(77 days)
The PhoTex30 Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck. orthopedics, ophthalmology, pulmonology, and thoracic surgery.
The PhoTex30 Diode Laser Series are diode lasers emitting radiation in either a continuous-wave (CVV), pulsed or external modulation modes in the initialians and series provides a means. wavelengths: 980nm, 810nm, and 940nm. The PhoTexy Diode Laser Series dollygry wavelengths. 960mm, and vaporization of tissue using a compatible fiber optic delivery for cutting, coagulation, and vaporization of tiber optic delivery accessory terminated with a numerical accessory. The laser is compatible with uny hist "bptro" and one of larger with a numerical aperture of at least .37.
The provided document is a 510(k) summary for the PhoTex30 Diode Laser Series. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical or analytical testing with quantitative performance metrics.
Instead, the document states generally that "Engineering studies have demonstrated the substantial equivalence of the PhoTex30 Diode Laser Series" to predicate devices. The conclusion is that "the lasers functioned as intended and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications."
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The information that can be extracted relates to the comparison to predicate devices and general compliance:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document implies the acceptance criterion is "substantial equivalence" to the predicate devices (PhoTex15 Diode Laser Series (K060304) and SLT Thermalite Diode Laser Series (K952661)) in terms of "technological features, device performance, and indications for use." It also states compliance with "FDA standards 21CFR1040.10 and 21CFR1040.11."
- Reported Device Performance: "The studies concluded that the lasers functioned as intended and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications." However, no specific quantitative performance metrics (e.g., accuracy, precision, wavelength stability, power output consistency, etc.) are provided in the summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K060304, K952661) in technological features, device performance, and indications for use. | The PhoTex30 Diode Laser Series has been shown to be substantially equivalent to the predicate devices. Differences were determined to be minor and are each within the overall safety and effectiveness of the device. |
| Compliance with FDA standards 21CFR1040.10 and 21CFR1040.11. | Engineering studies concluded that the lasers are in compliance with FDA standards 21CFR1040.10 and 21CFR1040.11. The studies concluded that the lasers functioned as intended and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications. |
2. Sample size used for the test set and the data provenance: Not applicable. The document refers to "engineering studies" rather than a test set with data collected from human subjects or retrospective/prospective medical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies mentioned are "engineering studies," not clinical or diagnostic studies requiring expert review for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) 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 device is a surgical laser, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "Engineering studies" of the device itself, implying standalone performance evaluation, but without specific quantitative metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic performance. The "ground truth" for an engineering study would be the device's adherence to design specifications and regulatory standards, evaluated through physical measurements and tests.
8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" through engineering studies, rather than providing detailed performance metrics from clinical or analytical studies as one might expect for a diagnostic or AI-powered 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.