(90 days)
The Ceralas Diode Laser System ("Ceralas D15") is intended to be used for incision, excision, vaporization, hemostasis, and coagulation of soft tissues in open and closed (endoscopic) procedures. The Ceralas D15 is indicated for use in general surgery, urology, gynecology, neurosurgery (hemostasis), gastroenterology, plastic surgery, dermatology (vascular lesions), and otolaryngology (i.e., ear, nose, and throat ("ENT")), including the specific ENT procedures of tonsillectomy, hemiglossectomy, vocal cord polypectomy, tracheal stenosis, polypectomy, thyroidectomy, neck dissection, and oral cavity lesions.
The Ceralas D15 utilizes gallium aluminum arsenide semiconductor diodes to generate near-infrared laser radiation. The laser is air cooled with thermoelectric coolers. The exposure mode for the laser is 0 -15 watts, either in a continuous or pulsed delivery mode. The Ceralas D15, like the Ceralas D50 is microprocessor controlled. The delivery systems for the Ceralas D15 consist of fiber optic cables which are fitted with an SMA-905 connector at the proximal end. The distal ends are available in a variety of configurations, including cleaved/flat or sculpted/shaped (conical, round, and chisel). The fiber optic cables are composed of a quartz fiber core with a coaxially mounted protective sheath. The cables are available with or without handpiece accessories.
This is a 510(k) summary for a Ceralas Diode Laser System (Model D15). This document describes a medical device, not an AI/ML algorithm. Therefore, the requested information about acceptance criteria and studies related to AI/ML performance metrics, ground truth, sample sizes for training/test sets, expert adjudication, or MRMC studies is not applicable.
The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (Ceralas Diode Laser System Model D50) based on intended use, technological characteristics, and safety/effectiveness.
Here's how the provided information relates to the general concept of device acceptance and evaluation:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implied by Substantial Equivalence): The primary "acceptance criterion" for a 510(k) pathway is that the new device (Ceralas D15) is "substantially equivalent" to a legally marketed predicate device (Ceralas D50). This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.
- Reported Device Performance: The document states:
- Intended Use: "incision, excision, vaporization, hemostasis, and coagulation of soft tissues in open and closed (endoscopic) procedures... in general surgery, urology, gynecology, neurosurgery (hemostasis), gastroenterology, plastic surgery, dermatology (vascular lesions), and otolaryngology..." This is explicitly stated to be the same as the predicate device.
- Technological Characteristics:
- Utilizes gallium aluminum arsenide semiconductor diodes.
- Generates near-infrared laser radiation.
- Air cooled with thermoelectric coolers.
- Exposure mode: 0-15 watts, continuous or pulsed.
- Microprocessor controlled.
- Delivery systems: fiber optic cables with SMA-905 connector, various distal configurations.
- Wavelength: 980 ± 30 nm (same as predicate).
- Aiming beam: 670 nm, 4 mW max (same as predicate).
- Key Difference and Rationale: The only difference is the power output (0-15 watts for D15 vs. 0-50 watts for D50). The document asserts this "does not raise new issues of safety or effectiveness because the cleared laser's power output range encompasses the Ceralas D15's 0-15 power output range." This is the core argument for substantial equivalence regarding safety and effectiveness.
Studies Conducted (Implied for the 510(k) process, but not detailed as "studies" in the AI/ML sense):
The 510(k) process typically relies on:
- Bench Testing/Engineering Analysis: To verify that the device meets its own specifications (e.g., power output accuracy, wavelength, safety features).
- Comparison to Predicate: A direct comparison of specifications, functionality, and intended use as laid out in the summary.
- Risk Analysis: To determine if the changes (lower power) in the D15 introduce new risks compared to the D50. The assertion in the document is that it does not.
Without further documentation (which would be part of the full 510(k) submission, not just the summary), specific details about particular "studies" proving these points are not provided in this excerpt. There's no mention of clinical trials or specific performance tests for "accuracy," "sensitivity," or "specificity" as would be relevant for an AI/ML diagnostic device.
Regarding the specific numbered points from the prompt (and why they are not applicable here):
- A table of acceptance criteria and the reported device performance: As explained above, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate, not performance metrics like accuracy for an AI system.
- Sample size used for the test set and the data provenance: Not applicable. This is a hardware device, not an AI model evaluated on a "test set" of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no diagnostic "ground truth" being established by experts for this laser device in this context.
- Adjudication method: Not applicable. No human expert adjudication for AI model outputs.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for evaluating human reader performance, often with and without AI assistance. This device is a surgical laser.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical device, not a standalone algorithm.
- The type of ground truth used: Not applicable. Surgical lasers don't have "ground truth" in the AI/ML sense. Their performance is assessed by meeting engineering specifications and clinical safety/effectiveness for their intended use.
- The sample size for the training set: Not applicable. No AI model being trained.
- 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.