(14 days)
The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.
The, Azuryt Model CTL 1401 CO2 Surgical Laser System is a CO2 laser consisting of a power supply, cooling system, laser head, articulated arm, handpiece, microcontroller and control panel.
The provided text describes a 510(k) Premarket Notification for the Azuryt Model CTL 1401, CO2 Surgical Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving upfront that a new device meets specific performance criteria through extensive clinical studies.
Therefore, the information requested in your prompt related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is largely not applicable or not provided in this specific 510(k) summary.
Here's why and what information can be extracted:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. For a 510(k) clearance, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This isn't about numerical performance metrics in a clinical study but rather about ensuring the new device has the same intended use, technological characteristics, and raises no new safety or effectiveness issues compared to a device already on the market.
- What is provided: The submission states that "The system performs as intended and raises no new safety or effectiveness issues." This is the general conclusion, not a quantified performance report against specific criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. No clinical test set or data provenance is mentioned as this is a device clearance based on substantial equivalence and compliance with standards, not a clinical trial.
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/Not provided. No expert review for ground truth on a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a surgical laser, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" here is the established safety and effectiveness of the predicate device and compliance with recognized standards.
8. The sample size for the training set
- Not applicable. As this is a physical medical device (surgical laser) and not an AI/algorithm, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable.
Summary of what IS provided regarding "acceptance criteria" and "study":
The "study" or evidence proving the device meets the "acceptance criteria" (which in this context means demonstrating safety, effectiveness, and substantial equivalence) primarily relies on:
Acceptance Criteria & Reported Performance (Based on Substantial Equivalence and Standards Compliance):
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance |
|---|---|
| 1. Substantial Equivalence to Predicate Device (K042439) | The Azuryt Model CTL 1401, CO2 Surgical Laser System is "substantially equivalent to the Azuryt Model CTL 1401 cleared under K042439." It has the "same intended uses, with the same technological characteristics" as the predicate. |
| 2. Intended Use and Indications | Indicated for "incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues" across specialties like general/plastic surgery, dentistry, dermatology, etc. This matches the predicate's intended uses. The submission concludes the device "performs as intended." |
| 3. Technological Characteristics | Operates as a CO2 surgical laser with a 10.6 um wavelength. Consists of a power supply, cooling system, laser head, articulated arm, handpiece, microcontroller, and control panel. These characteristics are described as "the same" as the predicate. |
| 4. Safety Standards Compliance | Complies with: |
- IEC 60825-1 (Safety of laser products)
- IEC 60601-2-22 (Safety of diagnostic and therapeutic laser equipment)
- IEC 60601-1 (General requirements for safety)
- IEC 60601-1-2 (Electromagnetic compatibility)
- European Medical Device Directive 92/42/EEC
- US Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products (with noted deviations pursuant to Laser Notice No. 50). |
| 5. No New Safety or Effectiveness Issues | The submission concludes that "Based upon the testing and comparison to the predicate devices, the Azuryt Model CTI. 1401... raises no new safety or effectiveness issues." |
Study/Evidence:
The "study" that proves the device meets (or rather, satisfies the requirements for) these criteria is primarily through engineering verification and validation based on international and national standards, and a comparison of technological characteristics to a legally marketed predicate device.
- Type of "Study": This is a premarket notification (510(k)), which is a regulatory pathway for demonstrating substantial equivalence. It is not a clinical trial or performance study in the way one might evaluate an AI algorithm.
- Methodology:
- Comparison to Predicate: Direct comparison of intended use and technological characteristics to the Azuryt Model CTL 1401 (cleared under K042439).
- Compliance with Standards: Verification that the device adheres to a list of specified international and US federal safety and performance standards for laser products and medical electrical equipment (IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2, European MDD 92/42/EEC, US 21 CFR 1040.10, 21 CFR 1040.11).
In essence, for a 510(k) for a device like a surgical laser, the "acceptance criteria" are regulatory and technical compliance, and the "study" is the demonstrated adherence to these through bench testing, design specifications, and comparison to existing products.
§ 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.