(159 days)
The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision. ablation, vaporization, coagulation, with hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.
Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.
The provided documents are a 510(k) summary and FDA clearance letter for the Sciton Profile 1320 Laser System. These documents primarily focus on regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted directly from these documents. These types of studies are typically found in more detailed technical reports or clinical trial summaries, which are not included here.
However, I can provide the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided documents, specific quantitative acceptance criteria or reported device performance metrics (e.g., precision, accuracy, sensitivity, specificity for a specific clinical task) are not available. The 510(k) summary focuses on the device's technical specifications and intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in these documents | Not specified in these documents |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided documents. The clearance is based on substantial equivalence to a predicate device, rather than a de novo clinical performance study detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not available in the provided documents.
4. Adjudication Method for the Test Set:
This information is not available in the provided documents.
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:
This information is not applicable/not available. The Sciton Profile 1320 Laser System is a medical laser for surgical and dermatological procedures, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable/not available. As noted above, this device is a laser system, not an algorithm.
7. The Type of Ground Truth Used:
This information is not available in the provided documents. When assessing laser systems, "ground truth" typically refers to the confirmed clinical outcome or tissue effect, which would be assessed in clinical trials. However, the details of such assessments are not present here.
8. The Sample Size for the Training Set:
This information is not applicable/not available. This device is a laser system, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not available. This device is a laser system, not a machine learning algorithm.
Summary of Device and Regulatory Context (from provided documents):
- Device Trade Name: Profile 1320 Laser System
- Common Name: Nd:YAG Laser System
- Intended Use: For use in general surgery and dermatology for incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.
- Predicate Device: CoolTouch Nd:YAG Laser System (K003715 and K014035)
- Regulatory Pathway: 510(k) clearance, based on substantial equivalence to the predicate device. This pathway does not typically require the detailed clinical performance studies that would include the specific acceptance criteria and study details requested, unless there are new technological characteristics or different intended uses that raise different safety and effectiveness questions.
§ 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.