(176 days)
The Optica XT Thulium Fiber Laser and Accessories is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
The Optica XT Thulium Fiber Laser is a thulium fiber laser radiation at 1940 nm with a laser output power of 60 Watts. Laser activation is by footswitch. The overall weight of the laser is 95 lbs., and the size is 20" W x 24" L x 16" H. The Optica XT Thulium Fiber Laser has an electrical requirement of 100-240 VAC, 50/60 Hz. Laser energy is delivered to the target site using a fiber optic delivery system with diameters from 150-1000 micron.
The provided text describes a 510(k) submission for the Optica XT Thulium Fiber Laser and Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with specific acceptance criteria as one might find for a new drug or a de novo medical device. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, human reader performance, training data, and specific ground truth establishment is not present in this document.
Instead, this submission focuses on demonstrating that the new device (Optica XT) performs similarly to an already cleared device (Olympus SOLTIVE™ Laser System) and does not raise new questions of safety or effectiveness. The "acceptance criteria" here are largely met through adherence to recognized performance standards and comparative analysis of technological characteristics.
Here's an analysis based on the provided text, addressing your points where applicable and explaining the absence of other information:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of quantitative performance acceptance criteria in the way a clinical study might (e.g., minimum sensitivity/specificity). Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized electrical, safety, and electromagnetic compatibility (EMC) standards, as well as showing comparable technological characteristics and performance to the predicate device.
The reported device performance is primarily described through the comparison table of technological characteristics.
| Acceptance Criteria (Implicit) | Reported Device Performance (Optica XT) |
|---|---|
| Electrical Safety Standard Compliance | AAMI/ANSI ES60601-1:2005+A1 and IEC 60601-1:2005+C1;C2;A1 compliant. |
| Laser Safety Standard Compliance | IEC 60825-1:2014, Edition 3.0 compliant. |
| Medical Electrical Equipment Laser-Specific Standard Compliance | IEC 60601-2-22:2012, Edition 3.1 compliant. |
| Electromagnetic Compatibility (EMC) Standard Compliance | IEC 60601-1-2:2014, Edition 4 compliant. |
| Usability Standard Compliance | IEC 60601-1-6:2013, Edition 3.1 compliant. |
| Software Life Cycle Process Compliance | IEC 62304:2006, Ed. 1.0 + A1 compliant. |
| Biocompatibility Standard Compliance | ISO 10993-1 compliant for cytotoxicity, acute systemic toxicity, sensitization, material-mediated pyrogenicity, hemocompatibility, and irritation/intracutaneous reactivity. |
| Fiber Performance (Bending Stress) | Bench testing demonstrates comparable fiber performance to predicate. |
| Technological Characteristics | Similar or within range of predicate device for wavelength, power, pulse duration, frequency, pulse energy, fiber diameter, control methods, and safety features. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "This premarket submission for the Optica XT Thulium Fiber Laser and Accessories does not require clinical studies to support substantial equivalence."
Therefore, there is no test set of patient data, no sample size, and no data provenance in the context of clinical performance evaluation. The data presented is non-clinical performance data (bench testing, standards compliance).
3. 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, as no clinical test set requiring expert ground truth was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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-assisted diagnostic or therapeutic device that involves "human readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a laser surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical ground truth was established for this submission. The "ground truth" for this device's safety and effectiveness is established through compliance with established engineering and safety standards and comparison to a legally marketed predicate device.
8. The sample size for the training set
Not applicable, as this is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not a machine learning 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.