(49 days)
The Theravant TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick types I-VI).
The Theravant System is comprised of the following main components: Main console, Treatment Handpiece(s). The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment.
The provided text is a 510(k) summary for the Theravant TheraClear System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data for the Theravant system itself.
Therefore, many of the requested items (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance) are not explicitly present in this type of regulatory submission.
Here's an analysis based on the information provided:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This document does NOT present a study with specific acceptance criteria and performance data for the Theravant TheraClear System.
Instead, the submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Aesthera Isolaz System, K083730). The rationale for substantial equivalence is based on:
- Identical Indications for Use: The TheraClear System has the same stated indications for use as the predicate device.
- Same or Similar Device Operation: The device functions in a comparable manner to the predicate.
- Overall Technical and Functional Capabilities: The technical specifications and functional performance are considered similar enough to the predicate.
Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly met if the device is found to be substantially equivalent to the predicate, which has already established its safety and effectiveness. There are no direct performance metrics for the Theravant TheraClear System presented as part of this 510(k) summary to be compared against specific acceptance criteria.
Additional Requested Information (Based on the document):
1. A table of acceptance criteria and the reported device performance
- Not Applicable. As explained above, this 510(k) summary does not provide specific acceptance criteria or reported device performance data for the Theravant TheraClear System. It relies on demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document does not describe a clinical trial or test set with a specific sample size for the Theravant TheraClear System. The information provided is for regulatory submission focused on substantial equivalence.
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)
- Not Applicable. No test set or ground truth establishment process is described for the Theravant TheraClear System in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or related adjudication method is described.
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 laser surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical device (laser system), not an algorithm or software-only device. Performance would inherently involve a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No specific ground truth for performance evaluation of the Theravant TheraClear System is described in this document. The "ground truth" for the regulatory approval relies on the predicate device having already demonstrated safety and effectiveness for its indications.
8. The sample size for the training set
- Not Applicable. This document describes a physical medical device, not a machine learning model that would require a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set is relevant to this type of device and 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.