(687 days)
The RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 laser systems and their 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, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery. and Arthroscopy
The RevoLix Family of diode pump solid state ( that include the RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200) are part of a family of surgical laser systems operating at a wavelength of 2.01 micron. The purpose of these lasers is to ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic surgical applications and procedures in an aqueous and non-aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a hand piece. endoscopic or laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
Here's an analysis of the provided text regarding the acceptance criteria and study for the RevoLix Family of Laser Systems:
It is important to note that the provided document is a 510(k) Summary for a medical device (laser surgical instrument), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. As such, the information you've requested regarding specific acceptance criteria, sample sizes, expert qualifications, and ground truth for a study proving the device meets acceptance criteria (as would be found for a diagnostic AI device, for example) is largely not present in this type of submission.
The document describes bench testing to support substantial equivalence, but not a full-fledged clinical trial to establish quantitative performance against defined acceptance criteria in the way a diagnostic AI device would.
Acceptance Criteria and Reported Device Performance
Given the nature of the submission (510(k) for a surgical laser), the "acceptance criteria" are primarily related to demonstrating substantial equivalence to existing predicate devices in terms of intended use, indications for use, and functional features, and similar performance characteristics in bench testing. Performance is described qualitatively, rather than via quantitative metrics with defined thresholds like sensitivity, specificity, etc.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Surgical procedures for ablation, coagulation, dissection, and resection of soft tissue. | "The RevoLix Family... are part of a family of surgical laser systems operating at a wavelength of 2.01 micron. The purpose of these lasers is to ablation, coagulation, dissection and resection of soft tissue." (Page 1) |
| Indications for Use: Matching predicate device across various medical specialties (Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery, Arthroscopy). | Multiple pages (2-5, 8-13) detail extensive and identical indications for use across all listed specialties as the predicate device. |
| Wavelength: 2.01 micron. | "operating at a wavelength of 2.01 micron." (Page 1) |
| Delivery Method: Fiber optic delivery system through handpiece, endoscopic, or laparoscopic instruments. | "The laser power is delivered via standard silica laser fibers. The distal tip is guided by a hand piece. endoscopic or laparoscopic surgical instrument." (Page 1) |
| Similar Design and Functional Features: Comparable to predicate devices. | "The Revolix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 laser systems and their fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are substantially equivalent to the RevoLix Jr, RevoLix 120 and Quanta Cyber TM 150." (Page 6) |
| Depth of Thermal Injury and Coagulation: Not significantly different from predicate device. | "The depth of thermal injury and coagulation were measured and compared to the RevoLix 120 and did not show significant differences." (Page 6) |
| Ablation Depth: Comparable to predicate device, with adjustment for translation speed based on power level. | "The ablation depth was also measured and found to be of comparable depth, with an adjustment in the translation speed depended on the power level." (Page 6) |
| Other Tissue Effects (e.g., carbonization): Comparable to predicate device. | "Other tissue effects such as carbonization were also found to be comparable." (Page 6) |
| Safety and Effectiveness: "Safe and effective" determination based on substantial equivalence. | "The Revolix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 Laser Systems with fiber optic delivery devices was found to be safe and effective and therefore substantially equivalent to the predicate surgical laser systems and delivery devices." (Page 6) |
Study Details (Based on the provided 510(k) Summary)
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Sample size used for the test set and the data provenance:
- The document mentions "All necessary bench testing was conducted on the proposed family of RevoLix lasers." It does not specify the sample size (e.g., number of tissue samples, animals, or human subjects) used for these bench tests.
- Data provenance: "Bench testing" generally refers to in-vitro or ex-vivo testing in a laboratory setting, not patient data. No specific country of origin is mentioned, but typically such testing would occur in the manufacturer's R&D facilities or contracted labs. The testing appears to be "prospective" in the sense that it was performed specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For physical performance testing of a laser, "ground truth" would likely be established by objective measurements (e.g., using calibrated instruments for depth, temperature, visual assessment of tissue effects) rather than expert consensus on interpretive data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for evaluating the interpretation of medical images or diagnostic outputs, where subjective assessment by multiple readers is required. For bench testing of a laser's physical effects, objective measurement and comparison to specifications or predicate device performance are the primary methods.
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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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This submission is for a surgical laser, where the primary function is direct tissue interaction, not aiding human readers in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical laser system, which is inherently a human-in-the-loop device (a surgeon operates it). It is not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the bench testing would be objective physical measurements (e.g., direct measurement of thermal injury depth, ablation depth, observation of tissue effects like carbonization) and comparison to the known performance of the predicate device. Pathology or outcomes data would be part of clinical trials, which are beyond the scope of this 510(k) summary focused on substantial equivalence via bench testing.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm requiring a training set with ground truth.
Summary of what the document does provide regarding the "study" (bench testing):
The "study" refers to bench testing performed on the RevoLix family of lasers. This testing aimed to demonstrate that the new devices perform in a "comparable" manner to the predicate device in terms of direct tissue effects. The key findings were:
- Depth of thermal injury and coagulation: No "significant differences" when compared to the RevoLix 120 (predicate).
- Ablation depth: "Comparable depth" with an adjustment in translation speed.
- Other tissue effects (e.g., carbonization): "Comparable."
This information supports the claim of substantial equivalence, which is the core requirement for a 510(k) clearance, rather than establishing novel quantitative performance metrics for a diagnostic or AI device.
§ 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.