(60 days)
The Revolix Duo continuous wave 2.01 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The Revolix Duo pulsed Holmium 2.1 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in use in medical specialties including: Urnlogy, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The RevoLix Duo is a combination of a diode pump solid state laser operating at a wavelength of 2.01 micron and a pulsed flashlamp Holmium laser operating at 2.1 microns. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
The provided text is a 510(k) Summary for the Revolix Duo Laser System (K070466). Due to the nature of 510(k) submissions for Class II medical devices like surgical lasers, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than performing a de novo clinical study with explicit acceptance criteria for device performance.
Therefore, the input document does not contain the detailed information requested regarding acceptance criteria, a specific study proving the device meets those criteria, test set sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, ground truth types for test sets, training set sizes, or how training set ground truth was established.
Instead, the "study" proving the device meets acceptance criteria (via substantial equivalence) is the comparison to predicate devices.
Here's a breakdown of why the requested information is absent and what the document does provide:
1. A table of acceptance criteria and the reported device performance:
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Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for a new device. The "acceptance criteria" here are implicitly that the Revolix Duo Laser System performs equally well or similarly enough to the predicate devices for the specified indications for use, without raising new questions of safety and effectiveness.
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Reported Device Performance: Not presented as a distinct performance evaluation from a clinical trial. The "performance" is considered equivalent to that of the predicate devices.
Acceptance Criteria (Implied) Reported Device Performance Substantial equivalence to predicate devices (Lisa Laser RevoLix continuous wave 2 micron laser and Lisa Laser Sphinx 80 Watt Holmium Laser (K070466)) for stated Indications for Use. The Revolix Duo Laser System was found to be substantially equivalent to the predicate devices for its intended use and indications for use.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document does not describe a clinical performance study with a distinct "test set" of patient data.
- Data Provenance: Not applicable. The submission relies on the established safety and effectiveness of the predicate devices, not on new clinical data from the Revolix Duo system itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with expert-established ground truth.
4. Adjudication method for the test set:
- Not applicable.
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 is a laser surgical instrument, not an AI diagnostic device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm, it's a physical surgical laser system that requires a human operator. Its performance is inherent to its physical operation, not an algorithm's output.
7. The type of ground truth used:
- Not applicable in the context of a new performance study. The "ground truth" for the submission is the regulatory precedent set by the predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.