(275 days)
Dental soft tissue indications: incision, vaporization, ablation, and coagulation of oral soft tissues including the following:
- · Gingival troughing for crown impression
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- · Fibroma removal
- · Frenectomy and frenotomy
- · Implant recovery
- · Incision and drainage of abscess
- · Leukoplakia
- Operculectomy
- · Oral papillectomies
- · Pulpotomy
- Pulpotomy as an adjunct to root canal therapy
- · Reduction of gingival hypertrophy
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and ulcers
- · Vestibuloplasty
- · Tissue retraction for impression
Laser periodontal indications including:
· Sulcular debridement (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss, and tooth mobility).
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.
The Ultrafast series (Ultrafast, Ultrafast Plus, and Ultrafast Lite) are cordless diode laser systems designed for a wide variety of dental soft tissue procedures. The products have three separate models under the model names: Ultrafast, Ultrafast Plus and Ultrafast Lite. They use solid-state laser diodes as sources of infrared radiation. The energy from the infrared radiation is delivered to the treatment site via a single-use fiber optic tip.
The product kit consists of a laser handpiece, laser goggles, charging stand, power adapter, laser shield, barrier sleeves, product warning labels and instructions for use. The laser handpiece is constructed from anodized aluminum and contains a single-use, disposable fiber optic tip and main body containing laser diode, main control and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface to control and deliver the laser and a green aiming beam to guide the laser procedures. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery.
Based on the wavelength and power of the laser diodes used, the kit can be preconfigured into three separate models:
| Trade Name | Wavelength (nm) | Max CW Power (Watt) |
|---|---|---|
| Ultrafast | 808 | 3 |
| Ultrafast Plus | 980 | 3 |
| Ultrafast Lite | 808 | 1.5 |
The provided text, a 510(k) summary for the DentLight Inc. Ultrafast series dental lasers, describes the device's technical specifications and asserts its substantial equivalence to previously cleared predicate devices. It does not present a study with acceptance criteria and device performance data in the typical format of an AI/ML device performance study.
Instead, the document focuses on demonstrating that the Ultrafast series shares similar indications for use, technology, design, and performance characteristics with its predicates. The "performance testing" mentioned is related to non-clinical safety and design specifications, not clinical efficacy or diagnostic accuracy as would be relevant for an AI/ML-driven device.
Therefore, I cannot extract the information required for your request in the format you provided because the document describes a traditional medical device (dental laser) and its regulatory clearance process through substantial equivalence, not an AI/ML-driven device that would involve concepts like sensitivity, specificity, human reader performance, ground truth establishment by experts, or training/test sets for machine learning models.
The "acceptance criteria" for this device are implicitly tied to meeting the safety and performance standards demonstrated by the predicate devices and relevant IEC/ISO standards. The "study proving the device meets acceptance criteria" refers to non-clinical bench testing and compliance with those aforementioned standards.
Here's what can be inferred from the document regarding "acceptance criteria" and "performance" for a dental laser, but please note this is NOT an AI/ML performance study as you've outlined:
Based on the provided document, the "acceptance criteria" and "study proving the device meets acceptance criteria" are aligned with demonstrating substantial equivalence for a dental laser, not an AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a laser device):
| Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance (from document) |
|---|---|
| Safety Standards Compliance | • Complies with IEC 60601-1 (medical electrical equipment general requirements) |
| • Complies with IEC 60601-1-2 (electromagnetic compatibility) | |
| • Complies with IEC 60825-1 (safety of laser products) | |
| • Complies with IEC 60601-2-22 (particular requirements for surgical and therapeutic laser equipment) | |
| Biocompatibility | • Complies with ISO 10993-1 (Biological Evaluation of Medical Devices) |
| Power Accuracy | • Power Accuracy: ±20% (Ultrafast/Ultrafast Plus/Ultrafast Lite) – Matches predicate device |
| Wavelength | • Ultrafast/Ultrafast Lite: 808 ± 10 nm |
| • Ultrafast Plus: 980 ± 10 nm | |
| Maximum CW Power | • Ultrafast/Ultrafast Plus: 3 Watt (vs. predicate 1.5W, reference 3.5W) |
| • Ultrafast Lite: 1.5 Watt (vs. predicate 1.5W, reference 3.5W) | |
| Maximum Pulse Power | • Ultrafast/Ultrafast Plus: 5 Watt (vs. predicate 2W, reference 6W) |
| • Ultrafast Lite: 2 Watt (vs. predicate 2W, reference 6W) | |
| Fiber Core Diameter | • 400 µm (Matches predicates) |
| Aiming Beam Specifications | • 525 (±10nm, 0.6mW) (vs. predicate 650nm/0.5mW, reference 635nm/5mW – noted as a difference but not a concern for substantial equivalence) |
| Operational Modes | • Continuous / Pulse (Matches predicates) |
| Design Specifications & Key Features | • Meets all design specifications; similar design, construction materials, weight, size, and key features to predicate devices. (e.g., LCD vs OLED, green vs red aiming beam noted as differences not affecting equivalence) |
| Indications for Use (Substantial Equivalence) | • Has the same indications for use as the predicate/reference devices. |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of an AI/ML test set. The document describes non-clinical performance testing for optical, thermal, electrical, and mechanical safety, and biocompatibility. This typically involves testing of physical units of the device, not a "data set" in the AI/ML sense. Data provenance would be from internal lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to clinical data ground truth, which is not part of this 510(k) summary for a non-AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical data adjudication, not applicable here.
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:
- No. This is a dental laser device, not an AI/ML product. MRMC studies are not relevant for this type of device clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical laser device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable. For this device, "ground truth" equates to established engineering and safety standards (e.g., IEC, ISO) and the performance of the predicate devices. Performance is measured against these technical specifications and safety limits.
8. The sample size for the training set:
- Not applicable. This refers to machine learning training data, which is irrelevant for this traditional medical device.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided text is a regulatory filing for a dental laser device, demonstrating substantial equivalence through non-clinical testing against established safety standards and comparison to predicate devices' specifications, not an AI/ML device requiring clinical performance studies with human readers, ground truth from experts, or training/test datasets.
§ 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.