(90 days)
Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.
Volnewmer™ is a noninvasive monopolar radiofrequency (RF) therapy system. The radiofrequency output of the device is 6.78 MHz, and the maximum output power is 115 W.
- . Volnewmer™ delivers radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis.
- Volnewmer™ delivers energy from the disposable/reusable tip to the patient.
- . Volnewmer™ employs radiofrequency tuning to provide radiofrequency energy across a range of impedances for delivery to the patient through the disposable/reusable tip.
Volnewmer™ consists of the following components: - Console ●
- . Handpiece x2
- Treatment Tips ●
- Accessories:
- Return Pad -
- Return Pad Cable -
- Coupling Gel -
- Footswitch -
The provided text, K240248, is an FDA 510(k) clearance letter for the Volnewmer™ device, an electrosurgical cutting and coagulation device. It details the device's characteristics, its comparison to predicate devices, and a summary of non-clinical testing performed to demonstrate substantial equivalence.
However, the document specifically states "Summary of Non-Clinical Testing" and explains that "Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate device." It then lists tests like EMC, electrical safety, thermal effect & safety in-vivo test, bench testing, biocompatibility, and software verification/validation.
Crucially, the document does NOT contain information about acceptance criteria or specific studies that prove the device meets acceptance criteria related to a clinical performance study involving human subjects or AI performance. The questions you've posed, particularly those regarding sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for training/test sets, are typical for the evaluation of AI/ML-enabled medical devices or diagnostic devices with clinical performance claims. This document pertains to a Class II electrosurgical device that relies on non-clinical testing and comparison to predicates for substantial equivalence, not a device with such complex performance metrics.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to address the points based only on the information available in the given document:
Acceptance Criteria and Device Performance (Based on provided Non-Clinical Testing):
Since this is a 510(k) for an electrosurgical device cleared based on substantial equivalence and non-clinical testing, the "acceptance criteria" discussed are largely related to safety and fundamental performance characteristics as demonstrated through engineering tests and comparison to predicates, rather than clinical efficacy metrics (like sensitivity, specificity, accuracy, or improvements from AI assistance) which would require clinical studies.
The document implicitly states that the acceptance criterion for the non-clinical tests was that the device performs as intended and meets design specifications and that the differences (from predicate) do not raise any new issues of safety or effectiveness.
Here's a table reflecting what can be inferred as acceptance criteria and reported performance from the "Summary of Non-Clinical Testing" section:
| Acceptance Criteria (Inferred from Non-Clinical Tests) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Compliance with Electrical Safety Standards (e.g., IEC 60601-1, IEC 60601-1-2) | EMC and Electrical safety of the subject device was tested in compliance with IEC 60601-1 Edition 3.2; IEC 60601-1-2 Edition 4.0 and IEC 60601-2-2 Edition 6.0 (Implies successful compliance). |
| Acceptable Thermal Effect & Safety Profile (In-Vivo) | Thermal Effect & Safety In-Vivo Test were conducted for evaluating the safety and performance profile of the subject device. The test results support the substantial equivalence. (Implies positive results demonstrating safety and performance comparable to expectations for substantial equivalence). |
| Device Performs as Intended and Meets Design Specifications (Bench Testing) | Bench testing was performed to ensure that the subject device performs as intended and meets design specifications. (Implies successful performance against design specifications). |
| Biocompatibility of Patient-Contacting Components | Biocompatibility testing was performed in compliance with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..." to demonstrate biocompatibility of the patient-contacting components of the device. (Implies successful demonstration of biocompatibility). |
| Software Verification and Validation as per FDA Guidance (Enhanced Documentation) | Software Verification and Validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" (issued on June 14, 2023). The software documentation level for the subject device is considered as 'Enhanced Documentation'. (Implies successful and documented V&V commensurate with the 'Enhanced' documentation level, suggesting software reliability and proper function for its intended purpose within the device). |
| Differences from Predicate Device Do Not Raise New Safety/Effectiveness Issues | Non-clinical test results demonstrate that the Volnewmer™ safety and performance are substantially equivalent to the predicate device for the requested indications for use. (Overall conclusion based on all non-clinical tests). |
Since the document focuses on non-clinical testing for a device leveraging substantial equivalence, the following points address what is not present in the provided text:
- Sample size used for the test set and the data provenance: Not applicable/not mentioned. The "test set" here refers to non-clinical tests (e.g., electrical safety tests, bench tests, in-vivo thermal tests on an animal model, likely, although not explicitly stated). No human patient "test set" data for clinical performance is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This type of information is relevant for AI/ML or diagnostic devices where human expert consensus often forms the ground truth for clinical evaluation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
- 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, an MRMC study was not done (or at least not reported in this document). This device is not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not mentioned for clinical performance. For the non-clinical tests, the "ground truth" would be established by validated test methodologies and engineering specifications.
- The sample size for the training set: Not applicable/not mentioned. This device is not an AI/ML device that requires a training set in the typical sense (e.g., for image recognition). Its software undergoes verification and validation, but not machine learning model training.
- How the ground truth for the training set was established: Not applicable/not mentioned.
In summary, the provided FDA 510(k) clearance letter for the Volnewmer™ device focuses on non-clinical performance and substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating its efficacy or the performance of an AI/ML component. Therefore, the detailed questions regarding clinical test sets, expert ground truth, and AI training data are not addressed by this type of regulatory submission document.
§ 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.