(281 days)
The NeoLas Er: Y A G laser, and its accessories, are in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry for:
Endodontic Surgery (Root Amputation) Indications:
· Root end preparation for retrofill amalgam or composite
· Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex.
NOTE: Any tissue growth (i.e. cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation
Laser Periodontal Procedures:
- · Full thickness flap
- · Partial thickness flap
- · Split thickness flap
- · Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
· Removal of granulation tissue from bony defects
· Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
The NeoLas 810nm Soft Tissue laser and its accessories are intended for use on adult and pediatric patients in dentistry, dermatology and other surgical areas in the following procedures:
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation or oral soft tissues, including:
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- · Fibroma removal
- · Flap preparation-incision of soft tissue to prepare a flap and expose the bone.
- · Flap preparation-incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
- · Frenectomy and frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
NeoLas is a portable, microprocessor controlled dual laser system with both ER: Y AG and Soft Tissue capabilities. The NeoLas provides treatment capabilities via two separate fiber jumper and handpiece assemblies; NeoLas1 (ER:YAG) and NeoLas2 (Soft Tissue).The NeoLas1 treatment delivery system emits a 2.94um infrared photon pulses that used in the treatment of various endodonic and soft tissue indications. The NeoLas2 treatment delivery system utilizes solid-state diode laser (GaAlAs) technology to emit constant wavelength and pulsed energy of 808nm to perform soft tissue treatments.
The provided document is a 510(k) summary for the NeoLas laser system. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria from scratch. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes, expert involvement, and ground truth for a new clinical study is not explicitly present in this type of submission.
However, I can extract the information that is available and explain why some of the requested details are not in this document.
Summary of Acceptance Criteria and Performance (Based on Substantial Equivalence):
The core "acceptance criteria" here are that the NeoLas device demonstrates substantial equivalence in safety and effectiveness to its predicate devices for the stated indications for use. This is proven by showing that the NeoLas has similar specifications and treatment capabilities, and that any differences do not raise new safety or efficacy concerns.
| Acceptance Criteria Category | Reported NeoLas Performance (Relative to Predicate) |
|---|---|
| ER:YAG Laser Subsystem (NeoLas1) | Similar specifications and treatment capabilities to AdvErL Evo Er:YAG Laser (MEY-1-A) (K120377). |
| Differences/Mitigation | Acknowledged difference in average output power; NeoLas has omitted indications requiring higher output power, thereby mitigating potential safety/efficacy concerns. |
| Soft Tissue Laser Subsystem (NeoLas2) | No differences in specifications or intended use compared to Picasso Lite (K102359). |
| Sterilization (Disposable Tips) | Validated for Ethylene Oxide Sterilization, confirming effectiveness of biological indicators and revalidation testing. Complies with residual EO and ECH levels. |
| Sterilization (Handpiece Ends) | Validated for sterilization by autoclaving consistent with FDA guidance. |
Detailed Breakdown of Requested Information:
-
A table of acceptance criteria and the reported device performance
See table above. The acceptance criteria are largely implied by the concept of substantial equivalence to the predicate devices. Performance is described in terms of its similarity to these legally marketed devices. -
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of a 510(k) summary focused on substantial equivalence. This document does not describe a clinical study with a "test set" of patients in the way a de novo or PMA submission might. The "test set" implicitly refers to the device itself and its components undergoing non-clinical bench testing.
- Data Provenance: Not specified as no clinical data from a patient cohort is presented. The data provenance mentioned is primarily from manufacturing and validation testing (e.g., sterilization validation).
-
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)
- Number of Experts/Qualifications: Not applicable. Since this is a 510(k) submission based on substantial equivalence and primarily non-clinical testing, there is no mention of external clinical experts establishing ground truth for a patient test set. The "ground truth" for the non-clinical tests would be defined by the relevant engineering and sterilization standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this 510(k) summary.
-
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
- MRMC Study: Not applicable. The NeoLas is a laser surgical instrument, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC study is not relevant to its type of submission.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. The NeoLas is a surgical instrument operated by a human, not an algorithm. Its "performance" is assessed through its physical specifications, safety features, and the demonstrated capabilities of its predicate devices, rather than an algorithm's standalone performance. Non-clinical bench tests (e.g., sterilization) are done in a "standalone" manner for the components.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the non-clinical tests (e.g., sterilization), the ground truth is established by validated laboratory methods and recognized consensus standards (e.g., ISO standards for sterilization, FDA guidance documents). For the device's main claim, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective, and the NeoLas is sufficiently similar. The Note section under Indications for Use emphasizes that any removed tissue must be submitted for histopathological evaluation, which would serve as a ground truth for pathology diagnosis if such tissue is removed.
-
The sample size for the training set
- Training Set Sample Size: Not applicable. This document does not describe a machine learning algorithm that requires a training set.
-
How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable. As there is no training set for a machine learning algorithm, this question is not relevant.
In summary, this 510(k) submission for the NeoLas laser system primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices through comparison of specifications, intended use, and non-clinical bench testing (e.g., sterilization validation). It does not present a de novo clinical study with patient cohorts, expert readers, or AI algorithms, which are typically associated with many of the detailed questions posed.
§ 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.