(70 days)
The DenLaser 800 Plus is indicated for the procedures of removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, plastic surgery, urology, gynecology, and plastic surgery.
The DenLaser 800 Plus is a device for delivering laser energy to human soft tissue for a variety of surgical procedures. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to surgical site by means of a proprietary optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery option. The working end of the delivery fiber is contained within metal handpiece with a disposable single-use tip. This handpiece system is provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
The provided text is a 510(k) Summary for the DenLaser 800 Plus, an 810nm Diode Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards, rather than presenting a clinical study with detailed acceptance criteria and performance data in the typical sense for AI/software devices.
Here's an analysis based on the information provided:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria and reported device performance in the manner one would expect for a diagnostic or AI-driven device clinical study (e.g., sensitivity, specificity, AUC, etc.). Instead, the "acceptance criteria" are implied by compliance with various performance standards and demonstrated substantial equivalence to predicate devices. The "reported device performance" is described qualitatively through its technical characteristics and intended uses.
Acceptance Criterion (Implied) Reported Device Performance Substantial Equivalence to Predicate Devices (K050453, K032864, K993285) The DenLaser 800 Plus shares similar indications for use on soft tissue (cutting, lesions, photocoagulation), design features (wavelength, operating controls, laser delivery), control systems, safety features, performance monitoring, power output, energy type, and applications to soft tissue with the predicate devices. Compliance with 21 CFR 1040.10 and 1040.11 (Laser Product Performance Standards) Device complies with these standards, with permissible deviations relative to Laser Notice 50. Compliance with IEC 60601-1 (Medical Electrical Equipment - General requirements for basic safety and essential performance) Device complies with this standard. Compliance with IEC 60601-2-22 (Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) Device complies with this standard. Compliance with IEC 60825-1 (Safety of laser products - Equipment classification and requirements) Device complies with this standard. Compliance with 47 CFR 15 and 18 (FCC rules for radio frequency devices) Device complies with these standards. Compliance with ETSI 301-489-1 (Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements) Device complies with this standard. Safe and Effective for Intended Use The device delivers laser energy at 810 ± 20nm for a maximum of 5 watts, via a proprietary optical fiber system, with a 630nm aiming beam, adjustable power, and continuous/pulsed delivery option. It is intended for removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue across several medical fields. -
Sample size used for the test set and the data provenance:
The document explicitly states "Clinical Performance Data" as a heading on page 2 but then provides no content under it, only moving directly to the "Conclusion" on page 3. This indicates that no clinical performance study, test set, or specific data provenance was used or reported in this 510(k) summary. The substantial equivalence argument relies on comparison to predicate devices and adherence to recognized performance standards. This type of submission generally does not require a specific clinical test set if substantial equivalence can be demonstrated through other means (e.g., technological characteristics, bench testing, and adherence to standards).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. As no clinical test set was reported, there was no need for experts to establish ground truth.
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Adjudication method for the test set:
Not applicable. No clinical test set was reported.
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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:
Not applicable. This device is a surgical laser, not an AI/diagnostic software. No MRMC study was performed or is relevant for this type of device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device (surgical laser), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No clinical study requiring ground truth was reported. The "ground truth" for this submission are the established performance standards and the characteristics of legally marketed predicate devices.
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The sample size for the training set:
Not applicable. This is a hardware device, not an AI/machine learning algorithm, so there is no training set in that context.
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How the ground truth for the training set was established:
Not applicable. As above, no training set for an algorithm was used.
§ 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.