(413 days)
The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, incision, and hemostasis in soft tissue surgical procedures.
The subject device Soniquence Reusable 3 Button Fingerswitch Wand is an accessory to the Soniquence SmoothWave RF Generator. It is connected to a High Frequency Generator via the male end, and the female end termination connects to the Monopolar Electrode. This device will be provided non-sterile and is intended to be used with Soniquence Monopolar Electrodes. The 3-Button Fingerswitch Wand includes access to all three monopolar waveforms without unit manipulation. This patented, unique handpiece is utilized to activate CUT, BLEND, and HEMO modes via finqerswitch for general surqical procedures. The depressed button function will be the actual output function and disregards the front display settings. The fingerswitch operational features are as follows: a) The CUT button will activate CUT mode. When depressed, the vellow indicator (CUT) illuminates. b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates. c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.
The provided document is a 510(k) summary for the Soniquence Reusable 3 Button Fingerswitch Wand. It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML product.
Instead, this document describes a traditional medical device (an electrosurgical accessory) and its substantial equivalence to a predicate device. The "acceptance criteria" discussed are related to electrical safety, biocompatibility, and sterilization validation for this hardware device, not performance metrics for an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details (test/training set size, data provenance, expert consensus, adjudication, MRMC studies, standalone performance, ground truth establishment) as this document does not pertain to an AI/ML device.
The document indicates "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence," further confirming that it's not a performance study for an AI/ML algorithm.
However, I can extract the specific non-clinical testing performed for the Soniquence Reusable 3 Button Fingerswitch Wand, which serve as its "acceptance criteria" and the "study" proving it meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1: 3rd edition, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance | Successfully performed |
| IEC 60601-2-2: 2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Successfully performed | |
| Biocompatibility | Intracutaneous Reactivity Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization | Passed all tests |
| Skin Sensitization Test, ISO 10993-10:2010, Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization | Passed all tests | |
| In Vitro Cytotoxicity, ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | Passed all tests | |
| Sterilization Validation | ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices | Passing results |
| AAMI TIR12:2020 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers | Passing results | |
| ASTM E1766-15 - Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices | Passing results |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document as these are non-clinical hardware tests, not data-driven performance studies.
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 information is not provided as the tests are based on established engineering and biological standards, not expert medical opinion for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as this is not an expert-driven ground truth assessment for an AI/ML product.
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:
Not applicable; this device is a hardware accessory, not an AI/ML product designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable; this is a hardware device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for these tests are the pass/fail criteria defined by the listed international and industry standards (e.g., ISO, IEC, ASTM, AAMI).
8. The sample size for the training set:
Not applicable; this is not an AI/ML product that utilizes 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.