(402 days)
Coagulation (thermo-ablation) of soft tissue. Not for use in cardiac procedures.
HS AMICA devices family is a fully featured soft tissue ablation system that is intended for coagulation (thermo-ablation) of soft tissues. Not for use in cardiac procedures.
AMICA-GEN is available in the following different models: AMICA-GEN AGN (Microwave generator only), AMICA-GEN AGN-R (Radiofrequency generator only), and AMICA-GEN AGN-H (Hybrid Microwave and Radiofrequency generator). The MW and RF outputs can never be activated simultaneously. The actual energy source in use depends on the applied part type, RF or MW, connected to the generator.
There are several available variants of PROBE (i.e. the applied parts for direct energy delivery into the patient's body for percutaneous or intra-operative use): AMICA-PROBE (disposable device for MW energy delivery) and RF AMICA-PROBE (monopolar, straight, stainless steel electrode for RF energy delivery).
HS AMICA devices family consists of non-sterile reusable electronic parts, and sterile disposable applied parts. The sterilization method used for all the sterile components is Ethylene Oxide.
The microwave devices can be operated in continuous and PULSE mode. The PULSE mode is new operational mode with a duty cycle of 40% and a max output power of 190 Watts.
The provided text is a 510(k) Summary for a medical device (HS AMICA devices family) seeking clearance from the FDA. It primarily focuses on comparing the new device to a predicate device and demonstrating substantial equivalence through various tests and compliance with standards.
However, the document does not describe an AI/ML-based medical device. The "AI" term in the prompt implies such a device. This document describes an "Electrosurgical Cutting and Coagulation Device and Accessories," which uses microwave and radiofrequency energy for thermo-ablation of soft tissues. The software update mentioned (Rev. 1.7.1) appears to be a general software update for device control, not an AI/ML algorithm for diagnostic or prognostic purposes.
Therefore, the specific information requested about acceptance criteria and studies for an AI/ML device (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) is not present in the provided text as it pertains to an AI/ML aspect.
The document does mention "Performance Data" and "Thermal Effects performance tests" with ex-vivo bovine liver, kidney, and muscle as part of the verification and validation studies. It states that "the system passed all pre-determined acceptance criteria identified in the test plan." However, it does not explicitly list these acceptance criteria or the reported performance in a quantitative, granular way as would be expected for an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). The nearest it comes to a performance claim is that "PULSE mode ablations allowed for slightly more spherical ablations."
Based on the provided text, I cannot fulfill the request for information regarding AI/ML device acceptance criteria and study details because the device described is not an AI/ML device.
If the question were rephrased to be about the non-AI medical device described in the document, here's what could be extracted, though it would still be limited:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliance with EN 60601-1:2006+A11:2011+A1:2013 (Medical electrical equipment – General requirements for basic safety and essential performance) | Device complies. |
| Compliance with EN 60601-2-2:2009+A11:2011 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of high frequency surgical equipment) | Device complies. |
| Compliance with EN60601-2-6:2015+A11:2016 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of microwave therapy equipment) | Device complies. |
| Compliance with EN 60601-1-2:2015 (Medical electrical equipment – Electromagnetic disturbances – Requirements and tests) | Device complies. |
| Compliance with IEC 62304:2015-06 (Medical device software – Software life cycle processes) | Device complies. |
| Compliance with ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) | Device complies. |
| Compliance with ISO 10993-7-2008 (Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals) | Device complies. |
| Compliance with ISO 11135-2014 (Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices) | Device complies. |
| Compliance with ISO 11138-1-2006 (Sterilization of health care products – Biological indicators – Part 1: General requirements) | Device complies. |
| Compliance with ISO 11737-1-2006 (Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products) | Device complies. |
| Compliance with ISO 11737-2-2009 (Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process) | Device complies. |
| Performance test-bench for Thermal Effects (as per FDA guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery) - "safely and effectively as predicate device" for soft tissue coagulation. | Demonstrated safe and effective performance in coagulation of soft tissues with microwave energy, comparable to the predicate. PULSE mode enabled "slightly more spherical ablations." |
2. Sample sized used for the test set and the data provenance:
- The document mentions "Thermal Effects tests with ex-vivo bovine liver, kidney and muscle." No specific sample sizes (number of tissue samples or experiments) are provided.
- Data provenance: Ex-vivo bovine tissues.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned, as this is a performance test on tissue, not an AI ground truth establishment.
4. Adjudication method for the test set:
- Not applicable/Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done as this is not an AI/ML device for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone electrosurgical system. The performance tests were of the device's ability to ablate tissue.
7. The type of ground truth used:
- The "ground truth" for the performance tests was the observable thermal ablation effects on ex-vivo bovine tissues (e.g., size and shape of ablation zone).
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- 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.