(274 days)
Secret Duo RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. Secret Duo RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
Not Found
I am sorry, but the provided text does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested by your detailed prompt.
The document is an FDA 510(k) clearance letter for the "Secret Duo" device. It primarily states that the device has been determined to be substantially equivalent to legally marketed predicate devices for its stated indications for use (electro-coagulation and hemostasis in dermatologic and general surgical procedures).
Here's a breakdown of what is in the text versus what is missing based on your prompt:
What is in the text:
- Device Name: Secret Duo (and Secret Duo RF Smartcure applicator)
- Regulation Number: 21 CFR 878.4810
- Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
- Regulatory Class: Class II
- Product Code: GEX, GEI
- Indications for Use: "for electro-coagulation and hemostasis."
- 510(k) Number: K202043
What is NOT in the text (and is required by your prompt):
- A table of acceptance criteria and the reported device performance: This document does not detail any specific performance metrics or acceptance criteria for the device itself, beyond its substantial equivalence determination.
- Sample sizes used for the test set and the data provenance: There is no mention of any study, test data, or sample sizes.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of experts or ground truth establishment.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No mention of any test set or adjudication.
- 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 device is a surgical instrument (laser/RF), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be applicable or described for this type of device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This pertains to AI algorithms. The Secret Duo is hardware.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed.
- The sample size for the training set: No training sets are mentioned, as this is not an AI/software device in the context of the prompt's focus.
- How the ground truth for the training set was established: Not applicable for the same reasons as above.
In summary, the provided document is a regulatory clearance letter, not a detailed study report that would contain the requested information about device performance, study methodology, or ground truth establishment.
§ 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.