(218 days)
The XOD diathermia radiofrequency device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The XOD device also is intended to provide a temporary reduction in the appearance of cellulite.
The XOD diathermia radiofrequency device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed, and RF therapy can be provided. The device can be operated in a resistive monopolar mode.
The product consists of a portable power console with a color touchscreen, and accessories including resistive threaded electrodes, and a silicon return plate. The unit can be adjusted to provide various levels of treatment frequency ranging from 442kHz to 454MHz.
The provided text describes the 510(k) submission for the XOD Diathermia Radiofrequency Device and its substantial equivalence to a predicate device. However, it does not contain information about a clinical study involving human readers, AI assistance, or the creation of a ground truth for a test set or training set.
The document primarily focuses on:
- Device Description and Intended Use: The XOD device provides topical heating using radiofrequency for pain relief, muscle spasms, increased local circulation, and temporary reduction of cellulite.
- Substantial Equivalence Comparison: It compares the XOD device to a predicate device (Indiba Diathermia Radiofrequency Device K161458) based on product code, indications for use, device description, principle of operation, frequency range, input voltage/power, treatment time, intensity, maximum tissue temperature, and regulatory testing standards (EMC, Electrical Safety, Biocompatibility).
- Regulatory Compliance: It highlights that the XOD device meets various electrical safety, EMC, and biocompatibility standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, ISO 10993-1).
Therefore, based on the provided text, I cannot answer most of your questions as the requested information is not present. I can only provide details on the performance testing that was mentioned.
Here's what can be extracted from the text:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on meeting regulatory and design specifications rather than specific clinical performance criteria from a human-AI study. The "performance criteria" here refer to compliance with technical standards and design specifications.
| Acceptance Criteria (Performance Aspect) | Reported Device Performance |
|---|---|
| EMC Testing | Meets IEC 60601-1-2 |
| Electrical Safety Testing | Meets IEC 60601-1 and IEC 60601-1-6 |
| Biocompatibility Assessment | Evaluated according to ISO 10993-1 |
| General Performance | Meets design specifications |
| Frequency Range | 442kHz to 454MHz (within expected therapeutic range) |
| Maximum Temperature Range for Tissue | 40-45°C (within expected therapeutic range) |
| Indications for Use Equivalence | Substantially equivalent to predicate for specified uses |
| Principle of Operation Equivalence | Substantially equivalent to predicate (radiofrequency and tissue heating) |
| Monopolar Mode of Application | Yes (matches predicate's primary mode) |
The following information is NOT available in the provided text:
- Sample size used for the test set and the data provenance: Not applicable, as there is no mention of a test set for AI performance or clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the document refers to a physical radiofrequency device, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- 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.