the defined functional requirements and design specifications that the software was programmed to meet.
§ 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.