(134 days)
The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
Phantom Erbium lasers are composed of the following components:
- a laser console .
- a counterbalanced articulated arm and handpiece .
- a control / display panel ●
- a finger trigger or foot petal control ●
- ● a laser head w / beam optics
- a CPU control system
- . a power supply
- an internal cooling system
Models range from 5 to 50 Watts average power.
This 510(k) summary (K972915) for the Erbium 2000 Laser Family does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets them. This document is a premarket notification for substantial equivalence, not a clinical study report.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal acceptance criteria in terms of specific performance metrics (like percentage of efficacy or adverse event rates) against which the device was measured. Instead, it refers to performance standards for safety and electrical compatibility, and claims substantial equivalence to predicate devices for its intended uses.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with electrical safety and laser radiation standards | UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10 & 1040.11 (Compliance is implied by listing these standards) |
| Performance for stated indications (excision, incision, ablation, vaporization, coagulation of soft tissue, skin resurfacing) | Substantially equivalent to predicate devices for these indications. The document does not provide specific performance data (e.g., success rates, tissue removal efficiency) for the Erbium 2000. |
2. Sample size used for the test set and the data provenance
The document does not describe a specific test set or clinical study with a defined sample size for evaluating the Erbium 2000 Laser Family's clinical performance. As a 510(k) submission, the primary evidence presented for substantial equivalence often relies on comparison to existing, legally marketed predicate devices, rather than new, large-scale clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided document. There is no mention of a test set or ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided document, as no specific test set or clinical study involving adjudication is described.
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 is not applicable. The device described is a surgical laser, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical surgical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting clinical trial data that would require a defined "ground truth."
8. The sample size for the training set
This information is not applicable/not available. Training sets are relevant for machine learning algorithms. The Erbium 2000 is a laser device, and its development would involve engineering and physical testing, not machine learning training.
9. How the ground truth for the training set was established
This information is not applicable/not available.
Summary of the Study (as described in the document):
The document does not describe a "study" in the sense of a clinical trial used to prove the device meets specific performance criteria. Instead, it is a 510(k) Premarket Notification which argues for "substantial equivalence" of the Erbium 2000 Laser Family to previously cleared predicate devices.
The "study" or evidence provided to the FDA largely consists of:
- Device Description: Detailing the components and functionality of the Erbium 2000.
- Indications For Use: Stating the proposed clinical applications, which are broad surgical procedures for soft tissue and skin resurfacing.
- Performance Standards Compliance: Declaring adherence to safety and electrical standards (UL544, UL2601.1, IEC601.1, IEC825, 21 CFR 1040.10 & 1040.11). This demonstrates safety and electrical compatibility, but not clinical efficacy in terms of treatment outcomes.
- Predicate Device Comparison: Listing numerous predicate devices (with K-numbers where known) for a range of laser systems. The core of a 510(k) is to demonstrate that the new device is as safe and effective as these previously marketed devices for the same intended use. This comparison is typically based on technological characteristics, intended use, and existing performance data of the predicate devices, rather than new clinical data for the submitted device itself.
In essence, the "proof" the device meets acceptance criteria is the FDA's determination of substantial equivalence to legally marketed predicate devices, implying that if the predicate devices were accepted, and the new device is sufficiently similar and meets relevant safety standards, it too can be accepted. The document does not provide a separate, dedicated clinical study report.
§ 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.