(23 days)
The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.
The SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions. The SPR has the same intended use, with similar indications for use, and is technologically identical to the cleared SkinStation with respect to the operation and function of the SkinStation's pigmented and vascular lesions module.
The provided text is a 510(k) summary for the Radiancy (Israel) Ltd.'s SPR System.
A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed studies demonstrating device performance against specific acceptance criteria in the manner one might find for novel device approvals or software algorithms.
Based on the information provided in the text, it is not possible to complete the requested table and answer the questions related to acceptance criteria, study details, sample sizes, expert involvement, and ground truth.
Here's why and what information is available:
Key Takeaways from the document:
- Device Type: The SPR System is a pulsed light device.
- Intended Use: Providing light therapy to the body, specifically indicated for treatment of pigmented and vascular lesions.
- Substantial Equivalence: The submission asserts substantial equivalence to Radiancy's SkinStation® System (K030897). Crucially, the document states: "The SPR has the same intended use, with similar indications for use, and is technologically identical to the cleared SkinStation with respect to the operation and function of the SkinStation's pigmented and vascular lesions module."
- No Performance Data Presented: The document focuses on regulatory classification, contact information, and the claim of substantial equivalence. It does not contain any performance data, clinical study results, or specific acceptance criteria for treatment efficacy or safety.
Why the requested information cannot be found in the provided text:
- 510(k)s often rely on existing predicate devices and technological characteristics, especially for devices like light therapy systems where the mechanism of action is well-established and previous devices have cleared the regulatory hurdles. They typically do not involve the same level of detailed performance study reporting as a PMA (Pre-Market Approval) or a software as a medical device (SaMD) submission that requires extensive clinical validation metrics like sensitivity, specificity, or AUC against ground truth.
- The questions posed (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth) are highly relevant for diagnostic AI algorithms or novel therapeutic devices requiring extensive clinical trials to prove efficacy and safety. This document is for a pulsed light therapy device and demonstrates substantial equivalence to an already cleared device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided 510(k) summary.
The document states the device is "technologically identical" to its predicate for the relevant functions, suggesting that the basis for approval is primarily this equivalence rather than new performance data against numerical acceptance criteria.
§ 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.