(108 days)
The AccuSculpt II Laser System is indicated for use the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The AccuSculpt II is further indicated for laser assisted lipolysis.
The AccuSculpt II Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the heart of the AccuSculpt II Laser System and contains the Nd-YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the LCD display.
Here's a summary of the acceptance criteria and study information for the Lutronic Corporation AccuSculpt II Laser System, based on the provided document:
This 510(k) summary explicitly states: "No performance data was provided since no new questions of safety or efficacy have been raised."
Therefore, the device's acceptance was based on substantial equivalence to predicate devices rather than new performance data or a specific study proving it meets acceptance criteria. The document does not contain information on acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study details.
Here's a breakdown of the requested information, noting what is present and what is absent in the document:
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria Reported Device Performance Not specified. Not specified. (No new performance data was provided as the device was deemed substantially equivalent to predicate devices.) (No new performance data was provided.) -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set or performance study was conducted.
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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 was established for this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used.
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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
- No. This device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a laser system, not an algorithm. No standalone performance study was conducted.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established as no performance study was conducted.
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The sample size for the training set
- Not applicable. No training set was used as no new algorithm or performance study was conducted.
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How the ground truth for the training set was established
- Not applicable. No training set or ground truth was established.
Summary of Device Acceptance Rationale:
The AccuSculpt II Laser System gained 510(k) clearance based on substantial equivalence to previously cleared predicate devices:
- Lutronic Corporation PowerLipo (AccuSculpt) Laser System (K082096)
- Sciton, Inc. Profile Multi-Platform System (K070388)
The submission explicitly states that the AccuSculpt II Laser System "has the same indications for use, technological characteristics and principles of operation as the predicate devices." Because of this, it was determined that "no new questions of safety or efficacy have been raised," and therefore, no new performance data or clinical studies were required or provided 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.