(27 days)
The Soliton Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for short-term improvement in the appearance of cellulite.
The Soliton Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Hand Piece and the Cable connecting the Hand Piece to the Console. The Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent Window and acoustic ultrasound gel or similar hydrogel pad, which when placed against the surface of the skin to be treated.
This document describes the Soliton Resonic™ Rapid Acoustic Pulse device, concentrating on its substantial equivalence to a previously cleared device (K201801). The information provided focuses on the modifications made and the types of testing performed to demonstrate that these changes do not alter the fundamental technology or safety/effectiveness.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the modified device functions "as specified" and is "as safe and effective as its predicate device." The performance data section focuses on ensuring the modifications did not negatively impact safety or fundamental operation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as specified | Verification testing confirmed the Resonic RAP device functions as specified. |
| As safe as predicate device | Electrical safety and EMC testing repeated an independent lab (IEC 60601-1, IEC 60601-1-2). Biocompatibility established based on predicate (no new patient-contacting materials). |
| As effective as predicate device | Verification testing demonstrated the Resonic RAP device is as effective as its predicate. |
| Software changes are acceptable | Software verification testing conducted and results found acceptable. |
| No alteration to fundamental scientific technology | Modifications did not alter the fundamental scientific technology (shape, frequency, repetition rate of acoustic waves unchanged). |
| No new questions of safety or effectiveness | Minor differences do not alter fundamental technological characteristics or present new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a separate sample size for a "test set" in the context of clinical performance. The "verification testing" mentioned would typically refer to engineering and functional tests.
- Data Provenance: The document does not provide information about the country of origin or whether data是在retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document focuses on engineering verification and equivalence to a predicate, not a clinical study involving expert assessment of ground truth.
4. Adjudication method for the test set:
This information is not provided as there is no specific mention of a clinical test set requiring adjudication in this document.
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:
This is not applicable. The device described, the Soliton Resonic™ Rapid Acoustic Pulse device, is a physical medical device (an accessory to a laser for tattoo removal and for cellulite improvement), not an AI/software device that would involve human readers or AI assistance in image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable for the same reason as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the context of demonstrating substantial equivalence for hardware modifications, "ground truth" as typically understood in clinical or AI studies (e.g., pathology for disease diagnosis) is not relevant here. The "truth" used for verification is that the device functions according to its engineering specifications and meets safety standards, and that its output (acoustic waves) remains fundamentally unchanged from the predicate device.
8. The sample size for the training set:
This is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set mentioned.
Summary of what the document does provide regarding the study:
The document focuses on a design control and risk analysis approach to demonstrate substantial equivalence for minor hardware and software modifications to an already cleared device (K201801). The "study" isn't a traditional clinical efficacy study but rather a series of engineering and functional verification tests.
- Verification testing: Conducted using the "same methods as used for the predicate device" to show the Resonic RAP functions as specified and is as safe and effective.
- Electrical safety and EMC testing: Repeated by an independent lab in accordance with IEC 60601-1 and IEC 60601-1-2.
- Biocompatibility: Established based on the predicate device, as "no new materials are used on the surface of the device that contacts the patient skin."
- Software verification testing: Conducted, and results were found acceptable for the software changes.
The core argument is that the "minor differences in the newer device version (the subject device) do not alter the fundamental technological characteristics or present different questions of safety or effectiveness as compared to the predicate device." Therefore, extensive new clinical studies to establish efficacy or clinical ground truth were not deemed necessary for this 510(k) submission.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.