(420 days)
The RSHOCK 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 RSHOCK massage device is intended to provide a temporary reduction in the appearance of cellulite.
The RSHOCK 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 power console, LCD monitor, and accessories including resistive electrodes. The unit can provide one level of treatment frequency at 300kHz.
The provided text is a 510(k) summary for the RSHOCK device, a radiofrequency cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Winback Back 3SE) rather than detailing a study that proves the device meets specific acceptance criteria based on clinical performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this document because this is a 510(k) submission, not a clinical trial report. 510(k) clearances typically rely on demonstrating equivalence to a legally marketed predicate device through technical and performance comparisons, rather than extensive new clinical studies proving efficacy or specific performance metrics that would require the detailed information you've requested.
However, I can extract the information that is present and explain why other information is not available in this type of document.
1. A table of acceptance criteria and the reported device performance
The document does not present a table of acceptance criteria for clinical performance and reported device performance in the way a clinical study report would. Instead, it demonstrates substantial equivalence to a predicate device (Winback Back 3SE) by comparing their characteristics. The "acceptance criteria" here are implicitly that the RSHOCK device's characteristics are similar enough to the predicate device to be considered substantially equivalent, particularly regarding safety and intended use.
Here's a table based on the "Predicate Device Comparison Table" provided, highlighting key comparisons:
| Element of Comparison | 510(k) Device: RSHOCK | Predicate Device: Winback Back 3SE (K162828) | Explanation of Differences |
|---|---|---|---|
| Regulation and Product Classification Code | 21 CFR 878.4400 (PBX) | 21 CFR 878.4400 (PBX) | None |
| Indications for Use | Intended to provide topical heating for elevating tissue temperature to treat pain, muscle spasms, and increase local circulation. Also intended for temporary reduction in the appearance of cellulite. | Identical to RSHOCK. | Identical |
| RF Type | Unipolar | Multipolar/Unipolar | No significant difference |
| RF Frequency | 300kHz | 300kHz – 1MHz | No significant difference |
| Max RF Power | 100W | 300W | No significant difference (presumably because 100W is within acceptable range or sufficient for intended use, and lower power often implies equivalent or greater safety) |
| Intensity Adjustment | 0-3 levels | 0-100% | Not the same scale but the same values (implies comparable range of effect) |
| Electrical Safety & Biocompatibility | Established through testing (IEC 60601-1) & Biocompatibility testing | Established for predicate | Identical safety profile for equivalence |
The "acceptance criteria" are implied by the "Explanation of Differences" column, which consistently states "None," "Identical," or "No significant difference." This indicates that the device's characteristics meet the implicit criterion of being sufficiently similar to the predicate to warrant substantial equivalence.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical "test set" with a sample size for evaluating clinical performance. The testing mentioned (Electrical Safety, Biocompatibility, Software Assessment, EMC, Usability, Risk Management) is regulatory compliance testing, not a clinical trial. Therefore, information about data provenance (country, retrospective/prospective) for a clinical test set is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical "test set" for performance evaluation against a ground truth is described, there's no information about experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set.
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 not an AI-assisted diagnostic tool; it's an electrosurgical device for therapeutic heating. Therefore, an MRMC study is not relevant to its clearance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical performance study against a ground truth is described. The "ground truth" for this 510(k) submission is the demonstrated safety and performance of the substantially equivalent predicate device, as well as the successful completion of various engineering and safety tests.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device undergoing model training.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device undergoing model training.
Summary of the study/evidence presented in the 510(k) submission:
The "study" in this context refers to the due diligence and testing conducted to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device (Winback Back 3SE, K162828). The core of the evidence is a comparison of technical characteristics and the completion of regulatory safety and performance testing.
- Acceptance Criteria (Implicit): That the RSHOCK device's technical specifications, intended use, and safety profile are "substantially equivalent" to (i.e., do not raise different questions of safety and effectiveness from) the Winback Back 3SE predicate device. The detailed comparison table illustrates how these criteria were met by showing similarities or non-significant differences.
- Performance/Testing:
- Electrical Safety: Complied with IEC 60601-1.
- Biocompatibility: Samples of tissue-contacting probes tested for cytotoxicity, sensitization, and intracutaneous reactivity.
- Software Assessment: Assessed in accordance with FDA software validation guidelines (Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing).
- Electromagnetic Compatibility (EMC): Evaluated emissions and immunity to electromagnetic fields in accordance with IEC 60601-1-2.
- Usability and Risk Management: Assessments done using "worst-case assumptions" to verify user interface, safety features, and satisfactory performance.
The document concludes that the RSHOCK device is substantially equivalent based on these assessments, indicating that it meets the regulatory requirements for clearance.
§ 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.