(153 days)
The Reliant Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
The Reliant Laser System consists of a set of diode lasers, controlled by an embedded processor, to be used in dermatology for the coagulation of soft tissue. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis.
The provided text is a 510(k) summary for the Reliant Laser System, which is a dermatology laser. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Here's a breakdown of why this information is absent in this type of document:
- Acceptance Criteria and Device Performance Table: Not applicable for a 510(k) summary. A 510(k) demonstrates substantial equivalence, often through comparisons of technological characteristics and intended use, not by meeting predefined performance criteria in a clinical trial.
- Sample sizes for test set and data provenance: No "test set" information is provided because a formal statistical study to prove performance against acceptance criteria was not conducted for this 510(k) submission.
- Number of experts and qualifications for ground truth: No such information is present as no "ground truth" was established in the context of a performance study described here.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported in this document. The device is a laser system, not an AI or diagnostic imaging device that would typically involve MRMC studies.
- Standalone algorithm performance: Not applicable, as this is a laser hardware system, not an algorithm.
- Type of ground truth used: Not applicable, as no performance study requiring ground truth is detailed.
- Sample size for training set: Not applicable, as this is a physical device and not an AI/machine learning algorithm that requires a training set.
- How ground truth for training set was established: Not applicable.
The document primarily focuses on:
- Describing the device and its intended use.
- Stating its compliance with laser product regulations (21 CFR § 1010 and 21 CFR § 1040).
- Declaring substantial equivalence to a predicate device (Lumenis Ultrapulse Encore).
- Listing references (K031795 2 of 2) which are general clinical research papers about CO2 lasers and skin, not specific studies validating the Reliant Laser System's performance against predefined criteria.
In summary, this 510(k) document is not designed to provide the kind of performance study data and acceptance criteria you've asked for. It serves a different regulatory purpose. This type of information is usually found in Pre-Market Approval (PMA) applications or more extensive clinical trial reports for devices requiring higher levels of evidence.
§ 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.